Sample records for laboratory validation study

  1. Studying Sexual Aggression: A Review of the Evolution and Validity of Laboratory Paradigms

    PubMed Central

    Davis, Kelly Cue; George, William H.; Nagayama Hall, Gordon C.; Parrott, Dominic J.; Tharp, Andra Teten; Stappenbeck, Cynthia A.

    2018-01-01

    Objective Researchers have endeavored for decades to develop and implement experimental assessments of sexual aggression and its precursors to capitalize on the many scientific advantages offered by laboratory experiments, such as rigorous control of key variables and identification of causal relationships. The purpose of this review is to provide an overview of and commentary on the evolution of these laboratory-based methods. Conclusions To date, two primary types of sexual aggression laboratory studies have been developed: those that involve behavioral analogues of sexual aggression and those that assess postulated precursors to sexually aggressive behavior. Although the study of sexual aggression in the laboratory is fraught with methodological challenges, validity concerns, and ethical considerations, advances in the field have resulted in greater methodological rigor, more precise dependent measures, and improved experimental validity, reliability, and realism. Because highly effective sexual aggression prevention strategies remain elusive, continued laboratory-based investigation of sexual aggression coupled with translation of critical findings to the development and modification of sexual aggression prevention programs remains an important task for the field. PMID:29675289

  2. Toddler physical activity study: laboratory and community studies to evaluate accelerometer validity and correlates.

    PubMed

    Hager, Erin R; Gormley, Candice E; Latta, Laura W; Treuth, Margarita S; Caulfield, Laura E; Black, Maureen M

    2016-09-06

    Toddlerhood is an important age for physical activity (PA) promotion to prevent obesity and support a physically active lifestyle throughout childhood. Accurate assessment of PA is needed to determine trends/correlates of PA, time spent in sedentary, light, or moderate-vigorous PA (MVPA), and the effectiveness of PA promotion programs. Due to the limited availability of objective measures that have been validated and evaluated for feasibility in community studies, it is unclear which subgroups of toddlers are at the highest risk for inactivity. Using Actical ankle accelerometry, the objectives of this study are to develop valid thresholds, examine feasibility, and examine demographic/ anthropometric PA correlates of MVPA among toddlers from low-income families. Two studies were conducted with toddlers (12-36 months). Laboratory Study (n = 24)- Two Actical accelerometers were placed on the ankle. PA was observed using the Child Activity Rating Scale (CARS, prescribed activities). Analyses included device equivalence reliability (correlation: activity counts of two Acticals), criterion-related validity (correlation: activity counts and CARS ratings), and sensitivity/specificity for thresholds. Community Study (n = 277, low-income mother-toddler dyads recruited)- An Actical was worn on the ankle for > 7 days (goal >5, 24-h days). Height/weight was measured. Mothers reported demographics. Analyses included frequencies (feasibility) and stepwise multiple linear regression (sMLR). Laboratory Study- Acticals demonstrated reliability (r = 0.980) and validity (r = 0.75). Thresholds demonstrated sensitivity (86 %) and specificity (88 %). Community Study- 86 % wore accelerometer, 69 % had valid data (mean = 5.2 days). Primary reasons for missing/invalid data: refusal (14 %) and wear-time ≤2 days (11 %). The MVPA threshold (>2200 cpm) yielded 54 min/day. In sMLR, MVPA was associated with age (older > younger, β = 32.8, p < 0

  3. 42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

  4. 42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

  5. 42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

  6. 42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

  7. 42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

  8. Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189.

    PubMed

    Biljak, Vanja Radisic; Ozvald, Ivan; Radeljak, Andrea; Majdenic, Kresimir; Lasic, Branka; Siftar, Zoran; Lovrencic, Marijana Vucic; Flegar-Mestric, Zlata

    2012-01-01

    The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia. Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%). The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose.

  9. Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189

    PubMed Central

    Biljak, Vanja Radisic; Ozvald, Ivan; Radeljak, Andrea; Majdenic, Kresimir; Lasic, Branka; Siftar, Zoran; Lovrencic, Marijana Vucic; Flegar-Mestric, Zlata

    2012-01-01

    Introduction The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia. Materials and methods: Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%). Results: The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. Conclusion: We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose. PMID:22384522

  10. Teaching method validation in the clinical laboratory science curriculum.

    PubMed

    Moon, Tara C; Legrys, Vicky A

    2008-01-01

    With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application.

  11. Comparative Study in Laboratory Rats to Validate Sperm Quality Methods and Endpoints

    NASA Technical Reports Server (NTRS)

    Price, W. A.; Briggs, G. B.; Alexander, W. K.; Still, K. R.; Grasman, K. A.

    2000-01-01

    Abstract The Naval Health Research Center, Detachment (Toxicology) performs toxicity studies in laboratory animals to characterize the risk of exposure to chemicals of Navy interest. Research was conducted at the Toxicology Detachment at WPAFB, OH in collaboration with Wright State University, Department of Biological Sciences for the validation of new bioassay methods for evaluating reproductive toxicity. The Hamilton Thorne sperm analyzer was used to evaluate sperm damage produced by exposure to a known testicular toxic agent, methoxyacetic acid and by inhalation exposure to JP-8 and JP-5 in laboratory rats. Sperm quality parameters were evaluated (sperm concentration, motility, and morphology) to provide evidence of sperm damage. The Hamilton Thorne sperm analyzer utilizes a DNA specific fluorescent stain (similar to flow cytometry) and digitized optical computer analysis to detect sperm cell damage. The computer assisted sperm analysis (CASA) is a more rapid, robust, predictive and sensitive method for characterizing reproductive toxicity. The results presented in this poster report validation information showing exposure to methoxyacetic acid causes reproductive toxicity and inhalation exposure to JP-8 and JP-5 had no significant effects. The CASA method detects early changes that result in reproductive deficits and these data will be used in a continuing program to characterize the toxicity of chemicals, and combinations of chemicals, of military interest to formulate permissible exposure limits.

  12. Design, development, testing and validation of a Photonics Virtual Laboratory for the study of LEDs

    NASA Astrophysics Data System (ADS)

    Naranjo, Francisco L.; Martínez, Guadalupe; Pérez, Ángel L.; Pardo, Pedro J.

    2014-07-01

    This work presents the design, development, testing and validation of a Photonic Virtual Laboratory, highlighting the study of LEDs. The study was conducted from a conceptual, experimental and didactic standpoint, using e-learning and m-learning platforms. Specifically, teaching tools that help ensure that our students perform significant learning have been developed. It has been brought together the scientific aspect, such as the study of LEDs, with techniques of generation and transfer of knowledge through the selection, hierarchization and structuring of information using concept maps. For the validation of the didactic materials developed, it has been used procedures with various assessment tools for the collection and processing of data, applied in the context of an experimental design. Additionally, it was performed a statistical analysis to determine the validity of the materials developed. The assessment has been designed to validate the contributions of the new materials developed over the traditional method of teaching, and to quantify the learning achieved by students, in order to draw conclusions that serve as a reference for its application in the teaching and learning processes, and comprehensively validate the work carried out.

  13. Analytical difficulties facing today's regulatory laboratories: issues in method validation.

    PubMed

    MacNeil, James D

    2012-08-01

    The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures. © 2012 John Wiley & Sons, Ltd.

  14. Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.

    PubMed

    Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

    This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.

  15. [Validation of a questionnaire to evaluate patient safety in clinical laboratories].

    PubMed

    Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

    2012-01-01

    The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

  16. Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

    PubMed

    Wiegers, Ann L

    2003-07-01

    Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

  17. Heart rate variability indicates emotional value during pro-social economic laboratory decisions with large external validity.

    PubMed

    Fooken, Jonas

    2017-03-10

    The present study investigates the external validity of emotional value measured in economic laboratory experiments by using a physiological indicator of stress, heart rate variability (HRV). While there is ample evidence supporting the external validity of economic experiments, there is little evidence comparing the magnitude of internal levels of emotional stress during decision making with external stress. The current study addresses this gap by comparing the magnitudes of decision stress experienced in the laboratory with the stress from outside the laboratory. To quantify a large change in HRV, measures observed in the laboratory during decision-making are compared to the difference between HRV during a university exam and other mental activity for the same individuals in and outside of the laboratory. The results outside the laboratory inform about the relevance of laboratory findings in terms of their relative magnitude. Results show that psychologically induced HRV changes observed in the laboratory, particularly in connection with social preferences, correspond to large effects outside. This underscores the external validity of laboratory findings and shows the magnitude of emotional value connected to pro-social economic decisions in the laboratory.

  18. Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.

    PubMed

    Park, Douglas L; Coates, Scott; Brewer, Vickery A; Garber, Eric A E; Abouzied, Mohamed; Johnson, Kurt; Ritter, Bruce; McKenzie, Deborah

    2005-01-01

    Performance Tested Method multiple laboratory validations for the detection of peanut protein in 4 different food matrixes were conducted under the auspices of the AOAC Research Institute. In this blind study, 3 commercially available ELISA test kits were validated: Neogen Veratox for Peanut, R-Biopharm RIDASCREEN FAST Peanut, and Tepnel BioKits for Peanut Assay. The food matrixes used were breakfast cereal, cookies, ice cream, and milk chocolate spiked at 0 and 5 ppm peanut. Analyses of the samples were conducted by laboratories representing industry and international and U.S governmental agencies. All 3 commercial test kits successfully identified spiked and peanut-free samples. The validation study required 60 analyses on test samples at the target level 5 microg peanut/g food and 60 analyses at a peanut-free level, which was designed to ensure that the lower 95% confidence limit for the sensitivity and specificity would not be <90%. The probability that a test sample contains an allergen given a prevalence rate of 5% and a positive test result using a single test kit analysis with 95% sensitivity and 95% specificity, which was demonstrated for these test kits, would be 50%. When 2 test kits are run simultaneously on all samples, the probability becomes 95%. It is therefore recommended that all field samples be analyzed with at least 2 of the validated kits.

  19. Validity of diagnoses, procedures, and laboratory data in Japanese administrative data.

    PubMed

    Yamana, Hayato; Moriwaki, Mutsuko; Horiguchi, Hiromasa; Kodan, Mariko; Fushimi, Kiyohide; Yasunaga, Hideo

    2017-10-01

    Validation of recorded data is a prerequisite for studies that utilize administrative databases. The present study evaluated the validity of diagnoses and procedure records in the Japanese Diagnosis Procedure Combination (DPC) data, along with laboratory test results in the newly-introduced Standardized Structured Medical Record Information Exchange (SS-MIX) data. Between November 2015 and February 2016, we conducted chart reviews of 315 patients hospitalized between April 2014 and March 2015 in four middle-sized acute-care hospitals in Shizuoka, Kochi, Fukuoka, and Saga Prefectures and used them as reference standards. The sensitivity and specificity of DPC data in identifying 16 diseases and 10 common procedures were identified. The accuracy of SS-MIX data for 13 laboratory test results was also examined. The specificity of diagnoses in the DPC data exceeded 96%, while the sensitivity was below 50% for seven diseases and variable across diseases. When limited to primary diagnoses, the sensitivity and specificity were 78.9% and 93.2%, respectively. The sensitivity of procedure records exceeded 90% for six procedures, and the specificity exceeded 90% for nine procedures. Agreement between the SS-MIX data and the chart reviews was above 95% for all 13 items. The validity of diagnoses and procedure records in the DPC data and laboratory results in the SS-MIX data was high in general, supporting their use in future studies. Copyright © 2017 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

  20. Reliability and validity of job content questionnaire for university research laboratory staff in Malaysia.

    PubMed

    Nehzat, F; Huda, B Z; Tajuddin, S H Syed

    2014-03-01

    Job Content Questionnaire (JCQ) has been proven a reliable and valid instrument to assess job stress in many countries and among various occupations. In Malaysia, both English and Malay versions of the JCQ have been administered to automotive workers, schoolteachers, and office workers. This study assessed the reliability and validity of the instrument with research laboratory staff in a university. A cross sectional study was conducted among 258 research laboratory staff in Universiti Putra Malaysia (UPM). Malaysian laboratory staff who have worked for at least one year were randomly selected from nine faculties and institutes in the university that have research laboratory. A self-administered English and Malay version of Job Content Questionnaire (JCQ) was used. Three major scales of JCQ: decision latitude, psychological job demands, and social support were assessed. Cronbach's alpha coefficients of two scales were acceptable, decision latitude and psychological job demands (0.70 and 0.72, respectively), while Cronbach's alpha coefficient for social support (0.86) was good. Exploratory factor analysis showed five factors that correspond closely to the theoretical construct of the questionnaire. The results of this research suggest that the JCQ is reliable and valid for examining psychosocial work situations and job strain among research laboratory staff. Further studies should be done for confirmative results, and further evaluation is needed on the decision authority subscale for this occupation.

  1. Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

    PubMed

    Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

    2017-09-01

    - A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

  2. Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues.

    PubMed

    Mourya, Devendra T; Yadav, Pragya D; Khare, Ajay; Khan, Anwar H

    2017-10-01

    With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

  3. 49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2013-10-01 2013-10-01 false What is validity testing, and are laboratories...

  4. 49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2011-10-01 2011-10-01 false What is validity testing, and are laboratories...

  5. 49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2010-10-01 2010-10-01 false What is validity testing, and are laboratories...

  6. 49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2012-10-01 2012-10-01 false What is validity testing, and are laboratories...

  7. 49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2014-10-01 2014-10-01 false What is validity testing, and are laboratories...

  8. Software validation applied to spreadsheets used in laboratories working under ISO/IEC 17025

    NASA Astrophysics Data System (ADS)

    Banegas, J. M.; Orué, M. W.

    2016-07-01

    Several documents deal with software validation. Nevertheless, more are too complex to be applied to validate spreadsheets - surely the most used software in laboratories working under ISO/IEC 17025. The method proposed in this work is intended to be directly applied to validate spreadsheets. It includes a systematic way to document requirements, operational aspects regarding to validation, and a simple method to keep records of validation results and modifications history. This method is actually being used in an accredited calibration laboratory, showing to be practical and efficient.

  9. Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues

    PubMed Central

    Mourya, Devendra T.; Yadav, Pragya D.; Khare, Ajay; Khan, Anwar H.

    2017-01-01

    With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process. PMID:29434059

  10. Intra-/inter-laboratory validation study on reactive oxygen species assay for chemical photosafety evaluation using two different solar simulators.

    PubMed

    Onoue, Satomi; Hosoi, Kazuhiro; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Nakamura, Kazuichi; Ohno, Yasuo; Kojima, Hajime

    2014-06-01

    A previous multi-center validation study demonstrated high transferability and reliability of reactive oxygen species (ROS) assay for photosafety evaluation. The present validation study was undertaken to verify further the applicability of different solar simulators and assay performance. In 7 participating laboratories, 2 standards and 42 coded chemicals, including 23 phototoxins and 19 non-phototoxic drugs/chemicals, were assessed by the ROS assay using two different solar simulators (Atlas Suntest CPS series, 3 labs; and Seric SXL-2500V2, 4 labs). Irradiation conditions could be optimized using quinine and sulisobenzone as positive and negative standards to offer consistent assay outcomes. In both solar simulators, the intra- and inter-day precisions (coefficient of variation; CV) for quinine were found to be below 10%. The inter-laboratory CV for quinine averaged 15.4% (Atlas Suntest CPS) and 13.2% (Seric SXL-2500V2) for singlet oxygen and 17.0% (Atlas Suntest CPS) and 7.1% (Seric SXL-2500V2) for superoxide, suggesting high inter-laboratory reproducibility even though different solar simulators were employed for the ROS assay. In the ROS assay on 42 coded chemicals, some chemicals (ca. 19-29%) were unevaluable because of limited solubility and spectral interference. Although several false positives appeared with positive predictivity of ca. 76-92% (Atlas Suntest CPS) and ca. 75-84% (Seric SXL-2500V2), there were no false negative predictions in both solar simulators. A multi-center validation study on the ROS assay demonstrated satisfactory transferability, accuracy, precision, and predictivity, as well as the availability of other solar simulators. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015

    PubMed Central

    Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

    2017-01-01

    Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. PMID:28277220

  12. Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015.

    PubMed

    Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

    2017-03-02

    Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. This article is copyright of The Authors, 2017.

  13. Analytic Validation of Immunohistochemical Assays: A Comparison of Laboratory Practices Before and After Introduction of an Evidence-Based Guideline.

    PubMed

    Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Souers, Rhona J; Fatheree, Lisa A; Volmar, Keith E; Stuart, Lauren N; Nowak, Jan A; Astles, J Rex; Nakhleh, Raouf E

    2017-09-01

    - Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. - To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. - A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. - Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. - Dissemination of the 2014 evidence-based guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents.

  14. Validation of Physical Activity Tracking via Android Smartphones Compared to ActiGraph Accelerometer: Laboratory-Based and Free-Living Validation Studies.

    PubMed

    Hekler, Eric B; Buman, Matthew P; Grieco, Lauren; Rosenberger, Mary; Winter, Sandra J; Haskell, William; King, Abby C

    2015-04-15

    There is increasing interest in using smartphones as stand-alone physical activity monitors via their built-in accelerometers, but there is presently limited data on the validity of this approach. The purpose of this work was to determine the validity and reliability of 3 Android smartphones for measuring physical activity among midlife and older adults. A laboratory (study 1) and a free-living (study 2) protocol were conducted. In study 1, individuals engaged in prescribed activities including sedentary (eg, sitting), light (sweeping), moderate (eg, walking 3 mph on a treadmill), and vigorous (eg, jogging 5 mph on a treadmill) activity over a 2-hour period wearing both an ActiGraph and 3 Android smartphones (ie, HTC MyTouch, Google Nexus One, and Motorola Cliq). In the free-living study, individuals engaged in usual daily activities over 7 days while wearing an Android smartphone (Google Nexus One) and an ActiGraph. Study 1 included 15 participants (age: mean 55.5, SD 6.6 years; women: 56%, 8/15). Correlations between the ActiGraph and the 3 phones were strong to very strong (ρ=.77-.82). Further, after excluding bicycling and standing, cut-point derived classifications of activities yielded a high percentage of activities classified correctly according to intensity level (eg, 78%-91% by phone) that were similar to the ActiGraph's percent correctly classified (ie, 91%). Study 2 included 23 participants (age: mean 57.0, SD 6.4 years; women: 74%, 17/23). Within the free-living context, results suggested a moderate correlation (ie, ρ=.59, P<.001) between the raw ActiGraph counts/minute and the phone's raw counts/minute and a strong correlation on minutes of moderate-to-vigorous physical activity (MVPA; ie, ρ=.67, P<.001). Results from Bland-Altman plots suggested close mean absolute estimates of sedentary (mean difference=-26 min/day of sedentary behavior) and MVPA (mean difference=-1.3 min/day of MVPA) although there was large variation. Overall, results suggest

  15. Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

    PubMed

    Brodish, D L

    1998-01-01

    The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

  16. Validation of Radiometric Standards for the Laboratory Calibration of Reflected-Solar Earth Observing Satellite Instruments

    NASA Technical Reports Server (NTRS)

    Butler, James J.; Johnson, B. Carol; Rice, Joseph P.; Brown, Steven W.; Barnes, Robert A.

    2007-01-01

    Historically, the traceability of the laboratory calibration of Earth-observing satellite instruments to a primary radiometric reference scale (SI units) is the responsibility of each instrument builder. For the NASA Earth Observing System (EOS), a program has been developed using laboratory transfer radiometers, each with its own traceability to the primary radiance scale of a national metrology laboratory, to independently validate the radiances assigned to the laboratory sources of the instrument builders. The EOS Project Science Office also developed a validation program for the measurement of onboard diffuse reflecting plaques, which are also used as radiometric standards for Earth-observing satellite instruments. Summarized results of these validation campaigns, with an emphasis on the current state-of-the-art uncertainties in laboratory radiometric standards, will be presented. Future mission uncertainty requirements, and possible enhancements to the EOS validation program to ensure that those uncertainties can be met, will be presented.

  17. Implementing the Science Assessment Standards: Developing and validating a set of laboratory assessment tasks in high school biology

    NASA Astrophysics Data System (ADS)

    Saha, Gouranga Chandra

    Very often a number of factors, especially time, space and money, deter many science educators from using inquiry-based, hands-on, laboratory practical tasks as alternative assessment instruments in science. A shortage of valid inquiry-based laboratory tasks for high school biology has been cited. Driven by this need, this study addressed the following three research questions: (1) How can laboratory-based performance tasks be designed and developed that are doable by students for whom they are designed/written? (2) Do student responses to the laboratory-based performance tasks validly represent at least some of the intended process skills that new biology learning goals want students to acquire? (3) Are the laboratory-based performance tasks psychometrically consistent as individual tasks and as a set? To answer these questions, three tasks were used from the six biology tasks initially designed and developed by an iterative process of trial testing. Analyses of data from 224 students showed that performance-based laboratory tasks that are doable by all students require careful and iterative process of development. Although the students demonstrated more skill in performing than planning and reasoning, their performances at the item level were very poor for some items. Possible reasons for the poor performances have been discussed and suggestions on how to remediate the deficiencies have been made. Empirical evidences for validity and reliability of the instrument have been presented both from the classical and the modern validity criteria point of view. Limitations of the study have been identified. Finally implications of the study and directions for further research have been discussed.

  18. Validation and Implementation of Clinical Laboratory Improvements Act-Compliant Whole-Genome Sequencing in the Public Health Microbiology Laboratory

    PubMed Central

    Kozyreva, Varvara K.; Truong, Chau-Linda; Greninger, Alexander L.; Crandall, John; Mukhopadhyay, Rituparna

    2017-01-01

    ABSTRACT Public health microbiology laboratories (PHLs) are on the cusp of unprecedented improvements in pathogen identification, antibiotic resistance detection, and outbreak investigation by using whole-genome sequencing (WGS). However, considerable challenges remain due to the lack of common standards. Here, we describe the validation of WGS on the Illumina platform for routine use in PHLs according to Clinical Laboratory Improvements Act (CLIA) guidelines for laboratory-developed tests (LDTs). We developed a validation panel comprising 10 Enterobacteriaceae isolates, 5 Gram-positive cocci, 5 Gram-negative nonfermenting species, 9 Mycobacterium tuberculosis isolates, and 5 miscellaneous bacteria. The genome coverage range was 15.71× to 216.4× (average, 79.72×; median, 71.55×); the limit of detection (LOD) for single nucleotide polymorphisms (SNPs) was 60×. The accuracy, reproducibility, and repeatability of base calling were >99.9%. The accuracy of phylogenetic analysis was 100%. The specificity and sensitivity inferred from multilocus sequence typing (MLST) and genome-wide SNP-based phylogenetic assays were 100%. The following objectives were accomplished: (i) the establishment of the performance specifications for WGS applications in PHLs according to CLIA guidelines, (ii) the development of quality assurance and quality control measures, (iii) the development of a reporting format for end users with or without WGS expertise, (iv) the availability of a validation set of microorganisms, and (v) the creation of a modular template for the validation of WGS processes in PHLs. The validation panel, sequencing analytics, and raw sequences could facilitate multilaboratory comparisons of WGS data. Additionally, the WGS performance specifications and modular template are adaptable for the validation of other platforms and reagent kits. PMID:28592550

  19. Validation and Implementation of Clinical Laboratory Improvements Act-Compliant Whole-Genome Sequencing in the Public Health Microbiology Laboratory.

    PubMed

    Kozyreva, Varvara K; Truong, Chau-Linda; Greninger, Alexander L; Crandall, John; Mukhopadhyay, Rituparna; Chaturvedi, Vishnu

    2017-08-01

    Public health microbiology laboratories (PHLs) are on the cusp of unprecedented improvements in pathogen identification, antibiotic resistance detection, and outbreak investigation by using whole-genome sequencing (WGS). However, considerable challenges remain due to the lack of common standards. Here, we describe the validation of WGS on the Illumina platform for routine use in PHLs according to Clinical Laboratory Improvements Act (CLIA) guidelines for laboratory-developed tests (LDTs). We developed a validation panel comprising 10 Enterobacteriaceae isolates, 5 Gram-positive cocci, 5 Gram-negative nonfermenting species, 9 Mycobacterium tuberculosis isolates, and 5 miscellaneous bacteria. The genome coverage range was 15.71× to 216.4× (average, 79.72×; median, 71.55×); the limit of detection (LOD) for single nucleotide polymorphisms (SNPs) was 60×. The accuracy, reproducibility, and repeatability of base calling were >99.9%. The accuracy of phylogenetic analysis was 100%. The specificity and sensitivity inferred from multilocus sequence typing (MLST) and genome-wide SNP-based phylogenetic assays were 100%. The following objectives were accomplished: (i) the establishment of the performance specifications for WGS applications in PHLs according to CLIA guidelines, (ii) the development of quality assurance and quality control measures, (iii) the development of a reporting format for end users with or without WGS expertise, (iv) the availability of a validation set of microorganisms, and (v) the creation of a modular template for the validation of WGS processes in PHLs. The validation panel, sequencing analytics, and raw sequences could facilitate multilaboratory comparisons of WGS data. Additionally, the WGS performance specifications and modular template are adaptable for the validation of other platforms and reagent kits. Copyright © 2017 Kozyreva et al.

  20. Clinical Laboratory Automation: A Case Study.

    PubMed

    Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

    2017-04-13

    This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs.

  1. Laboratory Validation and Demonstrations of Non-Hexavalent Chromium Conversion Coatings for Steel Substrates (Briefing Charts)

    DTIC Science & Technology

    2011-02-01

    UNCLASSIFIED: Approved for public release; distribution unlimited. Laboratory Validation and Demonstrations of Non-Hexavalent Chromium Conversion...00-00-2011 4. TITLE AND SUBTITLE Laboratory Validation and Demonstrations of Non-Hexavalent Chromium Conversion Coatings for Steel Substrates 5a...Coatings for HHA • SurTec 650 - ChromitAL TCP - Trivalent Chrome Pretreatment Developed by NAVAIR for Aluminum. • Chemetall Oxsilan 9810/2 - Non-chrome

  2. PRN 96-1: Tolerance Enforcement Methods - Independent Laboratory Validation by Petitioner

    EPA Pesticide Factsheets

    This notice is intended to clarify the requirements for submission of an Independent Laboratory Validation to accompany new pesticide analytical methods and does not contain additional data requirements.This notice supersedes PR Notice 88-5.

  3. Validation of a basic neurosonology laboratory for detecting cervical carotid artery stenosis.

    PubMed

    de la Cruz Cosme, C; Dawid Milner, M S; Ojeda Burgos, G; Gallardo Tur, A; Márquez Martínez, M; Segura, T

    2017-03-24

    Most of the cases of ischaemic stroke in our setting are of atherothrombotic origin. Detecting intracranial and cervical carotid artery stenosis in patients with ischaemic stroke is therefore essential. Ultrasonography has become the tool of choice for diagnosing carotid artery stenosis because it is both readily accessibility and reliable. However, use of this technique must be validated in each laboratory. The purpose of this study is to validate Doppler ultrasound in our laboratory as a means of detecting severe carotid artery stenosis. We conducted an observational descriptive study to evaluate diagnostic tests. The results from transcranial and cervical carotid Doppler ultrasound scans conducted by neurologists were compared to those from carotid duplex scans performed by radiologists in patients diagnosed with stroke. Arteriography was considered the gold standard (MR angiography, CT angiography, or conventional arteriography). Our sample included 228 patients. Transcranial and cervical carotid Doppler ultrasound showed a sensitivity of 95% and specificity of 100% for detection of carotid artery stenosis > 70%, whereas carotid duplex displayed a sensitivity of 87% and a specificity of 94%. Transcranial carotid Doppler ultrasound achieved a sensitivity of 78% and a specificity of 98% for detection of intracranial stenosis. Doppler ultrasound in our neurosonology laboratory was found to be a useful diagnostic tool for detecting cervical carotid artery stenosis and demonstrated superiority to carotid duplex despite the lack of B-mode. Furthermore, this technique was found to be useful for detecting intracranial stenosis. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  4. Validation of "laboratory-supported" criteria for functional (psychogenic) tremor.

    PubMed

    Schwingenschuh, Petra; Saifee, Tabish A; Katschnig-Winter, Petra; Macerollo, Antonella; Koegl-Wallner, Mariella; Culea, Valeriu; Ghadery, Christine; Hofer, Edith; Pendl, Tamara; Seiler, Stephan; Werner, Ulrike; Franthal, Sebastian; Maurits, Natasha M; Tijssen, Marina A; Schmidt, Reinhold; Rothwell, John C; Bhatia, Kailash P; Edwards, Mark J

    2016-04-01

    In a small group of patients, we have previously shown that a combination of electrophysiological tests was able to distinguish functional (psychogenic) tremor and organic tremor with excellent sensitivity and specificity. This study aims to validate an electrophysiological test battery as a tool to diagnose patients with functional tremor with a "laboratory-supported" level of certainty. For this prospective data collection study, we recruited 38 new patients with functional tremor (mean age 37.9 ± 24.5 years; mean disease duration 5.9 ± 9.0 years) and 73 new patients with organic tremor (mean age 55.4 ± 25.4 years; mean disease duration 15.8 ± 17.7 years). Tremor was recorded at rest, posture (with and without loading), action, while performing tapping tasks (1, 3, and 5 Hz), and while performing ballistic movements with the less-affected hand. Electrophysiological tests were performed by raters blinded to the clinical diagnosis. We calculated a sum score for all performed tests (maximum of 10 points) and used a previously suggested cut-off score of 3 points for a diagnosis of laboratory-supported functional tremor. We demonstrated good interrater reliability and test-retest reliability. Patients with functional tremor had a higher average score on the test battery when compared with patients with organic tremor (3.6 ± 1.4 points vs 1.0 ± 0.8 points; P < .001), and the predefined cut-off score for laboratory-supported functional tremor yielded a test sensitivity of 89.5% and a specificity of 95.9%. We now propose this test battery as the basis of laboratory-supported criteria for the diagnosis of functional tremor, and we encourage its use in clinical and research practice. © 2016 International Parkinson and Movement Disorder Society.

  5. Cost-effective and business-beneficial computer validation for bioanalytical laboratories.

    PubMed

    McDowall, Rd

    2011-07-01

    Computerized system validation is often viewed as a burden and a waste of time to meet regulatory requirements. This article presents a different approach by looking at validation in a bioanalytical laboratory from the business benefits that computer validation can bring. Ask yourself the question, have you ever bought a computerized system that did not meet your initial expectations? This article will look at understanding the process to be automated, the paper to be eliminated and the records to be signed to meet the requirements of the GLP or GCP and Part 11 regulations. This paper will only consider commercial nonconfigurable and configurable software such as plate readers and LC-MS/MS data systems rather than LIMS or custom applications. Two streamlined life cycle models are presented. The first one consists of a single document for validation of nonconfigurable software. The second is for configurable software and is a five-stage model that avoids the need to write functional and design specifications. Both models are aimed at managing the risk each type of software poses whist reducing the amount of documented evidence required for validation.

  6. Laboratory-based validation of the baseline sensors of the ITER diagnostic residual gas analyzer

    NASA Astrophysics Data System (ADS)

    Klepper, C. C.; Biewer, T. M.; Marcus, C.; Andrew, P.; Gardner, W. L.; Graves, V. B.; Hughes, S.

    2017-10-01

    The divertor-specific ITER Diagnostic Residual Gas Analyzer (DRGA) will provide essential information relating to DT fusion plasma performance. This includes pulse-resolving measurements of the fuel isotopic mix reaching the pumping ducts, as well as the concentration of the helium generated as the ash of the fusion reaction. In the present baseline design, the cluster of sensors attached to this diagnostic's differentially pumped analysis chamber assembly includes a radiation compatible version of a commercial quadrupole mass spectrometer, as well as an optical gas analyzer using a plasma-based light excitation source. This paper reports on a laboratory study intended to validate the performance of this sensor cluster, with emphasis on the detection limit of the isotopic measurement. This validation study was carried out in a laboratory set-up that closely prototyped the analysis chamber assembly configuration of the baseline design. This includes an ITER-specific placement of the optical gas measurement downstream from the first turbine of the chamber's turbo-molecular pump to provide sufficient light emission while preserving the gas dynamics conditions that allow for \\textasciitilde 1 s response time from the sensor cluster [1].

  7. Evolution and validation of a personal form of an instrument for assessing science laboratory classroom environments

    NASA Astrophysics Data System (ADS)

    Fraser, Barry J.; Giddings, Geoffrey J.; McRobbie, Campbell J.

    The research reported in this article makes two distinctive contributions to the field of classroom environment research. First, because existing instruments are unsuitable for science laboratory classes, the Science Laboratory Environment Inventory (SLEI) was developed and validated. Second, a new Personal form of the SLEI (involving a student's perceptions of his or her own role within the class) was developed and validated in conjunction with the conventional Class form (involving a student's perceptions of the class as a whole), and its usefulness was investigated. The instrument was cross-nationally fieldtested with 5,447 students in 269 senior high school and university classes in six countries, and cross-validated with 1,594 senior high school students in 92 classes in Australia. Each SLEI scale exhibited satisfactory internal consistency reliability, discriminant validity, and factorial validity, and differentiated between the perceptions of students in different classes. A variety of applications with the new instrument furnished evidence about its usefulness and revealed that science laboratory classes are dominated by closed-ended activities; mean scores obtained on the Class form were consistently somewhat more favorable than on the corresponding Personal form; females generally held more favorable perceptions than males, but these differences were somewhat larger for the Personal form than the Class form; associations existed between attitudinal outcomes and laboratory environment dimensions; and the Class and Personal forms of the SLEI each accounted for unique variance in student outcomes which was independent of that accounted for by the other form.

  8. Determination of Ethanol in Kombucha Products: Single-Laboratory Validation, First Action 2016.12.

    PubMed

    Ebersole, Blake; Liu, Ying; Schmidt, Rich; Eckert, Matt; Brown, Paula N

    2017-05-01

    Kombucha is a fermented nonalcoholic beverage that has drawn government attention due to the possible presence of excess ethanol (≥0.5% alcohol by volume; ABV). A validated method that provides better precision and accuracy for measuring ethanol levels in kombucha is urgently needed by the kombucha industry. The current study validated a method for determining ethanol content in commercial kombucha products. The ethanol content in kombucha was measured using headspace GC with flame ionization detection. An ethanol standard curve ranging from 0.05 to 5.09% ABV was used, with correlation coefficients greater than 99.9%. The method detection limit was 0.003% ABV and the LOQ was 0.01% ABV. The RSDr ranged from 1.62 to 2.21% and the Horwitz ratio ranged from 0.4 to 0.6. The average accuracy of the method was 98.2%. This method was validated following the guidelines for single-laboratory validation by AOAC INTERNATIONAL and meets the requirements set by AOAC SMPR 2016.001, "Standard Method Performance Requirements for Determination of Ethanol in Kombucha."

  9. Development and Score Validation of a Chemistry Laboratory Anxiety Instrument (CLAI) for College Chemistry Students.

    ERIC Educational Resources Information Center

    Bowen, Craig W.

    1999-01-01

    Reports the development and score validation of an instrument for measuring anxieties students experience in college chemistry laboratories. Factor analysis of scores from 361 college students shows that the developed Chemistry Laboratory Anxiety Instrument measures five constructs. Results from a second sample of 598 students show that scores on…

  10. Setup, Validation and Quality Control of a Centralized WGS laboratory - Lessons Learned.

    PubMed

    Arnold, Cath; Edwards, Kirstin; Desai, Meeta; Platt, Steve; Green, Jonathan; Conway, David

    2018-04-25

    Routine use of Whole Genome analysis for infectious diseases can be used to enlighten various scenarios pertaining to Public Health, including identification of microbial pathogens; relating individual cases to an outbreak of infectious disease; establishing an association between an outbreak of food poisoning and a specific food vehicle; inferring drug susceptibility; source tracing of contaminants and study of variations in the genome affect pathogenicity/virulence. We describe the setup, validation and ongoing verification of a centralised WGS laboratory to carry out the sequencing for these public health functions for the National Infection Services, Public Health England in the UK. The performance characteristics and Quality Control metrics measured during validation and verification of the entire end to end process (accuracy, precision, reproducibility and repeatability) are described and include information regarding the automated pass and release of data to service users without intervention. © Crown copyright 2018.

  11. Clinical Laboratory Automation: A Case Study

    PubMed Central

    Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

    2017-01-01

    Background This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. Materials and Methods The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. Results The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. Conclusions The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs. Significance for public health Automation is an emerging trend in modern clinical laboratories with a positive impact on service level to patients and on staff safety as shown by different studies. In fact, it allows process standardization which, in turn, decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff safety. In this study, we analyse a further potential benefit of automation, that is economic convenience. We study the case of the automated laboratory of one of the biggest hospital in Italy and compare the cost related to the pre and post automation situation. Introducing automation lead to a cost decrease without affecting the service level to patients

  12. Universal immunogenicity validation and assessment during early biotherapeutic development to support a green laboratory.

    PubMed

    Bautista, Ami C; Zhou, Lei; Jawa, Vibha

    2013-10-01

    Immunogenicity support during nonclinical biotherapeutic development can be resource intensive if supported by conventional methodologies. A universal indirect species-specific immunoassay can eliminate the need for biotherapeutic-specific anti-drug antibody immunoassays without compromising quality. By implementing the R's of sustainability (reduce, reuse, rethink), conservation of resources and greener laboratory practices were achieved in this study. Statistical analysis across four biotherapeutics supported identification of consistent product performance standards (cut points, sensitivity and reference limits) and a streamlined universal anti-drug antibody immunoassay method implementation strategy. We propose an efficient, fit-for-purpose, scientifically and statistically supported nonclinical immunogenicity assessment strategy. Utilization of a universal method and streamlined validation, while retaining comparability to conventional immunoassays and meeting the industry recommended standards, provides environmental credits in the scientific laboratory. Collectively, individual reductions in critical material consumption, energy usage, waste and non-environment friendly consumables, such as plastic and paper, support a greener laboratory environment.

  13. Development and Cross-National Validation of a Laboratory Classroom Environment Instrument for Senior High School Science.

    ERIC Educational Resources Information Center

    Fraser, Barry J.; And Others

    1993-01-01

    Describes the development of the Science Laboratory Environment Inventory (SLEI) instrument for assessing perceptions of the psychosocial environment in science laboratory classrooms, and reports validation information for samples of senior high school students from six different countries. The SLEI assesses five dimensions of the actual and…

  14. Validation of laboratory-scale recycling test method of paper PSA label products

    Treesearch

    Carl Houtman; Karen Scallon; Richard Oldack

    2008-01-01

    Starting with test methods and a specification developed by the U.S. Postal Service (USPS) Environmentally Benign Pressure Sensitive Adhesive Postage Stamp Program, a laboratory-scale test method and a specification were developed and validated for pressure-sensitive adhesive labels, By comparing results from this new test method and pilot-scale tests, which have been...

  15. Evaluation of Non-Laboratory and Laboratory Prediction Models for Current and Future Diabetes Mellitus: A Cross-Sectional and Retrospective Cohort Study

    PubMed Central

    Hahn, Seokyung; Moon, Min Kyong; Park, Kyong Soo; Cho, Young Min

    2016-01-01

    Background Various diabetes risk scores composed of non-laboratory parameters have been developed, but only a few studies performed cross-validation of these scores and a comparison with laboratory parameters. We evaluated the performance of diabetes risk scores composed of non-laboratory parameters, including a recently published Korean risk score (KRS), and compared them with laboratory parameters. Methods The data of 26,675 individuals who visited the Seoul National University Hospital Healthcare System Gangnam Center for a health screening program were reviewed for cross-sectional validation. The data of 3,029 individuals with a mean of 6.2 years of follow-up were reviewed for longitudinal validation. The KRS and 16 other risk scores were evaluated and compared with a laboratory prediction model developed by logistic regression analysis. Results For the screening of undiagnosed diabetes, the KRS exhibited a sensitivity of 81%, a specificity of 58%, and an area under the receiver operating characteristic curve (AROC) of 0.754. Other scores showed AROCs that ranged from 0.697 to 0.782. For the prediction of future diabetes, the KRS exhibited a sensitivity of 74%, a specificity of 54%, and an AROC of 0.696. Other scores had AROCs ranging from 0.630 to 0.721. The laboratory prediction model composed of fasting plasma glucose and hemoglobin A1c levels showed a significantly higher AROC (0.838, P < 0.001) than the KRS. The addition of the KRS to the laboratory prediction model increased the AROC (0.849, P = 0.016) without a significant improvement in the risk classification (net reclassification index: 4.6%, P = 0.264). Conclusions The non-laboratory risk scores, including KRS, are useful to estimate the risk of undiagnosed diabetes but are inferior to the laboratory parameters for predicting future diabetes. PMID:27214034

  16. Determination of total sulfur in fertilizers by high temperature combustion: single-laboratory validation.

    PubMed

    Bernius, Jean; Kraus, Sabine; Hughes, Sandra; Margraf, Dominik; Bartos, James; Newlon, Natalie; Sieper, Hans-Peter

    2014-01-01

    Asingle-laboratory validation study was conducted for the determination of total sulfur (S) in a variety of common, inorganic fertilizers by combustion. The procedure involves conversion of S species into SO2 through combustion at 1150 degrees C, absorption then desorption from a purge and trap column, followed by measurement by a thermal conductivity detector. Eleven different validation materials were selected for study, which included four commercial fertilizer products, five fertilizers from the Magruder Check Sample Program, one reagent grade product, and one certified organic reference material. S content ranged between 1.47 and 91% as sulfate, thiosulfate, and elemental and organically bound S. Determinations of check samples were performed on 3 different days with four replicates/day. Determinations for non-Magruder samples were performed on 2 different days. Recoveries ranged from 94.3 to 125.9%. ABS SL absolute SD among runs ranged from 0.038 to 0.487%. Based on the accuracy and precision demonstrated here, it is recommended that this method be collaboratively studied for the determination of total S in fertilizers.

  17. Development and inter-laboratory validation study of an improved new real-time PCR assay with internal control for detection and laboratory diagnosis of African swine fever virus.

    PubMed

    Tignon, Marylène; Gallardo, Carmina; Iscaro, Carmen; Hutet, Evelyne; Van der Stede, Yves; Kolbasov, Denis; De Mia, Gian Mario; Le Potier, Marie-Frédérique; Bishop, Richard P; Arias, Marisa; Koenen, Frank

    2011-12-01

    A real-time polymerase chain reaction (PCR) assay for the rapid detection of African swine fever virus (ASFV), multiplexed for simultaneous detection of swine beta-actin as an endogenous control, has been developed and validated by four National Reference Laboratories of the European Union for African swine fever (ASF) including the European Union Reference Laboratory. Primers and a TaqMan(®) probe specific for ASFV were selected from conserved regions of the p72 gene. The limit of detection of the new real-time PCR assay is 5.7-57 copies of the ASFV genome. High accuracy, reproducibility and robustness of the PCR assay (CV ranging from 0.7 to 5.4%) were demonstrated both within and between laboratories using different real-time PCR equipments. The specificity of virus detection was validated using a panel of 44 isolates collected over many years in various geographical locations in Europe, Africa and America, including recent isolates from the Caucasus region, Sardinia, East and West Africa. Compared to the OIE-prescribed conventional and real-time PCR assays, the sensitivity of the new assay with internal control was improved, as demonstrated by testing 281 field samples collected in recent outbreaks and surveillance areas in Europe and Africa (170 samples) together with samples obtained through experimental infections (111 samples). This is particularly evident in the early days following experimental infection and during the course of the disease in pigs sub-clinically infected with strains of low virulence (from 35 up to 70dpi). The specificity of the assay was also confirmed on 150 samples from uninfected pigs and wild boar from ASF-free areas. Measured on the total of 431 tested samples, the positive deviation of the new assay reaches 21% or 26% compared to PCR and real-time PCR methods recommended by OIE. This improved and rigorously validated real-time PCR assay with internal control will provide a rapid, sensitive and reliable molecular tool for ASFV

  18. OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing.

    PubMed

    Busquet, François; Strecker, Ruben; Rawlings, Jane M; Belanger, Scott E; Braunbeck, Thomas; Carr, Gregory J; Cenijn, Peter; Fochtman, Przemyslaw; Gourmelon, Anne; Hübler, Nicole; Kleensang, André; Knöbel, Melanie; Kussatz, Carola; Legler, Juliette; Lillicrap, Adam; Martínez-Jerónimo, Fernando; Polleichtner, Christian; Rzodeczko, Helena; Salinas, Edward; Schneider, Katharina E; Scholz, Stefan; van den Brandhof, Evert-Jan; van der Ven, Leo T M; Walter-Rohde, Susanne; Weigt, Stefan; Witters, Hilda; Halder, Marlies

    2014-08-01

    The OECD validation study of the zebrafish embryo acute toxicity test (ZFET) for acute aquatic toxicity testing evaluated the ZFET reproducibility by testing 20 chemicals at 5 different concentrations in 3 independent runs in at least 3 laboratories. Stock solutions and test concentrations were analytically confirmed for 11 chemicals. Newly fertilised zebrafish eggs (20/concentration and control) were exposed for 96h to chemicals. Four apical endpoints were recorded daily as indicators of acute lethality: coagulation of the embryo, lack of somite formation, non-detachment of the tail bud from the yolk sac and lack of heartbeat. Results (LC50 values for 48/96h exposure) show that the ZFET is a robust method with a good intra- and inter-laboratory reproducibility (CV<30%) for most chemicals and laboratories. The reproducibility was lower (CV>30%) for some very toxic or volatile chemicals, and chemicals tested close to their limit of solubility. The ZFET is now available as OECD Test Guideline 236. Considering the high predictive capacity of the ZFET demonstrated by Belanger et al. (2013) in their retrospective analysis of acute fish toxicity and fish embryo acute toxicity data, the ZFET is ready to be considered for acute fish toxicity for regulatory purposes. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Comparison of on-site field measured inorganic arsenic in rice with laboratory measurements using a field deployable method: Method validation.

    PubMed

    Mlangeni, Angstone Thembachako; Vecchi, Valeria; Norton, Gareth J; Raab, Andrea; Krupp, Eva M; Feldmann, Joerg

    2018-10-15

    A commercial arsenic field kit designed to measure inorganic arsenic (iAs) in water was modified into a field deployable method (FDM) to measure iAs in rice. While the method has been validated to give precise and accurate results in the laboratory, its on-site field performance has not been evaluated. This study was designed to test the method on-site in Malawi in order to evaluate its accuracy and precision in determination of iAs on-site by comparing with a validated reference method and giving original data on inorganic arsenic in Malawian rice and rice-based products. The method was validated by using the established laboratory-based HPLC-ICPMS. Statistical tests indicated there were no significant differences between on-site and laboratory iAs measurements determined using the FDM (p = 0.263, ά = 0.05) and between on-site measurements and measurements determined using HPLC-ICP-MS (p = 0.299, ά = 0.05). This method allows quick (within 1 h) and efficient screening of rice containing iAs concentrations on-site. Copyright © 2018 Elsevier Ltd. All rights reserved.

  20. Validating the Goldstein-Wehner Law for the Stratified Positive Column of DC Discharge in an Undergraduate Laboratory

    ERIC Educational Resources Information Center

    Lisovskiy, V. A.; Koval, V. A.; Artushenko, E. P.; Yegorenkov, V. D.

    2012-01-01

    In this paper we suggest a simple technique for validating the Goldstein-Wehner law for a stratified positive column of dc glow discharge while studying the properties of gas discharges in an undergraduate laboratory. To accomplish this a simple device with a pre-vacuum mechanical pump, dc source and gas pressure gauge is required. Experiments may…

  1. A SURVEY OF LABORATORY AND STATISTICAL ISSUES RELATED TO FARMWORKER EXPOSURE STUDIES

    EPA Science Inventory

    Developing internally valid, and perhaps generalizable, farmworker exposure studies is a complex process that involves many statistical and laboratory considerations. Statistics are an integral component of each study beginning with the design stage and continuing to the final da...

  2. Implementation of a digital preparation validation tool in dental skills laboratory training.

    PubMed

    Kozarovska, A; Larsson, C

    2018-05-01

    To describe the implementation of a digital tool for preparation validation and evaluate it as an aid in students' self-assessment. Students at the final semester of skills laboratory training were asked to use a digital preparation validation tool (PVT) when performing two different tasks; preparation of crowns for teeth 11 and 21. The students were divided into two groups. Group A self-assessed and scanned all three attempts at 21 ("prep-and-scan"). Group B self-assessed all attempts chose the best one and scanned it ("best-of-three"). The situation was reversed for 11. The students assessed five parameters of the preparation and marked them as approved (A) or failed (F). These marks were compared with the information from the PVT. The students also completed a questionnaire. Each question was rated from 1 to 5. Teachers' opinions were collected at staff meetings throughout the project. Most students in the "prep-and-scan" groups showed an increase in agreement between their self-assessment and the information from the PVT, whereas students in the "best-of-three" groups showed lower levels of agreement. All students rated the PVT positively. Most strongly agreed that the tool was helpful in developing skills (mean 4.15), easy to use (mean 4.23) and that it added benefits in comparison to existing assessment tools (mean 4.05). They did not however, fully agree that the tool is time efficient (mean 2.55), and they did not consider it a substitute for verbal teacher feedback. Teachers' feedback suggested advantages of the tool in the form of ease of use, visual aid and increasing interest and motivation during skills laboratory training however, they did not notice a reduction in need of verbal feedback. Within the limitations of the study, our conclusion is that a digital PVT may be a valuable adjunct to other assessment tools in skills laboratory training. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Validating the Technology Acceptance Model in the Context of the Laboratory Information System-Electronic Health Record Interface System

    ERIC Educational Resources Information Center

    Aquino, Cesar A.

    2014-01-01

    This study represents a research validating the efficacy of Davis' Technology Acceptance Model (TAM) by pairing it with the Organizational Change Readiness Theory (OCRT) to develop another extension to the TAM, using the medical Laboratory Information Systems (LIS)--Electronic Health Records (EHR) interface as the medium. The TAM posits that it is…

  4. Knowledge, attitude, and practice (KAP) of 'teaching laboratory' technicians towards laboratory safety and waste management: a pilot interventional study.

    PubMed

    El-Gilany, A-H; El-Shaer, S; Khashaba, E; El-Dakroory, S A; Omar, N

    2017-06-01

    A quasi-experimental study was performed on 20 technicians working in the Faculty of Medicine, Mansoura University, Egypt. The knowledge, attitude, and practice (KAP) of laboratory technicians was measured before and two months after enrolling them in an intervention programme about laboratory best practice procedures. The programme addressed laboratory safety and medical waste management. The assessment was performed using a validated Arabic self-administered questionnaire. Pre- and post-intervention scores were compared using non-parametric tests. There are significant increases in the scores of KAP after implementation of the training programme. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  5. PIG's Speed Estimated with Pressure Transducers and Hall Effect Sensor: An Industrial Application of Sensors to Validate a Testing Laboratory.

    PubMed

    Lima, Gustavo F; Freitas, Victor C G; Araújo, Renan P; Maitelli, André L; Salazar, Andrés O

    2017-09-15

    The pipeline inspection using a device called Pipeline Inspection Gauge (PIG) is safe and reliable when the PIG is at low speeds during inspection. We built a Testing Laboratory, containing a testing loop and supervisory system to study speed control techniques for PIGs. The objective of this work is to present and validate the Testing Laboratory, which will allow development of a speed controller for PIGs and solve an existing problem in the oil industry. The experimental methodology used throughout the project is also presented. We installed pressure transducers on pipeline outer walls to detect the PIG's movement and, with data from supervisory, calculated an average speed of 0.43 m/s. At the same time, the electronic board inside the PIG received data from odometer and calculated an average speed of 0.45 m/s. We found an error of 4.44%, which is experimentally acceptable. The results showed that it is possible to successfully build a Testing Laboratory to detect the PIG's passage and estimate its speed. The validation of the Testing Laboratory using data from the odometer and its auxiliary electronic was very successful. Lastly, we hope to develop more research in the oil industry area using this Testing Laboratory.

  6. A STUDY OF SMALL GROUP DYNAMICS AND PRODUCTIVITY IN THE BSCS LABORATORY BLOCK PROGRAM.

    ERIC Educational Resources Information Center

    HURD, PAUL DEHART; ROWE, MARY BUDD

    THE RELATIONSHIP BETWEEN SMALL GROUP COMPATIBILITY AND ACHIEVEMENT IN THE BIOLOGICAL SCIENCE CURRICULUM STUDY LABORATORY BLOCK PROGRAM WAS TESTED. STUDENTS IN 14 CLASSES FROM FOUR HIGH SCHOOLS WERE ASSIGNED TO FOUR-MEMBER LABORATORY GROUPS CLASSIFIED AS COMPATIBLE OR INCOMPATIBLE. GROUP CLASSIFICATION WAS VALIDATED BY OBSERVERS WHO WERE NOT AWARE…

  7. Assessment of physical activity with the Computer Science and Applications, Inc., accelerometer: laboratory versus field validation.

    PubMed

    Nichols, J F; Morgan, C G; Chabot, L E; Sallis, J F; Calfas, K J

    2000-03-01

    Our purpose was to compare the validity of the Computer Science and Applications, (CSA) Inc., accelerometer in laboratory and field settings and establish CSA count ranges for light, moderate, and vigorous physical activity. Validity was determined in 60 adults during treadmill exercise, using oxygen consumption (VO2) as the criterion measure, while 30 adults walked and jogged outdoors on a 400-m track. The relationship between CSA counts and VO2 was linear (R2 = .89 SEE = 3.72 ml.kg-1.min-1), as was the relationship between velocity and counts in the field (R2 = .89, SEE = 0.89 mi.hr-1). However, significant differences were found (p < .05) between laboratory and field measures of CSA counts for light and vigorous intensity. We conclude that the CSA can be used to quantify walking and jogging outdoors on level ground; however, laboratory equations may not be appropriate for use in field settings, particularly for light and vigorous activity.

  8. Inter-laboratory validation of bioaccessibility testing for metals.

    PubMed

    Henderson, Rayetta G; Verougstraete, Violaine; Anderson, Kim; Arbildua, José J; Brock, Thomas O; Brouwers, Tony; Cappellini, Danielle; Delbeke, Katrien; Herting, Gunilla; Hixon, Greg; Odnevall Wallinder, Inger; Rodriguez, Patricio H; Van Assche, Frank; Wilrich, Peter; Oller, Adriana R

    2014-10-01

    Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (sr) and reproducibility (sR) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the sR:sr ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of sr showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Validation of a Laboratory Method for Evaluating Dynamic Properties of Reconstructed Equine Racetrack Surfaces

    PubMed Central

    Setterbo, Jacob J.; Chau, Anh; Fyhrie, Patricia B.; Hubbard, Mont; Upadhyaya, Shrini K.; Symons, Jennifer E.; Stover, Susan M.

    2012-01-01

    Background Racetrack surface is a risk factor for racehorse injuries and fatalities. Current research indicates that race surface mechanical properties may be influenced by material composition, moisture content, temperature, and maintenance. Race surface mechanical testing in a controlled laboratory setting would allow for objective evaluation of dynamic properties of surface and factors that affect surface behavior. Objective To develop a method for reconstruction of race surfaces in the laboratory and validate the method by comparison with racetrack measurements of dynamic surface properties. Methods Track-testing device (TTD) impact tests were conducted to simulate equine hoof impact on dirt and synthetic race surfaces; tests were performed both in situ (racetrack) and using laboratory reconstructions of harvested surface materials. Clegg Hammer in situ measurements were used to guide surface reconstruction in the laboratory. Dynamic surface properties were compared between in situ and laboratory settings. Relationships between racetrack TTD and Clegg Hammer measurements were analyzed using stepwise multiple linear regression. Results Most dynamic surface property setting differences (racetrack-laboratory) were small relative to surface material type differences (dirt-synthetic). Clegg Hammer measurements were more strongly correlated with TTD measurements on the synthetic surface than the dirt surface. On the dirt surface, Clegg Hammer decelerations were negatively correlated with TTD forces. Conclusions Laboratory reconstruction of racetrack surfaces guided by Clegg Hammer measurements yielded TTD impact measurements similar to in situ values. The negative correlation between TTD and Clegg Hammer measurements confirms the importance of instrument mass when drawing conclusions from testing results. Lighter impact devices may be less appropriate for assessing dynamic surface properties compared to testing equipment designed to simulate hoof impact (TTD

  10. Internal validation of STRmix™ - A multi laboratory response to PCAST.

    PubMed

    Bright, Jo-Anne; Richards, Rebecca; Kruijver, Maarten; Kelly, Hannah; McGovern, Catherine; Magee, Alan; McWhorter, Andrew; Ciecko, Anne; Peck, Brian; Baumgartner, Chase; Buettner, Christina; McWilliams, Scott; McKenna, Claire; Gallacher, Colin; Mallinder, Ben; Wright, Darren; Johnson, Deven; Catella, Dorothy; Lien, Eugene; O'Connor, Craig; Duncan, George; Bundy, Jason; Echard, Jillian; Lowe, John; Stewart, Joshua; Corrado, Kathleen; Gentile, Sheila; Kaplan, Marla; Hassler, Michelle; McDonald, Naomi; Hulme, Paul; Oefelein, Rachel H; Montpetit, Shawn; Strong, Melissa; Noël, Sarah; Malsom, Simon; Myers, Steven; Welti, Susan; Moretti, Tamyra; McMahon, Teresa; Grill, Thomas; Kalafut, Tim; Greer-Ritzheimer, MaryMargaret; Beamer, Vickie; Taylor, Duncan A; Buckleton, John S

    2018-05-01

    We report a large compilation of the internal validations of the probabilistic genotyping software STRmix™. Thirty one laboratories contributed data resulting in 2825 mixtures comprising three to six donors and a wide range of multiplex, equipment, mixture proportions and templates. Previously reported trends in the LR were confirmed including less discriminatory LRs occurring both for donors and non-donors at low template (for the donor in question) and at high contributor number. We were unable to isolate an effect of allelic sharing. Any apparent effect appears to be largely confounded with increased contributor number. Copyright © 2018. Published by Elsevier B.V.

  11. PIG’s Speed Estimated with Pressure Transducers and Hall Effect Sensor: An Industrial Application of Sensors to Validate a Testing Laboratory

    PubMed Central

    Freitas, Victor C. G.; Araújo, Renan P.; Maitelli, André L.; Salazar, Andrés O.

    2017-01-01

    The pipeline inspection using a device called Pipeline Inspection Gauge (PIG) is safe and reliable when the PIG is at low speeds during inspection. We built a Testing Laboratory, containing a testing loop and supervisory system to study speed control techniques for PIGs. The objective of this work is to present and validate the Testing Laboratory, which will allow development of a speed controller for PIGs and solve an existing problem in the oil industry. The experimental methodology used throughout the project is also presented. We installed pressure transducers on pipeline outer walls to detect the PIG’s movement and, with data from supervisory, calculated an average speed of 0.43 m/s. At the same time, the electronic board inside the PIG received data from odometer and calculated an average speed of 0.45 m/s. We found an error of 4.44%, which is experimentally acceptable. The results showed that it is possible to successfully build a Testing Laboratory to detect the PIG’s passage and estimate its speed. The validation of the Testing Laboratory using data from the odometer and its auxiliary electronic was very successful. Lastly, we hope to develop more research in the oil industry area using this Testing Laboratory. PMID:28914757

  12. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results.

    PubMed

    Uno, Yoshifumi; Kojima, Hajime; Omori, Takashi; Corvi, Raffaella; Honma, Masamistu; Schechtman, Leonard M; Tice, Raymond R; Burlinson, Brian; Escobar, Patricia A; Kraynak, Andrew R; Nakagawa, Yuzuki; Nakajima, Madoka; Pant, Kamala; Asano, Norihide; Lovell, David; Morita, Takeshi; Ohno, Yasuo; Hayashi, Makoto

    2015-07-01

    The in vivo rodent alkaline comet assay (comet assay) is used internationally to investigate the in vivo genotoxic potential of test chemicals. This assay, however, has not previously been formally validated. The Japanese Center for the Validation of Alternative Methods (JaCVAM), with the cooperation of the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)/the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the European Centre for the Validation of Alternative Methods (ECVAM), and the Japanese Environmental Mutagen Society/Mammalian Mutagenesis Study Group (JEMS/MMS), organized an international validation study to evaluate the reliability and relevance of the assay for identifying genotoxic carcinogens, using liver and stomach as target organs. The ultimate goal of this validation effort was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The purpose of the pre-validation studies (i.e., Phase 1 through 3), conducted in four or five laboratories with extensive comet assay experience, was to optimize the protocol to be used during the definitive validation study. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. A laboratory validation study of the time-lapse oscillatory pumping test for leakage detection in geological repositories

    NASA Astrophysics Data System (ADS)

    Sun, Alexander Y.; Lu, Jiemin; Islam, Akand

    2017-05-01

    Geologic repositories are extensively used for disposing byproducts in mineral and energy industries. The safety and reliability of these repositories are a primary concern to environmental regulators and the public. Time-lapse oscillatory pumping test (OPT) has been introduced recently as a pressure-based technique for detecting potential leakage in geologic repositories. By routinely conducting OPT at a number of pulsing frequencies, an operator may identify the potential repository anomalies in the frequency domain, alleviating the ambiguity caused by reservoir noise and improving the signal-to-noise ratio. Building on previous theoretical and field studies, this work performed a series of laboratory experiments to validate the concept of time-lapse OPT using a custom made, stainless steel tank under relatively high pressures. The experimental configuration simulates a miniature geologic storage repository consisting of three layers (i.e., injection zone, caprock, and above-zone aquifer). Results show that leakage in the injection zone led to deviations in the power spectrum of observed pressure data, and the amplitude of which also increases with decreasing pulsing frequencies. The experimental results are further analyzed by developing a 3D flow model, using which the model parameters are estimated through frequency domain inversion.

  14. A laboratory validation study of the time-lapse oscillatory pumping test concept for leakage detection in geological repositories

    NASA Astrophysics Data System (ADS)

    Sun, A. Y.; Islam, A.; Lu, J.

    2017-12-01

    Time-lapse oscillatory pumping test (OPT) has been introduced recently as a pressure-based monitoring technique for detecting potential leakage in geologic repositories. By routinely conducting OPT at a number of pulsing frequencies, a site operator may identify the potential anomalies in the frequency domain, alleviating the ambiguity caused by reservoir noise and improving the signal-to-noise ratio. Building on previous theoretical and field studies, this work performed a series of laboratory experiments to validate the concept of time-lapse OPT using a custom made, stainless steel tank under relatively high pressures ( 120psi). The experimental configuration simulates a miniature geologic storage repository consisting of three layers (i.e., injection zone, caprock, and above-zone aquifer). Results show that leakage in the injection zone led to deviations in the power spectrum of observed pressure data, and the amplitude of which also increases with decreasing pulsing frequencies. The experimental results were further analyzed by developing a 3D flow model, using which the model parameters were estimated through frequency domain inversion.

  15. Improving efficiency of a small forensic DNA laboratory: validation of robotic assays and evaluation of microcapillary array device.

    PubMed

    Crouse, Cecelia A; Yeung, Stephanie; Greenspoon, Susan; McGuckian, Amy; Sikorsky, Julie; Ban, Jeff; Mathies, Richard

    2005-08-01

    To present validation studies performed for the implementation of existing and new technologies to increase the efficiency in the forensic DNA Section of the Palm Beach County Sheriff's Office (PBSO) Crime Laboratory. Using federally funded grants, internal support, and an external Process Mapping Team, the PBSO collaborated with forensic vendors, universities, and other forensic laboratories to enhance DNA testing procedures, including validation of the DNA IQ magnetic bead extraction system, robotic DNA extraction using the BioMek2000, the ABI7000 Sequence Detection System, and is currently evaluating a micro Capillary Array Electrophoresis device. The PBSO successfully validated and implemented both manual and automated Promega DNA IQ magnetic bead extractions system, which have increased DNA profile results from samples with low DNA template concentrations. The Beckman BioMek2000 DNA robotic workstation has been validated for blood, tissue, bone, hair, epithelial cells (touch evidence), and mixed stains such as semen. There has been a dramatic increase in the number of samples tested per case since implementation of the robotic extraction protocols. The validation of the ABI7000 real-time quantitative polymerase chain reaction (qPCR) technology and the single multiplex short tandem repeat (STR) PowerPlex16 BIO amplification system has provided both a time and a financial benefit. In addition, the qPCR system allows more accurate DNA concentration data and the PowerPlex 16 BIO multiplex generates DNA profiles data in half the time when compared to PowerPlex1.1 and PowerPlex2.1 STR systems. The PBSO's future efficiency requirements are being addressed through collaboration with the University of California at Berkeley and the Virginia Division of Forensic Science to validate microcapillary array electrophoresis instrumentation. Initial data demonstrated the electrophoresis of 96 samples in less than twenty minutes. The PBSO demonstrated, through the validation of

  16. Validity of a heart rate monitor during work in the laboratory and on the Space Shuttle

    NASA Technical Reports Server (NTRS)

    Moore, A. D. Jr; Lee, S. M.; Greenisen, M. C.; Bishop, P.

    1997-01-01

    Accurate heart rate measurement during work is required for many industrial hygiene and ergonomics situations. The purpose of this investigation was to determine the validity of heart rate measurements obtained by a simple, lightweight, commercially available wrist-worn heart rate monitor (HRM) during work (cycle exercise) sessions conducted in the laboratory and also during the particularly challenging work environment of space flight. Three different comparisons were made. The first compared HRM data to simultaneous electrocardiogram (ECG) recordings of varying heart rates that were generated by an ECG simulator. The second compared HRM data to ECG recordings collected during work sessions of 14 subjects in the laboratory. Finally, ECG downlink and HRM data were compared in four astronauts who performed cycle exercise during space flight. The data were analyzed using regression techniques. The results were that the HRM recorded virtually identical heart rates compared with ECG recordings for the data set generated by an ECG simulator. The regression equation for the relationship between ECG versus HRM heart rate data during work in the laboratory was: ECG HR = 0.99 x (HRM) + 0.82 (r2 = 0.99). Finally, the agreement between ECG downlink data and HRM data during space flight was also very high, with the regression equation being: Downlink ECG HR = 1.05 x (HRM) -5.71 (r2 = 0.99). The results of this study indicate that the HRM provides accurate data and may be used to reliably obtain valid data regarding heart rate responses during work.

  17. Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation.

    PubMed

    Alépée, N; Bessou-Touya, S; Cotovio, J; de Smedt, A; de Wever, B; Faller, C; Jones, P; Le Varlet, B; Marrec-Fairley, M; Pfannenbecker, U; Tailhardat, M; van Goethem, F; McNamee, P

    2013-08-01

    Cosmetics Europe, The Personal Care Association, known as Colipa before 2012, conducted a program of technology transfer and assessment of Within/Between Laboratory (WLV/BLV) reproducibility of the SkinEthic™ Reconstituted Human Corneal Epithelium (HCE) as one of two human reconstructed tissue eye irritation test methods. The SkinEthic™ HCE test method involves two exposure time treatment procedures - one for short time exposure (10 min - SE) and the other for long time exposure (60 min - LE) of tissues to test substance. This paper describes pre-validation studies of the SkinEthic™ HCE test method (SE and LE protocols) as well as the Eye Peptide Reactivity Assay (EPRA). In the SE WLV study, 30 substances were evaluated. A consistent outcome with respect to viability measurement across all runs was observed with all substances showing an SD of less than 18%. In the LE WLV study, 44 out of 45 substances were consistently classified. These data demonstrated a high level of reproducibility within laboratory for both the SE and LE treatment procedures. For the LE BLV, 19 out of 20 substances were consistently classified between the three laboratories, again demonstrating a high level of reproducibility between laboratories. The results for EPRA WLV and BLV studies demonstrated that all substances analysed were categorised similarly and that the method is reproducible. The SkinEthic™ HCE test method entered into the experimental phase of a formal ECVAM validation program in 2010. Copyright © 2013. Published by Elsevier Ltd.

  18. Blood collection tubes as medical devices: The potential to affect assays and proposed verification and validation processes for the clinical laboratory.

    PubMed

    Bowen, Raffick A R; Adcock, Dorothy M

    2016-12-01

    Blood collection tubes (BCTs) are an often under-recognized variable in the preanalytical phase of clinical laboratory testing. Unfortunately, even the best-designed and manufactured BCTs may not work well in all clinical settings. Clinical laboratories, in collaboration with healthcare providers, should carefully evaluate BCTs prior to putting them into clinical use to determine their limitations and ensure that patients are not placed at risk because of inaccuracies due to poor tube performance. Selection of the best BCTs can be achieved through comparing advertising materials, reviewing the literature, observing the device at a scientific meeting, receiving a demonstration, evaluating the device under simulated conditions, or testing the device with patient samples. Although many publications have discussed method validations, few detail how to perform experiments for tube verification and validation. This article highlights the most common and impactful variables related to BCTs and discusses the validation studies that a typical clinical laboratory should perform when selecting BCTs. We also present a brief review of how in vitro diagnostic devices, particularly BCTs, are regulated in the United States, the European Union, and Canada. The verification and validation of BCTs will help to avoid the economic and human costs associated with incorrect test results, including poor patient care, unnecessary testing, and delays in test results. We urge laboratorians, tube manufacturers, diagnostic companies, and other researchers to take all the necessary steps to protect against the adverse effects of BCT components and their additives on clinical assays. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  19. Pre-trial inter-laboratory analytical validation of the FOCUS4 personalised therapy trial.

    PubMed

    Richman, Susan D; Adams, Richard; Quirke, Phil; Butler, Rachel; Hemmings, Gemma; Chambers, Phil; Roberts, Helen; James, Michelle D; Wozniak, Sue; Bathia, Riya; Pugh, Cheryl; Maughan, Timothy; Jasani, Bharat

    2016-01-01

    Molecular characterisation of tumours is increasing personalisation of cancer therapy, tailored to an individual and their cancer. FOCUS4 is a molecularly stratified clinical trial for patients with advanced colorectal cancer. During an initial 16-week period of standard first-line chemotherapy, tumour tissue will undergo several molecular assays, with the results used for cohort allocation, then randomisation. Laboratories in Leeds and Cardiff will perform the molecular testing. The results of a rigorous pre-trial inter-laboratory analytical validation are presented and discussed. Wales Cancer Bank supplied FFPE tumour blocks from 97 mCRC patients with consent for use in further research. Both laboratories processed each sample according to an agreed definitive FOCUS4 laboratory protocol, reporting results directly to the MRC Trial Management Group for independent cross-referencing. Pyrosequencing analysis of mutation status at KRAS codons12/13/61/146, NRAS codons12/13/61, BRAF codon600 and PIK3CA codons542/545/546/1047, generated highly concordant results. Two samples gave discrepant results; in one a PIK3CA mutation was detected only in Leeds, and in the other, a PIK3CA mutation was only detected in Cardiff. pTEN and mismatch repair (MMR) protein expression was assessed by immunohistochemistry (IHC) resulting in 6/97 discordant results for pTEN and 5/388 for MMR, resolved upon joint review. Tumour heterogeneity was likely responsible for pyrosequencing discrepancies. The presence of signet-ring cells, necrosis, mucin, edge-effects and over-counterstaining influenced IHC discrepancies. Pre-trial assay analytical validation is essential to ensure appropriate selection of patients for targeted therapies. This is feasible for both mutation testing and immunohistochemical assays and must be built into the workup of such trials. ISRCTN90061564. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  20. Validation of the MARS: a combined physiological and laboratory risk prediction tool for 5- to 7-day in-hospital mortality.

    PubMed

    Öhman, M C; Atkins, T E H; Cooksley, T; Brabrand, M

    2018-06-01

    The Medical Admission Risk System (MARS) uses 11 physiological and laboratory data and had promising results in its derivation study for predicting 5- and 7- day mortality. To perform an external independent validation of the MARS score. An unplanned secondary cohort study. Patients admitted to the medical admission unit at The Hospital of South West Jutland were included from 2 October 2008 until 19 February 2009 and 23 February 2010 until 26 May 2010 were analysed. Validation of the MARS scores using 5- and 7- day mortality was the primary endpoint. Patients of 5858 were included in the study. Patients of 2923 (49.9%) were women with a median age of 65 years (15-107). The MARS score had an area under the receiving operator characteristic curve of 0.858 (95% CI: 0.831-0.884) for 5-day mortality and 0.844 (0.818-0.870) for 7 day mortality with poor calibration for both outcomes. The MARS score had excellent discriminatory power but poor calibration in predicting both 5- and 7-day mortality. The development of accurate combination physiological/laboratory data risk scores has the potential to improve the recognition of at risk patients.

  1. 42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

  2. 42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

  3. 42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

  4. 42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

  5. 42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

  6. Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 testing guidelines: a 3-year comparison of validation procedures.

    PubMed

    Dyhdalo, Kathryn S; Fitzgibbons, Patrick L; Goldsmith, Jeffery D; Souers, Rhona J; Nakhleh, Raouf E

    2014-07-01

    The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) published guidelines in 2007 regarding testing accuracy, interpretation, and reporting of results for HER2 studies. A 2008 survey identified areas needing improved compliance. To reassess laboratory response to those guidelines following a full accreditation cycle for an updated snapshot of laboratory practices regarding ASCO/CAP guidelines. In 2011, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program identical to the 2008 survey. Of the 1150 surveys sent, 977 (85.0%) were returned, comparable to the original survey response in 2008 (757 of 907; 83.5%). New participants submitted 124 of 977 (12.7%) surveys. The median laboratory accession rate was 14,788 cases with 211 HER2 tests performed annually. Testing was validated with fluorescence in situ hybridization in 49.1% (443 of 902) of the laboratories; 26.3% (224 of 853) of the laboratories used another IHC assay. The median number of cases to validate fluorescence in situ hybridization (n = 40) and IHC (n = 27) was similar to those in 2008. Ninety-five percent concordance with fluorescence in situ hybridization was achieved by 76.5% (254 of 332) of laboratories for IHC(-) findings and 70.4% (233 of 331) for IHC(+) cases. Ninety-five percent concordance with another IHC assay was achieved by 71.1% (118 of 168) of the laboratories for negative findings and 69.6% (112 of 161) of the laboratories for positive cases. The proportion of laboratories interpreting HER2 IHC using ASCO/CAP guidelines (86.6% [798 of 921] in 2011; 83.8% [605 of 722] in 2008) remains similar. Although fixation time improvements have been made, assay validation deficiencies still exist. The results of this survey were shared within the CAP, including the Laboratory Accreditation Program and the ASCO/CAP panel revising the HER2 guidelines published in October 2013. The Laboratory Accreditation Program checklist was

  7. Validating Laboratory Results in Electronic Health Records

    PubMed Central

    Perrotta, Peter L.; Karcher, Donald S.

    2017-01-01

    Context Laboratories must ensure that the test results and pathology reports they transmit to a patient’s electronic health record (EHR) are accurate, complete, and presented in a useable format. Objective To determine the accuracy, completeness, and formatting of laboratory test results and pathology reports transmitted from the laboratory to the EHR. Design Participants from 45 institutions retrospectively reviewed results from 16 different laboratory tests, including clinical and anatomic pathology results, within the EHR used by their providers to view laboratory results. Results were evaluated for accuracy, presence of required elements, and usability. Both normal and abnormal results were reviewed for tests, some of which were performed in-house and others at a reference laboratory. Results Overall accuracy for test results transmitted to the EHR was greater than 99.3% (1052 of 1059). There was lower compliance for completeness of test results, with 69.6% (732 of 1051) of the test results containing all essential reporting elements. Institutions that had fewer than half of their orders entered electronically had lower test result completeness rates. The rate of appropriate formatting of results was 90.9% (98 of 1010). Conclusions The great majority of test results are accurately transmitted from the laboratory to the EHR; however, lower percentages are transmitted completely and in a useable format. Laboratories should verify the accuracy, completeness, and format of test results at the time of test implementation, after test changes, and periodically. PMID:27575266

  8. The bogus taste test: Validity as a measure of laboratory food intake.

    PubMed

    Robinson, Eric; Haynes, Ashleigh; Hardman, Charlotte A; Kemps, Eva; Higgs, Suzanne; Jones, Andrew

    2017-09-01

    Because overconsumption of food contributes to ill health, understanding what affects how much people eat is of importance. The 'bogus' taste test is a measure widely used in eating behaviour research to identify factors that may have a causal effect on food intake. However, there has been no examination of the validity of the bogus taste test as a measure of food intake. We conducted a participant level analysis of 31 published laboratory studies that used the taste test to measure food intake. We assessed whether the taste test was sensitive to experimental manipulations hypothesized to increase or decrease food intake. We examined construct validity by testing whether participant sex, hunger and liking of taste test food were associated with the amount of food consumed in the taste test. In addition, we also examined whether BMI (body mass index), trait measures of dietary restraint and over-eating in response to palatable food cues were associated with food consumption. Results indicated that the taste test was sensitive to experimental manipulations hypothesized to increase or decrease food intake. Factors that were reliably associated with increased consumption during the taste test were being male, have a higher baseline hunger, liking of the taste test food and a greater tendency to overeat in response to palatable food cues, whereas trait dietary restraint and BMI were not. These results indicate that the bogus taste test is likely to be a valid measure of food intake and can be used to identify factors that have a causal effect on food intake. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: first round.

    PubMed

    Ehling, G; Hecht, M; Heusener, A; Huesler, J; Gamer, A O; van Loveren, H; Maurer, Th; Riecke, K; Ullmann, L; Ulrich, P; Vandebriel, R; Vohr, H-W

    2005-08-15

    The new OECD guideline 429 (skin sensitization: local lymph node assay) is based upon a protocol, which utilises the incorporation of radioactivity into DNA as a measure for cell proliferation in vivo. The guideline also enables the use of alternative endpoints in order to assess draining lymph node (LN) cell proliferation. Here we describe the first round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in seven laboratories. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products, Swissmedic. Statistical analyses of all data were performed by an independent centre at the University of Bern, Department of Statistics. Ear-draining, LN weight and cell count were used to assess proliferation instead of radioactive labeling of lymph node cells. In addition, the acute inflammatory skin reaction was measured by ear swelling and weight of circular biopsies of the ears to identify skin irritating properties of the test items. Hexylcinnamaldehyde (HCA) and three blinded test items were applied to female, 8--10 weeks old NMRI and BALB/c mice. Results were sent via the independent study coordinator to the statistician. The results of this first round showed that the alternative endpoints of the LLNA are sensitive and robust parameters. The use of ear weights added an important parameter assessing the skin irritation potential, which supports the differentiation of pure irritative from contact allergenic potential. There were absolute no discrepancies between the categorisation of the three test substances A--C determined by each single participating laboratories. The results highlighted also that many parameters do have an impact on the strength of the responses. Therefore, such parameters have to be taken into consideration for the categorisation of compounds due to their relative sensitizing potencies.

  10. Studying the neurobiology of human social interaction: Making the case for ecological validity.

    PubMed

    Hogenelst, Koen; Schoevers, Robert A; aan het Rot, Marije

    2015-01-01

    With this commentary we make the case for an increased focus on the ecological validity of the measures used to assess aspects of human social functioning. Impairments in social functioning are seen in many types of psychopathology, negatively affecting the lives of psychiatric patients and those around them. Yet the neurobiology underlying abnormal social interaction remains unclear. As an example of human social neuroscience research with relevance to biological psychiatry and clinical psychopharmacology, this commentary discusses published experimental studies involving manipulation of the human brain serotonin system that included assessments of social behavior. To date, these studies have mostly been laboratory-based and included computer tasks, observations by others, or single-administration self-report measures. Most laboratory measures used so far inform about the role of serotonin in aspects of social interaction, but the relevance for real-life interaction is often unclear. Few studies have used naturalistic assessments in real life. We suggest several laboratory methods with high ecological validity as well as ecological momentary assessment, which involves intensive repeated measures in naturalistic settings. In sum, this commentary intends to stimulate experimental research on the neurobiology of human social interaction as it occurs in real life.

  11. Inter-laboratory validation of an inexpensive streamlined method to measure inorganic arsenic in rice grain.

    PubMed

    Chaney, Rufus L; Green, Carrie E; Lehotay, Steven J

    2018-05-04

    With the establishment by CODEX of a 200 ng/g limit of inorganic arsenic (iAs) in polished rice grain, more analyses of iAs will be necessary to ensure compliance in regulatory and trade applications, to assess quality control in commercial rice production, and to conduct research involving iAs in rice crops. Although analytical methods using high-performance liquid chromatography-inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) have been demonstrated for full speciation of As, this expensive and time-consuming approach is excessive when regulations are based only on iAs. We report a streamlined sample preparation and analysis of iAs in powdered rice based on heated extraction with 0.28 M HNO 3 followed by hydride generation (HG) under control of acidity and other simple conditions. Analysis of iAs is then conducted using flow-injection HG and inexpensive ICP-atomic emission spectroscopy (AES) or other detection means. A key innovation compared with previous methods was to increase the acidity of the reagent solution with 4 M HCl (prior to reduction of As 5+ to As 3+ ), which minimized interferences from dimethylarsinic acid. An inter-laboratory method validation was conducted among 12 laboratories worldwide in the analysis of six shared blind duplicates and a NIST Standard Reference Material involving different types of rice and iAs levels. Also, four laboratories used the standard HPLC-ICP-MS method to analyze the samples. The results between the methods were not significantly different, and the Horwitz ratio averaged 0.52 for the new method, which meets official method validation criteria. Thus, the simpler, more versatile, and less expensive method may be used by laboratories for several purposes to accurately determine iAs in rice grain. Graphical abstract Comparison of iAs results from new and FDA methods.

  12. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results.

    PubMed

    Uno, Yoshifumi; Kojima, Hajime; Omori, Takashi; Corvi, Raffaella; Honma, Masamistu; Schechtman, Leonard M; Tice, Raymond R; Beevers, Carol; De Boeck, Marlies; Burlinson, Brian; Hobbs, Cheryl A; Kitamoto, Sachiko; Kraynak, Andrew R; McNamee, James; Nakagawa, Yuzuki; Pant, Kamala; Plappert-Helbig, Ulla; Priestley, Catherine; Takasawa, Hironao; Wada, Kunio; Wirnitzer, Uta; Asano, Norihide; Escobar, Patricia A; Lovell, David; Morita, Takeshi; Nakajima, Madoka; Ohno, Yasuo; Hayashi, Makoto

    2015-07-01

    The in vivo rodent alkaline comet assay (comet assay) is used internationally to investigate the in vivo genotoxic potential of test chemicals. This assay, however, has not previously been formally validated. The Japanese Center for the Validation of Alternative Methods (JaCVAM), with the cooperation of the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)/the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the European Centre for the Validation of Alternative Methods (ECVAM), and the Japanese Environmental Mutagen Society/Mammalian Mutagenesis Study Group (JEMS/MMS), organized an international validation study to evaluate the reliability and relevance of the assay for identifying genotoxic carcinogens, using liver and stomach as target organs. The ultimate goal of this exercise was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The study protocol was optimized in the pre-validation studies, and then the definitive (4th phase) validation study was conducted in two steps. In the 1st step, assay reproducibility was confirmed among laboratories using four coded reference chemicals and the positive control ethyl methanesulfonate. In the 2nd step, the predictive capability was investigated using 40 coded chemicals with known genotoxic and carcinogenic activity (i.e., genotoxic carcinogens, genotoxic non-carcinogens, non-genotoxic carcinogens, and non-genotoxic non-carcinogens). Based on the results obtained, the in vivo comet assay is concluded to be highly capable of identifying genotoxic chemicals and therefore can serve as a reliable predictor of rodent carcinogenicity. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness.

    PubMed

    Ialongo, Cristiano; Bernardini, Sergio

    2018-03-28

    The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.

  14. Variances and uncertainties of the sample laboratory-to-laboratory variance (S(L)2) and standard deviation (S(L)) associated with an interlaboratory study.

    PubMed

    McClure, Foster D; Lee, Jung K

    2012-01-01

    The validation process for an analytical method usually employs an interlaboratory study conducted as a balanced completely randomized model involving a specified number of randomly chosen laboratories, each analyzing a specified number of randomly allocated replicates. For such studies, formulas to obtain approximate unbiased estimates of the variance and uncertainty of the sample laboratory-to-laboratory (lab-to-lab) STD (S(L)) have been developed primarily to account for the uncertainty of S(L) when there is a need to develop an uncertainty budget that includes the uncertainty of S(L). For the sake of completeness on this topic, formulas to estimate the variance and uncertainty of the sample lab-to-lab variance (S(L)2) were also developed. In some cases, it was necessary to derive the formulas based on an approximate distribution for S(L)2.

  15. NETL Extreme Drilling Laboratory Studies High Pressure High Temperature Drilling Phenomena

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lyons, K.D.; Honeygan, S.; Moroz, T.H.

    2008-12-01

    The U.S. Department of Energy's National Energy Technology Laboratory (NETL) established the Extreme Drilling Laboratory to engineer effective and efficient drilling technologies viable at depths greater than 20,000 ft. This paper details the challenges of ultradeep drilling, documents reports of decreased drilling rates as a result of increasing fluid pressure and temperature, and describes NETL's research and development activities. NETL is invested in laboratory-scale physical simulation. Its physical simulator will have capability of circulating drilling fluids at 30,000 psi and 480°F around a single drill cutter. This simulator is not yet operational; therefore, the results will be limited to themore » identification of leading hypotheses of drilling phenomena and NETL's test plans to validate or refute such theories. Of particular interest to the Extreme Drilling Laboratory's studies are the combinatorial effects of drilling fluid pressure, drilling fluid properties, rock properties, pore pressure, and drilling parameters, such as cutter rotational speed, weight on bit, and hydraulics associated with drilling fluid introduction to the rock-cutter interface. A detailed discussion of how each variable is controlled in a laboratory setting will be part of the conference paper and presentation.« less

  16. Assessing Clinical Laboratory Quality: A College of American Pathologists Q-Probes Study of Prothrombin Time INR Structures, Processes, and Outcomes in 98 Laboratories.

    PubMed

    Howanitz, Peter J; Darcy, Theresa P; Meier, Frederick A; Bashleben, Christine P

    2015-09-01

    The anticoagulant warfarin has been identified as the second most frequent drug responsible for serious, disabling, and fatal adverse drug events in the United States, and its effect on blood coagulation is monitored by the laboratory test called international normalized ratio (INR). To determine the presence of INR policies and procedures, INR practices, and completeness and timeliness of reporting critical INR results in participants' clinical laboratories. Participants reviewed their INR policies and procedure requirements, identified their practices by using a questionnaire, and studied completeness of documentation and timeliness of reporting critical value INR results for outpatients and emergency department patients. In 98 participating institutions, the 5 required policies and procedures were in place in 93% to 99% of clinical laboratories. Fifteen options for the allowable variations among duplicate results from different analyzers, 12 different timeliness goals for reporting critical values, and 18 unique critical value limits were used by participants. All required documentation elements were present in 94.8% of 192 reviewed INR validation reports. Critical value INR results were reported within the time frame established by the laboratory for 93.4% of 2604 results, but 1.0% of results were not reported. Although the median laboratories successfully communicated all critical results within their established time frames and had all the required validation elements based in their 2 most recent INR calculations, those participants at the lowest 10th percentile were successful in 80.0% and 85.7% of these requirements, respectively. Significant opportunities exist for adherence to INR procedural requirements and for practice patterns and timeliness goals for INR critical results' reporting.

  17. Validation of Autonomic and Endocrine Reactivity to a Laboratory Stressor in Young Children

    PubMed Central

    Roos, Leslie E.; Giuliano, Ryan J.; Beauchamp, Kathryn G.; Gunnar, Megan; Amidon, Brigette; Fisher, Philip A.

    2017-01-01

    The validation of laboratory paradigms that reliably induce a stress response [including hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system (ANS) activation], is critical for understanding how children’s stress-response systems support emotional and cognitive function. Early childhood research to date is markedly limited, given the difficulty in establishing paradigms that reliably induce a cortisol response. Furthermore, research to date has not included a control condition or examined concurrent ANS reactivity. We addressed these limitations by characterizing the extent to which a modified matching task stressor paradigm induces HPA and ANS activation, beyond a closely matched control condition. Modifications include an unfamiliar and unfriendly assessor to increase the stressful nature of the task. Results validate the matching task as a laboratory stressor, with significant differences in HPA and ANS responsivity between conditions. The Stressor group exhibited a cortisol increase post-stressor, while the Control group was stable over time. Children in both conditions exhibited reduced parasympathetic activity to the first-half of the task, but in the second-half, only children in the Stressor condition, who were experiencing exaggerated signals of failure, exhibited further parasympathetic decline. The Stressor condition induced higher sympathetic activity (versus Control) throughout the task, with exaggerated second-half differences. Within the Stressor condition, responsivity was convergent across systems, with greater cortisol reactivity correlated with the magnitude of parasympathetic withdrawal and sympathetic engagement. Future research employing the matching task will facilitate understanding the role of HPA and ANS function in development. PMID:28024268

  18. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 2nd round.

    PubMed

    Ehling, G; Hecht, M; Heusener, A; Huesler, J; Gamer, A O; van Loveren, H; Maurer, Th; Riecke, K; Ullmann, L; Ulrich, P; Vandebriel, R; Vohr, H-W

    2005-08-15

    The original local lymph node assay (LLNA) is based on the use of radioactive labelling to measure cell proliferation. Other endpoints for the assessment of proliferation are also authorized by the OECD Guideline 429 provided there is appropriate scientific support, including full citations and description of the methodology (OECD, 2002. OECD Guideline for the Testing of Chemicals; Skin Sensitization: Local Lymph Node Assay, Guideline 429. Paris, adopted 24th April 2002.). Here, we describe the outcome of the second round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in nine laboratories in Europe. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products (Swissmedic) in Bern. Ear-draining lymph node (LN) weight and cell counts were used to assess LN cell proliferation instead of [3H]TdR incorporation. In addition, the acute inflammatory skin reaction was measured by ear weight determination of circular biopsies of the ears to identify skin irritation properties of the test items. The statistical analysis was performed in the department of statistics at the university of Bern. Similar to the EC(3) values defined for the radioactive method, threshold values were calculated for the endpoints measured in this modification of the LLNA. It was concluded that all parameters measured have to be taken into consideration for the categorisation of compounds due to their sensitising potencies. Therefore, an assessment scheme has been developed which turned out to be of great importance to consistently assess sensitisation versus irritancy based on the data of the different parameters. In contrast to the radioactive method, irritants have been picked up by all the laboratories applying this assessment scheme.

  19. Validation study of the in vitro skin irritation test with the LabCyte EPI-MODEL24.

    PubMed

    Kojima, Hajime; Ando, Yoko; Idehara, Kenji; Katoh, Masakazu; Kosaka, Tadashi; Miyaoka, Etsuyoshi; Shinoda, Shinsuke; Suzuki, Tamie; Yamaguchi, Yoshihiro; Yoshimura, Isao; Yuasa, Atsuko; Watanabe, Yukihiko; Omori, Takashi

    2012-03-01

    A validation study on an in vitro skin irritation assay was performed with the reconstructed human epidermis (RhE) LabCyte EPI-MODEL24, developed by Japan Tissue Engineering Co. Ltd (Gamagori, Japan). The protocol that was followed in the current study was an optimised version of the EpiSkin protocol (LabCyte assay). According to the United Nations Globally Harmonised System (UN GHS) of classification for assessing the skin irritation potential of a chemical, 12 irritants and 13 non-irritants were validated by a minimum of six laboratories from the Japanese Society for Alternatives to Animal Experiments (JSAAE) skin irritation assay validation study management team (VMT). The 25 chemicals were listed in the European Centre for the Validation of Alternative Methods (ECVAM) performance standards. The reconstructed tissues were exposed to the chemicals for 15 minutes and incubated for 42 hours in fresh culture medium. Subsequently, the level of interleukin-1 alpha (IL-1 α) present in the conditioned medium was measured, and tissue viability was assessed by using the MTT assay. The results of the MTT assay obtained with the LabCyte EPI-MODEL24 (LabCyte MTT assay) demonstrated high within-laboratory and between-laboratory reproducibility, as well as high accuracy for use as a stand-alone assay to distinguish skin irritants from non-irritants. In addition, the IL-1α release measurements in the LabCyte assay were clearly unnecessary for the success of this model in the classification of chemicals for skin irritation potential. 2012 FRAME.

  20. Developing Guided Inquiry-Based Student Lab Worksheet for Laboratory Knowledge Course

    NASA Astrophysics Data System (ADS)

    Rahmi, Y. L.; Novriyanti, E.; Ardi, A.; Rifandi, R.

    2018-04-01

    The course of laboratory knowledge is an introductory course for biology students to follow various lectures practicing in the biology laboratory. Learning activities of laboratory knowledge course at this time in the Biology Department, Universitas Negeri Padang has not been completed by supporting learning media such as student lab worksheet. Guided inquiry learning model is one of the learning models that can be integrated into laboratory activity. The study aimed to produce student lab worksheet based on guided inquiry for laboratory knowledge course and to determine the validity of lab worksheet. The research was conducted using research and developmet (R&D) model. The instruments used in data collection in this research were questionnaire for student needed analysis and questionnaire to measure the student lab worksheet validity. The data obtained was quantitative from several validators. The validators consist of three lecturers. The percentage of a student lab worksheet validity was 94.18 which can be categorized was very good.

  1. Labtracker+, a medical smartphone app for the interpretation of consecutive laboratory results: an external validation study.

    PubMed

    Hilderink, Judith M; Rennenberg, Roger J M W; Vanmolkot, Floris H M; Bekers, Otto; Koopmans, Richard P; Meex, Steven J R

    2017-09-01

    When monitoring patients over time, clinicians may struggle to distinguish 'real changes' in consecutive blood parameters from so-called natural fluctuations. In practice, they have to do so by relying on their clinical experience and intuition. We developed Labtracker+ , a medical app that calculates the probability that an increase or decrease over time in a specific blood parameter is real, given the time between measurements. We presented patient cases to 135 participants to examine whether there is a difference between medical students, residents and experienced clinicians when it comes to interpreting changes between consecutive laboratory results. Participants were asked to interpret if changes in consecutive laboratory values were likely to be 'real' or rather due to natural fluctuations. The answers of the study participants were compared with the calculated probabilities by the app Labtracker+ and the concordance rates were assessed. Medical students (n=92), medical residents from the department of internal medicine (n=19) and internists (n=24) at a Dutch University Medical Centre. Concordance rates between the study participants and the calculated probabilities by the app Labtracker+ were compared. Besides, we tested whether physicians with clinical experience scored better concordance rates with the app Labtracker+ than inexperienced clinicians. Medical residents and internists showed significantly better concordance rates with the calculated probabilities by the app Labtracker+ than medical students, regarding their interpretation of differences between consecutive laboratory results (p=0.009 and p<0.001, respectively). The app Labtracker+ could serve as a clinical decision tool in the interpretation of consecutive laboratory test results and could contribute to rapid recognition of parameter changes by physicians. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial

  2. Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

    PubMed

    Block, Darci R; Algeciras-Schimnich, Alicia

    2013-01-01

    Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

  3. Performance of Proximity Loggers in Recording Intra- and Inter-Species Interactions: A Laboratory and Field-Based Validation Study

    PubMed Central

    Carter, Stephen P.; Bearhop, Stuart; Harrison, Xavier A.; Dall, Sasha R. X.; McDonald, Robbie A.; Delahay, Richard J.

    2012-01-01

    Knowledge of the way in which animals interact through social networks can help to address questions surrounding the ecological and evolutionary consequences of social organisation, and to understand and manage the spread of infectious diseases. Automated proximity loggers are increasingly being used to record interactions between animals, but the accuracy and reliability of the collected data remain largely un-assessed. Here we use laboratory and observational field data to assess the performance of these devices fitted to a herd of 32 beef cattle (Bos taurus) and nine groups of badgers (Meles meles, n  = 77) living in the surrounding woods. The distances at which loggers detected each other were found to decrease over time, potentially related to diminishing battery power that may be a function of temperature. Loggers were highly accurate in recording the identification of contacted conspecifics, but less reliable at determining contact duration. There was a tendency for extended interactions to be recorded as a series of shorter contacts. We show how data can be manipulated to correct this discrepancy and accurately reflect observed interaction patterns by combining records between any two loggers that occur within a 1 to 2 minute amalgamation window, and then removing any remaining 1 second records. We make universally applicable recommendations for the effective use of proximity loggers, to improve the validity of data arising from future studies. PMID:22745704

  4. Creation and Validation of a Novel Mobile Simulation Laboratory for High Fidelity, Prehospital, Difficult Airway Simulation.

    PubMed

    Bischof, Jason J; Panchal, Ashish R; Finnegan, Geoffrey I; Terndrup, Thomas E

    2016-10-01

    Introduction Endotracheal intubation (ETI) is a complex clinical skill complicated by the inherent challenge of providing care in the prehospital setting. Literature reports a low success rate of prehospital ETI attempts, partly due to the care environment and partly to the lack of consistent standardized training opportunities of prehospital providers in ETI. Hypothesis/Problem The availability of a mobile simulation laboratory (MSL) to study clinically critical interventions is needed in the prehospital setting to enhance instruction and maintain proficiency. This report is on the development and validation of a prehospital airway simulator and MSL that mimics in situ care provided in an ambulance. The MSL was a Type 3 ambulance with four cameras allowing audio-video recordings of observable behaviors. The prehospital airway simulator is a modified airway mannequin with increased static tongue pressure and a rigid cervical collar. Airway experts validated the model in a static setting through ETI at varying tongue pressures with a goal of a Grade 3 Cormack-Lehane (CL) laryngeal view. Following completion of this development, the MSL was launched with the prehospital airway simulator to distant communities utilizing a single facilitator/driver. Paramedics were recruited to perform ETI in the MSL, and the detailed airway management observations were stored for further analysis. Nineteen airway experts performed 57 ETI attempts at varying tongue pressures demonstrating increased CL views at higher tongue pressures. Tongue pressure of 60 mm Hg generated 31% Grade 3/4 CL view and was chosen for the prehospital trials. The MSL was launched and tested by 18 paramedics. First pass success was 33% with another 33% failing to intubate within three attempts. The MSL created was configured to deliver, record, and assess intubator behaviors with a difficult airway simulation. The MSL created a reproducible, high fidelity, mobile learning environment for assessment of

  5. Laboratory Governance: Issues for the Study Group on Regional Laboratories.

    ERIC Educational Resources Information Center

    Schultz, Thomas; Dominic, Joseph

    Background information and an analysis of issues involved in the governance of new regional educational laboratories are presented. The new laboratories are to be established through a 1984 competition administered by the National Institute of Education (NIE). The analysis is designed to assist the Study Group on Regional Laboratories to advise…

  6. Good Laboratory Practice. Part 1. An Introduction

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

    2013-01-01

    The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

  7. Validation of administrative and clinical case definitions for gestational diabetes mellitus against laboratory results.

    PubMed

    Bowker, S L; Savu, A; Donovan, L E; Johnson, J A; Kaul, P

    2017-06-01

    To examine the validity of International Classification of Disease, version 10 (ICD-10) codes for gestational diabetes mellitus in administrative databases (outpatient and inpatient), and in a clinical perinatal database (Alberta Perinatal Health Program), using laboratory data as the 'gold standard'. Women aged 12-54 years with in-hospital, singleton deliveries between 1 October 2008 and 31 March 2010 in Alberta, Canada were included in the study. A gestational diabetes diagnosis was defined in the laboratory data as ≥2 abnormal values on a 75-g oral glucose tolerance test or a 50-g glucose screen ≥10.3 mmol/l. Of 58 338 pregnancies, 2085 (3.6%) met gestational diabetes criteria based on laboratory data. The gestational diabetes rates in outpatient only, inpatient only, outpatient or inpatient combined, and Alberta Perinatal Health Program databases were 5.2% (3051), 4.8% (2791), 5.8% (3367) and 4.8% (2825), respectively. Although the outpatient or inpatient combined data achieved the highest sensitivity (92%) and specificity (97%), it was associated with a positive predictive value of only 57%. The majority of the false-positives (78%), however, had one abnormal value on oral glucose tolerance test, corresponding to a diagnosis of impaired glucose tolerance in pregnancy. The ICD-10 codes for gestational diabetes in administrative databases, especially when outpatient and inpatient databases are combined, can be used to reliably estimate the burden of the disease at the population level. Because impaired glucose tolerance in pregnancy and gestational diabetes may be managed similarly in clinical practice, impaired glucose tolerance in pregnancy is often coded as gestational diabetes. © 2016 Diabetes UK.

  8. Reverberation Chamber Uniformity Validation and Radiated Susceptibility Test Procedures for the NASA High Intensity Radiated Fields Laboratory

    NASA Technical Reports Server (NTRS)

    Koppen, Sandra V.; Nguyen, Truong X.; Mielnik, John J.

    2010-01-01

    The NASA Langley Research Center's High Intensity Radiated Fields Laboratory has developed a capability based on the RTCA/DO-160F Section 20 guidelines for radiated electromagnetic susceptibility testing in reverberation chambers. Phase 1 of the test procedure utilizes mode-tuned stirrer techniques and E-field probe measurements to validate chamber uniformity, determines chamber loading effects, and defines a radiated susceptibility test process. The test procedure is segmented into numbered operations that are largely software controlled. This document is intended as a laboratory test reference and includes diagrams of test setups, equipment lists, as well as test results and analysis. Phase 2 of development is discussed.

  9. Single laboratory validation of the determination of yohimbine in yohimbe bark and related dietary supplements using UHPLC/UV/MS

    USDA-ARS?s Scientific Manuscript database

    A single laboratory validation has been performed on a practical ultra high-performance liquid chromatography (UHPLC), diode array detection (DAD), and tandem mass spectrometry (MS) method for determination of yohimbine in yohimbe barks and related dietary supplements. Good separation was achieved u...

  10. External Validity, Internal Validity, and Organizational Reality: A Response to Robert L. Cardy (Commentary).

    ERIC Educational Resources Information Center

    Steinfatt, Thomas M.

    1991-01-01

    Responds to an article in the same issue of this journal which defends the applied value of laboratory studies to managers. Agrees that external validity is often irrelevant, and maintains that the problem of making inferences from any subject sample in management communication is one that demands internal, not external, validity. (SR)

  11. Comprehensive GMO detection using real-time PCR array: single-laboratory validation.

    PubMed

    Mano, Junichi; Harada, Mioko; Takabatake, Reona; Furui, Satoshi; Kitta, Kazumi; Nakamura, Kosuke; Akiyama, Hiroshi; Teshima, Reiko; Noritake, Hiromichi; Hatano, Shuko; Futo, Satoshi; Minegishi, Yasutaka; Iizuka, Tayoshi

    2012-01-01

    We have developed a real-time PCR array method to comprehensively detect genetically modified (GM) organisms. In the method, genomic DNA extracted from an agricultural product is analyzed using various qualitative real-time PCR assays on a 96-well PCR plate, targeting for individual GM events, recombinant DNA (r-DNA) segments, taxon-specific DNAs, and donor organisms of the respective r-DNAs. In this article, we report the single-laboratory validation of both DNA extraction methods and component PCR assays constituting the real-time PCR array. We selected some DNA extraction methods for specified plant matrixes, i.e., maize flour, soybean flour, and ground canola seeds, then evaluated the DNA quantity, DNA fragmentation, and PCR inhibition of the resultant DNA extracts. For the component PCR assays, we evaluated the specificity and LOD. All DNA extraction methods and component PCR assays satisfied the criteria set on the basis of previous reports.

  12. Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulin.

    PubMed

    Gross, S; Janssen, S W J; de Vries, B; Terao, E; Daas, A; Buchheit, K-H

    2009-10-01

    The European Pharmacopoeia (Ph. Eur.) monograph Human tetanus immunoglobulin (0398) gives a clear outline of the in vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the batch potency estimation. Since no further guidance is given on the in vitro assay, every control laboratory concerned is free to design and validate an in-house method. At the moment there is no agreed in vitro method available. The aim of this study was to validate and compare 2 alternative in vitro assays, i.e. an enzyme-linked immunoassay (EIA) and a toxoid inhibition assay (TIA), through an international collaborative study, in view of their eventual inclusion into the Ph. Eur.. The study was run in the framework of the Biological Standardisation Programme (BSP), under the aegis of the European Commission and the Council of Europe. The collaborative study reported here involved 21 laboratories (public and industry) from 15 countries. Initially, 3 samples with low, medium and high potencies were tested by EIA and TIA. Results showed good reproducibility and repeatability of the 2 in vitro methods. The correlation of the data with the in vivo potency assigned by the manufacturers however appeared initially poor for high potency samples. Thorough re-examination of the data showed that the in vivo potencies assigned by the manufacturers had to be corrected: one for potency loss at the time of in vitro testing and one because of a reporting error. After these corrections the values obtained by in vivo and in vitro methods were in close agreement. A supplementary collaborative work was carried out to validate the 2 methods for immunoglobulin products with high potencies. Eight laboratories (public and industry) took part in this additional study to test 3 samples with medium and high potencies by EIA and TIA. Results confirmed that the 2 alternative methods are

  13. Single-Laboratory Validation for the Determination of Flavonoids in Hawthorn Leaves and Finished Products by LC-UV.

    PubMed

    Mudge, Elizabeth M; Liu, Ying; Lund, Jensen A; Brown, Paula N

    2016-11-01

    Suitably validated analytical methods that can be used to quantify medicinally active phytochemicals in natural health products are required by regulators, manufacturers, and consumers. Hawthorn ( Crataegus ) is a botanical ingredient in natural health products used for the treatment of cardiovascular disorders. A method for the quantitation of vitexin-2″- O - rhamnoside, vitexin, isovitexin, rutin, and hyperoside in hawthorn leaf and flower raw materials and finished products was optimized and validated according to AOAC International guidelines. A two-level partial factorial study was used to guide the optimization of the sample preparation. The optimal conditions were found to be a 60-minute extraction using 50 : 48 : 2 methanol : water : acetic acid followed by a 25-minute separation using a reversed-phased liquid chromatography column with ultraviolet absorbance detection. The single-laboratory validation study evaluated method selectivity, accuracy, repeatability, linearity, limit of quantitation, and limit of detection. Individual flavonoid content ranged from 0.05 mg/g to 17.5 mg/g in solid dosage forms and raw materials. Repeatability ranged from 0.7 to 11.7 % relative standard deviation corresponding to HorRat ranges from 0.2 to 1.6. Calibration curves for each flavonoid were linear within the analytical ranges with correlation coefficients greater than 99.9 %. Herein is the first report of a validated method that is fit for the purpose of quantifying five major phytochemical marker compounds in both raw materials and finished products made from North American ( Crataegus douglasii ) and European ( Crataegus monogyna and Crataegus laevigata) hawthorn species. The method includes optimized extraction of samples without a prolonged drying process and reduced liquid chromatography separation time. Georg Thieme Verlag KG Stuttgart · New York.

  14. Reliability, robustness, and reproducibility in mouse behavioral phenotyping: a cross-laboratory study

    PubMed Central

    Mandillo, Silvia; Tucci, Valter; Hölter, Sabine M.; Meziane, Hamid; Banchaabouchi, Mumna Al; Kallnik, Magdalena; Lad, Heena V.; Nolan, Patrick M.; Ouagazzal, Abdel-Mouttalib; Coghill, Emma L.; Gale, Karin; Golini, Elisabetta; Jacquot, Sylvie; Krezel, Wojtek; Parker, Andy; Riet, Fabrice; Schneider, Ilka; Marazziti, Daniela; Auwerx, Johan; Brown, Steve D. M.; Chambon, Pierre; Rosenthal, Nadia; Tocchini-Valentini, Glauco; Wurst, Wolfgang

    2008-01-01

    Establishing standard operating procedures (SOPs) as tools for the analysis of behavioral phenotypes is fundamental to mouse functional genomics. It is essential that the tests designed provide reliable measures of the process under investigation but most importantly that these are reproducible across both time and laboratories. For this reason, we devised and tested a set of SOPs to investigate mouse behavior. Five research centers were involved across France, Germany, Italy, and the UK in this study, as part of the EUMORPHIA program. All the procedures underwent a cross-validation experimental study to investigate the robustness of the designed protocols. Four inbred reference strains (C57BL/6J, C3HeB/FeJ, BALB/cByJ, 129S2/SvPas), reflecting their use as common background strains in mutagenesis programs, were analyzed to validate these tests. We demonstrate that the operating procedures employed, which includes open field, SHIRPA, grip-strength, rotarod, Y-maze, prepulse inhibition of acoustic startle response, and tail flick tests, generated reproducible results between laboratories for a number of the test output parameters. However, we also identified several uncontrolled variables that constitute confounding factors in behavioral phenotyping. The EUMORPHIA SOPs described here are an important start-point for the ongoing development of increasingly robust phenotyping platforms and their application in large-scale, multicentre mouse phenotyping programs. PMID:18505770

  15. Optimization and single-laboratory validation of a method for the determination of flavonolignans in milk thistle seeds by high-performance liquid chromatography with ultraviolet detection.

    PubMed

    Mudge, Elizabeth; Paley, Lori; Schieber, Andreas; Brown, Paula N

    2015-10-01

    Seeds of milk thistle, Silybum marianum (L.) Gaertn., are used for treatment and prevention of liver disorders and were identified as a high priority ingredient requiring a validated analytical method. An AOAC International expert panel reviewed existing methods and made recommendations concerning method optimization prior to validation. A series of extraction and separation studies were undertaken on the selected method for determining flavonolignans from milk thistle seeds and finished products to address the review panel recommendations. Once optimized, a single-laboratory validation study was conducted. The method was assessed for repeatability, accuracy, selectivity, LOD, LOQ, analyte stability, and linearity. Flavonolignan content ranged from 1.40 to 52.86% in raw materials and dry finished products and ranged from 36.16 to 1570.7 μg/mL in liquid tinctures. Repeatability for the individual flavonolignans in raw materials and finished products ranged from 1.03 to 9.88% RSDr, with HorRat values between 0.21 and 1.55. Calibration curves for all flavonolignan concentrations had correlation coefficients of >99.8%. The LODs for the flavonolignans ranged from 0.20 to 0.48 μg/mL at 288 nm. Based on the results of this single-laboratory validation, this method is suitable for the quantitation of the six major flavonolignans in milk thistle raw materials and finished products, as well as multicomponent products containing dandelion, schizandra berry, and artichoke extracts. It is recommended that this method be adopted as First Action Official Method status by AOAC International.

  16. Non-physics peer demonstrators in undergraduate laboratories: a study of students’ perceptions

    NASA Astrophysics Data System (ADS)

    Braun, Michael; Kirkup, Les

    2016-01-01

    Laboratory demonstrators play a crucial role in facilitating students’ learning in physics subjects. Inspired by the success of peer-led activities, we introduced peer demonstrators to support student learning in first-year physics subjects that enrol students not intending to major in physics. Surveys were administered to 1700 students over 4 years in four subjects to examine student perceptions of how demonstrators assisted them in the laboratory. Scores awarded to peer demonstrators by students were no lower than those awarded to demonstrators traditionally employed in the first year physics laboratory. These latter demonstrators were drawn mainly from the ranks of physics research students. The findings validate the recruitment of peer demonstrators and will be used to inform the recruitment and support programmes for laboratory demonstrators.

  17. Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

    PubMed

    Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

    2017-06-01

    - The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

  18. Single-laboratory validation of a GC/MS method for the determination of 27 polycyclic aromatic hydrocarbons (PAHs) in oils and fats.

    PubMed

    Rose, M; White, S; Macarthur, R; Petch, R G; Holland, J; Damant, A P

    2007-06-01

    A protocol for the measurement of 27 polycyclic aromatic hydrocarbons (PAHs) in vegetable oils by GC/MS has undergone single-laboratory validation. PAHs were measured in three oils (olive pomace, sunflower and coconut oil). Five samples of each oil (one unfortified, and four fortified at concentrations between 2 and 50 microg kg(-1)) were analysed in replicate (four times in separate runs). Two samples (one unfortified and one fortified at 2 microg kg(-1)) of five oils (virgin olive oil, grapeseed oil, toasted sesame oil, olive margarine and palm oil) were also analysed. The validation included an assessment of measurement bias from the results of 120 measurements of a certified reference material (coconut oil BCR CRM458 certified for six PAHs). The method is capable of reliably detecting 26 out of 27 PAHs, at concentration <2 microg kg(-1) which is the European Union maximum limit for benzo[a]pyrene, in vegetable oils, olive pomace oil, sunflower oil and coconut oil. Quantitative results were obtained that are fit for purpose for concentrations from <2 to 50 microg kg(-1) for 24 out of 27 PAHs in olive pomace oil, sunflower oil and coconut oil. The reliable detection of 2 microg kg(-1) of PAHs in five additional oils (virgin olive oil, grapeseed oil, toasted sesame oil, olive margarine and palm oil) has been demonstrated. The method failed to produce fit-for-purpose results for the measurement of dibenzo[a,h]pyrene, anthanthrene and cyclopenta[c,d]pyrene. The reason for the failure was the large variation in results. The likely cause was the lack of availability of (13)C isotope internal standards for these PAHs at the time of the study. The protocol has been shown to be fit-for-purpose and is suitable for formal validation by inter-laboratory collaborative study.

  19. A Profilometry-Based Dentifrice Abrasion Method for V8 Brushing Machines Part III: Multi-Laboratory Validation Testing of RDA-PE.

    PubMed

    Schneiderman, Eva; Colón, Ellen L; White, Donald J; Schemehorn, Bruce; Ganovsky, Tara; Haider, Amir; Garcia-Godoy, Franklin; Morrow, Brian R; Srimaneepong, Viritpon; Chumprasert, Sujin

    2017-09-01

    We have previously reported on progress toward the refinement of profilometry-based abrasivity testing of dentifrices using a V8 brushing machine and tactile or optical measurement of dentin wear. The general application of this technique may be advanced by demonstration of successful inter-laboratory confirmation of the method. The objective of this study was to explore the capability of different laboratories in the assessment of dentifrice abrasivity using a profilometry-based evaluation technique developed in our Mason laboratories. In addition, we wanted to assess the interchangeability of human and bovine specimens. Participating laboratories were instructed in methods associated with Radioactive Dentin Abrasivity-Profilometry Equivalent (RDA-PE) evaluation, including site visits to discuss critical elements of specimen preparation, masking, profilometry scanning, and procedures. Laboratories were likewise instructed on the requirement for demonstration of proportional linearity as a key condition for validation of the technique. Laboratories were provided with four test dentifrices, blinded for testing, with a broad range of abrasivity. In each laboratory, a calibration curve was developed for varying V8 brushing strokes (0, 4,000, and 10,000 strokes) with the ISO abrasive standard. Proportional linearity was determined as the ratio of standard abrasion mean depths created with 4,000 and 10,000 strokes (2.5 fold differences). Criteria for successful calibration within the method (established in our Mason laboratory) was set at proportional linearity = 2.5 ± 0.3. RDA-PE was compared to Radiotracer RDA for the four test dentifrices, with the latter obtained by averages from three independent Radiotracer RDA sites. Individual laboratories and their results were compared by 1) proportional linearity and 2) acquired RDA-PE values for test pastes. Five sites participated in the study. One site did not pass proportional linearity objectives. Data for this site are

  20. Comparison of aquifer characterization approaches through steady state groundwater model validation: A controlled laboratory sandbox study

    USGS Publications Warehouse

    Illman, W.A.; Zhu, J.; Craig, A.J.; Yin, D.

    2010-01-01

    groundwater model validation is possible in this laboratory sandbox aquifer if the heterogeneous K distribution and forcing functions (boundary conditions and source/sink terms) are characterized sufficiently. ?? 2010 by the American Geophysical Union.

  1. Full-scale laboratory validation of a wireless MEMS-based technology for damage assessment of concrete structures

    NASA Astrophysics Data System (ADS)

    Trapani, Davide; Zonta, Daniele; Molinari, Marco; Amditis, Angelos; Bimpas, Matthaios; Bertsch, Nicolas; Spiering, Vincent; Santana, Juan; Sterken, Tom; Torfs, Tom; Bairaktaris, Dimitris; Bairaktaris, Manos; Camarinopulos, Stefanos; Frondistou-Yannas, Mata; Ulieru, Dumitru

    2012-04-01

    This paper illustrates an experimental campaign conducted under laboratory conditions on a full-scale reinforced concrete three-dimensional frame instrumented with wireless sensors developed within the Memscon project. In particular it describes the assumptions which the experimental campaign was based on, the design of the structure, the laboratory setup and the results of the tests. The aim of the campaign was to validate the performance of Memscon sensing systems, consisting of wireless accelerometers and strain sensors, on a real concrete structure during construction and under an actual earthquake. Another aspect of interest was to assess the effectiveness of the full damage recognition procedure based on the data recorded by the sensors and the reliability of the Decision Support System (DSS) developed in order to provide the stakeholders recommendations for building rehabilitation and the costs of this. With these ends, a Eurocode 8 spectrum-compatible accelerogram with increasing amplitude was applied at the top of an instrumented concrete frame built in the laboratory. MEMSCON sensors were directly compared with wired instruments, based on devices available on the market and taken as references, during both construction and seismic simulation.

  2. Youth Oriented Activity Trackers: Comprehensive Laboratory- and Field-Based Validation

    PubMed Central

    2017-01-01

    Background Commercial activity trackers are growing in popularity among adults and some are beginning to be marketed to children. There is, however, a paucity of independent research examining the validity of these devices to detect physical activity of different intensity levels. Objectives The purpose of this study was to determine the validity of the output from 3 commercial youth-oriented activity trackers in 3 phases: (1) orbital shaker, (2) structured indoor activities, and (3) 4 days of free-living activity. Methods Four units of each activity tracker (Movband [MB], Sqord [SQ], and Zamzee [ZZ]) were tested in an orbital shaker for 5-minutes at three frequencies (1.3, 1.9, and 2.5 Hz). Participants for Phase 2 (N=14) and Phase 3 (N=16) were 6-12 year old children (50% male). For Phase 2, participants completed 9 structured activities while wearing each tracker, the ActiGraph GT3X+ (AG) research accelerometer, and a portable indirect calorimetry system to assess energy expenditure (EE). For Phase 3, participants wore all 4 devices for 4 consecutive days. Correlation coefficients, linear models, and non-parametric statistics evaluated the criterion and construct validity of the activity tracker output. Results Output from all devices was significantly associated with oscillation frequency (r=.92-.99). During Phase 2, MB and ZZ only differentiated sedentary from light intensity (P<.01), whereas the SQ significantly differentiated among all intensity categories (all comparisons P<.01), similar to AG and EE. During Phase 3, AG counts were significantly associated with activity tracker output (r=.76, .86, and .59 for the MB, SQ, and ZZ, respectively). Conclusions Across study phases, the SQ demonstrated stronger validity than the MB and ZZ. The validity of youth-oriented activity trackers may directly impact their effectiveness as behavior modification tools, demonstrating a need for more research on such devices. PMID:28724509

  3. Reference method for detection of Pgp mediated multidrug resistance in human hematological malignancies: a method validated by the laboratories of the French Drug Resistance Network.

    PubMed

    Huet, S; Marie, J P; Gualde, N; Robert, J

    1998-12-15

    Multidrug resistance (MDR) associated with overexpression of the MDR1 gene and of its product, P-glycoprotein (Pgp), plays an important role in limiting cancer treatment efficacy. Many studies have investigated Pgp expression in clinical samples of hematological malignancies but failed to give definitive conclusion on its usefulness. One convenient method for fluorescent detection of Pgp in malignant cells is flow cytometry which however gives variable results from a laboratory to another one, partly due to the lack of a reference method rigorously tested. The purpose of this technical note is to describe each step of a reference flow cytometric method. The guidelines for sample handling, staining and analysis have been established both for Pgp detection with monoclonal antibodies directed against extracellular epitopes (MRK16, UIC2 and 4E3), and for Pgp functional activity measurement with Rhodamine 123 as a fluorescent probe. Both methods have been validated on cultured cell lines and clinical samples by 12 laboratories of the French Drug Resistance Network. This cross-validated multicentric study points out crucial steps for the accuracy and reproducibility of the results, like cell viability, data analysis and expression.

  4. Single Laboratory Validated Method for Determination of Cylindrospermopsin and Anatoxin-a in Ambient Freshwaters by Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)

    EPA Pesticide Factsheets

    This document is a standardized single laboratory validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the detection and quantification of cyanotoxins (combined intracellular and extracellular) in ambient freshwaters.

  5. Walk this way: validity evidence of iphone health application step count in laboratory and free-living conditions.

    PubMed

    Duncan, Markus J; Wunderlich, Kelly; Zhao, Yingying; Faulkner, Guy

    2018-08-01

    Several attempts have been made to demonstrate the accuracy of the iPhone pedometer function in laboratory test conditions. However, no studies have attempted to evaluate evidence of convergent validity of the iPhone step counts as a surveillance tool in the field. This study takes a pragmatic approach to evaluating Health application derived iPhone step counts by measuring accuracy of a standardized criterion iPhone SE and a heterogeneous sample of participant owned iPhones (6 or newer) in a laboratory condition, as well as comparing personal iPhones to accelerometer derived steps in a free-living test. During lab tests, criterion and personal iPhones differed from manually counted steps by a mean bias of less than ±5% when walking at 5km/h, 7.5km/h and 10km/h on a treadmill, which is generally considered acceptable for pedometers. In the free-living condition steps differed by a mean bias of 21.5% or 1340 steps/day when averaged across observation days. Researchers should be cautioned in considering the use of iPhone models as a research grade pedometer for physical activity surveillance or evaluation, likely due to the iPhone not being continually carried by participants; if compliance can be maximized then the iPhone might be suitable.

  6. Evaluation of Calibration Laboratories Performance

    NASA Astrophysics Data System (ADS)

    Filipe, Eduarda

    2011-12-01

    One of the main goals of interlaboratory comparisons (ILCs) is the evaluation of the laboratories performance for the routine calibrations they perform for the clients. In the frame of Accreditation of Laboratories, the national accreditation boards (NABs) in collaboration with the national metrology institutes (NMIs) organize the ILCs needed to comply with the requirements of the international accreditation organizations. In order that an ILC is a reliable tool for a laboratory to validate its best measurement capability (BMC), it is needed that the NMI (reference laboratory) provides a better traveling standard—in terms of accuracy class or uncertainty—than the laboratories BMCs. Although this is the general situation, there are cases where the NABs ask the NMIs to evaluate the performance of the accredited laboratories when calibrating industrial measuring instruments. The aim of this article is to discuss the existing approaches for the evaluation of ILCs and propose a basis for the validation of the laboratories measurement capabilities. An example is drafted with the evaluation of the results of mercury-in-glass thermometers ILC with 12 participant laboratories.

  7. Lab meets real life: A laboratory assessment of spontaneous thought and its ecological validity

    PubMed Central

    Welz, Annett; Reinhard, Iris; Alpers, Georg W.

    2017-01-01

    People’s minds frequently wander towards self-generated thoughts, which are unrelated to external stimuli or demands. These phenomena, referred to as “spontaneous thought” (ST) and “mind wandering” (MW), have previously been linked with both costs and benefits. Current assessments of ST and MW have predominantly been conducted in the laboratory, whereas studies on the ecological validity of such lab-related constructs and their interrelations are rare. The current study examined the stability of ST dimensions assessed in the lab and their predictive value with respect to MW, repetitive negative thought (uncontrollable rumination, RUM), and affect in daily life. Forty-three university students were assessed with the Amsterdam Resting State Questionnaire (2nd version) to assess ten ST dimensions during the resting state in two laboratory sessions, which were separated by five days of electronic ambulatory assessment (AA). During AA, individuals indicated the intensity of MW and RUM, as well as of positive and negative affect in daily life ten times a day. ST dimensions measured in the lab were moderately stable across one week. Five out of ten ST lab dimensions were predicted by mental health-related symptoms or by dispositional cognitive traits. Hierarchical linear models revealed that a number of ST lab dimensions predicted cognitive and affective states in daily life. Mediation analyses showed that RUM, but not MW per se, accounted for the relationship between specific ST lab dimensions and mood in daily life. By using a simple resting state task, we could demonstrate that a number of lab dimensions of spontaneous thought are moderately stable, are predicted by mental health symptoms and cognitive traits, and show plausible associations with categories of self-generated thought and mood in daily life. PMID:28910351

  8. Effects of borehole design on complex electrical resistivity measurements: laboratory validation and numerical experiments

    NASA Astrophysics Data System (ADS)

    Treichel, A.; Huisman, J. A.; Zhao, Y.; Zimmermann, E.; Esser, O.; Kemna, A.; Vereecken, H.

    2012-12-01

    Geophysical measurements within a borehole are typically affected by the presence of the borehole. The focus of the current study is to quantify the effect of borehole design on broadband electrical impedance tomography (EIT) measurements within boreholes. Previous studies have shown that effects on the real part of the electrical resistivity are largest for boreholes with large diameters and for materials with a large formation factor. However, these studies have not considered the effect of the well casing and the filter gravel on the measurement of the real part of the electrical resistivity. In addition, the effect of borehole design on the imaginary part of the electrical resistivity has not been investigated yet. Therefore, the aim of this study is to investigate the effect of borehole design on the complex electrical resistivity using laboratory measurements and numerical simulations. In order to do so, we developed a high resolution two dimensional axisymmetric finite element model (FE) that enables us to simulate the effects of several key borehole design parameters (e.g. borehole diameter, thickness of PVC well casing) on the measurement process. For the material surrounding the borehole, realistic values for complex resistivity were obtained from a database of laboratory measurements of complex resistivity from the test site Krauthausen (Germany). The slotted PVC well casing is represented by an effective resistivity calculated from the water-filled slot volume and the PVC volume. Measurements with and without PVC well casing were made with a four-electrode EIT logging tool in a water-filled rain barrel. The initial comparison for the case that the logging tool was inserted in the PVC well casing showed a considerable mismatch between measured and modeled values. It was required to consider a complete electrode model instead of point electrodes to remove this mismatch. This validated model was used to investigate in detail how complex resistivity

  9. Validity for an integrated laboratory analogue of sexual aggression and bystander intervention.

    PubMed

    Parrott, Dominic J; Tharp, Andra Teten; Swartout, Kevin M; Miller, Cameron A; Hall, Gordon C Nagayama; George, William H

    2012-01-01

    This study sought to develop and validate an integrated laboratory paradigm of sexual aggression and bystander intervention. Participants were a diverse community sample (54% African American) of heterosexual males (N = 156) between 21 and 35 years of age who were recruited to complete the study with a male friend and an ostensibly single, heterosexual female who reported a strong dislike of sexual content in the media. Participants viewed a sexually explicit or nonsexually explicit film clip as part of contrived media rating task and made individual choices of which film clip to show the female confederate. Immediately thereafter, participants were required to reach consensus on a group decision of which film clip to show the female confederate. Subjecting a target to an unwanted experience with a sexual connotation was operationalized as selection of the sexually explicit video, whereas successful bystander intervention was operationalized as the event of one partner individually selecting the sexually explicit video but then selecting the nonsexually explicit video for the group choice. Results demonstrated that a 1-year history of sexual aggression and endorsement of pertinent misogynistic attitudes significantly predicted selection of the sexually-explicit video. In addition, bystander efficacy significantly predicted men's successful prevention of their male peer's intent to show the female confederate a sexually explicit video. Discussion focused on how these data inform future research and bystander intervention programming for sexual aggression. © 2012 Wiley Periodicals, Inc.

  10. Objectifying Content Validity: Conducting a Content Validity Study in Social Work Research.

    ERIC Educational Resources Information Center

    Rubio, Doris McGartland; Berg-Weger, Marla; Tebb, Susan S.; Lee, E. Suzanne; Rauch, Shannon

    2003-01-01

    The purpose of this article is to demonstrate how to conduct a content validity study. Instructions on how to calculate a content validity index, factorial validity index, and an interrater reliability index and guide for interpreting these indices are included. Implications regarding the value of conducting a content validity study for…

  11. Procedures For Microbial-Ecology Laboratory

    NASA Technical Reports Server (NTRS)

    Huff, Timothy L.

    1993-01-01

    Microbial Ecology Laboratory Procedures Manual provides concise and well-defined instructions on routine technical procedures to be followed in microbiological laboratory to ensure safety, analytical control, and validity of results.

  12. The ideal laboratory information system.

    PubMed

    Sepulveda, Jorge L; Young, Donald S

    2013-08-01

    Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

  13. Science Laboratory Learning Environments in Junior Secondary Schools

    ERIC Educational Resources Information Center

    Kwok, Ping Wai

    2015-01-01

    A Chinese version of the Science Laboratory Environment Inventory (SLEI) was used to study the students' perceptions of the actual and preferred laboratory learning environments in Hong Kong junior secondary science lessons. Valid responses of the SLEI from 1932 students of grade 7 to grade 9 indicated that an open-ended inquiry approach seldom…

  14. Accuracy Analysis and Validation of the Mars Science Laboratory (MSL) Robotic Arm

    NASA Technical Reports Server (NTRS)

    Collins, Curtis L.; Robinson, Matthew L.

    2013-01-01

    The Mars Science Laboratory (MSL) Curiosity Rover is currently exploring the surface of Mars with a suite of tools and instruments mounted to the end of a five degree-of-freedom robotic arm. To verify and meet a set of end-to-end system level accuracy requirements, a detailed positioning uncertainty model of the arm was developed and exercised over the arm operational workspace. Error sources at each link in the arm kinematic chain were estimated and their effects propagated to the tool frames.A rigorous test and measurement program was developed and implemented to collect data to characterize and calibrate the kinematic and stiffness parameters of the arm. Numerous absolute and relative accuracy and repeatability requirements were validated with a combination of analysis and test data extrapolated to the Mars gravity and thermal environment. Initial results of arm accuracy and repeatability on Mars demonstrate the effectiveness of the modeling and test program as the rover continues to explore the foothills of Mount Sharp.

  15. NETL Extreme Drilling Laboratory Studies High Pressure High Temperature Drilling Phenomena

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lyons, K.D.; Honeygan, S.; Moroz, T

    2007-06-01

    The U.S. Department of Energy’s National Energy Technology Laboratory (NETL) established an Extreme Drilling Lab to engineer effective and efficient drilling technologies viable at depths greater than 20,000 feet. This paper details the challenges of ultra-deep drilling, documents reports of decreased drilling rates as a result of increasing fluid pressure and temperature, and describes NETL’s Research and Development activities. NETL is invested in laboratory-scale physical simulation. Their physical simulator will have capability of circulating drilling fluids at 30,000 psi and 480 °F around a single drill cutter. This simulator will not yet be operational by the planned conference dates; therefore,more » the results will be limited to identification of leading hypotheses of drilling phenomena and NETL’s test plans to validate or refute such theories. Of particular interest to the Extreme Drilling Lab’s studies are the combinatorial effects of drilling fluid pressure, drilling fluid properties, rock properties, pore pressure, and drilling parameters, such as cutter rotational speed, weight on bit, and hydraulics associated with drilling fluid introduction to the rock-cutter interface. A detailed discussion of how each variable is controlled in a laboratory setting will be part of the conference paper and presentation.« less

  16. 42 CFR 493.563 - Validation inspections-Basis and focus.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Validation inspections-Basis and focus. 493.563... Validation inspections—Basis and focus. (a) Basis for validation inspection—(1) Laboratory with a certificate... of that State's licensed or approved laboratories from CLIA program requirements. (b) Validation...

  17. 42 CFR 493.563 - Validation inspections-Basis and focus.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Validation inspections-Basis and focus. 493.563... Validation inspections—Basis and focus. (a) Basis for validation inspection—(1) Laboratory with a certificate... of that State's licensed or approved laboratories from CLIA program requirements. (b) Validation...

  18. 42 CFR 493.563 - Validation inspections-Basis and focus.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Validation inspections-Basis and focus. 493.563... Validation inspections—Basis and focus. (a) Basis for validation inspection—(1) Laboratory with a certificate... of that State's licensed or approved laboratories from CLIA program requirements. (b) Validation...

  19. 42 CFR 493.563 - Validation inspections-Basis and focus.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Validation inspections-Basis and focus. 493.563... Validation inspections—Basis and focus. (a) Basis for validation inspection—(1) Laboratory with a certificate... of that State's licensed or approved laboratories from CLIA program requirements. (b) Validation...

  20. 42 CFR 493.563 - Validation inspections-Basis and focus.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Validation inspections-Basis and focus. 493.563... Validation inspections—Basis and focus. (a) Basis for validation inspection—(1) Laboratory with a certificate... of that State's licensed or approved laboratories from CLIA program requirements. (b) Validation...

  1. Determination of Antimycin-A in water by liquid chromatographic/mass spectrometry: single-laboratory validation

    USGS Publications Warehouse

    Bernardy, Jeffry A.; Hubert, Terrance D.; Ogorek, Jacob M.; Schmidt, Larry J.

    2013-01-01

    An LC/MS method was developed and validated for the quantitative determination and confirmation of antimycin-A (ANT-A) in water from lakes or streams. Three different water sample volumes (25, 50, and 250 mL) were evaluated. ANT-A was stabilized in the field by immediately extracting it from water into anhydrous acetone using SPE. The stabilized concentrated samples were then transported to a laboratory and analyzed by LC/MS using negative electrospray ionization. The method was determined to have adequate accuracy (78 to 113% recovery), precision (0.77 to 7.5% RSD with samples ≥500 ng/L and 4.8 to 17% RSD with samples ≤100 ng/L), linearity, and robustness over an LOQ range from 8 to 51 600 ng/L.

  2. Determination of antimycin-A in water by liquid chromatographic/mass spectrometry: single-laboratory validation.

    PubMed

    Bernardy, Jeffry A; Hubert, Terrance D; Ogorek, Jacob M; Schmidt, Larry J

    2013-01-01

    An LC/MS method was developed and validated for the quantitative determination and confirmation of antimycin-A (ANT-A) in water from lakes or streams. Three different water sample volumes (25, 50, and 250 mL) were evaluated. ANT-A was stabilized in the field by immediately extracting it from water into anhydrous acetone using SPE. The stabilized concentrated samples were then transported to a laboratory and analyzed by LC/MS using negative electrospray ionization. The method was determined to have adequate accuracy (78 to 113% recovery), precision (0.77 to 7.5% RSD with samples > or = 500 ng/L and 4.8 to 17% RSD with samples < or = 100 ng/L), linearity, and robustness over an LOQ range from 8 to 51 600 ng/L.

  3. Inter-laboratory validation of the modified murine local lymph node assay based on 5-bromo-2'-deoxyuridine incorporation.

    PubMed

    Kojima, Hajime; Takeyoshi, Masahiro; Sozu, Takashi; Awogi, Takumi; Arima, Kazunori; Idehara, Kenji; Ikarashi, Yoshiaki; Kanazawa, Yukiko; Maki, Eiji; Omori, Takashi; Yuasa, Atsuko; Yoshimura, Isao

    2011-01-01

    The murine local lymph node assay (LLNA) is a well-established alternative to the guinea pig maximization test (GPMT) or Buehler test (BT) for the assessment of the skin sensitizing ability of a drug, cosmetic material, pesticide or industrial chemical. Instead of radioisotope using in this method, Takeyoshi M. et al. (2001) has developed a modified LLNA based on the 5-bromo-2'-deoxyuridine (BrdU) incorporation (LLNA:BrdU-ELISA). The LLNA:BrdU-ELISA is practically identical to the LLNA methodology excluding the use of BrdU, for which a single intraperitoneal injection of BrdU is made on day 4, and colorimetric detection of cell turnover. We conducted the validation study to evaluate the reliability and relevance of LLNA:BrdU-ELISA. The experiment involved 7 laboratories, wherein 10 chemicals were examined under blinded conditions. In this study, 3 chemicals were examined in all laboratories and the remaining 7 were examined in 3 laboratories. The data were expressed as the BrdU incorporation using an ELISA method for each group, and the stimulation index (SI) for each chemical-treated group was determined as the increase in the BrdU incorporation relative to the concurrent vehicle control group. An SI of 2 was set as the cut-off value for exhibiting skin sensitization activity. The results obtained in the experiments conducted for all 10 chemicals were sufficiently consistent with small variations in their SI values. The sensitivity, specificity, and accuracy of LLNA:BrdU-ELISA against those of GPMT/BT were 7/7 (100%), 3/3 (100%), and 10/10 (100%), respectively. Copyright © 2010 John Wiley & Sons, Ltd.

  4. Development and Single-Laboratory Validation of a Liquid Chromatography Tandem Mass Spectrometry Method for Quantitation of Tetrodotoxin in Mussels and Oysters.

    PubMed

    Turner, Andrew D; Boundy, Michael J; Rapkova, Monika Dhanji

    2017-09-01

    In recent years, evidence has grown for the presence of tetrodotoxin (TTX) in bivalve mollusks, leading to the potential for consumers of contaminated products to be affected by Tetrodotoxin Shellfish Poisoning (TSP). A single-laboratory validation was conducted for the hydrophilic interaction LC (HILIC) tandem MS (MS/MS) analysis of TTX in common mussels and Pacific oysters-the bivalve species that have been found to contain TTXs in the United Kingdom in recent years. The method consists of a single-step dispersive extraction in 1% acetic acid, followed by a carbon SPE cleanup step before dilution and instrumental analysis. The full method was developed as a rapid tool for the quantitation of TTX, as well as for the associated analogs 4-epi-TTX; 5,6,11-trideoxy TTX; 11-nor TTX-6-ol; 5-deoxy TTX; and 4,9-anhydro TTX. The method can also be run as the acquisition of TTX together with paralytic shellfish toxins. Results demonstrated acceptable method performance characteristics for specificity, linearity, recovery, ruggedness, repeatability, matrix variability, and within-laboratory reproducibility for the analysis of TTX. The LOD and LOQ were fit-for-purpose in comparison to the current action limit for TTX enforced in The Netherlands. In addition, aspects of method performance (LOD, LOQ, and within-laboratory reproducibility) were found to be satisfactory for three other TTX analogs (11-nor TTX-6-ol, 5-deoxy TTX, and 4,9-anhydro TTX). The method was found to be practical and suitable for use in regulatory testing, providing rapid turnaround of sample analysis. Plans currently underway on a full collaborative study to validate a HILIC-MS/MS method for paralytic shellfish poisoning toxins will be extended to include TTX in order to generate international acceptance, ultimately for use as an alternative official control testing method should regulatory controls be adopted.

  5. [Quality assessment of microscopic examination in tuberculosis diagnostic laboratories: a preliminary study].

    PubMed

    Simşek, Hülya; Ceyhan, Ismail; Tarhan, Gülnur; Güner, Uğur

    2010-10-01

    Recently, the diagnosis of pulmonary tuberculosis (TB) has based on smear microscopy in the Direct Observed Treatment Strategy (DOTS) programme which provides the basis of treatment worldwide. Microscopic detection of AFB (Acid-Fast Bacilli) is one of the main components in the National TB Control Programmes (NTCP). Precision level in microscopy procedures and evaluations are the most important steps for accurate diagnosis of the disease and to initiate proper treatment. Therefore, the external quality assessment (EQA) is the most important implement to provide the reliability and validity of tests. In countries where NTCP are performed, this task is fulfilled by the National Reference Laboratories (NRL) according to the guidelines of the World Health Organization (WHO). For this purpose a pilot study was initiated by the central NRL of Turkey for EQA of AFB smear microscopy as part of the NTCP on January 1, 2005. A total of 5 laboratories of which 2 were district TB laboratories (A, B), 2 were tuberculosis control dispensaries (C, D), 1 was a national reference laboratory (E), participated in this study. Blind re-checking method (re-examination of randomly selected slides) was used for the evaluation, and the slides were sent to the central NRL with 3 months interval, four times a year, selected according to LQAS (Lot Quality Assurance Sampling) guides. In the re-evaluation of the slides, false positivity (FP), false negativity (FN) and quantification errors (QE) were noted. Laboratory A, sent totally 525 slides between January 1, 2005 and April 1, 2008. In the result of re-checking, 514 (97.9%) slides were found concordant, and 11 (2.1%) were discordant (10 FP, 1 FN). Laboratory B, participated in the study between October 1, 2005 and July 1, 2006 and of the 67 re-examined slides, 60 (89.5%) were concordant and 7 (10.5%) were discordant (2 FP, 0 FN, 5 QE). Laboratory C, sent 235 slides between January 1, 2005 and April 1, 2006; of them 218 (92.8%) were detected

  6. Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study.

    PubMed

    Birnie, Kate; Hay, Alastair D; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O'Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C; Sterne, Jonathan A C

    2017-01-01

    To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test"), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in

  7. Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study

    PubMed Central

    Birnie, Kate; Hay, Alastair D.; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O’Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C.; Sterne, Jonathan A. C.

    2017-01-01

    Objectives To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. Population and methods We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. Results 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. Conclusions The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service

  8. Extension of the validation of AOAC Official Method 2005.06 for dc-GTX2,3: interlaboratory study.

    PubMed

    Ben-Gigirey, Begoña; Rodríguez-Velasco, María L; Gago-Martínez, Ana

    2012-01-01

    AOAC Official Method(SM) 2005.06 for the determination of saxitoxin (STX)-group toxins in shellfish by LC with fluorescence detection with precolumn oxidation was previously validated and adopted First Action following a collaborative study. However, the method was not validated for all key STX-group toxins, and procedures to quantify some of them were not provided. With more STX-group toxin standards commercially available and modifications to procedures, it was possible to overcome some of these difficulties. The European Union Reference Laboratory for Marine Biotoxins conducted an interlaboratory exercise to extend AOAC Official Method 2005.06 validation for dc-GTX2,3 and to compile precision data for several STX-group toxins. This paper reports the study design and the results obtained. The performance characteristics for dc-GTX2,3 (intralaboratory and interlaboratory precision, recovery, and theoretical quantification limit) were evaluated. The mean recoveries obtained for dc-GTX2,3 were, in general, low (53.1-58.6%). The RSD for reproducibility (RSD(r)%) for dc-GTX2,3 in all samples ranged from 28.2 to 45.7%, and HorRat values ranged from 1.5 to 2.8. The article also describes a hydrolysis protocol to convert GTX6 to NEO, which has been proven to be useful for the quantification of GTX6 while the GTX6 standard is not available. The performance of the participant laboratories in the application of this method was compared with that obtained from the original collaborative study of the method. Intralaboratory and interlaboratory precision data for several STX-group toxins, including dc-NEO and GTX6, are reported here. This study can be useful for those laboratories determining STX-group toxins to fully implement AOAC Official Method 2005.06 for official paralytic shellfish poisoning control. However the overall quantitative performance obtained with the method was poor for certain toxins.

  9. Validation of the Sysmex sp-1000i automated slide preparer-stainer in a clinical laboratory

    PubMed Central

    de Bitencourt, Eberson Damião dos Santos; Voegeli, Carlos Franco; Onzi, Gabriela dos Santos; Boscato, Sara Cardoso; Ghem, Carine; Munhoz, Terezinha

    2013-01-01

    Background The speed and quality of information have become essential items in the release of laboratory reports. The Sysmex®SP1000-I device has been developed to prepare and stain smear slides. However, for a device to be cleared for use in the laboratory routine it must pass through a validation process. Objective To evaluate the performance and reliability of the Sysmex® SP-1000i slide preparer-stainer incorporated into the routine of a hospital laboratory in Porto Alegre. Methods Peripheral blood samples of patients attending the laboratory for ambulatory exams with leukocyte counts between 7000/°L and 12,000/°L were evaluated, independent of gender and age. Two slides were prepared for each sample using the Sysmex® SP-1000i equipment; one of the slides was used to perform quality control tests using the CellaVision® DM96 device, and the other slide was used to compare pre-classification by the same device and the classification performed by a pharmacist-biochemist. Results The results of all the slides used as controls were acceptable according to the quality control test as established by the manufacturer of the device. In the comparison between the automated pre-classification and the classification made by the professional, there was an acceptable variation in the differential counts of leukocytes for 90% of the analyzed slides. Pearson correlation coefficient showed a strong correlation for band neutrophils (r = 0.802; p-value < 0.001), segmented neutrophils (r = 0.963; p-value < 0.001), eosinophils (r = 0.958; p-value < 0.001), lymphocytes (r = 0.985; p-value < 0.001) and atypical lymphocytes (r = 0.866; p-value < 0.001) using both methods. The red blood cell analysis was adequate for all slides analyzed by the equipment and by the professional. Conclusion The new Sysmex®SP1000-i methodology was found to be reliable, fast and safe for the routines of medium and large laboratories, improving the quality of microscopic analysis in complete blood

  10. [Validation Study for Analytical Method of Diarrhetic Shellfish Poisons in 9 Kinds of Shellfish].

    PubMed

    Yamaguchi, Mizuka; Yamaguchi, Takahiro; Kakimoto, Kensaku; Nagayoshi, Haruna; Okihashi, Masahiro; Kajimura, Keiji

    2016-01-01

    A method was developed for the simultaneous determination of okadaic acid, dinophysistoxin-1 and dinophysistoxin-2 in shellfish using ultra performance liquid chromatography with tandem mass spectrometry. Shellfish poisons in spiked samples were extracted with methanol and 90% methanol, and were hydrolyzed with 2.5 mol/L sodium hydroxide solution. Purification was done on an HLB solid-phase extraction column. This method was validated in accordance with the notification of Ministry of Health, Labour and Welfare of Japan. As a result of the validation study in nine kinds of shellfish, the trueness, repeatability and within-laboratory reproducibility were 79-101%, less than 12 and 16%, respectively. The trueness and precision met the target values of notification.

  11. Zero-gravity cloud physics laboratory: Experiment program definition and preliminary laboratory concept studies

    NASA Technical Reports Server (NTRS)

    Eaton, L. R.; Greco, E. V.

    1973-01-01

    The experiment program definition and preliminary laboratory concept studies on the zero G cloud physics laboratory are reported. This program involves the definition and development of an atmospheric cloud physics laboratory and the selection and delineations of a set of candidate experiments that must utilize the unique environment of zero gravity or near zero gravity.

  12. Preliminary Validation and Reliability Testing of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians, in a Colony of Laboratory Cats

    PubMed Central

    Klinck, Mary P.; Rialland, Pascale; Guillot, Martin; Moreau, Maxim; Frank, Diane; Troncy, Eric

    2015-01-01

    Simple Summary Feline osteoarthritis (OA) is challenging to diagnose. A pain scale was developed for use by veterinarians, in association with their physical examination, and tested for reliability and validity. The scale items were: Interaction with the examiner, Exploration of the room, Body Posture, Gait, Body Condition, condition of Coat and Claws, and abnormal Findings or Cat Reaction upon joint Palpation. Expert review supported the scale content. Two studies using laboratory-housed cats found the most promising results for Gait and Body Posture, in terms of distinguishing between OA and non-OA cats, repeatability of results, and correlations with objectively measured kinetics (weight-bearing). Abstract Subtle signs and conflicting physical and radiographic findings make feline osteoarthritis (OA) challenging to diagnose. A physical examination-based assessment was developed, consisting of eight items: Interaction, Exploration, Posture, Gait, Body Condition, Coat and Claws, (joint) Palpation–Findings, and Palpation–Cat Reaction. Content (experts) and face (veterinary students) validity were excellent. Construct validity, internal consistency, and intra- and inter-rater reliability were assessed via a pilot and main study, using laboratory-housed cats with and without OA. Gait distinguished OA status in the pilot (p = 0.05) study. In the main study, no scale item achieved statistically significant OA detection. Forelimb peak vertical ground reaction force (PVF) correlated inversely with Gait (Rhos = −0.38 (p = 0.03) to −0.41 (p = 0.02)). Body Posture correlated with Gait, and inversely with forelimb PVF at two of three time points (Rhos = −0.38 (p = 0.03) to −0.43 (p = 0.01)). Palpation (Findings, Cat Reaction) did not distinguish OA from non-OA cats. Palpation—Cat Reaction (Forelimbs) correlated inversely with forelimb PVF at two time points (Rhos = −0.41 (p = 0.02) to −0.41 (p = 0.01)), but scores were highly variable, and poorly reliable

  13. Case-Study Investigation of Equine Maternity via PCR-RFLP: A Biochemistry Laboratory Experiment

    PubMed Central

    Millard, Julie T.; Chuang, Edward; Lucas, James S.; Nagy, Erzsebet E.; Davis, Griffin T.

    2013-01-01

    A simple and robust biochemistry laboratory experiment is described that uses restriction fragment length polymorphism (RFLP) of polymerase chain reaction (PCR) products to verify the identity of a potentially valuable horse. During the first laboratory period, students purify DNA from equine samples and amplify two loci of mitochondrial DNA. During the second laboratory period, students digest PCR products with restriction enzymes and analyze the fragment sizes through agarose gel electrophoresis. An optional step of validating DNA extracts through realtime PCR can expand the experiment to three weeks. This experiment, which has an engaging and versatile scenario, provides students with exposure to key principles and techniques of molecular biology, bioinformatics, and evolution in a forensic context. PMID:24363455

  14. ER-2: Flying Laboratory for Earth Science Studies

    NASA Technical Reports Server (NTRS)

    Navarro, Robert

    2007-01-01

    The National Aeronautics and Space Administration (NASA) Dryden Flight Research Center (DFRC), (Edwards, California, USA) has two Lockheed Martin Corporation (Bethesda, Maryland) Earth Research-2 (ER-2) aircraft that serve as high-altitude and long-range flying laboratories. The ER-2 has been utilized to conduct scientific studies of stratospheric and tropospheric chemistry, land-use mapping, disaster assessment, preliminary testing and calibration and validation of satellite sensors. The ER-2 aircraft provides experimenters with a wide array of payload accommodation areas with suitable environment control with required electrical and mechanical interfaces. Missions may be flown out of DFRC or from remote bases worldwide. The NASA ER-2 is utilized by a variety of customers, including U.S. Government agencies, civilian organizations, universities, and state governments. The combination of the ER-2 s range, endurance, altitude, payload power, payload volume and payload weight capabilities complemented by a trained maintenance and operations team provides an excellent and unique platform system to the science community.

  15. PSI-Center Validation Studies

    NASA Astrophysics Data System (ADS)

    Nelson, B. A.; Akcay, C.; Glasser, A. H.; Hansen, C. J.; Jarboe, T. R.; Marklin, G. J.; Milroy, R. D.; Morgan, K. D.; Norgaard, P. C.; Shumlak, U.; Sutherland, D. A.; Victor, B. S.; Sovinec, C. R.; O'Bryan, J. B.; Held, E. D.; Ji, J.-Y.; Lukin, V. S.

    2014-10-01

    The Plasma Science and Innovation Center (PSI-Center - http://www.psicenter.org) supports collaborating validation platform experiments with 3D extended MHD simulations using the NIMROD, HiFi, and PSI-TET codes. Collaborators include the Bellan Plasma Group (Caltech), CTH (Auburn U), HBT-EP (Columbia), HIT-SI (U Wash-UW), LTX (PPPL), MAST (Culham), Pegasus (U Wisc-Madison), SSX (Swarthmore College), TCSU (UW), and ZaP/ZaP-HD (UW). The PSI-Center is exploring application of validation metrics between experimental data and simulations results. Biorthogonal decomposition (BOD) is used to compare experiments with simulations. BOD separates data sets into spatial and temporal structures, giving greater weight to dominant structures. Several BOD metrics are being formulated with the goal of quantitive validation. Results from these simulation and validation studies, as well as an overview of the PSI-Center status will be presented.

  16. Tethered gravity laboratories study

    NASA Technical Reports Server (NTRS)

    Lucchetti, F.

    1989-01-01

    Variable Gravity Laboratory studies are discussed. The following subject areas are covered: (1) conceptual design and engineering analysis; (2) control strategies (fast crawling maneuvers, main perturbations and their effect upon the acceleration level); and (3) technology requirements.

  17. ETHOWATCHER: validation of a tool for behavioral and video-tracking analysis in laboratory animals.

    PubMed

    Crispim Junior, Carlos Fernando; Pederiva, Cesar Nonato; Bose, Ricardo Chessini; Garcia, Vitor Augusto; Lino-de-Oliveira, Cilene; Marino-Neto, José

    2012-02-01

    We present a software (ETHOWATCHER(®)) developed to support ethography, object tracking and extraction of kinematic variables from digital video files of laboratory animals. The tracking module allows controlled segmentation of the target from the background, extracting image attributes used to calculate the distance traveled, orientation, length, area and a path graph of the experimental animal. The ethography module allows recording of catalog-based behaviors from environment or from video files continuously or frame-by-frame. The output reports duration, frequency and latency of each behavior and the sequence of events in a time-segmented format, set by the user. Validation tests were conducted on kinematic measurements and on the detection of known behavioral effects of drugs. This software is freely available at www.ethowatcher.ufsc.br. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Sandia National Laboratories: Fabrication, Testing and Validation

    Science.gov Websites

    ; Technology Defense Systems & Assessments About Defense Systems & Assessments Program Areas safe, secure, reliable, and can fully support the Nation's deterrence policy. Employing only the most support of this mission, Sandia National Laboratories has a significant role in advancing the "state

  19. Single Laboratory Validated Method for Determination of Cylindrospermopsin and Anatoxin-a in Ambient Water by Liquid Chromatography/ Tandem Mass Spectrometry (LC/MS/MS)

    EPA Science Inventory

    This product is an LC/MS/MS single laboratory validated method for the determination of cylindrospermopsin and anatoxin-a in ambient waters. The product contains step-by-step instructions for sample preparation, analyses, preservation, sample holding time and QC protocols to ensu...

  20. Estimating body fat in NCAA Division I female athletes: a five-compartment model validation of laboratory methods.

    PubMed

    Moon, Jordan R; Eckerson, Joan M; Tobkin, Sarah E; Smith, Abbie E; Lockwood, Christopher M; Walter, Ashley A; Cramer, Joel T; Beck, Travis W; Stout, Jeffrey R

    2009-01-01

    The purpose of the present study was to determine the validity of various laboratory methods for estimating percent body fat (%fat) in NCAA Division I college female athletes (n = 29; 20 +/- 1 year). Body composition was assessed via hydrostatic weighing (HW), air displacement plethysmography (ADP), and dual-energy X-ray absorptiometry (DXA), and estimates of %fat derived using 4-compartment (C), 3C, and 2C models were compared to a criterion 5C model that included bone mineral content, body volume (BV), total body water, and soft tissue mineral. The Wang-4C and the Siri-3C models produced nearly identical values compared to the 5C model (r > 0.99, total error (TE) < 0.40%fat). For the remaining laboratory methods, constant error values (CE) ranged from -0.04%fat (HW-Siri) to -3.71%fat (DXA); r values ranged from 0.89 (ADP-Siri, ADP-Brozek) to 0.93 (DXA); standard error of estimate values ranged from 1.78%fat (DXA) to 2.19%fat (ADP-Siri, ADP-Brozek); and TE values ranged from 2.22%fat (HW-Brozek) to 4.90%fat (DXA). The limits of agreement for DXA (-10.10 to 2.68%fat) were the largest with a significant trend of -0.43 (P < 0.05). With the exception of DXA, all of the equations resulted in acceptable TE values (<3.08%fat). However, the results for individual estimates of %fat using the Brozek equation indicated that the 2C models that derived BV from ADP and HW overestimated (5.38, 3.65%) and underestimated (5.19, 4.88%) %fat, respectively. The acceptable TE values for both HW and ADP suggest that these methods are valid for estimating %fat in college female athletes; however, the Wang-4C and Siri-3C models should be used to identify individual estimates of %fat in this population.

  1. Laboratory Plasma Studies

    DTIC Science & Technology

    1989-05-23

    Intense Rela- tivistic Electron Beams S . A Compact Accelerator Powercd by the Relativistic Klystron Amplifier T. Numerical and Experimental Studies of...Research Laboratory Washingto, IX 2075.6000 NRL Memorandum Report 6419 Megavolt, Multi-Kiloamp K - Band Gyrotron Oscillator Experiment W. M. BLACK,* S . H...Ka- Band Gyrotron Oscillator Experiments with Slotted and Unslotted Cavities S . H. GOLD, MEMBER, IEEE. A. W. FLIFLET, MEMBER, IEEE, W. M. MANHEIMER

  2. Measuring preschool learning engagement in the laboratory.

    PubMed

    Halliday, Simone E; Calkins, Susan D; Leerkes, Esther M

    2018-03-01

    Learning engagement is a critical factor for academic achievement and successful school transitioning. However, current methods of assessing learning engagement in young children are limited to teacher report or classroom observation, which may limit the types of research questions one could assess about this construct. The current study investigated the validity of a novel assessment designed to measure behavioral learning engagement among young children in a standardized laboratory setting and examined how learning engagement in the laboratory relates to future classroom adjustment. Preschool-aged children (N = 278) participated in a learning-based Tangrams task and Story sequencing task and were observed based on seven behavioral indicators of engagement. Confirmatory factor analysis supported the construct validity for a behavioral engagement factor composed of six of the original behavioral indicators: attention to instructions, on-task behavior, enthusiasm/energy, persistence, monitoring progress/strategy use, and negative affect. Concurrent validity for this behavioral engagement factor was established through its associations with parent-reported mastery motivation and pre-academic skills in math and literacy measured in the laboratory, and predictive validity was demonstrated through its associations with teacher-reported classroom learning behaviors and performance in math and reading in kindergarten. These associations were found when behavioral engagement was observed during both the nonverbal task and the verbal story sequencing tasks and persisted even after controlling for child minority status, gender, and maternal education. Learning engagement in preschool appears to be successfully measurable in a laboratory setting. This finding has implications for future research on the mechanisms that support successful academic development. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Grid Modernization Laboratory Consortium - Testing and Verification

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kroposki, Benjamin; Skare, Paul; Pratt, Rob

    This paper highlights some of the unique testing capabilities and projects being performed at several national laboratories as part of the U. S. Department of Energy Grid Modernization Laboratory Consortium. As part of this effort, the Grid Modernization Laboratory Consortium Testing Network isbeing developed to accelerate grid modernization by enablingaccess to a comprehensive testing infrastructure and creating a repository of validated models and simulation tools that will be publicly available. This work is key to accelerating thedevelopment, validation, standardization, adoption, and deployment of new grid technologies to help meet U. S. energy goals.

  4. Number of organ dysfunctions predicts mortality in emergency department patients with suspected infection: a multicenter validation study.

    PubMed

    Jessen, Marie K; Skibsted, Simon; Shapiro, Nathan I

    2017-06-01

    The aim of this study was to validate the association between number of organ dysfunctions and mortality in emergency department (ED) patients with suspected infection. This study was conducted at two medical care center EDs. The internal validation set was a prospective cohort study conducted in Boston, USA. The external validation set was a retrospective case-control study conducted in Aarhus, Denmark. The study included adult patients (>18 years) with clinically suspected infection. Laboratory results and clinical data were used to assess organ dysfunctions. Inhospital mortality was the outcome measure. Multivariate logistic regression was used to determine the independent mortality odds for number and types of organ dysfunctions. We enrolled 4952 (internal) and 483 (external) patients. The mortality rate significantly increased with increasing number of organ dysfunctions: internal validation: 0 organ dysfunctions: 0.5% mortality, 1: 3.6%, 2: 9.5%, 3: 17%, and 4 or more: 37%; external validation: 2.2, 6.7, 17, 41, and 57% mortality (both P<0.001 for trend). Age-adjusted and comorbidity-adjusted number of organ dysfunctions remained an independent predictor. The effect of specific types of organ dysfunction on mortality was most pronounced for hematologic [odds ratio (OR) 3.3 (95% confidence interval (CI) 2.0-5.4)], metabolic [OR 3.3 (95% CI 2.4-4.6); internal validation], and cardiovascular dysfunctions [OR 14 (95% CI 3.7-50); external validation]. The number of organ dysfunctions predicts sepsis mortality.

  5. Validation of the sperm class analyser CASA system for sperm counting in a busy diagnostic semen analysis laboratory.

    PubMed

    Dearing, Chey G; Kilburn, Sally; Lindsay, Kevin S

    2014-03-01

    Sperm counts have been linked to several fertility outcomes making them an essential parameter of semen analysis. It has become increasingly recognised that Computer-Assisted Semen Analysis (CASA) provides improved precision over manual methods but that systems are seldom validated robustly for use. The objective of this study was to gather the evidence to validate or reject the Sperm Class Analyser (SCA) as a tool for routine sperm counting in a busy laboratory setting. The criteria examined were comparison with the Improved Neubauer and Leja 20-μm chambers, within and between field precision, sperm concentration linearity from a stock diluted in semen and media, accuracy against internal and external quality material, assessment of uneven flow effects and a receiver operating characteristic (ROC) analysis to predict fertility in comparison with the Neubauer method. This work demonstrates that SCA CASA technology is not a standalone 'black box', but rather a tool for well-trained staff that allows rapid, high-number sperm counting providing errors are identified and corrected. The system will produce accurate, linear, precise results, with less analytical variance than manual methods that correlate well against the Improved Neubauer chamber. The system provides superior predictive potential for diagnosing fertility problems.

  6. Preanalytical management: serum vacuum tubes validation for routine clinical chemistry.

    PubMed

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

    2012-01-01

    The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE, Tube II: LABOR IMPORT, Tube III: S-Monovette, Tube IV: SST and Tube V: SST II) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas 6000 module. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

  7. Simple non-laboratory- and laboratory-based risk assessment algorithms and nomogram for detecting undiagnosed diabetes mellitus.

    PubMed

    Wong, Carlos K H; Siu, Shing-Chung; Wan, Eric Y F; Jiao, Fang-Fang; Yu, Esther Y T; Fung, Colman S C; Wong, Ka-Wai; Leung, Angela Y M; Lam, Cindy L K

    2016-05-01

    The aim of the present study was to develop a simple nomogram that can be used to predict the risk of diabetes mellitus (DM) in the asymptomatic non-diabetic subjects based on non-laboratory- and laboratory-based risk algorithms. Anthropometric data, plasma fasting glucose, full lipid profile, exercise habits, and family history of DM were collected from Chinese non-diabetic subjects aged 18-70 years. Logistic regression analysis was performed on a random sample of 2518 subjects to construct non-laboratory- and laboratory-based risk assessment algorithms for detection of undiagnosed DM; both algorithms were validated on data of the remaining sample (n = 839). The Hosmer-Lemeshow test and area under the receiver operating characteristic (ROC) curve (AUC) were used to assess the calibration and discrimination of the DM risk algorithms. Of 3357 subjects recruited, 271 (8.1%) had undiagnosed DM defined by fasting glucose ≥7.0 mmol/L or 2-h post-load plasma glucose ≥11.1 mmol/L after an oral glucose tolerance test. The non-laboratory-based risk algorithm, with scores ranging from 0 to 33, included age, body mass index, family history of DM, regular exercise, and uncontrolled blood pressure; the laboratory-based risk algorithm, with scores ranging from 0 to 37, added triglyceride level to the risk factors. Both algorithms demonstrated acceptable calibration (Hosmer-Lemeshow test: P = 0.229 and P = 0.483) and discrimination (AUC 0.709 and 0.711) for detection of undiagnosed DM. A simple-to-use nomogram for detecting undiagnosed DM has been developed using validated non-laboratory-based and laboratory-based risk algorithms. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  8. Validation studies and proficiency testing.

    PubMed

    Ankilam, Elke; Heinze, Petra; Kay, Simon; Van den Eede, Guy; Popping, Bert

    2002-01-01

    Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain <1% GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.

  9. Laboratory study of orographic cloud-like flow

    NASA Astrophysics Data System (ADS)

    Singh, Kanwar Nain; Sreenivas, K. R.

    2013-11-01

    Clouds are one of the major sources of uncertainty in climate prediction, listed in ``the most urgent scientific problems requiring attention'' IPCC. Also, convective clouds are of utmost importance to study the dynamics of tropical meteorology and therefore, play a key role in understanding monsoons. The present work is to study the dynamics of orographic clouds. Parameterization of these clouds will help in forecasting the precipitation accurately. Also, one could validate laboratory results from our study by actually measuring cloud development along a sloping terrain. In this context a planar buoyant turbulent wall jet is considered as an appropriate low order fluid-dynamical model for studying the turbulence and entrainment in orographic-clouds. Flow is volumetrically heated to mimic the latent heat release due to condensation in an actual cloud. This is the first step in studying the entrainment dynamics of the evolving orographic cloud. We are going to present some results on the cloud development using techniques that allows us to construct a 3-dimensional flow field at each instance and its development over the time. By combining velocity field from PIV and flow volume from PLIF at successive instances, we estimate the entrainment coefficient. Since the life-cycle of a cloud is determined by the entrainment of ambient air, these results could be extremely helpful in understanding the dynamics of the clouds. Detailed results will be presented at the conference.

  10. Determination of Nitrogen, Phosphorus, and Potassium Release Rates of Slow- and Controlled-Release Fertilizers: Single-Laboratory Validation, First Action 2015.15.

    PubMed

    Thiex, Nancy

    2016-01-01

    A previously validated method for the determination of nitrogen release patterns of slow- and controlled-release fertilizers (SRFs and CRFs, respectively) was submitted to the Expert Review Panel (ERP) for Fertilizers for consideration of First Action Official Method(SM) status. The ERP evaluated the single-laboratory validation results and recommended the method for First Action Official Method status and provided recommendations for achieving Final Action. The 180 day soil incubation-column leaching technique was demonstrated to be a robust and reliable method for characterizing N release patterns from SRFs and CRFs. The method was reproducible, and the results were only slightly affected by variations in environmental factors such as microbial activity, soil moisture, temperature, and texture. The release of P and K were also studied, but at fewer replications than for N. Optimization experiments on the accelerated 74 h extraction method indicated that temperature was the only factor found to substantially influence nutrient-release rates from the materials studied, and an optimized extraction profile was established as follows: 2 h at 25°C, 2 h at 50°C, 20 h at 55°C, and 50 h at 60°C.

  11. 40 CFR 761.395 - A validation study.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false A validation study. 761.395 Section... PROHIBITIONS Comparison Study for Validating a New Performance-Based Decontamination Solvent Under § 761.79(d)(4) § 761.395 A validation study. (a) Decontaminate the following prepared sample surfaces using the...

  12. 40 CFR 761.395 - A validation study.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false A validation study. 761.395 Section... PROHIBITIONS Comparison Study for Validating a New Performance-Based Decontamination Solvent Under § 761.79(d)(4) § 761.395 A validation study. (a) Decontaminate the following prepared sample surfaces using the...

  13. Service Quality and Patient Satisfaction: An Exploratory Study of Pathology Laboratories in Jaipur.

    PubMed

    Agarwal, Anuradha; Singh, Maithili R P

    2016-01-01

    One of the most important parts of healthcare system is diagnostics. Nowadays, Indians have become more aware of their health, due to improved and better availability of health related information, increase in medical tourism, and expanding health insurance. The demand for better diagnostic facilities have increased with the increase in lifestyle related diseases, excesses use of chemicals in agriculture practices and change in food habits. It is expected that the Indian diagnostic market will grow from USD $5 billion in the year 2012 to USD $32 billion by the year 2020 with 20% CAGR (India Brand Equity Foundation 2015 ). Today patients have easy access of information regarding the health services and they have become more concerned about it as they look forward to receiving the maximum value for their money. To win the confidence of the patients and to maintain that trust, it is required to deliver the right services to the right person at the right time. The purpose of this study was to develop a scale to measure the service quality at pathology laboratory. A thorough review of literature revealed that there are studies related to healthcare service quality but there is no such established scale to measure service quality of pathology laboratory. Thus, the authors strived to develop a reliable and valid instrument to measure the patients' perception toward pathology laboratory service quality. For this exploratory study was conducted on the sample of 80 patients of the laboratories in Jaipur city. The reliability and factor structures were tested to purify the scale. The findings revealed 13 items, comprising of three dimensions of service quality: responsiveness, tangibility, and reliability.

  14. 40 CFR 761.395 - A validation study.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 false A validation study. 761.395 Section...)(4) § 761.395 A validation study. (a) Decontaminate the following prepared sample surfaces using the... must be 10 µg/100 cm2, then the validation study failed and the solvent may not be used for...

  15. 40 CFR 761.395 - A validation study.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false A validation study. 761.395 Section...)(4) § 761.395 A validation study. (a) Decontaminate the following prepared sample surfaces using the... must be 10 µg/100 cm2, then the validation study failed and the solvent may not be used for...

  16. 40 CFR 761.395 - A validation study.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false A validation study. 761.395 Section...)(4) § 761.395 A validation study. (a) Decontaminate the following prepared sample surfaces using the... must be 10 µg/100 cm2, then the validation study failed and the solvent may not be used for...

  17. Comparative Validation of Five Quantitative Rapid Test Kits for the Analysis of Salt Iodine Content: Laboratory Performance, User- and Field-Friendliness

    PubMed Central

    Rohner, Fabian; Kangambèga, Marcelline O.; Khan, Noor; Kargougou, Robert; Garnier, Denis; Sanou, Ibrahima; Ouaro, Bertine D.; Petry, Nicolai; Wirth, James P.; Jooste, Pieter

    2015-01-01

    Background Iodine deficiency has important health and development consequences and the introduction of iodized salt as national programs has been a great public health success in the past decades. To render national salt iodization programs sustainable and ensure adequate iodization levels, simple methods to quantitatively assess whether salt is adequately iodized are required. Several methods claim to be simple and reliable, and are available on the market or are in development. Objective This work has validated the currently available quantitative rapid test kits (quantRTK) in a comparative manner for both their laboratory performance and ease of use in field settings. Methods Laboratory performance parameters (linearity, detection and quantification limit, intra- and inter-assay imprecision) were conducted on 5 quantRTK. We assessed inter-operator imprecision using salt of different quality along with the comparison of 59 salt samples from across the globe; measurements were made both in a laboratory and a field setting by technicians and non-technicians. Results from the quantRTK were compared against iodometric titration for validity. An ‘ease-of-use’ rating system was developed to identify the most suitable quantRTK for a given task. Results Most of the devices showed acceptable laboratory performance, but for some of the devices, use by non-technicians revealed poorer performance when working in a routine manner. Of the quantRTK tested, the iCheck® and I-Reader® showed most consistent performance and ease of use, and a newly developed paper-based method (saltPAD) holds promise if further developed. Conclusions User- and field-friendly devices are now available and the most appropriate quantRTK can be selected depending on the number of samples and the budget available. PMID:26401655

  18. Simulating direct shear tests with the Bullet physics library: A validation study.

    PubMed

    Izadi, Ehsan; Bezuijen, Adam

    2018-01-01

    This study focuses on the possible uses of physics engines, and more specifically the Bullet physics library, to simulate granular systems. Physics engines are employed extensively in the video gaming, animation and movie industries to create physically plausible scenes. They are designed to deliver a fast, stable, and optimal simulation of certain systems such as rigid bodies, soft bodies and fluids. This study focuses exclusively on simulating granular media in the context of rigid body dynamics with the Bullet physics library. The first step was to validate the results of the simulations of direct shear testing on uniform-sized metal beads on the basis of laboratory experiments. The difference in the average angle of mobilized frictions was found to be only 1.0°. In addition, a very close match was found between dilatancy in the laboratory samples and in the simulations. A comprehensive study was then conducted to determine the failure and post-failure mechanism. We conclude with the presentation of a simulation of a direct shear test on real soil which demonstrated that Bullet has all the capabilities needed to be used as software for simulating granular systems.

  19. Validation conform ISO-15189 of assays in the field of autoimmunity: Joint efforts in The Netherlands.

    PubMed

    Mulder, Leontine; van der Molen, Renate; Koelman, Carin; van Leeuwen, Ester; Roos, Anja; Damoiseaux, Jan

    2018-05-01

    ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity. Validation data and reports are made available to interested Dutch laboratory specialists. Copyright © 2018 Elsevier B.V. All rights reserved.

  20. A Systematic Planning for Science Laboratory Instruction: Research-Based Evidence

    ERIC Educational Resources Information Center

    Balta, Nuri

    2015-01-01

    The aim of this study is to develop an instructional design model for science laboratory instruction. Well-known ID models were analysed and Dick and Carey model was imitated to produce a science laboratory instructional design (SLID) model. In order to validate the usability of the designed model, the views of 34 high school teachers related to…

  1. Single Laboratory Validated Method for Determination of Microcystins and Nodularin in Ambient Freshwaters by Solid Phase Extraction and Liquid Chromatography/ Tandem Mass Spectrometry (LC/MS/MS)

    EPA Pesticide Factsheets

    This document is a standardized, single laboratory validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the detection of cyanotoxins—microsystins and nodularin (combined intracellular and extracellular)—in ambient freshwaters.

  2. 40 CFR 761.392 - Preparing validation study samples.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Preparing validation study samples..., AND USE PROHIBITIONS Comparison Study for Validating a New Performance-Based Decontamination Solvent Under § 761.79(d)(4) § 761.392 Preparing validation study samples. (a)(1) To validate a procedure to...

  3. 40 CFR 761.392 - Preparing validation study samples.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Preparing validation study samples..., AND USE PROHIBITIONS Comparison Study for Validating a New Performance-Based Decontamination Solvent Under § 761.79(d)(4) § 761.392 Preparing validation study samples. (a)(1) To validate a procedure to...

  4. 29 CFR 1607.5 - General standards for validity studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 4 2010-07-01 2010-07-01 false General standards for validity studies. 1607.5 Section 1607... studies. A. Acceptable types of validity studies. For the purposes of satisfying these guidelines, users may rely upon criterion-related validity studies, content validity studies or construct validity...

  5. Preanalytical management: serum vacuum tubes validation for routine clinical chemistry

    PubMed Central

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

    2012-01-01

    Introduction The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Materials and methods: Blood specimens from 100 volunteers in five diff erent serum vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: SST® and Tube V: SST II®) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas® 6000 module. The significance of the diff erences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Results and conclusions: Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices. PMID:22838184

  6. Analysis of Ethanolamines: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS888

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Owens, J; Vu, A; Koester, C

    The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled 'Analysis of Diethanolamine, Triethanolamine, n-Methyldiethanolamine, and n-Ethyldiethanolamine in Water by Single Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS): EPA Method MS888'. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in 'EPA Method MS888' for analysis of themore » listed ethanolamines in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of 'EPA Method MS888' can be determined.« less

  7. Measuring the face-sensitive N170 with a gaming EEG system: A validation study.

    PubMed

    de Lissa, Peter; Sörensen, Sidsel; Badcock, Nicholas; Thie, Johnson; McArthur, Genevieve

    2015-09-30

    The N170 is a "face-sensitive" event-related potential (ERP) that occurs at around 170ms over occipito-temporal brain regions. The N170's potential to provide insight into the neural processing of faces in certain populations (e.g., children and adults with cognitive impairments) is limited by its measurement in scientific laboratories that can appear threatening to some people. The advent of cheap, easy-to-use portable gaming EEG systems provides an opportunity to record EEG in new contexts and populations. This study tested the validity of the face-sensitive N170 ERP measured with an adapted commercial EEG system (the Emotiv EPOC) that is used at home by gamers. The N170 recorded through both the gaming EEG system and the research EEG system exhibited face-sensitivity, with larger mean amplitudes in response to the face stimuli than the non-face stimuli, and a delayed N170 peak in response to face inversion. The EPOC system produced very similar N170 ERPs to a research-grade Neuroscan system, and was capable of recording face-sensitivity in the N170, validating its use as research tool in this arena. This opens new possibilities for measuring the face-sensitive N170 ERP in people who cannot travel to a traditional ERP laboratory (e.g., elderly people in care), who cannot tolerate laboratory conditions (e.g., people with autism), or who need to be tested in situ for practical or experimental reasons (e.g., children in schools). Copyright © 2015 Elsevier B.V. All rights reserved.

  8. 42 CFR 493.567 - Refusal to cooperate with validation inspection.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Refusal to cooperate with validation inspection... § 493.567 Refusal to cooperate with validation inspection. (a) Laboratory with a certificate of accreditation. (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation...

  9. 42 CFR 493.567 - Refusal to cooperate with validation inspection.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Refusal to cooperate with validation inspection... § 493.567 Refusal to cooperate with validation inspection. (a) Laboratory with a certificate of accreditation. (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation...

  10. 42 CFR 493.567 - Refusal to cooperate with validation inspection.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Refusal to cooperate with validation inspection... § 493.567 Refusal to cooperate with validation inspection. (a) Laboratory with a certificate of accreditation. (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation...

  11. 42 CFR 493.567 - Refusal to cooperate with validation inspection.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Refusal to cooperate with validation inspection... § 493.567 Refusal to cooperate with validation inspection. (a) Laboratory with a certificate of accreditation. (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation...

  12. 42 CFR 493.567 - Refusal to cooperate with validation inspection.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Refusal to cooperate with validation inspection... § 493.567 Refusal to cooperate with validation inspection. (a) Laboratory with a certificate of accreditation. (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation...

  13. Performing a Content Validation Study.

    ERIC Educational Resources Information Center

    Spool, Mark D.

    Content validity is concerned with three components: (1) the job content; (2) the test content, and (3) the strength of the relationship between the two. A content validation study, to be considered adequate and defensible should include at least the following four procedures: (1) A thorough and accurate job analysis (to define the job content);…

  14. Laboratory study of low-β forces in arched, line-tied magnetic flux ropes

    NASA Astrophysics Data System (ADS)

    Myers, C. E.; Yamada, M.; Ji, H.; Yoo, J.; Jara-Almonte, J.; Fox, W.

    2016-11-01

    The loss-of-equilibrium is a solar eruption mechanism whereby a sudden breakdown of the magnetohydrodynamic force balance in the Sun's corona ejects a massive burst of particles and energy into the heliosphere. Predicting a loss-of-equilibrium, which has more recently been formulated as the torus instability, relies on a detailed understanding of the various forces that hold the pre-eruption magnetic flux rope in equilibrium. Traditionally, idealized analytical force expressions are used to derive simplified eruption criteria that can be compared to solar observations and modeling. What is missing, however, is a validation that these idealized analytical force expressions can be applied to the line-tied, low-aspect-ratio conditions of the corona. In this paper, we address this shortcoming by using a laboratory experiment to study the forces that act on long-lived, arched, line-tied magnetic flux ropes. Three key force terms are evaluated over a wide range of experimental conditions: (1) the upward hoop force; (2) the downward strapping force; and (3) the downward toroidal field tension force. First, the laboratory force measurements show that, on average, the three aforementioned force terms cancel to produce a balanced line-tied equilibrium. This finding validates the laboratory force measurement techniques developed here, which were recently used to identify a dynamic toroidal field tension force that can prevent flux rope eruptions [Myers et al., Nature 528, 526 (2015)]. The verification of magnetic force balance also confirms the low-β assumption that the plasma thermal pressure is negligible in these experiments. Next, the measured force terms are directly compared to corresponding analytical expressions. While the measured and analytical forces are found to be well correlated, the low-aspect-ratio, line-tied conditions in the experiment are found to both reduce the measured hoop force and increase the measured tension force with respect to analytical

  15. Laboratory study of low- β forces in arched, line-tied magnetic flux ropes

    DOE PAGES

    Myers, C. E.; Yamada, M.; Ji, H.; ...

    2016-11-04

    Here, the loss-of-equilibrium is a solar eruption mechanism whereby a sudden breakdown of the magnetohydrodynamic force balance in the Sun's corona ejects a massive burst of particles and energy into the heliosphere. Predicting a loss-of-equilibrium, which has more recently been formulated as the torus instability, relies on a detailed understanding of the various forces that hold the pre-eruption magnetic flux rope in equilibrium. Traditionally, idealized analytical force expressions are used to derive simplified eruption criteria that can be compared to solar observations and modeling. What is missing, however, is a validation that these idealized analytical force expressions can be appliedmore » to the line-tied, low-aspect-ratio conditions of the corona. In this paper, we address this shortcoming by using a laboratory experiment to study the forces that act on long-lived, arched, line-tied magnetic flux ropes. Three key force terms are evaluated over a wide range of experimental conditions: (1) the upward hoop force; (2) the downward strapping force; and (3) the downward toroidal field tension force. First, the laboratory force measurements show that, on average, the three aforementioned force terms cancel to produce a balanced line-tied equilibrium. This finding validates the laboratory force measurement techniques developed here, which were recently used to identify a dynamic toroidal field tension force that can prevent flux rope eruption. The verification of magnetic force balance also confirms the low-beta assumption that the plasma thermal pressure is negligible in these experiments. Next, the measured force terms are directly compared to corresponding analytical expressions. While the measured and analytical forces are found to be well correlated, the low-aspect-ratio, line-tied conditions in the experiment are found to both reduce the measured hoop force and increase the measured tension force with respect to analytical expectations. These two co

  16. Laboratory study of low- β forces in arched, line-tied magnetic flux ropes

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Myers, C. E.; Yamada, M.; Ji, H.

    Here, the loss-of-equilibrium is a solar eruption mechanism whereby a sudden breakdown of the magnetohydrodynamic force balance in the Sun's corona ejects a massive burst of particles and energy into the heliosphere. Predicting a loss-of-equilibrium, which has more recently been formulated as the torus instability, relies on a detailed understanding of the various forces that hold the pre-eruption magnetic flux rope in equilibrium. Traditionally, idealized analytical force expressions are used to derive simplified eruption criteria that can be compared to solar observations and modeling. What is missing, however, is a validation that these idealized analytical force expressions can be appliedmore » to the line-tied, low-aspect-ratio conditions of the corona. In this paper, we address this shortcoming by using a laboratory experiment to study the forces that act on long-lived, arched, line-tied magnetic flux ropes. Three key force terms are evaluated over a wide range of experimental conditions: (1) the upward hoop force; (2) the downward strapping force; and (3) the downward toroidal field tension force. First, the laboratory force measurements show that, on average, the three aforementioned force terms cancel to produce a balanced line-tied equilibrium. This finding validates the laboratory force measurement techniques developed here, which were recently used to identify a dynamic toroidal field tension force that can prevent flux rope eruption. The verification of magnetic force balance also confirms the low-beta assumption that the plasma thermal pressure is negligible in these experiments. Next, the measured force terms are directly compared to corresponding analytical expressions. While the measured and analytical forces are found to be well correlated, the low-aspect-ratio, line-tied conditions in the experiment are found to both reduce the measured hoop force and increase the measured tension force with respect to analytical expectations. These two co

  17. Laboratory Validation and Field Assessment of Petroleum Laboratory Technicians' Dermal Exposure to Crude Oil Using a Wipe Sampling Method.

    PubMed

    Galea, Karen S; Mueller, Will; Arfaj, Ayman M; Llamas, Jose L; Buick, Jennifer; Todd, David; McGonagle, Carolyn

    2018-05-21

    Crude oil may cause adverse dermal effects therefore dermal exposure is an exposure route of concern. Galea et al. (2014b) reported on a study comparing recovery (wipe) and interception (cotton glove) dermal sampling methods. The authors concluded that both methods were suitable for assessing dermal exposure to oil-based drilling fluids and crude oil but that glove samplers may overestimate the amount of fluid transferred to the skin. We describe a study which aimed to further evaluate the wipe sampling method to assess dermal exposure to crude oil, with this assessment including extended sample storage periods and sampling efficiency tests being undertaken at environmental conditions to mimic those typical of outdoor conditions in Saudi Arabia. The wipe sampling method was then used to assess the laboratory technicians' actual exposure to crude oil during typical petroleum laboratory tasks. Overall, acceptable storage efficiencies up to 54 days were reported with results suggesting storage stability over time. Sampling efficiencies were also reported to be satisfactory at both ambient and elevated temperature and relative humidity environmental conditions for surrogate skin spiked with known masses of crude oil and left up to 4 h prior to wiping, though there was an indication of reduced sampling efficiency over time. Nineteen petroleum laboratory technicians provided a total of 35 pre- and 35 post-activity paired hand wipe samples. Ninety-three percent of the pre-exposure paired hand wipes were less than the analytical limit of detection (LOD), whereas 46% of the post-activity paired hand wipes were less than the LOD. The geometric mean paired post-activity wipe sample measurement was 3.09 µg cm-2 (range 1.76-35.4 µg cm-2). It was considered that dermal exposure most frequently occurred through direct contact with the crude oil (emission) or via deposition. The findings of this study suggest that the wipe sampling method is satisfactory in quantifying

  18. Structural Test Laboratory | Water Power | NREL

    Science.gov Websites

    Structural Test Laboratory Structural Test Laboratory NREL engineers design and configure structural components can validate models, demonstrate system reliability, inform design margins, and assess , including mass and center of gravity, to ensure compliance with design goals Dynamic Characterization Use

  19. Science Laboratory Environment and Academic Performance

    NASA Astrophysics Data System (ADS)

    Aladejana, Francisca; Aderibigbe, Oluyemisi

    2007-12-01

    The study determined how students assess the various components of their science laboratory environment. It also identified how the laboratory environment affects students' learning outcomes. The modified ex-post facto design was used. A sample of 328 randomly selected students was taken from a population of all Senior Secondary School chemistry students in a state in Nigeria. The research instrument, Science Laboratory Environment Inventory (SLEI) designed and validated by Fraser et al. (Sci Educ 77:1-24, 1993) was administered on the selected students. Data analysis was done using descriptive statistics and Product Moment Correlation. Findings revealed that students could assess the five components (Student cohesiveness, Open-endedness, Integration, Rule clarity, and Material Environment) of the laboratory environment. Student cohesiveness has the highest assessment while material environment has the least. The results also showed that the five components of the science laboratory environment are positively correlated with students' academic performance. The findings are discussed with a view to improving the quality of the laboratory environment, subsequent academic performance in science and ultimately the enrolment and retaining of learners in science.

  20. Development of performance assessment instrument based contextual learning for measuring students laboratory skills

    NASA Astrophysics Data System (ADS)

    Susilaningsih, E.; Khotimah, K.; Nurhayati, S.

    2018-04-01

    The assessment of laboratory skill in general hasn’t specific guideline in assessment, while the individual assessment of students during a performance and skill in performing laboratory is still not been observed and measured properly. Alternative assessment that can be used to measure student laboratory skill is use performance assessment. The purpose of this study was to determine whether the performance assessment instrument that the result of research can be used to assess basic skills student laboratory. This research was conducted by the Research and Development. The result of the data analysis performance assessment instruments developed feasible to implement and validation result 62.5 with very good categories for observation sheets laboratory skills and all of the components with the very good category. The procedure is the preliminary stages of research and development stages. Preliminary stages are divided in two, namely the field studies and literature studies. The development stages are divided into several parts, namely 1) development of the type instrument, 2) validation by an expert, 3) a limited scale trial, 4) large-scale trials and 5) implementation of the product. The instrument included in the category of effective because 26 from 29 students have very high laboratory skill and high laboratory skill. The research of performance assessment instrument is standard and can be used to assess basic skill student laboratory.

  1. Analysis of Carbamate Pesticides: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS666

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Owens, J; Koester, C

    The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for analysis of aldicarb, bromadiolone, carbofuran, oxamyl, and methomyl in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS666. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in MS666 for analysis of carbamatemore » pesticides in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS666 can be determined.« less

  2. Analysis of Phosphonic Acids: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS999

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Owens, J; Vu, A; Koester, C

    The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled Analysis of Diisopropyl Methylphosphonate, Ethyl Hydrogen Dimethylamidophosphate, Isopropyl Methylphosphonic Acid, Methylphosphonic Acid, and Pinacolyl Methylphosphonic Acid in Water by Multiple Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry: EPA Version MS999. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures describedmore » in EPA Method MS999 for analysis of the listed phosphonic acids and surrogates in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of EPA Method MS999 can be determined.« less

  3. Robust diagnosis of non-Hodgkin lymphoma phenotypes validated on gene expression data from different laboratories.

    PubMed

    Bhanot, Gyan; Alexe, Gabriela; Levine, Arnold J; Stolovitzky, Gustavo

    2005-01-01

    A major challenge in cancer diagnosis from microarray data is the need for robust, accurate, classification models which are independent of the analysis techniques used and can combine data from different laboratories. We propose such a classification scheme originally developed for phenotype identification from mass spectrometry data. The method uses a robust multivariate gene selection procedure and combines the results of several machine learning tools trained on raw and pattern data to produce an accurate meta-classifier. We illustrate and validate our method by applying it to gene expression datasets: the oligonucleotide HuGeneFL microarray dataset of Shipp et al. (www.genome.wi.mit.du/MPR/lymphoma) and the Hu95Av2 Affymetrix dataset (DallaFavera's laboratory, Columbia University). Our pattern-based meta-classification technique achieves higher predictive accuracies than each of the individual classifiers , is robust against data perturbations and provides subsets of related predictive genes. Our techniques predict that combinations of some genes in the p53 pathway are highly predictive of phenotype. In particular, we find that in 80% of DLBCL cases the mRNA level of at least one of the three genes p53, PLK1 and CDK2 is elevated, while in 80% of FL cases, the mRNA level of at most one of them is elevated.

  4. Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

    PubMed

    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

  5. Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

    PubMed Central

    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C.; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Background Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Methods Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Results Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Conclusion Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention

  6. Determination of Major Phenolic Compounds in Echinacea spp. Raw Materials and Finished Products by High-Performance Liquid Chromatography with Ultraviolet Detection: Single-Laboratory Validation Matrix Extension

    PubMed Central

    Brown, Paula N.; Chan, Michael; Paley, Lori; Betz, Joseph M.

    2013-01-01

    A method previously validated to determine caftaric acid, chlorogenic acid, cynarin, echinacoside, and cichoric acid in echinacea raw materials has been successfully applied to dry extract and liquid tincture products in response to North American consumer needs. Single-laboratory validation was used to assess the repeatability, accuracy, selectivity, LOD, LOQ, analyte stability (ruggedness), and linearity of the method, with emphasis on finished products. Repeatability precision for each phenolic compound was between 1.04 and 5.65% RSD, with HorRat values between 0.30 and 1.39 for raw and dry extract finished products. HorRat values for tinctures were between 0.09 and 1.10. Accuracy of the method was determined through spike recovery studies. Recovery of each compound from raw material negative control (ginseng) was between 90 and 114%, while recovery from the finished product negative control (maltodextrin and magnesium stearate) was between 97 and 103%. A study was conducted to determine if cichoric acid, a major phenolic component of Echinacea purpurea (L.) Moench and E. angustifolia DC, degrades during sample preparation (extraction) and HPLC analysis. No significant degradation was observed over an extended testing period using the validated method. PMID:22165004

  7. Determination of major phenolic compounds in Echinacea spp. raw materials and finished products by high-performance liquid chromatography with ultraviolet detection: single-laboratory validation matrix extension.

    PubMed

    Brown, Paula N; Chan, Michael; Paley, Lori; Betz, Joseph M

    2011-01-01

    A method previously validated to determine caftaric acid, chlorogenic acid, cynarin, echinacoside, and cichoric acid in echinacea raw materials has been successfully applied to dry extract and liquid tincture products in response to North American consumer needs. Single-laboratory validation was used to assess the repeatability, accuracy, selectivity, LOD, LOQ, analyte stability (ruggedness), and linearity of the method, with emphasis on finished products. Repeatability precision for each phenolic compound was between 1.04 and 5.65% RSD, with HorRat values between 0.30 and 1.39 for raw and dry extract finished products. HorRat values for tinctures were between 0.09 and 1.10. Accuracy of the method was determined through spike recovery studies. Recovery of each compound from raw material negative control (ginseng) was between 90 and 114%, while recovery from the finished product negative control (maltodextrin and magnesium stearate) was between 97 and 103%. A study was conducted to determine if cichoric acid, a major phenolic component of Echinacea purpurea (L.) Moench and E. angustifolia DC, degrades during sample preparation (extraction) and HPLC analysis. No significant degradation was observed over an extended testing period using the validated method.

  8. Validation of measures from the smartphone sway balance application: a pilot study.

    PubMed

    Patterson, Jeremy A; Amick, Ryan Z; Thummar, Tarunkumar; Rogers, Michael E

    2014-04-01

    A number of different balance assessment techniques are currently available and widely used. These include both subjective and objective assessments. The ability to provide quantitative measures of balance and posture is the benefit of objective tools, however these instruments are not generally utilized outside of research laboratory settings due to cost, complexity of operation, size, duration of assessment, and general practicality. The purpose of this pilot study was to assess the value and validity of using software developed to access the iPod and iPhone accelerometers output and translate that to the measurement of human balance. Thirty healthy college-aged individuals (13 male, 17 female; age = 26.1 ± 8.5 years) volunteered. Participants performed a static Athlete's Single Leg Test protocol for 10 sec, on a Biodex Balance System SD while concurrently utilizing a mobile device with balance software. Anterior/posterior stability was recorded using both devices, described as the displacement in degrees from level, and was termed the "balance score." There were no significant differences between the two reported balance scores (p = 0.818. Mean balance score on the balance platform was 1.41 ± 0.90, as compared to 1.38 ± 0.72 using the mobile device. There is a need for a valid, convenient, and cost-effective tool to objectively measure balance. Results of this study are promising, as balance score derived from the Smartphone accelerometers were consistent with balance scores obtained from a previously validated balance system. However, further investigation is necessary as this version of the mobile software only assessed balance in the anterior/posterior direction. Additionally, further testing is necessary on a healthy populations and as well as those with impairment of the motor control system. Level 2b (Observational study of validity)(1.)

  9. Data Validation & Laboratory Quality Assurance for Region 9

    EPA Pesticide Factsheets

    In all hazardous site investigations it is essential to know the quality of the data used for decision-making purposes. Validation of data requires that appropriate quality assurance and quality control (QA/QC) procedures be followed.

  10. Tethered gravity laboratories study

    NASA Technical Reports Server (NTRS)

    Lucchetti, F.

    1990-01-01

    The scope of the study is to investigate ways of controlling the microgravity environment of the International Space Station by means of a tethered system. Four main study tasks were performed. First, researchers analyzed the utilization of the tether systems to improve the lowest possible steady gravity level on the Space Station and the tether capability to actively control the center of gravity position in order to compensate for activities that would upset the mass distribution of the Station. The purpose of the second task was to evaluate the whole of the experiments performable in a variable gravity environment and the related beneficial residual accelerations, both for pure and applied research in the fields of fluid, materials, and life science, so as to assess the relevance of a variable g-level laboratory. The third task involves the Tethered Variable Gravity Laboratory. The use of the facility that would crawl along a deployed tether and expose experiments to varying intensities of reduced gravity is discussed. Last, a study performed on the Attitude Tether Stabilizer concept is discussed. The stabilization effect of ballast masses tethered to the Space Station was investigated as a means of assisting the attitude control system of the Station.

  11. Human Laboratory Studies on Cannabinoids and Psychosis.

    PubMed

    Sherif, Mohamed; Radhakrishnan, Rajiv; D'Souza, Deepak Cyril; Ranganathan, Mohini

    2016-04-01

    Some of the most compelling evidence supporting an association between cannabinoid agonists and psychosis comes from controlled laboratory studies in humans. Randomized, double-blind, placebo-controlled, crossover laboratory studies demonstrate that cannabinoid agonists, including phytocannabinoids and synthetic cannabinoids, produce a wide range of positive, negative, and cognitive symptoms and psychophysiologic deficits in healthy human subjects that resemble the phenomenology of schizophrenia. These effects are time locked to drug administration, are dose related, and are transient and rarely necessitate intervention. The magnitude of effects is similar to the effects of ketamine but qualitatively distinct from other psychotomimetic drugs, including ketamine, amphetamine, and salvinorin A. Cannabinoid agonists have also been shown to transiently exacerbate symptoms in individuals with schizophrenia in laboratory studies. Patients with schizophrenia are more vulnerable than healthy control subjects to the acute behavioral and cognitive effects of cannabinoid agonists and experience transient exacerbation of symptoms despite treatment with antipsychotic medications. Furthermore, laboratory studies have failed to demonstrate any "beneficial" effects of cannabinoid agonists in individuals with schizophrenia-challenging the cannabis self-medication hypothesis. Emerging evidence suggests that polymorphisms of several genes related to dopamine metabolism (e.g., COMT, DAT1, and AKT1) may moderate the effects of cannabinoid agonists in laboratory studies. Cannabinoid agonists induce dopamine release, although the magnitude of release does not appear to be commensurate to the magnitude and spectrum of their acute psychotomimetic effects. Interactions between the endocannabinoid, gamma-aminobutyric acid, and glutamate systems and their individual and interactive effects on neural oscillations provide a plausible mechanism underlying the psychotomimetic effects of

  12. K(3)EDTA Vacuum Tubes Validation for Routine Hematological Testing.

    PubMed

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Poli, Giovanni; Solero, Giovanni Pietro; Picheth, Geraldo; Guidi, Gian Cesare

    2012-01-01

    Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K(3)EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K(3)EDTA vacuum tubes were collected by a single, expert phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand's tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests.

  13. Probability of Detection (POD) as a statistical model for the validation of qualitative methods.

    PubMed

    Wehling, Paul; LaBudde, Robert A; Brunelle, Sharon L; Nelson, Maria T

    2011-01-01

    A statistical model is presented for use in validation of qualitative methods. This model, termed Probability of Detection (POD), harmonizes the statistical concepts and parameters between quantitative and qualitative method validation. POD characterizes method response with respect to concentration as a continuous variable. The POD model provides a tool for graphical representation of response curves for qualitative methods. In addition, the model allows comparisons between candidate and reference methods, and provides calculations of repeatability, reproducibility, and laboratory effects from collaborative study data. Single laboratory study and collaborative study examples are given.

  14. Validation of a quantitative cerebrospinal fluid alpha-synuclein assay in a European-wide interlaboratory study.

    PubMed

    Kruse, Niels; Persson, Staffan; Alcolea, Daniel; Bahl, Justyna M C; Baldeiras, Ines; Capello, Elisabetta; Chiasserini, Davide; Bocchio Chiavetto, Luisella; Emersic, Andreja; Engelborghs, Sebastiaan; Eren, Erden; Fladby, Tormod; Frisoni, Giovanni; García-Ayllón, María-Salud; Genc, Sermin; Gkatzima, Olymbia; Heegaard, Niels H H; Janeiro, André M; Kováčech, Branislav; Kuiperij, H Bea; Leitão, Maria J; Lleó, Alberto; Martins, Madalena; Matos, Mafalda; Mollergard, Hanne M; Nobili, Flavio; Öhrfelt, Annika; Parnetti, Lucilla; de Oliveira, Catarina Resende; Rot, Uros; Sáez-Valero, Javier; Struyfs, Hanne; Tanassi, Julia T; Taylor, Peggy; Tsolaki, Magda; Vanmechelen, Eugeen; Verbeek, Marcel M; Zilka, Norbert; Blennow, Kaj; Zetterberg, Henrik; Mollenhauer, Brit

    2015-09-01

    Decreased levels of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) in Parkinson's disease and related synucleinopathies have been reported, however, not consistently in all cross-sectional studies. To test the performance of one recently released human-specific enzyme-linked immunosorbent assay (ELISA) for the quantification of aSyn in CSF, we carried out a round robin trial with 18 participating laboratories trained in CSF ELISA analyses within the BIOMARKAPD project in the EU Joint Program - Neurodegenerative Disease Research. CSF samples (homogeneous aliquots from pools) and ELISA kits (one lot) were provided centrally and data reported back to one laboratory for data analysis. Our study showed that although factors such as preanalytical sample handling and lot-to-lot variability were minimized by our study design, we identified high variation in absolute values of CSF aSyn even when the same samples and same lots of assays were applied. We further demonstrate that although absolute concentrations differ between laboratories the quantitative results are comparable. With further standardization this assay may become an attractive tool for comparing aSyn measurements in diverse settings. Recommendations for further validation experiments and improvement of the interlaboratory results obtained are given. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation.

    PubMed

    Park, Dae-Sung; Lee, GyuChang

    2014-06-10

    A balance test provides important information such as the standard to judge an individual's functional recovery or make the prediction of falls. The development of a tool for a balance test that is inexpensive and widely available is needed, especially in clinical settings. The Wii Balance Board (WBB) is designed to test balance, but there is little software used in balance tests, and there are few studies on reliability and validity. Thus, we developed a balance assessment software using the Nintendo Wii Balance Board, investigated its reliability and validity, and compared it with a laboratory-grade force platform. Twenty healthy adults participated in our study. The participants participated in the test for inter-rater reliability, intra-rater reliability, and concurrent validity. The tests were performed with balance assessment software using the Nintendo Wii balance board and a laboratory-grade force platform. Data such as Center of Pressure (COP) path length and COP velocity were acquired from the assessment systems. The inter-rater reliability, the intra-rater reliability, and concurrent validity were analyzed by an intraclass correlation coefficient (ICC) value and a standard error of measurement (SEM). The inter-rater reliability (ICC: 0.89-0.79, SEM in path length: 7.14-1.90, SEM in velocity: 0.74-0.07), intra-rater reliability (ICC: 0.92-0.70, SEM in path length: 7.59-2.04, SEM in velocity: 0.80-0.07), and concurrent validity (ICC: 0.87-0.73, SEM in path length: 5.94-0.32, SEM in velocity: 0.62-0.08) were high in terms of COP path length and COP velocity. The balance assessment software incorporating the Nintendo Wii balance board was used in our study and was found to be a reliable assessment device. In clinical settings, the device can be remarkably inexpensive, portable, and convenient for the balance assessment.

  16. STR-validator: an open source platform for validation and process control.

    PubMed

    Hansson, Oskar; Gill, Peter; Egeland, Thore

    2014-11-01

    This paper addresses two problems faced when short tandem repeat (STR) systems are validated for forensic purposes: (1) validation is extremely time consuming and expensive, and (2) there is strong consensus about what to validate but not how. The first problem is solved by powerful data processing functions to automate calculations. Utilising an easy-to-use graphical user interface, strvalidator (hereafter referred to as STR-validator) can greatly increase the speed of validation. The second problem is exemplified by a series of analyses, and subsequent comparison with published material, highlighting the need for a common validation platform. If adopted by the forensic community STR-validator has the potential to standardise the analysis of validation data. This would not only facilitate information exchange but also increase the pace at which laboratories are able to switch to new technology. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Determination of Yohimbine in Yohimbe Bark and Related Dietary Supplements Using UHPLC-UV/MS: Single-Laboratory Validation.

    PubMed

    Chen, Pei; Bryden, Noella

    2015-01-01

    A single-laboratory validation was performed on a practical ultra-HPLC (UHPLC)-diode array detector (DAD)/tandem MS method for determination of yohimbine in yohimbe barks and related dietary supplements. Good separation was achieved using a Waters Acquity ethylene bridged hybrid C18 column with gradient elution using 0.1% (v/v) aqueous ammonium hydroxide and 0.1% ammonium hydroxide in methanol as the mobile phases. The method can separate corynanthine from yohimbine in yohimbe bark extract, which is critical for accurate quantitation of yohimbine in yohimbe bark and related dietary supplements. Accuracy of the method was demonstrated using standard addition methods. Both intraday and interday precisions of the method were good. The method can be used without MS since yohimbine concentration in yohimbe barks and related dietary supplements are usually high enough for DAD detection, which can make it an easy and economical method for routine analysis of yohimbe barks and related dietary supplements. On the other hand, the method can be used with MS if desired for more challenging work such as biological and/or clinical studies.

  18. Case Studies in Sustainability Used in an Introductory Laboratory Course to Enhance Laboratory Instruction

    ERIC Educational Resources Information Center

    Luster-Teasley, Stephanie; Hargrove-Leak, Sirena; Gibson, Willietta; Leak, Roland

    2017-01-01

    This educational research seeks to develop novel laboratory modules by using Case Studies in the Science Teaching method to introduce sustainability and environmental engineering laboratory concepts to 21st century learners. The increased interest in "going green" has led to a surge in the number of engineering students studying…

  19. [Reducing the use of laboratory animals].

    PubMed

    Claude, Nancy

    2009-11-01

    Since 1959, when Russel and Burch formulated the 3Rs principle (Reduce, Replace, Refine), the scientific community has been attempting to reduce the use of laboratory animals for research purposes. Current regulatory guidelines take this principle into account. Thanks to scientific and technical progress, and advances in bioinformatics, new tools are now available that reduce the need for laboratory animals, albeit without totally replacing them. Implementation of the International Conference on Harmonization recommendations in 1990 represented a major step forward, notably by helping to avoid duplication of studies using laboratory animals. The use of animals for cosmetics testing is now forbidden in the European Union. Although new in vitro and in silico models remain to be validated, they are proving particularly useful during the early stages of product development, by avoiding experimental studies of chemicals that are ineffective or excessively toxic. The success of these measures is reflected in the results of a European study showing a fall, between 1996 and 2005, in the number of laboratory animals used for research and development, despite a large increase in overall research activities. The challenge for the next decade is to amplify this trend.

  20. Design and validation of a multimethod assessment of metacognition and study of the effectiveness of Metacognitive Interventions

    NASA Astrophysics Data System (ADS)

    Sandi-Urena, Guillermo Santiago

    The central role of metacognition in learning and problem solving, in general and in chemistry in specific, has been substantially demonstrated and has raised pronounced interest in its study. However, the intrinsic difficulties associated with the inner processes of such a non-overt behavior have delayed the development of appropriate assessment instruments. The first research question addressed in this work originates from this observation: Is it possible to reliably assess metacognition use in chemistry problem solving? This study presents the development, validation, and application of a multimethod instrument for the assessment of metacognition use in chemistry problem solving. This multimethod is composed of two independent methods used at different times in relation to the task performance: (1) the prospective Metacognitive Activities Inventory, MCA-I; and (2) the concurrent Interactive MultiMedia Exercises software package, IMMEX. This work also includes the design, development, and validation of the MCA-I; evidence is discussed that supports its robustness, reliability and validity. Even though IMMEX is well-developed, its utilization as a metacognition assessment tool is novel and explained within this work. Among the benefits of utilizing IMMEX are: the automation of concurrent evidence collection and analysis which allows for the participation of large cohorts, the elimination of subjective assessments, and the collection of data in the absence of observers which presumably favors a more realistic deployment of skills by the participants. The independent instruments produced convergent results and the multimethod designed was proven to be reliable, robust and valid for the intended purpose. The second guiding question refers to the development of metacognition: Can regulatory metacognition use be enhanced by learning environments? Two interventions were utilized to explore this inquiry: a Collaborative Metacognitive Intervention and a Cooperative

  1. Quantifying Human Movement Using the Movn Smartphone App: Validation and Field Study

    PubMed Central

    2017-01-01

    Background The use of embedded smartphone sensors offers opportunities to measure physical activity (PA) and human movement. Big data—which includes billions of digital traces—offers scientists a new lens to examine PA in fine-grained detail and allows us to track people’s geocoded movement patterns to determine their interaction with the environment. Objective The objective of this study was to examine the validity of the Movn smartphone app (Moving Analytics) for collecting PA and human movement data. Methods The criterion and convergent validity of the Movn smartphone app for estimating energy expenditure (EE) were assessed in both laboratory and free-living settings, compared with indirect calorimetry (criterion reference) and a stand-alone accelerometer that is commonly used in PA research (GT1m, ActiGraph Corp, convergent reference). A supporting cross-validation study assessed the consistency of activity data when collected across different smartphone devices. Global positioning system (GPS) and accelerometer data were integrated with geographical information software to demonstrate the feasibility of geospatial analysis of human movement. Results A total of 21 participants contributed to linear regression analysis to estimate EE from Movn activity counts (standard error of estimation [SEE]=1.94 kcal/min). The equation was cross-validated in an independent sample (N=42, SEE=1.10 kcal/min). During laboratory-based treadmill exercise, EE from Movn was comparable to calorimetry (bias=0.36 [−0.07 to 0.78] kcal/min, t82=1.66, P=.10) but overestimated as compared with the ActiGraph accelerometer (bias=0.93 [0.58-1.29] kcal/min, t89=5.27, P<.001). The absolute magnitude of criterion biases increased as a function of locomotive speed (F1,4=7.54, P<.001) but was relatively consistent for the convergent comparison (F1,4=1.26, P<.29). Furthermore, 95% limits of agreement were consistent for criterion and convergent biases, and EE from Movn was strongly

  2. Analysis of cocoa flavanols and procyanidins (DP 1-10) in cocoa-containing ingredients and products by rapid resolution liquid chromatography: single-laboratory validation.

    PubMed

    Machonis, Philip R; Jones, Matthew A; Kwik-Uribe, Catherine

    2014-01-01

    Recently, a multilaboratory validation (MLV) of AOAC Official Method 2012.24 for the determination of cocoa flavanols and procyanidins (CF-CP) in cocoa-based ingredients and products determined that the method was robust, reliable, and transferrable. Due to the complexity of the CF-CP molecules, this method required a run time exceeding 1 h to achieve acceptable separations. To address this issue, a rapid resolution normal phase LC method was developed, and a single-laboratory validation (SLV) study conducted. Flavanols and procyanidins with a degree of polymerization (DP) up to 10 were eluted in 15 min using a binary gradient applied to a diol stationary phase, detected using fluorescence detection, and reported as a total sum of DP 1-10. Quantification was achieved using (-)-epicatechin-based relative response factors for DP 2-10. Spike recovery samples and seven different types of cocoa-based samples were analyzed to evaluate the accuracy, precision, LOD, LOQ, and linearity of the method. The within-day precision of the reported content for the samples was 1.15-5.08%, and overall precision was 3.97-13.61%. Spike-recovery experiments demonstrated recoveries of over 98%. The results of this SLV were compared to those previously obtained in the MLV and found to be consistent. The translation to rapid resolution LC allowed for an 80% reduction in analysis time and solvent usage, while retaining the accuracy and reliability of the original method. The savings in both cost and time of this rapid method make it well-suited for routine laboratory use.

  3. Preliminary Validation and Reliability Testing of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians, in a Colony of Laboratory Cats.

    PubMed

    Klinck, Mary P; Rialland, Pascale; Guillot, Martin; Moreau, Maxim; Frank, Diane; Troncy, Eric

    2015-12-02

    Subtle signs and conflicting physical and radiographic findings make feline osteoarthritis (OA) challenging to diagnose. A physical examination-based assessment was developed, consisting of eight items: Interaction, Exploration, Posture, Gait, Body Condition, Coat and Claws, (joint) Palpation-Findings, and Palpation-Cat Reaction. Content (experts) and face (veterinary students) validity were excellent. Construct validity, internal consistency, and intra- and inter-rater reliability were assessed via a pilot and main study, using laboratory-housed cats with and without OA. Gait distinguished OA status in the pilot ( p = 0.05) study. In the main study, no scale item achieved statistically significant OA detection. Forelimb peak vertical ground reaction force (PVF) correlated inversely with Gait (Rho s = -0.38 ( p = 0.03) to -0.41 ( p = 0.02)). Body Posture correlated with Gait, and inversely with forelimb PVF at two of three time points (Rho s = -0.38 ( p = 0.03) to -0.43 ( p = 0.01)). Palpation (Findings, Cat Reaction) did not distinguish OA from non-OA cats. Palpation-Cat Reaction (Forelimbs) correlated inversely with forelimb PVF at two time points (Rho s = -0.41 ( p = 0.02) to -0.41 ( p = 0.01)), but scores were highly variable, and poorly reliable. Gait and Posture require improved sensitivity, and Palpation should be interpreted cautiously, in diagnosing feline OA.

  4. Laboratory development and testing of spacecraft diagnostics

    NASA Astrophysics Data System (ADS)

    Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric

    2017-10-01

    The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.

  5. Determination of catechins and caffeine in camillia sinensis raw materials, extracts, and dietary supplements by HPLC-uv: single-laboratory validation.

    PubMed

    Roman, Mark C

    2013-01-01

    A rapid method has been developed to quantify seven catechins and caffeine in green tea (Camillia sinensis) raw material and powdered extract, and dietary supplements containing green tea extract. The method utilizes RP HPLC with a phenyl-based stationary phase and gradient elution. Detection is by UV absorbance. The total run time, including column re-equilibration, is 13 min. Single-laboratory validation (SLV) has been performed on the method to determine the repeatability, accuracy, selectivity, LOD, LOQ, ruggedness, and linearity for (+)-catechin, (-)-epicatechin, (-)-epicatechin gallate, (-)-epigallocatechin, (-)-gallocatechin gallate, (-)-epigallocatechin gallate, and (+)-gallocatechin, as well as caffeine. Repeatability precision and recovery results met AOAC guidelines for SLV studies for all catechins and caffeine down to a level of approximately 20 mg/g. Finished products containing high concentrations of minerals require the use of EDTA to prevent decomposition of the catechins.

  6. Intra- and inter-laboratory validation of a dipstick immunoassay for the detection of tropane alkaloids hyoscyamine and scopolamine in animal feed.

    PubMed

    Mulder, Patrick P J; von Holst, Christoph; Nivarlet, Noan; van Egmond, Hans P

    2014-01-01

    Tropane alkaloids (TAs) are toxic secondary metabolites produced by plants of, inter alia, the genera Datura (thorn apple) and Atropa (deadly nightshade). The most relevant TAs are (-)-L-hyoscyamine and (-)-L-scopolamine, which act as antagonists of acetylcholine muscarinic receptors and can induce a variety of distinct toxic syndromes in mammals (anti-cholinergic poisoning). The European Union has regulated the presence of seeds of Datura sp. in animal feeds, specifying that the content should not exceed 1000 mg kg(-1) (Directive 2002/32/EC). For materials that have not been ground, visual screening methods are often used to comply with these regulations, but these cannot be used for ground materials and compound feeds. Immunological assays, preferably in dipstick format, can be a simple and cost-effective approach to monitor feedstuffs in an HACCP setting in control laboratories. So far no reports have been published on immunoassays that are capable of detecting both hyoscyamine and scopolamine with equal sensitivity and that can be used, preferably in dipstick format, for application as a fast screening tool in feed analysis. This study presents the results obtained for the in-house and inter-laboratory validation of a dipstick immunoassay for the detection of hyoscyamine and scopolamine in animal feed. The target level was set at 800 µg kg(-1) for the sum of both alkaloids. By using a representative set of compound feeds during validation and a robust study design, a reliable impression of the relevant characteristics of the assay could be obtained. The dipstick test displayed similar sensitivity towards the two alkaloids and it could be concluded that the test has a very low probability of producing a false-positive result at blank level or a false-negative result at target level. The assay can be used for monitoring of TAs in feedstuffs, but has also potential as a quick screening tool in food- or feed-related poisonings.

  7. Validation of the Apnea Risk Evaluation System (ARES) Device Against Laboratory Polysomnography in Pregnant Women at Risk for Obstructive Sleep Apnea Syndrome

    PubMed Central

    Sharkey, Katherine M.; Waters, Kelly; Millman, Richard P.; Moore, Robin; Martin, Susan M.; Bourjeily, Ghada

    2014-01-01

    Study Objective: To assess the validity of using the Apnea Risk Evaluation System (ARES) Unicorder for detecting obstructive sleep apnea (OSA) in pregnant women. Methods: Sixteen pregnant women, mean age (SD) = 29.8 (5.4) years, average gestational age (SD) = 28.6 (6.3) weeks, mean body mass index (SD) = 44.7 (6.9) kg/m2 with signs and symptoms of OSA wore the ARES Unicorder during one night of laboratory polysomnography (PSG). PSG was scored according to AASM 2007 criteria, and PSG AHI and RDI were compared to the ARES 1%, 3%, and 4% AHIs calculated with the ARES propriety software. Results: Median PSG AHI and PSG RDI were 3.1 and 10.3 events/h of sleep, respectively. Six women had a PSG AHI ≥ 5 events/h of sleep and 11 had a PSG RDI ≥ 5 events/h of sleep. PSG AHI and RDI were strongly correlated with the ARES AHI measures. When compared with polysomnographic diagnosis of OSA, the ARES 3% algorithm provided the best balance between sensitivity (1.0 for PSG AHI, 0.91 for PSG RDI) and specificity (0.5 for PSG AHI, 0.8 for PSG RDI) for detecting sleep disordered breathing in our sample. Conclusions: The ARES Unicorder demonstrated reasonable consistency with PSG for diagnosing OSA in this small, heterogeneous sample of obese pregnant women. Citation: Sharkey KM, Waters K, Millman RP, Moore R, Martin SM, Bourjeily G. Validation of the Apnea Risk Evaluation System (ARES) device against laboratory polysomnography in pregnant women at risk for obstructive sleep apnea syndrome. J Clin Sleep Med 2014;10(5):497-502. PMID:24910550

  8. [External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

    PubMed

    Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado

    2015-01-01

    This study aims to evaluate the performance of a few biochemistry analysis and make recommendations to the place of the stakeholders. It is a cross-sectional study conducted between the October 1(st), 2012 and the July 31, 2013 bearing on the results of 5 common examinations of clinical biochemistry, provided by 11 laboratories volunteers opening in the public and private sectors. These laboratories have analysed during the 3 cycles, 2 levels (medium and high) of serum concentration of urea, glucose, creatinine and serum aminotransferases. The performance of laboratories have been determined from the acceptable limits corresponding to the limits of total errors, defined by the French Society of Clinical Biology (SFBC). A system of internal quality control is implemented by all laboratories and 45% of them participated in international programs of external quality assessment (EQA). The rate of acceptable results for the entire study was of 69%. There was a significant difference (p<0.002) between the performance of the group of laboratories engaged in a quality approach and the group with default implementation of the quality approach. Also a significant difference was observed between the laboratories of the central level and those of the peripheral level of our health system (p<0.047). The performance of the results provided by the laboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

  9. Automation and validation of DNA-banking systems.

    PubMed

    Thornton, Melissa; Gladwin, Amanda; Payne, Robin; Moore, Rachael; Cresswell, Carl; McKechnie, Douglas; Kelly, Steve; March, Ruth

    2005-10-15

    DNA banking is one of the central capabilities on which modern genetic research rests. The DNA-banking system plays an essential role in the flow of genetic data from patients and genetics researchers to the application of genetic research in the clinic. Until relatively recently, large collections of DNA samples were not common in human genetics. Now, collections of hundreds of thousands of samples are common in academic institutions and private companies. Automation of DNA banking can dramatically increase throughput, eliminate manual errors and improve the productivity of genetics research. An increased emphasis on pharmacogenetics and personalized medicine has highlighted the need for genetics laboratories to operate within the principles of a recognized quality system such as good laboratory practice (GLP). Automated systems are suitable for such laboratories but require a level of validation that might be unfamiliar to many genetics researchers. In this article, we use the AstraZeneca automated DNA archive and reformatting system (DART) as a case study of how such a system can be successfully developed and validated within the principles of GLP.

  10. Validity Studies of the Filial Anxiety Scale.

    ERIC Educational Resources Information Center

    Murray, Paul D.; And Others

    1996-01-01

    Factor analytic and construct validity studies were conducted to explore the validity of Cicirelli's 13-item Filial Anxiety Scale (FAS). The State-Trait Anxiety Inventory and the Marlowe-Crowne Social Desirability Scale were a part of the investigation. Results offer support for the validity of the FAS subscales and the FAS' usefulness as an…

  11. Simulators' validation study: Problem solution logic

    NASA Technical Reports Server (NTRS)

    Schoultz, M. B.

    1974-01-01

    A study was conducted to validate the ground based simulators used for aircraft environment in ride-quality research. The logic to the approach for solving this problem is developed. The overall problem solution flow chart is presented. The factors which could influence the human response to the environment on board the aircraft are analyzed. The mathematical models used in the study are explained. The steps which were followed in conducting the validation tests are outlined.

  12. Standardization of Laboratory Methods for the PERCH Study

    PubMed Central

    Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

    2017-01-01

    Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

  13. Validation of Metagenomic Next-Generation Sequencing Tests for Universal Pathogen Detection.

    PubMed

    Schlaberg, Robert; Chiu, Charles Y; Miller, Steve; Procop, Gary W; Weinstock, George

    2017-06-01

    - Metagenomic sequencing can be used for detection of any pathogens using unbiased, shotgun next-generation sequencing (NGS), without the need for sequence-specific amplification. Proof-of-concept has been demonstrated in infectious disease outbreaks of unknown causes and in patients with suspected infections but negative results for conventional tests. Metagenomic NGS tests hold great promise to improve infectious disease diagnostics, especially in immunocompromised and critically ill patients. - To discuss challenges and provide example solutions for validating metagenomic pathogen detection tests in clinical laboratories. A summary of current regulatory requirements, largely based on prior guidance for NGS testing in constitutional genetics and oncology, is provided. - Examples from 2 separate validation studies are provided for steps from assay design, and validation of wet bench and bioinformatics protocols, to quality control and assurance. - Although laboratory and data analysis workflows are still complex, metagenomic NGS tests for infectious diseases are increasingly being validated in clinical laboratories. Many parallels exist to NGS tests in other fields. Nevertheless, specimen preparation, rapidly evolving data analysis algorithms, and incomplete reference sequence databases are idiosyncratic to the field of microbiology and often overlooked.

  14. Culture Training: Validation Evidence for the Culture Assimilator.

    ERIC Educational Resources Information Center

    Mitchell, Terence R.; And Others

    The culture assimilator, a programed self-instructional approach to culture training, is described and a series of laboratory experiments and field studies validating the culture assimilator are reviewed. These studies show that the culture assimilator is an effective method of decreasing some of the stress experienced when one works with people…

  15. [Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

    PubMed

    Ishibashi, Midori

    2015-01-01

    The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

  16. European external quality control study on the competence of laboratories to recognize rare sequence variants resulting in unusual genotyping results.

    PubMed

    Márki-Zay, János; Klein, Christoph L; Gancberg, David; Schimmel, Heinz G; Dux, László

    2009-04-01

    Depending on the method used, rare sequence variants adjacent to the single nucleotide polymorphism (SNP) of interest may cause unusual or erroneous genotyping results. Because such rare variants are known for many genes commonly tested in diagnostic laboratories, we organized a proficiency study to assess their influence on the accuracy of reported laboratory results. Four external quality control materials were processed and sent to 283 laboratories through 3 EQA organizers for analysis of the prothrombin 20210G>A mutation. Two of these quality control materials contained sequence variants introduced by site-directed mutagenesis. One hundred eighty-nine laboratories participated in the study. When samples gave a usual result with the method applied, the error rate was 5.1%. Detailed analysis showed that more than 70% of the failures were reported from only 9 laboratories. Allele-specific amplification-based PCR had a much higher error rate than other methods (18.3% vs 2.9%). The variants 20209C>T and [20175T>G; 20179_20180delAC] resulted in unusual genotyping results in 67 and 85 laboratories, respectively. Eighty-three (54.6%) of these unusual results were not recognized, 32 (21.1%) were attributed to technical issues, and only 37 (24.3%) were recognized as another sequence variant. Our findings revealed that some of the participating laboratories were not able to recognize and correctly interpret unusual genotyping results caused by rare SNPs. Our study indicates that the majority of the failures could be avoided by improved training and careful selection and validation of the methods applied.

  17. Analytical validation of a reference laboratory ELISA for the detection of feline leukemia virus p27 antigen.

    PubMed

    Buch, Jesse S; Clark, Genevieve H; Cahill, Roberta; Thatcher, Brendon; Smith, Peter; Chandrashekar, Ramaswamy; Leutenegger, Christian M; O'Connor, Thomas P; Beall, Melissa J

    2017-09-01

    Feline leukemia virus (FeLV) is an oncogenic retrovirus of cats. Immunoassays for the p27 core protein of FeLV aid in the detection of FeLV infections. Commercial microtiter-plate ELISAs have rapid protocols and visual result interpretation, limiting their usefulness in high-throughput situations. The purpose of our study was to validate the PetChek FeLV 15 ELISA, which is designed for the reference laboratory, and incorporates sequential, orthogonal screening and confirmatory protocols. A cutoff for the screening assay was established with 100% accuracy using 309 feline samples (244 negative, 65 positive) defined by the combined results of FeLV PCR and an independent reference p27 antigen ELISA. Precision of the screening assay was measured using a panel of 3 samples (negative, low-positive, and high-positive). The intra-assay coefficient of variation (CV) was 3.9-7.9%; the inter-assay CV was 6.0-8.6%. For the confirmatory assay, the intra-assay CV was 3.0-4.7%, and the inter-assay CV was 7.4-9.7%. The analytical sensitivity for p27 antigen was 3.7 ng/mL for inactivated whole FeLV and 1.2 ng/mL for purified recombinant FeLV p27. Analytical specificity was demonstrated based on the absence of cross-reactivity to related retroviruses. No interference was observed for samples containing added bilirubin, hemoglobin, or lipids. Based on these results, the new high-throughput design of the PetChek FeLV 15 ELISA makes it suitable for use in reference laboratory settings and maintains overall analytical performance.

  18. K3EDTA Vacuum Tubes Validation for Routine Hematological Testing

    PubMed Central

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Poli, Giovanni; Solero, Giovanni Pietro; Picheth, Geraldo; Guidi, Gian Cesare

    2012-01-01

    Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand's tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests. PMID:22888448

  19. Achieving external validity in home advantage research: generalizing crowd noise effects

    PubMed Central

    Myers, Tony D.

    2014-01-01

    Different factors have been postulated to explain the home advantage phenomenon in sport. One plausible explanation investigated has been the influence of a partisan home crowd on sports officials' decisions. Different types of studies have tested the crowd influence hypothesis including purposefully designed experiments. However, while experimental studies investigating crowd influences have high levels of internal validity, they suffer from a lack of external validity; decision-making in a laboratory setting bearing little resemblance to decision-making in live sports settings. This focused review initially considers threats to external validity in applied and theoretical experimental research. Discussing how such threats can be addressed using representative design by focusing on a recently published study that arguably provides the first experimental evidence of the impact of live crowd noise on officials in sport. The findings of this controlled experiment conducted in a real tournament setting offer a level of confirmation of the findings of laboratory studies in the area. Finally directions for future research and the future conduct of crowd noise studies are discussed. PMID:24917839

  20. Microbial ecology laboratory procedures manual NASA/MSFC

    NASA Technical Reports Server (NTRS)

    Huff, Timothy L.

    1990-01-01

    An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

  1. Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins.

    PubMed

    Gross, S; Janssen, S W J; de Vries, B; Terao, E; Daas, A; Buchheit, K-H

    2010-07-01

    An international collaborative study to validate 2 alternative in vitro methods for the potency testing of human tetanus immunoglobulin products was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The study, run in the framework of the Biological Standardisation Programme (BSP) under the aegis of the European Commission and the Council of Europe, involved 21 official medicines control and industry laboratories from 15 countries. Both methods, an enzyme-linked immunoassay (EIA) and a toxoid inhibition assay (TIA), showed good reproducibility, repeatability and precision. EIA and TIA discriminated between low, medium and high potency samples. Potency estimates correlated well and both values were in close agreement with those obtained by in vivo methods. Moreover, these alternative methods allowed to resolve discrepant results between laboratories that were due to product potency loss and reporting errors. The study demonstrated that EIA and TIA are suitable quality control methods for tetanus immunoglobulin, which can be standardised in a control laboratory using a quality assurance system. Consequently, the Group of Experts on Human Blood and Blood Products of the European Pharmacopoeia revised the monograph on human tetanus immunoglobulins to include both the methods as compendial alternatives to the in vivo mouse challenge assay. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

  2. Using wound care algorithms: a content validation study.

    PubMed

    Beitz, J M; van Rijswijk, L

    1999-09-01

    Valid and reliable heuristic devices facilitating optimal wound care are lacking. The objectives of this study were to establish content validation data for a set of wound care algorithms, to identify their associated strengths and weaknesses, and to gain insight into the wound care decision-making process. Forty-four registered nurse wound care experts were surveyed and interviewed at national and regional educational meetings. Using a cross-sectional study design and an 83-item, 4-point Likert-type scale, this purposive sample was asked to quantify the degree of validity of the algorithms' decisions and components. Participants' comments were tape-recorded, transcribed, and themes were derived. On a scale of 1 to 4, the mean score of the entire instrument was 3.47 (SD +/- 0.87), the instrument's Content Validity Index was 0.86, and the individual Content Validity Index of 34 of 44 participants was > 0.8. Item scores were lower for those related to packing deep wounds (P < .001). No other significant differences were observed. Qualitative data analysis revealed themes of difficulty associated with wound assessment and care issues, that is, the absence of valid and reliable definitions. The wound care algorithms studied proved valid. However, the lack of valid and reliable wound assessment and care definitions hinders optimal use of these instruments. Further research documenting their clinical use is warranted. Research-based practice recommendations should direct the development of future valid and reliable algorithms designed to help nurses provide optimal wound care.

  3. Reliability and validity of ten consumer activity trackers.

    PubMed

    Kooiman, Thea J M; Dontje, Manon L; Sprenger, Siska R; Krijnen, Wim P; van der Schans, Cees P; de Groot, Martijn

    2015-01-01

    Activity trackers can potentially stimulate users to increase their physical activity behavior. The aim of this study was to examine the reliability and validity of ten consumer activity trackers for measuring step count in both laboratory and free-living conditions. Healthy adult volunteers (n = 33) walked twice on a treadmill (4.8 km/h) for 30 min while wearing ten different activity trackers (i.e. Lumoback, Fitbit Flex, Jawbone Up, Nike+ Fuelband SE, Misfit Shine, Withings Pulse, Fitbit Zip, Omron HJ-203, Yamax Digiwalker SW-200 and Moves mobile application). In free-living conditions, 56 volunteers wore the same activity trackers for one working day. Test-retest reliability was analyzed with the Intraclass Correlation Coefficient (ICC). Validity was evaluated by comparing each tracker with the gold standard (Optogait system for laboratory and ActivPAL for free-living conditions), using paired samples t-tests, mean absolute percentage errors, correlations and Bland-Altman plots. Test-retest analysis revealed high reliability for most trackers except for the Omron (ICC .14), Moves app (ICC .37) and Nike+ Fuelband (ICC .53). The mean absolute percentage errors of the trackers in laboratory and free-living conditions respectively, were: Lumoback (-0.2, -0.4), Fibit Flex (-5.7, 3.7), Jawbone Up (-1.0, 1.4), Nike+ Fuelband (-18, -24), Misfit Shine (0.2, 1.1), Withings Pulse (-0.5, -7.9), Fitbit Zip (-0.3, 1.2), Omron (2.5, -0.4), Digiwalker (-1.2, -5.9), and Moves app (9.6, -37.6). Bland-Altman plots demonstrated that the limits of agreement varied from 46 steps (Fitbit Zip) to 2422 steps (Nike+ Fuelband) in the laboratory condition, and 866 steps (Fitbit Zip) to 5150 steps (Moves app) in the free-living condition. The reliability and validity of most trackers for measuring step count is good. The Fitbit Zip is the most valid whereas the reliability and validity of the Nike+ Fuelband is low.

  4. Implementing a laboratory automation system: experience of a large clinical laboratory.

    PubMed

    Lam, Choong Weng; Jacob, Edward

    2012-02-01

    Laboratories today face increasing pressure to automate their operations as they are challenged by a continuing increase in workload, need to reduce expenditure, and difficulties in recruitment of experienced technical staff. Was the implementation of a laboratory automation system (LAS) in the Clinical Biochemistry Laboratory at Singapore General Hospital successful? There is no simple answer, so the following topics comparing and contrasting pre- and post-LAS have been explored: turnaround time (TAT), laboratory errors, and staff satisfaction. The benefits and limitations of LAS from the laboratory experience were also reviewed. The mean TAT for both stat and routine samples decreased post-LAS (30% and 13.4%, respectively). In the 90th percentile TAT chart, a 29% reduction was seen in the processing of stat samples on the LAS. However, no significant difference in the 90th percentile TAT was observed with routine samples. It was surprising to note that laboratory errors increased post-LAS. Considerable effort was needed to overcome the initial difficulties associated with adjusting to a new system, new software, and new working procedures. Although some of the known advantages and limitations of LAS have been validated, the claimed benefits such as improvements in TAT, laboratory errors, and staff morale were not evident in the initial months.

  5. Safety validation test equipment operation

    NASA Astrophysics Data System (ADS)

    Kurosaki, Tadaaki; Watanabe, Takashi

    1992-08-01

    An overview of the activities conducted on safety validation test equipment operation for materials used for NASA manned missions is presented. Safety validation tests, such as flammability, odor, offgassing, and so forth were conducted in accordance with NASA-NHB-8060.1C using test subjects common with those used by NASA, and the equipment used were qualified for their functions and performances in accordance with NASDA-CR-99124 'Safety Validation Test Qualification Procedures.' Test procedure systems were established by preparing 'Common Procedures for Safety Validation Test' as well as test procedures for flammability, offgassing, and odor tests. The test operation organization chaired by the General Manager of the Parts and Material Laboratory of NASDA (National Space Development Agency of Japan) was established, and the test leaders and operators in the organization were qualified in accordance with the specified procedures. One-hundred-one tests had been conducted so far by the Parts and Material Laboratory according to the request submitted by the manufacturers through the Space Station Group and the Safety and Product Assurance for Manned Systems Office.

  6. Validation of the Filovirus Plaque Assay for Use in Preclinical Studies

    PubMed Central

    Shurtleff, Amy C.; Bloomfield, Holly A.; Mort, Shannon; Orr, Steven A.; Audet, Brian; Whitaker, Thomas; Richards, Michelle J.; Bavari, Sina

    2016-01-01

    A plaque assay for quantitating filoviruses in virus stocks, prepared viral challenge inocula and samples from research animals has recently been fully characterized and standardized for use across multiple institutions performing Biosafety Level 4 (BSL-4) studies. After standardization studies were completed, Good Laboratory Practices (GLP)-compliant plaque assay method validation studies to demonstrate suitability for reliable and reproducible measurement of the Marburg Virus Angola (MARV) variant and Ebola Virus Kikwit (EBOV) variant commenced at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The validation parameters tested included accuracy, precision, linearity, robustness, stability of the virus stocks and system suitability. The MARV and EBOV assays were confirmed to be accurate to ±0.5 log10 PFU/mL. Repeatability precision, intermediate precision and reproducibility precision were sufficient to return viral titers with a coefficient of variation (%CV) of ≤30%, deemed acceptable variation for a cell-based bioassay. Intraclass correlation statistical techniques for the evaluation of the assay’s precision when the same plaques were quantitated by two analysts returned values passing the acceptance criteria, indicating high agreement between analysts. The assay was shown to be accurate and specific when run on Nonhuman Primates (NHP) serum and plasma samples diluted in plaque assay medium, with negligible matrix effects. Virus stocks demonstrated stability for freeze-thaw cycles typical of normal usage during assay retests. The results demonstrated that the EBOV and MARV plaque assays are accurate, precise and robust for filovirus titration in samples associated with the performance of GLP animal model studies. PMID:27110807

  7. Bio-Oil Analysis Laboratory Procedures | Bioenergy | NREL

    Science.gov Websites

    Bio-Oil Analysis Laboratory Procedures Bio-Oil Analysis Laboratory Procedures NREL develops standard procedures have been validated and allow for reliable bio-oil analysis. Procedures Determination different hydroxyl groups (-OH) in pyrolysis bio-oil: aliphatic-OH, phenolic-OH, and carboxylic-OH. Download

  8. Clinical Laboratory Helper.

    ERIC Educational Resources Information Center

    Szucs, Susan C.; And Others

    This curriculum guide provides competencies and tasks for the position of clinical laboratory helper; it serves as both a career exploration experience and/or entry-level employment training. A list of 25 validated competencies and tasks covers careers from entry level to those that must be mastered to earn an associate degree in clinical…

  9. Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

    PubMed

    Dagostino, Concetta; De Gregori, Manuela; Gieger, Christian; Manz, Judith; Gudelj, Ivan; Lauc, Gordan; Divizia, Laura; Wang, Wei; Sim, Moira; Pemberton, Iain K; MacDougall, Jane; Williams, Frances; Van Zundert, Jan; Primorac, Dragan; Aulchenko, Yurii; Kapural, Leonardo; Allegri, Massimo

    2017-01-01

    Chronic low back pain (CLBP) is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine). Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories) to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs) for genetic/-omics studies in chronic pain have been developed. In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective "PainOmics" study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. The SOPs describe the specific procedures for (1) blood collection, (2) sample processing and storage, (3) shipping details and (4) cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses. The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.

  10. 29 CFR 1607.7 - Use of other validity studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 4 2011-07-01 2011-07-01 false Use of other validity studies. 1607.7 Section 1607.7 Labor... EMPLOYEE SELECTION PROCEDURES (1978) General Principles § 1607.7 Use of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection...

  11. Validating the Collision-Dominated Child-Langmuir Law for a DC Discharge Cathode Sheath in an Undergraduate Laboratory

    ERIC Educational Resources Information Center

    Lisovskiy, V.; Yegorenkov, V.

    2009-01-01

    In this paper, we propose a simple method of observing the collision-dominated Child-Langmuir law in the course of an undergraduate laboratory work devoted to studying the properties of gas discharges. To this end we employ the dc gas discharge whose properties are studied in sufficient detail. The undergraduate laboratory work itself is reduced…

  12. Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation

    PubMed Central

    2014-01-01

    Background A balance test provides important information such as the standard to judge an individual’s functional recovery or make the prediction of falls. The development of a tool for a balance test that is inexpensive and widely available is needed, especially in clinical settings. The Wii Balance Board (WBB) is designed to test balance, but there is little software used in balance tests, and there are few studies on reliability and validity. Thus, we developed a balance assessment software using the Nintendo Wii Balance Board, investigated its reliability and validity, and compared it with a laboratory-grade force platform. Methods Twenty healthy adults participated in our study. The participants participated in the test for inter-rater reliability, intra-rater reliability, and concurrent validity. The tests were performed with balance assessment software using the Nintendo Wii balance board and a laboratory-grade force platform. Data such as Center of Pressure (COP) path length and COP velocity were acquired from the assessment systems. The inter-rater reliability, the intra-rater reliability, and concurrent validity were analyzed by an intraclass correlation coefficient (ICC) value and a standard error of measurement (SEM). Results The inter-rater reliability (ICC: 0.89-0.79, SEM in path length: 7.14-1.90, SEM in velocity: 0.74-0.07), intra-rater reliability (ICC: 0.92-0.70, SEM in path length: 7.59-2.04, SEM in velocity: 0.80-0.07), and concurrent validity (ICC: 0.87-0.73, SEM in path length: 5.94-0.32, SEM in velocity: 0.62-0.08) were high in terms of COP path length and COP velocity. Conclusion The balance assessment software incorporating the Nintendo Wii balance board was used in our study and was found to be a reliable assessment device. In clinical settings, the device can be remarkably inexpensive, portable, and convenient for the balance assessment. PMID:24912769

  13. 76 FR 15945 - National Voluntary Laboratory Accreditation Program (NVLAP) Workshop for Laboratories Interested...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... Accreditation Program (NVLAP) is considering establishing an accreditation program for laboratories that test... the general accreditation criteria referenced in Sections 4 and 5 of the NIST handbook 150 to the test... accreditation, test and measurement equipment, personnel requirements, validation of test methods, and reporting...

  14. ICP-MS Data Validation

    EPA Pesticide Factsheets

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  15. LABORATORY SCALE STEAM INJECTION TREATABILITY STUDIES

    EPA Science Inventory

    Laboratory scale steam injection treatability studies were first developed at The University of California-Berkeley. A comparable testing facility has been developed at USEPA's Robert S. Kerr Environmental Research Center. Experience has already shown that many volatile organic...

  16. An Application of Practical Strategies in Assessing the Criterion-Related Validity of Credentialing Examinations.

    ERIC Educational Resources Information Center

    Fidler, James R.

    1993-01-01

    Criterion-related validities of 2 laboratory practitioner certification examinations for medical technologists (MTs) and medical laboratory technicians (MLTs) were assessed for 81 MT and 70 MLT examinees. Validity coefficients are presented for both measures. Overall, summative ratings yielded stronger validity coefficients than ratings based on…

  17. Unlocking the Laboratory: Autonomous Wireless Sensor Authentication in Practice

    ERIC Educational Resources Information Center

    Huggard, Meriel; McGoldrick, Ciaran

    2013-01-01

    Purpose: The purpose of this study is to evaluate a practical laboratory task where final year undergraduate students design, implement and validate an inferred security wireless sensor access system. Design/methodology/approach: The quality of the learning and technical environment was evaluated from a number of perspectives using a mixed methods…

  18. Determination of Phosphorus and Potassium in Commercial Inorganic Fertilizers by Inductively Coupled Plasma-Optical Emission Spectrometry: Single-Laboratory Validation, First Action 2015.18.

    PubMed

    Thiex, Nancy J

    2016-07-01

    A previously validated method for the determination of both citrate-EDTA-soluble P and K and acid-soluble P and K in commercial inorganic fertilizers by inductively coupled plasma-optical emission spectrometry was submitted to the expert review panel (ERP) for fertilizers for consideration of First Action Official Method(SM) status. The ERP evaluated the single-laboratory validation results and recommended the method for First Action Official Method status and provided recommendations for achieving Final Action. Validation materials ranging from 4.4 to 52.4% P2O5 (1.7-22.7% P) and 3-62% K2O (2.5-51.1% K) were used for the validation. Recoveries from validation materials for citrate-soluble P and K ranged from 99.3 to 124.9% P and from 98.4 to 100.7% K. Recoveries from validation materials for acid-soluble "total" P and K ranged from 95.53 to 99.40% P and from 98.36 to 107.28% K. Values of r for citrate-soluble P and K, expressed as RSD, ranged from 0.28 to 1.30% for P and from 0.41 to 1.52% for K. Values of r for total P and K, expressed as RSD, ranged from 0.71 to 1.13% for P and from 0.39 to 1.18% for K. Based on the validation data, the ERP recommended the method (with alternatives for the citrate-soluble and the acid-soluble extractions) for First Action Official Method status and provided recommendations for achieving Final Action status.

  19. ICP-AES Data Validation

    EPA Pesticide Factsheets

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program (CLP) Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  20. Trace Volatile Data Validation

    EPA Pesticide Factsheets

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program (CLP) Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  1. The Myotonometer: Not a Valid Measurement Tool for Active Hamstring Musculotendinous Stiffness.

    PubMed

    Pamukoff, Derek N; Bell, Sarah E; Ryan, Eric D; Blackburn, J Troy

    2016-05-01

    Hamstring musculotendinous stiffness (MTS) is associated with lower-extremity injury risk (ie, hamstring strain, anterior cruciate ligament injury) and is commonly assessed using the damped oscillatory technique. However, despite a preponderance of studies that measure MTS reliably in laboratory settings, there are no valid clinical measurement tools. A valid clinical measurement technique is needed to assess MTS and permit identification of individuals at heightened risk of injury and track rehabilitation progress. To determine the validity and reliability of the Myotonometer for measuring active hamstring MTS. Descriptive laboratory study. Laboratory. 33 healthy participants (15 men, age 21.33 ± 2.94 y, height 172.03 ± 16.36 cm, mass 74.21 ± 16.36 kg). Hamstring MTS was assessed using the damped oscillatory technique and the Myotonometer. Intraclass correlations were used to determine the intrasession, intersession, and interrater reliability of the Myotonometer. Criterion validity was assessed via Pearson product-moment correlation between MTS measures obtained from the Myotonometer and from the damped oscillatory technique. The Myotonometer demonstrated good intrasession (ICC3,1 = .807) and interrater reliability (ICC2,k = .830) and moderate intersession reliability (ICC2,k = .693). However, it did not provide a valid measurement of MTS compared with the damped oscillatory technique (r = .346, P = .061). The Myotonometer does not provide a valid measure of active hamstring MTS. Although the Myotonometer does not measure active MTS, it possesses good reliability and portability and could be used clinically to measure tissue compliance, muscle tone, or spasticity associated with multiple musculoskeletal disorders. Future research should focus on portable and clinically applicable tools to measure active hamstring MTS in efforts to prevent and monitor injuries.

  2. Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation.

    PubMed

    Yao, Katy; McKinney, Barbara; Murphy, Anna; Rotz, Phil; Wafula, Winnie; Sendagire, Hakim; Okui, Scolastica; Nkengasong, John N

    2010-09-01

    The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed to promote immediate, measurable improvement in laboratories of developing countries. The laboratory management framework, a tool that prescribes managerial job tasks, forms the basis of the hands-on, activity-based curriculum. SLMTA is implemented through multiple workshops with intervening site visits to support improvement projects. To evaluate the effectiveness of SLMTA, the laboratory accreditation checklist was developed and subsequently adopted by the World Health Organization Regional Office for Africa (WHO AFRO). The SLMTA program and the implementation model were validated through a pilot in Uganda. SLMTA yielded observable, measurable results in the laboratories and improved patient flow and turnaround time in a laboratory simulation. The laboratory staff members were empowered to improve their own laboratories by using existing resources, communicate with clinicians and hospital administrators, and advocate for system strengthening. The SLMTA program supports laboratories by improving management and building preparedness for accreditation.

  3. Laboratory validation of MEMS-based sensors for post-earthquake damage assessment image

    NASA Astrophysics Data System (ADS)

    Pozzi, Matteo; Zonta, Daniele; Santana, Juan; Colin, Mikael; Saillen, Nicolas; Torfs, Tom; Amditis, Angelos; Bimpas, Matthaios; Stratakos, Yorgos; Ulieru, Dumitru; Bairaktaris, Dimitirs; Frondistou-Yannas, Stamatia; Kalidromitis, Vasilis

    2011-04-01

    The evaluation of seismic damage is today almost exclusively based on visual inspection, as building owners are generally reluctant to install permanent sensing systems, due to their high installation, management and maintenance costs. To overcome this limitation, the EU-funded MEMSCON project aims to produce small size sensing nodes for measurement of strain and acceleration, integrating Micro-Electro-Mechanical Systems (MEMS) based sensors and Radio Frequency Identification (RFID) tags in a single package that will be attached to reinforced concrete buildings. To reduce the impact of installation and management, data will be transmitted to a remote base station using a wireless interface. During the project, sensor prototypes were produced by assembling pre-existing components and by developing ex-novo miniature devices with ultra-low power consumption and sensing performance beyond that offered by sensors available on the market. The paper outlines the device operating principles, production scheme and working at both unit and network levels. It also reports on validation campaigns conducted in the laboratory to assess system performance. Accelerometer sensors were tested on a reduced scale metal frame mounted on a shaking table, back to back with reference devices, while strain sensors were embedded in both reduced and full-scale reinforced concrete specimens undergoing increasing deformation cycles up to extensive damage and collapse. The paper assesses the economical sustainability and performance of the sensors developed for the project and discusses their applicability to long-term seismic monitoring.

  4. [Study of quality of a branch laboratory--an opinion of a laboratory manager].

    PubMed

    Yazawa, Naoyuki

    2006-11-01

    At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

  5. [Mathematical model of technical equipment of a clinical-diagnostic laboratory].

    PubMed

    Bukin, S I; Busygin, D V; Tilevich, M E

    1990-01-01

    The paper is concerned with the problems of technical equipment of standard clinico-diagnostic laboratories (CDL) in this country. The authors suggest a mathematic model that may minimize expenditures for laboratory studies. The model enables the following problems to be solved: to issue scientifically-based recommendations for technical equipment of CDL; to validate the medico-technical requirements for newly devised items; to select the optimum types of uniform items; to define optimal technical decisions at the stage of the design; to determine the lab assistant's labour productivity and the cost of some investigations; to compute the medical laboratory engineering requirement for treatment and prophylactic institutions of this country.

  6. Laboratory studies in ultraviolet solar physics

    NASA Technical Reports Server (NTRS)

    Parkinson, W. H.; Kohl, J. L.; Gardner, L. D.; Raymond, J. C.; Smith, P. L.

    1991-01-01

    The research activity comprised the measurement of basic atomic processes and parameters which relate directly to the interpretation of solar ultraviolet observations and to the development of comprehensive models of the component structures of the solar atmosphere. The research was specifically directed towards providing the relevant atomic data needed to perform and to improve solar diagnostic techniques which probe active and quiet portions of the solar chromosphere, the transition zone, the inner corona, and the solar wind acceleration regions of the extended corona. The accuracy with which the physical conditions in these structures can be determined depends directly on the accuracy and completeness of the atomic and molecular data. These laboratory data are used to support the analysis programs of past and current solar observations (e.g., the Orbiting solar Observatories, the Solar Maximum Mission, the Skylab Apollo Telescope Mount, and the Naval Research Laboratory's rocket-borne High Resolution Telescope and Spectrograph). In addition, we attempted to anticipate the needs of future space-borne solar studies such as from the joint ESA/NASA Solar and Heliospheric Observatory (SOHO) spacecraft. Our laboratory activities stressed two categories of study: (1) the measurement of absolute rate coefficients for dielectronic recombination and electron impact excitation; and (2) the measurement of atomic transition probabilities for solar density diagnostics. A brief summary of the research activity is provided.

  7. CANFOR Portuguese version: validation study.

    PubMed

    Talina, Miguel; Thomas, Stuart; Cardoso, Ana; Aguiar, Pedro; Caldas de Almeida, Jose M; Xavier, Miguel

    2013-05-30

    The increase in prisoner population is a troublesome reality in several regions of the world. Along with this growth there is increasing evidence that prisoners have a higher proportion of mental illnesses and suicide than the general population. In order to implement strategies that address criminal recidivism and the health and social status of prisoners, particularly in mental disordered offenders, it is necessary to assess their care needs in a comprehensive, but individual perspective. This assessment must include potential harmful areas like comorbid personality disorder, substance misuse and offending behaviours. The Camberwell Assessment of Need - Forensic Version (CANFOR) has proved to be a reliable tool designed to accomplish such aims. The present study aimed to validate the CANFOR Portuguese version. The translation, adaptation to the Portuguese context, back-translation and revision followed the usual procedures. The sample comprised all detainees receiving psychiatric care in four forensic facilities, over a one year period. A total of 143 subjects, and respective case manager, were selected. The forensic facilities were chosen by convenience: one prison hospital psychiatric ward (n=68; 47.6%), one male (n=24; 16.8%) and one female (n=22; 15.4%) psychiatric clinic and one civil security ward (n=29; 20.3%), all located nearby Lisbon. Basic descriptive statistics and Kappa weighted coefficients were calculated for the inter-rater and the test-retest reliability studies. The convergent validity was evaluated using the Global Assessment of Functioning and the Brief Psychiatric Rating Scale scores. The majority of the participants were male and single, with short school attendance, and accused of a crime involving violence against persons. The most frequent diagnosis was major depression (56.1%) and almost half presented positive suicide risk. The reliability study showed average Kappa weighted coefficients of 0.884 and 0.445 for inter-rater and test

  8. Development, Implementation, and Analysis of a National Survey of Faculty Goals for Undergraduate Chemistry Laboratory

    ERIC Educational Resources Information Center

    Bruck, Aaron D.; Towns, Marcy

    2013-01-01

    This work reports the development of a survey for laboratory goals in undergraduate chemistry, the analysis of reliable and valid data collected from a national survey of college chemistry faculty, and a synthesis of the findings. The study used a sequential exploratory mixed-methods design. Faculty goals for laboratory emerged across seven…

  9. Critical validation studies of neurofeedback.

    PubMed

    Gruzelier, John; Egner, Tobias

    2005-01-01

    The field of neurofeedback training has proceeded largely without validation. In this article the authors review studies directed at validating sensory motor rhythm, beta and alpha-theta protocols for improving attention, memory, and music performance in healthy participants. Importantly, benefits were demonstrable with cognitive and neurophysiologic measures that were predicted on the basis of regression models of learning to enhance sensory motor rhythm and beta activity. The first evidence of operant control over the alpha-theta ratio is provided, together with remarkable improvements in artistic aspects of music performance equivalent to two class grades in conservatory students. These are initial steps in providing a much needed scientific basis to neurofeedback.

  10. Intra-laboratory validation of chronic bee paralysis virus quantitation using an accredited standardised real-time quantitative RT-PCR method.

    PubMed

    Blanchard, Philippe; Regnault, Julie; Schurr, Frank; Dubois, Eric; Ribière, Magali

    2012-03-01

    Chronic bee paralysis virus (CBPV) is responsible for chronic bee paralysis, an infectious and contagious disease in adult honey bees (Apis mellifera L.). A real-time RT-PCR assay to quantitate the CBPV load is now available. To propose this assay as a reference method, it was characterised further in an intra-laboratory study during which the reliability and the repeatability of results and the performance of the assay were confirmed. The qPCR assay alone and the whole quantitation method (from sample RNA extraction to analysis) were both assessed following the ISO/IEC 17025 standard and the recent XP U47-600 standard issued by the French Standards Institute. The performance of the qPCR assay and of the overall CBPV quantitation method were validated over a 6 log range from 10(2) to 10(8) with a detection limit of 50 and 100 CBPV RNA copies, respectively, and the protocol of the real-time RT-qPCR assay for CBPV quantitation was approved by the French Accreditation Committee. Copyright © 2011 Elsevier B.V. All rights reserved.

  11. Assessing reliability and validity measures in managed care studies.

    PubMed

    Montoya, Isaac D

    2003-01-01

    To review the reliability and validity literature and develop an understanding of these concepts as applied to managed care studies. Reliability is a test of how well an instrument measures the same input at varying times and under varying conditions. Validity is a test of how accurately an instrument measures what one believes is being measured. A review of reliability and validity instructional material was conducted. Studies of managed care practices and programs abound. However, many of these studies utilize measurement instruments that were developed for other purposes or for a population other than the one being sampled. In other cases, instruments have been developed without any testing of the instrument's performance. The lack of reliability and validity information may limit the value of these studies. This is particularly true when data are collected for one purpose and used for another. The usefulness of certain studies without reliability and validity measures is questionable, especially in cases where the literature contradicts itself

  12. 40 CFR 761.392 - Preparing validation study samples.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... establish a surface concentration to be included in the standard operating procedure. The surface levels of... Under § 761.79(d)(4) § 761.392 Preparing validation study samples. (a)(1) To validate a procedure to... surfaces must be ≥20 µg/100 cm2. (2) To validate a procedure to decontaminate a specified surface...

  13. 40 CFR 761.392 - Preparing validation study samples.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... establish a surface concentration to be included in the standard operating procedure. The surface levels of... Under § 761.79(d)(4) § 761.392 Preparing validation study samples. (a)(1) To validate a procedure to... surfaces must be ≥20 µg/100 cm2. (2) To validate a procedure to decontaminate a specified surface...

  14. 40 CFR 761.392 - Preparing validation study samples.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... establish a surface concentration to be included in the standard operating procedure. The surface levels of... Under § 761.79(d)(4) § 761.392 Preparing validation study samples. (a)(1) To validate a procedure to... surfaces must be ≥20 µg/100 cm2. (2) To validate a procedure to decontaminate a specified surface...

  15. Computational simulation of laboratory-scale volcanic jets

    NASA Astrophysics Data System (ADS)

    Solovitz, S.; Van Eaton, A. R.; Mastin, L. G.; Herzog, M.

    2017-12-01

    Volcanic eruptions produce ash clouds that may travel great distances, significantly impacting aviation and communities downwind. Atmospheric hazard forecasting relies partly on numerical models of the flow physics, which incorporate data from eruption observations and analogue laboratory tests. As numerical tools continue to increase in complexity, they must be validated to fine-tune their effectiveness. Since eruptions are relatively infrequent and challenging to observe in great detail, analogue experiments can provide important insights into expected behavior over a wide range of input conditions. Unfortunately, laboratory-scale jets cannot easily attain the high Reynolds numbers ( 109) of natural volcanic eruption columns. Comparisons between the computational models and analogue experiments can help bridge this gap. In this study, we investigate a 3-D volcanic plume model, the Active Tracer High-resolution Atmospheric Model (ATHAM), which has been used to simulate a variety of eruptions. However, it has not been previously validated using laboratory-scale data. We conducted numerical simulations of three flows that we have studied in the laboratory: a vertical jet in a quiescent environment, a vertical jet in horizontal cross flow, and a particle-laden jet. We considered Reynolds numbers from 10,000 to 50,000, jet-to-cross flow velocity ratios of 2 to 10, and particle mass loadings of up to 25% of the exit mass flow rate. Vertical jet simulations produce Gaussian velocity profiles in the near exit region by 3 diameters downstream, matching the mean experimental profiles. Simulations of air entrainment are of the correct order of magnitude, but they show decreasing entrainment with vertical distance from the vent. Cross flow simulations reproduce experimental trajectories for the jet centerline initially, although confinement appears to impact the response later. Particle-laden simulations display minimal variation in concentration profiles between cases with

  16. Transferability and inter-laboratory variability assessment of the in vitro bovine oocyte fertilization test.

    PubMed

    Tessaro, Irene; Modina, Silvia C; Crotti, Gabriella; Franciosi, Federica; Colleoni, Silvia; Lodde, Valentina; Galli, Cesare; Lazzari, Giovanna; Luciano, Alberto M

    2015-01-01

    The dramatic increase in the number of animals required for reproductive toxicity testing imposes the validation of alternative methods to reduce the use of laboratory animals. As we previously demonstrated for in vitro maturation test of bovine oocytes, the present study describes the transferability assessment and the inter-laboratory variability of an in vitro test able to identify chemical effects during the process of bovine oocyte fertilization. Eight chemicals with well-known toxic properties (benzo[a]pyrene, busulfan, cadmium chloride, cycloheximide, diethylstilbestrol, ketoconazole, methylacetoacetate, mifepristone/RU-486) were tested in two well-trained laboratories. The statistical analysis demonstrated no differences in the EC50 values for each chemical in within (inter-runs) and in between-laboratory variability of the proposed test. We therefore conclude that the bovine in vitro fertilization test could advance toward the validation process as alternative in vitro method and become part of an integrated testing strategy in order to predict chemical hazards on mammalian fertility. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. The Essential Role for Laboratory Studies in Atmospheric Chemistry.

    PubMed

    Burkholder, James B; Abbatt, Jonathan P D; Barnes, Ian; Roberts, James M; Melamed, Megan L; Ammann, Markus; Bertram, Allan K; Cappa, Christopher D; Carlton, Annmarie G; Carpenter, Lucy J; Crowley, John N; Dubowski, Yael; George, Christian; Heard, Dwayne E; Herrmann, Hartmut; Keutsch, Frank N; Kroll, Jesse H; McNeill, V Faye; Ng, Nga Lee; Nizkorodov, Sergey A; Orlando, John J; Percival, Carl J; Picquet-Varrault, Bénédicte; Rudich, Yinon; Seakins, Paul W; Surratt, Jason D; Tanimoto, Hiroshi; Thornton, Joel A; Tong, Zhu; Tyndall, Geoffrey S; Wahner, Andreas; Weschler, Charles J; Wilson, Kevin R; Ziemann, Paul J

    2017-03-07

    Laboratory studies of atmospheric chemistry characterize the nature of atmospherically relevant processes down to the molecular level, providing fundamental information used to assess how human activities drive environmental phenomena such as climate change, urban air pollution, ecosystem health, indoor air quality, and stratospheric ozone depletion. Laboratory studies have a central role in addressing the incomplete fundamental knowledge of atmospheric chemistry. This article highlights the evolving science needs for this community and emphasizes how our knowledge is far from complete, hindering our ability to predict the future state of our atmosphere and to respond to emerging global environmental change issues. Laboratory studies provide rich opportunities to expand our understanding of the atmosphere via collaborative research with the modeling and field measurement communities, and with neighboring disciplines.

  18. 41 CFR 60-3.7 - Use of other validity studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... studies. 60-3.7 Section 60-3.7 Public Contracts and Property Management Other Provisions Relating to... of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection procedures by validity studies conducted by other users or conducted...

  19. 41 CFR 60-3.7 - Use of other validity studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... studies. 60-3.7 Section 60-3.7 Public Contracts and Property Management Other Provisions Relating to... of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection procedures by validity studies conducted by other users or conducted...

  20. Measuring meaningful learning in the undergraduate chemistry laboratory

    NASA Astrophysics Data System (ADS)

    Galloway, Kelli R.

    The undergraduate chemistry laboratory has been an essential component in chemistry education for over a century. The literature includes reports on investigations of singular aspects laboratory learning and attempts to measure the efficacy of reformed laboratory curriculum as well as faculty goals for laboratory learning which found common goals among instructors for students to learn laboratory skills, techniques, experimental design, and to develop critical thinking skills. These findings are important for improving teaching and learning in the undergraduate chemistry laboratory, but research is needed to connect the faculty goals to student perceptions. This study was designed to explore students' ideas about learning in the undergraduate chemistry laboratory. Novak's Theory of Meaningful Learning was used as a guide for the data collection and analysis choices for this research. Novak's theory states that in order for meaningful learning to occur the cognitive, affective, and psychomotor domains must be integrated. The psychomotor domain is inherent in the chemistry laboratory, but the extent to which the cognitive and affective domains are integrated is unknown. For meaningful learning to occur in the laboratory, students must actively integrate both the cognitive domain and the affective domains into the "doing" of their laboratory work. The Meaningful Learning in the Laboratory Instrument (MLLI) was designed to measure students' cognitive and affective expectations and experiences within the context of conducting experiments in the undergraduate chemistry laboratory. Evidence for the validity and reliability of the data generated by the MLLI were collected from multiple quantitative studies: a one semester study at one university, a one semester study at 15 colleges and universities across the United States, and a longitudinal study where the MLLI was administered 6 times during two years of general and organic chemistry laboratory courses. Results from

  1. Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories.

    PubMed

    Nakhleh, Raouf E; Grimm, Erin E; Idowu, Michael O; Souers, Rhona J; Fitzgibbons, Patrick L

    2010-05-01

    To ensure quality human epidermal growth receptor 2 (HER2) testing in breast cancer, the American Society of Clinical Oncology/College of American Pathologists guidelines were introduced with expected compliance by 2008. To assess the effect these guidelines have had on pathology laboratories and their ability to address key components. In late 2008, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program. It included questions regarding pathology practice characteristics and assay validation using fluorescence in situ hybridization or another IHC laboratory assay and assessed pathologist HER2 scoring competency. Of the 907 surveys sent, 757 (83.5%) were returned. The median laboratory accessioned 15 000 cases and performed 190 HER2 tests annually. Quantitative computer image analysis was used by 33% of laboratories. In-house fluorescence in situ hybridization was performed in 23% of laboratories, and 60% of laboratories addressed the 6- to 48-hour tissue fixation requirement by embedding tissue on the weekend. HER2 testing was performed on the initial biopsy in 40%, on the resection specimen in 6%, and on either in 56% of laboratories. Testing was validated with only fluorescence in situ hybridization in 47% of laboratories, whereas 10% of laboratories used another IHC assay only; 13% used both assays, and 12% and 15% of laboratories had not validated their assays or chose "not applicable" on the survey question, respectively. The 90% concordance rate with fluorescence in situ hybridization results was achieved by 88% of laboratories for IHC-negative findings and by 81% of laboratories for IHC-positive cases. The 90% concordance rate for laboratories using another IHC assay was achieved by 80% for negative findings and 75% for positive cases. About 91% of laboratories had a pathologist competency assessment program. This survey demonstrates the extent and characteristics of HER2 testing. Although some American Society of

  2. The ad-libitum alcohol 'taste test': secondary analyses of potential confounds and construct validity.

    PubMed

    Jones, Andrew; Button, Emily; Rose, Abigail K; Robinson, Eric; Christiansen, Paul; Di Lemma, Lisa; Field, Matt

    2016-03-01

    Motivation to drink alcohol can be measured in the laboratory using an ad-libitum 'taste test', in which participants rate the taste of alcoholic drinks whilst their intake is covertly monitored. Little is known about the construct validity of this paradigm. The objective of this study was to investigate variables that may compromise the validity of this paradigm and its construct validity. We re-analysed data from 12 studies from our laboratory that incorporated an ad-libitum taste test. We considered time of day and participants' awareness of the purpose of the taste test as potential confounding variables. We examined whether gender, typical alcohol consumption, subjective craving, scores on the Alcohol Use Disorders Identification Test and perceived pleasantness of the drinks predicted ad-libitum consumption (construct validity). We included 762 participants (462 female). Participant awareness and time of day were not related to ad-libitum alcohol consumption. Males drank significantly more alcohol than females (p < 0.001), and individual differences in typical alcohol consumption (p = 0.04), craving (p < 0.001) and perceived pleasantness of the drinks (p = 0.04) were all significant predictors of ad-libitum consumption. We found little evidence that time of day or participant awareness influenced alcohol consumption. The construct validity of the taste test was supported by relationships between ad-libitum consumption and typical alcohol consumption, craving and pleasantness ratings of the drinks. The ad-libitum taste test is a valid method for the assessment of alcohol intake in the laboratory.

  3. A qualitative case study of instructional support for web-based simulated laboratory exercises in online college chemistry laboratory courses

    NASA Astrophysics Data System (ADS)

    Schulman, Kathleen M.

    This study fills a gap in the research literature regarding the types of instructional support provided by instructors in online introductory chemistry laboratory courses that employ chemistry simulations as laboratory exercises. It also provides information regarding students' perceptions of the effectiveness of that instructional support. A multiple case study methodology was used to carry out the research. Two online introductory chemistry courses were studied at two community colleges. Data for this study was collected using phone interviews with faculty and student participants, surveys completed by students, and direct observation of the instructional designs of instructional support in the online Blackboard web sites and the chemistry simulations used by the participating institutions. The results indicated that the instructors provided multiple types of instructional support that correlated with forms of effective instructional support identified in the research literature, such as timely detailed feedback, detailed instructions for the laboratory experiments, and consistency in the instructional design of lecture and laboratory course materials, including the chemistry lab simulation environment. The students in one of these courses identified the following as the most effective types of instructional support provided: the instructor's feedback, opportunities to apply chemistry knowledge in the chemistry lab exercises, detailed procedures for the simulated laboratory exercises, the organization of the course Blackboard sites and the chemistry lab simulation web sites, and the textbook homework web sites. Students also identified components of instructional support they felt were missing. These included a desire for more interaction with the instructor, more support for the simulated laboratory exercises from the instructor and the developer of the chemistry simulations, and faster help with questions about the laboratory exercises or experimental

  4. Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a Containment Level-III Laboratory as part of a Laboratory Risk Assessment Program

    PubMed Central

    Blackwood, Kym S; Burdz, Tamara V; Turenne, Christine Y; Sharma, Meenu K; Kabani, Amin M; Wolfe, Joyce N

    2005-01-01

    Background In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating /chemical fixation) may not consistently kill MTB organisms. Methods An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. Results Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80°C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. Conclusions This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This

  5. Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a containment level-III laboratory as part of a Laboratory Risk Assessment Program.

    PubMed

    Blackwood, Kym S; Burdz, Tamara V; Turenne, Christine Y; Sharma, Meenu K; Kabani, Amin M; Wolfe, Joyce N

    2005-01-24

    In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating/chemical fixation) may not consistently kill MTB organisms. An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80 degrees C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This process is vital to establish in

  6. Prospective Validation of Objective Prognostic Score for Advanced Cancer Inpatients in South Korea: A Multicenter Study.

    PubMed

    Yoon, Seok Joon; Suh, Sang-Yeon; Lee, Yong Joo; Park, Jeanno; Hwang, Sunwook; Lee, Sanghee Shiny; Ahn, Hong Yup; Koh, Su-Jin; Park, Keon Uk

    2017-01-01

    Objective Prognostic Score (OPS) was developed as an easy and simple prognosticating tool in South Korea. It has been validated retrospectively in a single center in South Korea. We aimed to validate the OPS prospectively for advanced cancer inpatients in South Korea using a multicenter study. This was a prospective cohort study. We enrolled 243 advanced cancer patients admitted in five palliative care units in South Korea from May 2013 till March 2015. Seven members of the Korean Palliative Medicine Research Network who are experts of palliative care led the study. Clinical variables (dyspnea/anorexia/performance status) and laboratory variables (total leukocyte counts/serum total bilirubin/serum creatinine/lactate dehydrogenase) were collected at the enrollment. Survival time was calculated as days from enrollment to death during admission. A total of 217 patients were included in the final analysis (feasibility: 89.3%). Survival time of the higher OPS group (OPS ≥3) and the lower OPS group (OPS <3) was 10.0 (95% confidence interval (CI) 7.72-12.28) days and 32.0 (95% CI 25.44-38.56) days, respectively. There were significant differences between the 2 groups (p < 0.001). Overall accuracy of OPS ≥3 for predicting survival less than three weeks was 71.0%. OPS was successfully validated using a prospective multicenter study in South Korea. It is a useful method to predict three-week survival of Korean inpatients with advanced cancer.

  7. Stirling Laboratory Research Engine: Preprototype configuration report

    NASA Technical Reports Server (NTRS)

    Hoehn, F. W.

    1982-01-01

    The concept of a simple Stirling research engine that could be used by industrial, university, and government laboratories was studied. The conceptual and final designs, hardware fabrication and the experimental validation of a preprototype stirling laboratory research engine (SLRE) were completed. Also completed was a task to identify the potential markets for research engines of this type. An analytical effort was conducted to provide a stirling cycle computer model. The versatile engine is a horizontally opposed, two piston, single acting stirling engine with a split crankshaft drive mechanism; special instrumentation is installed at all component interfaces. Results of a thermodynamic energy balance for the system are reported. Also included are the engine performance results obtained over a range of speeds, working pressures, phase angles and gas temperatures. The potential for a stirling research engine to support the laboratory requirements of educators and researchers was demonstrated.

  8. The Essential Role for Laboratory Studies in Atmospheric Chemistry

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Burkholder, James B.; Abbatt, Jonathan P. D.; Barnes, Ian

    Laboratory studies of atmospheric chemistry characterize the nature of atmospherically relevant processes down to the molecular level, providing fundamental information used to assess how human activities drive environmental phenomena such as climate change, urban air pollution, ecosystem health, indoor air quality, and stratospheric ozone depletion. Laboratory studies have a central role in addressing the incomplete fundamental knowledge of atmospheric chemistry. This paper highlights the evolving science needs for this community and emphasizes how our knowledge is far from complete, hindering our ability to predict the future state of our atmosphere and to respond to emerging global environmental change issues. Finally,more » laboratory studies provide rich opportunities to expand our understanding of the atmosphere via collaborative research with the modeling and field measurement communities, and with neighboring disciplines.« less

  9. An imputed genotype resource for the laboratory mouse

    PubMed Central

    Szatkiewicz, Jin P.; Beane, Glen L.; Ding, Yueming; Hutchins, Lucie; de Villena, Fernando Pardo-Manuel; Churchill, Gary A.

    2009-01-01

    We have created a high-density SNP resource encompassing 7.87 million polymorphic loci across 49 inbred mouse strains of the laboratory mouse by combining data available from public databases and training a hidden Markov model to impute missing genotypes in the combined data. The strong linkage disequilibrium found in dense sets of SNP markers in the laboratory mouse provides the basis for accurate imputation. Using genotypes from eight independent SNP resources, we empirically validated the quality of the imputed genotypes and demonstrate that they are highly reliable for most inbred strains. The imputed SNP resource will be useful for studies of natural variation and complex traits. It will facilitate association study designs by providing high density SNP genotypes for large numbers of mouse strains. We anticipate that this resource will continue to evolve as new genotype data become available for laboratory mouse strains. The data are available for bulk download or query at http://cgd.jax.org/. PMID:18301946

  10. The Development of Laboratory Safety Questionnaire for Middle School Science Teachers

    ERIC Educational Resources Information Center

    Akpullukcu, Simge; Cavas, Bulent

    2017-01-01

    The purpose of this paper is to develop a "valid and reliable laboratory safety questionnaire" which could be used to identify science teachers' understanding about laboratory safety issues during their science laboratory activities. The questionnaire was developed from a literature review and prior instruments developed on laboratory…

  11. 41 CFR 60-3.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... likely to affect validity differences; or that these factors are included in the design of the study and... construct validity is both an extensive and arduous effort involving a series of research studies, which... validity studies. 60-3.14 Section 60-3.14 Public Contracts and Property Management Other Provisions...

  12. 41 CFR 60-3.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... likely to affect validity differences; or that these factors are included in the design of the study and... construct validity is both an extensive and arduous effort involving a series of research studies, which... validity studies. 60-3.14 Section 60-3.14 Public Contracts and Property Management Other Provisions...

  13. 41 CFR 60-3.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... likely to affect validity differences; or that these factors are included in the design of the study and... construct validity is both an extensive and arduous effort involving a series of research studies, which... validity studies. 60-3.14 Section 60-3.14 Public Contracts and Property Management Other Provisions...

  14. 41 CFR 60-3.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... likely to affect validity differences; or that these factors are included in the design of the study and... construct validity is both an extensive and arduous effort involving a series of research studies, which... validity studies. 60-3.14 Section 60-3.14 Public Contracts and Property Management Other Provisions...

  15. 41 CFR 60-3.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... likely to affect validity differences; or that these factors are included in the design of the study and... construct validity is both an extensive and arduous effort involving a series of research studies, which... validity studies. 60-3.14 Section 60-3.14 Public Contracts and Property Management Other Provisions...

  16. Method for the determination of catechin and epicatechin enantiomers in cocoa-based ingredients and products by high-performance liquid chromatography: single-laboratory validation.

    PubMed

    Machonis, Philip R; Jones, Matthew A; Schaneberg, Brian T; Kwik-Uribe, Catherine L

    2012-01-01

    A single-laboratory validation study was performed for an HPLC method to identify and quantify the flavanol enantiomers (+)- and (-)-epicatechin and (+)- and (-)-catechin in cocoa-based ingredients and products. These compounds were eluted isocratically with an ammonium acetate-methanol mobile phase applied to a modified beta-cyclodextrin chiral stationary phase and detected using fluorescence. Spike recovery experiments using appropriate matrix blanks, along with cocoa extract, cocoa powder, and dark chocolate, were used to evaluate accuracy, repeatability, specificity, LOD, LOQ, and linearity of the method as performed by a single analyst on multiple days. In all samples analyzed, (-)-epicatechin was the predominant flavanol and represented 68-91% of the total monomeric flavanols detected. For the cocoa-based products, within-day (intraday) precision for (-)-epicatechin was between 1.46-3.22%, for (+)-catechin between 3.66-6.90%, and for (-)-catechin between 1.69-6.89%; (+)-epicatechin was not detected in these samples. Recoveries for the three sample types investigated ranged from 82.2 to 102.1% at the 50% spiking level, 83.7 to 102.0% at the 100% spiking level, and 80.4 to 101.1% at the 200% spiking level. Based on performance results, this method may be suitable for routine laboratory use in analysis of cocoa-based ingredients and products.

  17. VALIDATION GUIDELINES FOR LABORATORIES PERFORMING FORENSIC ANALYSIS OF CHEMICAL TERRORISM

    EPA Science Inventory

    The Scientific Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT) has developed the following guidelines for laboratories engaged in the forensic analysis of chemical evidence associated with terrorism. This document provides a baseline framework and guidance for...

  18. 42 CFR 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... result of a validation inspection. 493.569 Section 493.569 Public Health CENTERS FOR MEDICARE & MEDICAID... validation inspection. (a) Laboratory with a certificate of accreditation. If a validation inspection results... validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or...

  19. 42 CFR 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... result of a validation inspection. 493.569 Section 493.569 Public Health CENTERS FOR MEDICARE & MEDICAID... validation inspection. (a) Laboratory with a certificate of accreditation. If a validation inspection results... validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or...

  20. 42 CFR 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... result of a validation inspection. 493.569 Section 493.569 Public Health CENTERS FOR MEDICARE & MEDICAID... validation inspection. (a) Laboratory with a certificate of accreditation. If a validation inspection results... validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or...

  1. 42 CFR 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... result of a validation inspection. 493.569 Section 493.569 Public Health CENTERS FOR MEDICARE & MEDICAID... validation inspection. (a) Laboratory with a certificate of accreditation. If a validation inspection results... validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or...

  2. 42 CFR 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... result of a validation inspection. 493.569 Section 493.569 Public Health CENTERS FOR MEDICARE & MEDICAID... validation inspection. (a) Laboratory with a certificate of accreditation. If a validation inspection results... validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or...

  3. Laboratory Information Management System (LIMS): A case study

    NASA Technical Reports Server (NTRS)

    Crandall, Karen S.; Auping, Judith V.; Megargle, Robert G.

    1987-01-01

    In the late 70's, a refurbishment of the analytical laboratories serving the Materials Division at NASA Lewis Research Center was undertaken. As part of the modernization efforts, a Laboratory Information Management System (LIMS) was to be included. Preliminary studies indicated a custom-designed system as the best choice in order to satisfy all of the requirements. A scaled down version of the original design has been in operation since 1984. The LIMS, a combination of computer hardware, provides the chemical characterization laboratory with an information data base, a report generator, a user interface, and networking capabilities. This paper is an account of the processes involved in designing and implementing that LIMS.

  4. A Three-Year Feedback Study of a Remote Laboratory Used in Control Engineering Studies

    ERIC Educational Resources Information Center

    Chevalier, Amélie; Copot, Cosmin; Ionescu, Clara; De Keyser, Robin

    2017-01-01

    This paper discusses the results of a feedback study for a remote laboratory used in the education of control engineering students. The goal is to show the effectiveness of the remote laboratory on examination results. To provide an overview, the two applications of the remote laboratory are addressed: 1) the Stewart platform, and 2) the quadruple…

  5. Selecting clinical quality indicators for laboratory medicine.

    PubMed

    Barth, Julian H

    2012-05-01

    Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

  6. Decision support for clinical laboratory capacity planning.

    PubMed

    van Merode, G G; Hasman, A; Derks, J; Goldschmidt, H M; Schoenmaker, B; Oosten, M

    1995-01-01

    The design of a decision support system for capacity planning in clinical laboratories is discussed. The DSS supports decisions concerning the following questions: how should the laboratory be divided into job shops (departments/sections), how should staff be assigned to workstations and how should samples be assigned to workstations for testing. The decision support system contains modules for supporting decisions at the overall laboratory level (concerning the division of the laboratory into job shops) and for supporting decisions at the job shop level (assignment of staff to workstations and sample scheduling). Experiments with these modules are described showing both the functionality and the validity.

  7. Knowledge Retention for Computer Simulations: A study comparing virtual and hands-on laboratories

    NASA Astrophysics Data System (ADS)

    Croom, John R., III

    The use of virtual laboratories has the potential to change physics education. These low-cost, interactive computer activities interest students, allow for easy setup, and give educators a way to teach laboratory based online classes. This study investigated whether virtual laboratories could replace traditional hands-on laboratories and whether students could retain the same long-term knowledge in virtual laboratories as compared to hands-on laboratories. This study is a quantitative quasi-experiment that used a multiple posttest design to determine if students using virtual laboratories would retain the same knowledge as students who performed hands-on laboratories after 9 weeks. The study was composed of 336 students from 14 school districts. Students had their performances on the laboratories and their retention of the laboratories compared to a series of factors that might have affected their retention using a pretest and two posttests, which were compared using a t test. The results showed no significant difference in short-term learning between the hands-on laboratory groups and virtual laboratory groups. There was, however, a significant difference (p = .005) between the groups in long-term retention; students in the hands-on laboratory groups retained more information than those in the virtual laboratory groups. These results suggest that long-term learning is enhanced when a laboratory contains a hands-on component. Finally, the results showed that both groups of students felt their particular laboratory style was superior to the alternative method. The findings of this study can be used to improve the integration of virtual laboratories into science curriculum.

  8. 21 CFR 58.185 - Reporting of nonclinical laboratory study results.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Reporting of nonclinical laboratory study results. 58.185 Section 58.185 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Reporting of nonclinical laboratory study results. (a) A final report shall be prepared for each nonclinical...

  9. 21 CFR 58.185 - Reporting of nonclinical laboratory study results.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Reporting of nonclinical laboratory study results. 58.185 Section 58.185 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Reporting of nonclinical laboratory study results. (a) A final report shall be prepared for each nonclinical...

  10. 21 CFR 58.185 - Reporting of nonclinical laboratory study results.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Reporting of nonclinical laboratory study results. 58.185 Section 58.185 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Reporting of nonclinical laboratory study results. (a) A final report shall be prepared for each nonclinical...

  11. Mercury and Cyanide Data Validation

    EPA Pesticide Factsheets

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program (CLP) Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  12. Low/Medium Volatile Data Validation

    EPA Pesticide Factsheets

    Document designed to offer data reviewers guidance in determining the validity of analytical data generated through the US EPA Contract Laboratory Program Statement of Work ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  13. Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

    PubMed

    Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

    2016-10-01

    To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Relationship disruption stress in human infants: a validation study with experimental and control groups.

    PubMed

    Haley, David W

    2011-09-01

    The current study examined whether the psychological stress of the still-face (SF) task (i.e. stress resulting from a parent's unresponsiveness) is a valid laboratory stress paradigm for evaluating infant cortisol reactivity. Given that factors external to the experimental paradigm, such as arriving at a new place, may cause an elevation in cortisol secretion; we tested the hypothesis that infants would show a cortisol response to the SF task but not to a normal FF task (control). Saliva was collected for cortisol measurement from 6-month-old infants (n = 31) randomly assigned to either a repeated SF task or to a continuous FF task. Parent-infant dyads were videotaped. Salivary cortisol concentration was measured at baseline, 20, and 30 min after the start of the procedure. Infant salivary cortisol concentrations showed a significant increase over time for the SF task but not for the FF task. The results provide new evidence that the repeated SF task provides a psychological challenge that is due to the SF condition rather than to some non-task related factor; these results provide internal validity for the paradigm. The study offers new insight into the role of parent-infant interactions in the activation of the infant stress response system.

  15. 41 CFR 60-3.5 - General standards for validity studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... should avoid making employment decisions on the basis of measures of knowledges, skills, or abilities... General standards for validity studies. A. Acceptable types of validity studies. For the purposes of... of these guidelines, section 14 of this part. New strategies for showing the validity of selection...

  16. Successful Sampling Strategy Advances Laboratory Studies of NMR Logging in Unconsolidated Aquifers

    NASA Astrophysics Data System (ADS)

    Behroozmand, Ahmad A.; Knight, Rosemary; Müller-Petke, Mike; Auken, Esben; Barfod, Adrian A. S.; Ferré, Ty P. A.; Vilhelmsen, Troels N.; Johnson, Carole D.; Christiansen, Anders V.

    2017-11-01

    The nuclear magnetic resonance (NMR) technique has become popular in groundwater studies because it responds directly to the presence and mobility of water in a porous medium. There is a need to conduct laboratory experiments to aid in the development of NMR hydraulic conductivity models, as is typically done in the petroleum industry. However, the challenge has been obtaining high-quality laboratory samples from unconsolidated aquifers. At a study site in Denmark, we employed sonic drilling, which minimizes the disturbance of the surrounding material, and extracted twelve 7.6 cm diameter samples for laboratory measurements. We present a detailed comparison of the acquired laboratory and logging NMR data. The agreement observed between the laboratory and logging data suggests that the methodologies proposed in this study provide good conditions for studying NMR measurements of unconsolidated near-surface aquifers. Finally, we show how laboratory sample size and condition impact the NMR measurements.

  17. The validity of the 4-Skills Scan: A double validation study.

    PubMed

    van Kernebeek, W G; de Kroon, M L A; Savelsbergh, G J P; Toussaint, H M

    2018-06-01

    Adequate gross motor skills are an essential aspect of a child's healthy development. Where physical education (PE) is part of the primary school curriculum, a strong curriculum-based emphasis on evaluation and support of motor skill development in PE is apparent. Monitoring motor development is then a task for the PE teacher. In order to fulfil this task, teachers need adequate tools. The 4-Skills Scan is a quick and easily manageable gross motor skill instrument; however, its validity has never been assessed. Therefore, the purpose of this study is to assess the construct and concurrent validity of both 4-Skills Scans (version 2007 and version 2015). A total of 212 primary school children (6 - 12 years old), was requested to participate in both versions of the 4-Skills Scan. For assessing construct validity, children covered an obstacle course with video recordings for observation by an expert panel. For concurrent validity, a comparison was made with the MABC-2, by calculating Pearson correlations. Multivariable linear regression analyses were performed to determine the contribution of each subscale to the construct of gross motor skills, according to the MABC-2 and the expert panel. Correlations between the 4-Skills Scans and expert valuations were moderate, with coefficients of .47 (version 2007) and .46 (version 2015). Correlations between the 4-Skills Scans and the MABC-2 (gross) were moderate (.56) for version 2007 and high (.64) for version 2015. It is concluded that both versions of the 4-Skills Scans are satisfactory valid instruments for assessing gross motor skills during PE lessons. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  18. A validated methodology for determination of laboratory instrument computer interface efficacy

    NASA Astrophysics Data System (ADS)

    1984-12-01

    This report is intended to provide a methodology for determining when, and for which instruments, direct interfacing of laboratory instrument and laboratory computers is beneficial. This methodology has been developed to assist the Tri-Service Medical Information Systems Program Office in making future decisions regarding laboratory instrument interfaces. We have calculated the time savings required to reach a break-even point for a range of instrument interface prices and corresponding average annual costs. The break-even analyses used empirical data to estimate the number of data points run per day that are required to meet the break-even point. The results indicate, for example, that at a purchase price of $3,000, an instrument interface will be cost-effective if the instrument is utilized for at least 154 data points per day if operated in the continuous mode, or 216 points per day if operated in the discrete mode. Although this model can help to ensure that instrument interfaces are cost effective, additional information should be considered in making the interface decisions. A reduction in results transcription errors may be a major benefit of instrument interfacing.

  19. Measuring laboratory-based influenza surveillance capacity: development of the 'International Influenza Laboratory Capacity Review' Tool.

    PubMed

    Muir-Paulik, S A; Johnson, L E A; Kennedy, P; Aden, T; Villanueva, J; Reisdorf, E; Humes, R; Moen, A C

    2016-01-01

    The 2005 International Health Regulations (IHR 2005) emphasized the importance of laboratory capacity to detect emerging diseases including novel influenza viruses. To support IHR 2005 requirements and the need to enhance influenza laboratory surveillance capacity, the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC) Influenza Division developed the International Influenza Laboratory Capacity Review (Tool). Data from 37 assessments were reviewed and analyzed to verify that the quantitative analysis results accurately depicted a laboratory's capacity and capabilities. Subject matter experts in influenza and laboratory practice used an iterative approach to develop the Tool incorporating feedback and lessons learnt through piloting and implementation. To systematically analyze assessment data, a quantitative framework for analysis was added to the Tool. The review indicated that changes in scores consistently reflected enhanced or decreased capacity. The review process also validated the utility of adding a quantitative analysis component to the assessments and the benefit of establishing a baseline from which to compare future assessments in a standardized way. Use of the Tool has provided APHL, CDC and each assessed laboratory with a standardized analysis of the laboratory's capacity. The information generated is used to improve laboratory systems for laboratory testing and enhance influenza surveillance globally. We describe the development of the Tool and lessons learnt. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. Laboratory simulation of space plasma phenomena*

    NASA Astrophysics Data System (ADS)

    Amatucci, B.; Tejero, E. M.; Ganguli, G.; Blackwell, D.; Enloe, C. L.; Gillman, E.; Walker, D.; Gatling, G.

    2017-12-01

    Laboratory devices, such as the Naval Research Laboratory's Space Physics Simulation Chamber, are large-scale experiments dedicated to the creation of large-volume plasmas with parameters realistically scaled to those found in various regions of the near-Earth space plasma environment. Such devices make valuable contributions to the understanding of space plasmas by investigating phenomena under carefully controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. By working in collaboration with in situ experimentalists to create realistic conditions scaled to those found during the observations of interest, the microphysics responsible for the observed events can be investigated in detail not possible in space. To date, numerous investigations of phenomena such as plasma waves, wave-particle interactions, and particle energization have been successfully performed in the laboratory. In addition to investigations such as plasma wave and instability studies, the laboratory devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this presentation, we will describe several examples of the laboratory investigation of space plasma waves and instabilities and diagnostic development. *This work supported by the NRL Base Program.

  1. A Science Librarian in the Laboratory: A Case Study

    ERIC Educational Resources Information Center

    Tomaszewski, Robert

    2011-01-01

    A science librarian in the laboratory can become a "point of access" for database instruction and provide a learning opportunity for students to develop their information literacy skills. A case study describes how a librarian in an organic chemistry laboratory helps the class run smoothly and identifies the science librarian as an ally and a…

  2. Determination of aristolochic acid in botanicals and dietary supplements by liquid chromatography with ultraviolet detection and by liquid chromatography/mass spectrometry: single laboratory validation confirmation.

    PubMed

    Trujillo, William A; Sorenson, Wendy R; La Luzerne, Paul; Austad, John W; Sullivan, Darryl

    2006-01-01

    The presence of aristolochic acid in some dietary supplements is a concern to regulators and consumers. A method has been developed, by initially using a reference method as a guide, during single laboratory validation (SLV) for the determination of aristolochic acid I, also known as aristolochic acid A, in botanical species and dietary supplements at concentrations of approximately 2 to 32 microg/g. Higher levels were determined by dilution to fit the standard curve. Through the SLV, the method was optimized for quantification by liquid chromatography with ultraviolet detection (LC-UV) and LC/mass spectrometry (MS) confirmation. The test samples were extracted with organic solvent and water, then injected on a reverse phase LC column. Quantification was achieved with linear regression using a laboratory automation system. The SLV study included systematically optimizing the LC-UV method with regard to test sample size, fine grinding of solids, and solvent extraction efficiency. These parameters were varied in increments (and in separate optimization studies), in order to ensure that each parameter was individually studied; the test results include corresponding tables of parameter variations. In addition, the chromatographic conditions were optimized with respect to injection volume and detection wavelength. Precision studies produced overall relative standard deviation values from 2.44 up to 8.26% for aristolochic acid I. Mean recoveries were between 100 and 103% at the 2 microg/g level, between 102 and 103% at the 10 microg/g level, and 104% at the 30 microg/g level.

  3. Validation of The Health Improvement Network (THIN) Database for Epidemiologic Studies of Chronic Kidney Disease

    PubMed Central

    Denburg, Michelle R.; Haynes, Kevin; Shults, Justine; Lewis, James D.; Leonard, Mary B.

    2011-01-01

    Purpose Chronic kidney disease (CKD) is a prevalent and important outcome and covariate in pharmacoepidemiology. The Health Improvement Network (THIN) in the U.K. represents a unique resource for population-based studies of CKD. We compiled a valid list of Read codes to identify subjects with moderate to advanced CKD. Methods A cross-sectional validation study was performed to identify codes that best define CKD stages 3–5. All subjects with at least one non-zero measure of serum creatinine after 1-Jan-2002 were included. Estimated glomerular filtration rate (eGFR) was calculated according to the Schwartz formula for subjects <18 years and the Modification of Diet in Renal Disease formula for subjects ≥18 years of age. CKD was defined as an eGFR <60 ml/min/1.73m2 on at least two occasions, more than 90 days apart. Results The laboratory definition identified 230,426 subjects with CKD, for a period prevalence in 2008 of 4.56% (95% CI: 4.54, 4.58). A list of 45 Read codes was compiled which yielded a positive predictive value of 88.9% (95% CI: 88.7, 89.1), sensitivity of 48.8%, negative predictive value of 86.5%, and specificity of 98.2%. Of the 11.1% of subjects with a code who did not meet the laboratory definition, 83.6% had at least one eGFR <60. The most commonly used code was for CKD stage 3. Conclusions The proposed list of codes can be used to accurately identify CKD when serum creatinine data are limited. The most sensitive approach for the detection of CKD is to use this list to supplement creatinine measures. PMID:22020900

  4. Validation of The Health Improvement Network (THIN) database for epidemiologic studies of chronic kidney disease.

    PubMed

    Denburg, Michelle R; Haynes, Kevin; Shults, Justine; Lewis, James D; Leonard, Mary B

    2011-11-01

    Chronic kidney disease (CKD) is a prevalent and important outcome and covariate in pharmacoepidemiology. The Health Improvement Network (THIN) in the UK represents a unique resource for population-based studies of CKD. We compiled a valid list of Read codes to identify subjects with moderate to advanced CKD. A cross-sectional validation study was performed to identify codes that best define CKD Stages 3-5. All subjects with at least one non-zero measure of serum creatinine after 1 January 2002 were included. Estimated glomerular filtration rate (eGFR) was calculated according to the Schwartz formula for subjects aged < 18 years and the Modification of Diet in Renal Disease formula for subjects aged ≥ 18 years. CKD was defined as an eGFR <60 mL/minute/1.73 m² on at least two occasions, more than 90 days apart. The laboratory definition identified 230,426 subjects with CKD, for a period prevalence in 2008 of 4.56% (95%CI, 4.54-4.58). A list of 45 Read codes was compiled, which yielded a positive predictive value of 88.9% (95%CI, 88.7-89.1), sensitivity of 48.8%, negative predictive value of 86.5%, and specificity of 98.2%. Of the 11.1% of subjects with a code who did not meet the laboratory definition, 83.6% had at least one eGFR <60. The most commonly used code was for CKD Stage 3. The proposed list of codes can be used to accurately identify CKD when serum creatinine data are limited. The most sensitive approach for the detection of CKD is to use this list to supplement creatinine measures. Copyright © 2011 John Wiley & Sons, Ltd.

  5. PSI-Center Simulations of Validation Platform Experiments

    NASA Astrophysics Data System (ADS)

    Nelson, B. A.; Akcay, C.; Glasser, A. H.; Hansen, C. J.; Jarboe, T. R.; Marklin, G. J.; Milroy, R. D.; Morgan, K. D.; Norgaard, P. C.; Shumlak, U.; Victor, B. S.; Sovinec, C. R.; O'Bryan, J. B.; Held, E. D.; Ji, J.-Y.; Lukin, V. S.

    2013-10-01

    The Plasma Science and Innovation Center (PSI-Center - http://www.psicenter.org) supports collaborating validation platform experiments with extended MHD simulations. Collaborators include the Bellan Plasma Group (Caltech), CTH (Auburn U), FRX-L (Los Alamos National Laboratory), HIT-SI (U Wash - UW), LTX (PPPL), MAST (Culham), Pegasus (U Wisc-Madison), PHD/ELF (UW/MSNW), SSX (Swarthmore College), TCSU (UW), and ZaP/ZaP-HD (UW). Modifications have been made to the NIMROD, HiFi, and PSI-Tet codes to specifically model these experiments, including mesh generation/refinement, non-local closures, appropriate boundary conditions (external fields, insulating BCs, etc.), and kinetic and neutral particle interactions. The PSI-Center is exploring application of validation metrics between experimental data and simulations results. Biorthogonal decomposition is proving to be a powerful method to compare global temporal and spatial structures for validation. Results from these simulation and validation studies, as well as an overview of the PSI-Center status will be presented.

  6. Validation of a multimarker model for assessing risk of type 2 diabetes from a five-year prospective study of 6784 Danish people (Inter99).

    PubMed

    Urdea, Mickey; Kolberg, Janice; Wilber, Judith; Gerwien, Robert; Moler, Edward; Rowe, Michael; Jorgensen, Paul; Hansen, Torben; Pedersen, Oluf; Jørgensen, Torben; Borch-Johnsen, Knut

    2009-07-01

    Improved identification of subjects at high risk for development of type 2 diabetes would allow preventive interventions to be targeted toward individuals most likely to benefit. In previous research, predictive biomarkers were identified and used to develop multivariate models to assess an individual's risk of developing diabetes. Here we describe the training and validation of the PreDx Diabetes Risk Score (DRS) model in a clinical laboratory setting using baseline serum samples from subjects in the Inter99 cohort, a population-based primary prevention study of cardiovascular disease. Among 6784 subjects free of diabetes at baseline, 215 subjects progressed to diabetes (converters) during five years of follow-up. A nested case-control study was performed using serum samples from 202 converters and 597 randomly selected nonconverters. Samples were randomly assigned to equally sized training and validation sets. Seven biomarkers were measured using assays developed for use in a clinical reference laboratory. The PreDx DRS model performed better on the training set (area under the curve [AUC] = 0.837) than fasting plasma glucose alone (AUC = 0.779). When applied to the sequestered validation set, the PreDx DRS showed the same performance (AUC = 0.838), thus validating the model. This model had a better AUC than any other single measure from a fasting sample. Moreover, the model provided further risk stratification among high-risk subpopulations with impaired fasting glucose or metabolic syndrome. The PreDx DRS provides the absolute risk of diabetes conversion in five years for subjects identified to be "at risk" using the clinical factors. Copyright 2009 Diabetes Technology Society.

  7. A single-laboratory validated method for the generation of DNA barcodes for the identification of fish for regulatory compliance.

    PubMed

    Handy, Sara M; Deeds, Jonathan R; Ivanova, Natalia V; Hebert, Paul D N; Hanner, Robert H; Ormos, Andrea; Weigt, Lee A; Moore, Michelle M; Yancy, Haile F

    2011-01-01

    The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.

  8. Validating soil denitrification models based on laboratory N_{2} and N_{2}O fluxes and underlying processes derived by stable isotope approaches

    NASA Astrophysics Data System (ADS)

    Well, Reinhard; Böttcher, Jürgen; Butterbach-Bahl, Klaus; Dannenmann, Michael; Deppe, Marianna; Dittert, Klaus; Dörsch, Peter; Horn, Marcus; Ippisch, Olaf; Mikutta, Robert; Müller, Carsten; Müller, Christoph; Senbayram, Mehmet; Vogel, Hans-Jörg; Wrage-Mönnig, Nicole

    2016-04-01

    Robust denitrification data suitable to validate soil N2 fluxes in denitrification models are scarce due to methodical limitations and the extreme spatio-temporal heterogeneity of denitrification in soils. Numerical models have become essential tools to predict denitrification at different scales. Model performance could either be tested for total gaseous flux (NO + N2O + N2), individual denitrification products (e.g. N2O and/or NO) or for the effect of denitrification factors (e.g. C-availability, respiration, diffusivity, anaerobic volume, etc.). While there are numerous examples for validating N2O fluxes, there are neither robust field data of N2 fluxes nor sufficiently resolved measurements of control factors used as state variables in the models. To the best of our knowledge there has been only one published validation of modelled soil N2 flux by now, using a laboratory data set to validate an ecosystem model. Hence there is a need for validation data at both, the mesocosm and the field scale including validation of individual denitrification controls. Here we present the concept for collecting model validation data which is be part of the DFG-research unit "Denitrification in Agricultural Soils: Integrated Control and Modelling at Various Scales (DASIM)" starting this year. We will use novel approaches including analysis of stable isotopes, microbial communities, pores structure and organic matter fractions to provide denitrification data sets comprising as much detail on activity and regulation as possible as a basis to validate existing and calibrate new denitrification models that are applied and/or developed by DASIM subprojects. The basic idea is to simulate "field-like" conditions as far as possible in an automated mesocosm system without plants in order to mimic processes in the soil parts not significantly influenced by the rhizosphere (rhizosphere soils are studied by other DASIM projects). Hence, to allow model testing in a wide range of conditions

  9. Beware of external validation! - A Comparative Study of Several Validation Techniques used in QSAR Modelling.

    PubMed

    Majumdar, Subhabrata; Basak, Subhash C

    2018-04-26

    Proper validation is an important aspect of QSAR modelling. External validation is one of the widely used validation methods in QSAR where the model is built on a subset of the data and validated on the rest of the samples. However, its effectiveness for datasets with a small number of samples but large number of predictors remains suspect. Calculating hundreds or thousands of molecular descriptors using currently available software has become the norm in QSAR research, owing to computational advances in the past few decades. Thus, for n chemical compounds and p descriptors calculated for each molecule, the typical chemometric dataset today has high value of p but small n (i.e. n < p). Motivated by the evidence of inadequacies of external validation in estimating the true predictive capability of a statistical model in recent literature, this paper performs an extensive and comparative study of this method with several other validation techniques. We compared four validation methods: leave-one-out, K-fold, external and multi-split validation, using statistical models built using the LASSO regression, which simultaneously performs variable selection and modelling. We used 300 simulated datasets and one real dataset of 95 congeneric amine mutagens for this evaluation. External validation metrics have high variation among different random splits of the data, hence are not recommended for predictive QSAR models. LOO has the overall best performance among all validation methods applied in our scenario. Results from external validation are too unstable for the datasets we analyzed. Based on our findings, we recommend using the LOO procedure for validating QSAR predictive models built on high-dimensional small-sample data. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. Accuracy and precision of Legionella isolation by US laboratories in the ELITE program pilot study.

    PubMed

    Lucas, Claressa E; Taylor, Thomas H; Fields, Barry S

    2011-10-01

    A pilot study for the Environmental Legionella Isolation Techniques Evaluation (ELITE) Program, a proficiency testing scheme for US laboratories that culture Legionella from environmental samples, was conducted September 1, 2008 through March 31, 2009. Participants (n=20) processed panels consisting of six sample types: pure and mixed positive, pure and mixed negative, pure and mixed variable. The majority (93%) of all samples (n=286) were correctly characterized, with 88.5% of samples positive for Legionella and 100% of negative samples identified correctly. Variable samples were incorrectly identified as negative in 36.9% of reports. For all samples reported positive (n=128), participants underestimated the cfu/ml by a mean of 1.25 logs with standard deviation of 0.78 logs, standard error of 0.07 logs, and a range of 3.57 logs compared to the CDC re-test value. Centering results around the interlaboratory mean yielded a standard deviation of 0.65 logs, standard error of 0.06 logs, and a range of 3.22 logs. Sampling protocol, treatment regimen, culture procedure, and laboratory experience did not significantly affect the accuracy or precision of reported concentrations. Qualitative and quantitative results from the ELITE pilot study were similar to reports from a corresponding proficiency testing scheme available in the European Union, indicating these results are probably valid for most environmental laboratories worldwide. The large enumeration error observed suggests that the need for remediation of a water system should not be determined solely by the concentration of Legionella observed in a sample since that value is likely to underestimate the true level of contamination. Published by Elsevier Ltd.

  11. Zero-gravity cloud physics laboratory: Candidate experiments definition and preliminary concept studies

    NASA Technical Reports Server (NTRS)

    Eaton, L. R.; Greco, R. V.; Hollinden, A. B.

    1973-01-01

    The candidate definition studies on the zero-g cloud physics laboratory are covered. This laboratory will be an independent self-contained shuttle sortie payload. Several critical technology areas have been identified and studied to assure proper consideration in terms of engineering requirements for the final design. Areas include chambers, gas and particle generators, environmental controls, motion controls, change controls, observational techniques, and composition controls. This unique laboratory will allow studies to be performed without mechanical, aerodynamics, electrical, or other type techniques to support the object under study. This report also covers the candidate experiment definitions, chambers and experiment classes, laboratory concepts and plans, special supporting studies, early flight opportunities and payload planning data for overall shuttle payload requirements assessments.

  12. Analysis of Thiodiglycol: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS777

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Owens, J; Koester, C

    The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for the analysis of thiodiglycol, the breakdown product of the sulfur mustard HD, in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS777 (hereafter referred to as EPA CRL SOP MS777). This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to verifymore » the analytical procedures described in MS777 for analysis of thiodiglycol in aqueous samples. The gathered data from this study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS777 can be determined.« less

  13. Laboratory Studies of Interstellar PAH Analogs

    NASA Technical Reports Server (NTRS)

    Salama, Farid; DeVincenzi, Donald (Technical Monitor)

    2000-01-01

    Polycyclic aromatic hydrocarbons (PAHs) are now considered to be an important and ubiquitous component of the organic material in space. PAHs are found in a large variety of extraterrestrial materials such as interplanetary dust particles (IDPs) and meteoritic materials. PAHs are also good candidates to account for the infrared emission bands (UIRs) and the diffuse interstellar optical absorption bands (DIBs) detected in various regions of the interstellar medium. The recent observations made with the Infrared Space Observatory (ISO) have confirmed the ubiquitous nature of the UIR bands and their carriers. PAHs are though to form through chemical reactions in the outflow from carbon-rich stars in a process similar to soot formation. Once injected in the interstellar medium, PAHs are further processed by the interstellar radiation field, interstellar shocks and energetic particles. A major, dedicated, laboratory effort has been undertaken over the past years to measure the physical and chemical characteristics of these complex molecules and their ions under experimental conditions that mimic the interstellar conditions. These measurements require collision-free conditions where the molecules and ions are cold and chemically isolated. The spectroscopy of PAHs under controlled conditions represents an essential diagnostic tool to study the evolution of extraterrestrial PAHs. The Astrochemistry Laboratory program will be discussed through its multiple aspects: objectives, approach and techniques adopted, adaptability to the nature of the problem(s), results and implications for astronomy as well as for molecular spectroscopy. A review of the data generated through laboratory simulations of space environments and the role these data have played in our current understanding of the properties of interstellar PAHs will be presented. The discussion will also introduce the newest generation of laboratory experiments that are currently being developed in order to provide a

  14. 29 CFR 1607.7 - Use of other validity studies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... EMPLOYEE SELECTION PROCEDURES (1978) General Principles § 1607.7 Use of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection... described in test manuals. While publishers of selection procedures have a professional obligation to...

  15. 29 CFR 1607.7 - Use of other validity studies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... EMPLOYEE SELECTION PROCEDURES (1978) General Principles § 1607.7 Use of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection... described in test manuals. While publishers of selection procedures have a professional obligation to...

  16. 29 CFR 1607.7 - Use of other validity studies.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... EMPLOYEE SELECTION PROCEDURES (1978) General Principles § 1607.7 Use of other validity studies. A. Validity studies not conducted by the user. Users may, under certain circumstances, support the use of selection... described in test manuals. While publishers of selection procedures have a professional obligation to...

  17. Measuring Long-Distance Romantic Relationships: A Validity Study

    ERIC Educational Resources Information Center

    Pistole, M. Carole; Roberts, Amber

    2011-01-01

    This study investigated aspects of construct validity for the scores of a new long-distance romantic relationship measure. A single-factor structure of the long-distance romantic relationship index emerged, with convergent and discriminant evidence of external validity, high internal consistency reliability, and applied utility of the scores.…

  18. The Self-Consciousness Scale: A Discriminant Validity Study

    ERIC Educational Resources Information Center

    Carver, Charles S.; Glass, David C.

    1976-01-01

    A validity study is conducted of the Self-Consciousness Scale components with male undergraduates. The components, Private and Public Self Consciousness and Social Anxiety did not correlate with any other measures used to establish their validity and thus seem to be independent of other measures tested. (Author/DEP)

  19. Collaborative study for the validation of an improved HPLC assay for recombinant IFN-alfa-2.

    PubMed

    Jönsson, K H; Daas, A; Buchheit, K H; Terao, E

    2016-01-01

    The current European Pharmacopoeia (Ph. Eur.) texts for Interferon (IFN)-alfa-2 include a nonspecific photometric protein assay using albumin as calibrator and a highly variable cell-based assay for the potency determination of the protective effects. A request was expressed by the Official Medicines Control Laboratories (OMCLs) for improved methods for the batch control of recombinant interferon alfa-2 bulk and market surveillance testing of finished products, including those formulated with Human Serum Albumin (HSA). A HPLC method was developed at the Medical Products Agency (MPA, Sweden) for the testing of IFN-alfa-2 products. An initial collaborative study run under the Biological Standardisation Programme (BSP; study code BSP039) revealed the need for minor changes to improve linearity of the calibration curves, assay reproducibility and robustness. The goal of the collaborative study, coded BSP071, was to transfer and further validate this improved HPLC method. Ten laboratories participated in the study. Four marketed IFN-alfa-2 preparations (one containing HSA) together with the Ph. Eur. Chemical Reference Substance (CRS) for IFN-alfa-2a and IFN-alfa-2b, and in-house reference standards from two manufacturers were used for the quantitative assay. The modified method was successfully transferred to all laboratories despite local variation in equipment. The resolution between the main and the oxidised forms of IFN-alfa-2 was improved compared to the results from the BSP039 study. The improved method even allowed partial resolution of an extra peak after the principal peak. Symmetry of the main IFN peak was acceptable for all samples in all laboratories. Calibration curves established with the Ph. Eur. IFN-alfa-2a and IFN-alfa-2b CRSs showed excellent linearity with intercepts close to the origin and coefficients of determination greater than 0.9995. Assay repeatability, intermediate precision and reproducibility varied with the tested sample within acceptable

  20. Maui Space Surveillance System Satellite Categorization Laboratory

    NASA Astrophysics Data System (ADS)

    Deiotte, R.; Guyote, M.; Kelecy, T.; Hall, D.; Africano, J.; Kervin, P.

    The MSSS satellite categorization laboratory is a fusion of robotics and digital imaging processes that aims to decompose satellite photometric characteristics and behavior in a controlled setting. By combining a robot, light source and camera to acquire non-resolved images of a model satellite, detailed photometric analyses can be performed to extract relevant information about shape features, elemental makeup, and ultimately attitude and function. Using the laboratory setting a detailed analysis can be done on any type of material or design and the results cataloged in a database that will facilitate object identification by "curve-fitting" individual elements in the basis set to observational data that might otherwise be unidentifiable. Currently the laboratory has created, an ST-Robotics five degree of freedom robotic arm, collimated light source and non-focused Apogee camera have all been integrated into a MATLAB based software package that facilitates automatic data acquisition and analysis. Efforts to date have been aimed at construction of the lab as well as validation and verification of simple geometric objects. Simple tests on spheres, cubes and simple satellites show promising results that could lead to a much better understanding of non-resolvable space object characteristics. This paper presents a description of the laboratory configuration and validation test results with emphasis on the non-resolved photometric characteristics for a variety of object shapes, spin dynamics and orientations. The future vision, utility and benefits of the laboratory to the SSA community as a whole are also discussed.

  1. Validation of new psychosocial factors questionnaires: a Colombian national study.

    PubMed

    Villalobos, Gloria H; Vargas, Angélica M; Rondón, Martin A; Felknor, Sarah A

    2013-01-01

    The study of workers' health problems possibly associated with stressful conditions requires valid and reliable tools for monitoring risk factors. The present study validates two questionnaires to assess psychosocial risk factors for stress-related illnesses within a sample of Colombian workers. The validation process was based on a representative sample survey of 2,360 Colombian employees, aged 18-70 years. Worker response rate was 90%; 46% of the responders were women. Internal consistency was calculated, construct validity was tested with factor analysis and concurrent validity was tested with Spearman correlations. The questionnaires demonstrated adequate reliability (0.88-0.95). Factor analysis confirmed the dimensions proposed in the measurement model. Concurrent validity resulted in significant correlations with stress and health symptoms. "Work and Non-work Psychosocial Factors Questionnaires" were found to be valid and reliable for the assessment of workers' psychosocial factors, and they provide information for research and intervention. Copyright © 2012 Wiley Periodicals, Inc.

  2. An investigation of normal urine with a creatinine concentration under the cutoff of 20 mg/dL for specimen validity testing in a toxicology laboratory.

    PubMed

    Holden, Brad; Guice, Erica A

    2014-05-01

    In clinical and forensic toxicology laboratories, one commonly used method for urine specimen validity testing is creatinine concentration. In this study, workplace guidelines are examined to determine their relevance to forensic and clinical toxicology samples. Specifically, it investigates the occurrence of urine creatinine concentrations under 20 mg/dL and notes potential issues with factors influencing creatinine concentration by utilizing a simple, novel method consisting of cation-paring high-pressure liquid chromatography in tandem with ultraviolet detection to determine the creatinine concentration in 3019 donors. Of the 4227 sample population in this study, 209 (4.94%) were below the cutoff value of 20 mg/dL for dilute urine. Because there are many factors that can influence the urinary creatinine concentration, samples that have creatinine under the 20 mg/dL cutoff do not always implicate sample adulteration. © 2014 American Academy of Forensic Sciences.

  3. Choice of experimental venue matters in ecotoxicology studies: Comparison of a laboratory-based and an outdoor mesocosm experiment.

    PubMed

    Mikó, Zsanett; Ujszegi, János; Gál, Zoltán; Imrei, Zoltán; Hettyey, Attila

    2015-10-01

    The heavy application of pesticides and its potential effects on natural communities has attracted increasing attention to inadvertent impacts of these chemicals. Toxicologists conventionally use laboratory-based tests to assess lethal concentrations of pesticides. However, these tests often do not take into account indirect, interactive and long-term effects, and tend to ignore different rates of disintegration in the laboratory and under natural conditions. Our aim was to investigate the importance of the experimental venue for ecotoxicology tests. We reared tadpoles of the agile frog (Rana dalmatina) in the laboratory and in outdoor mesocosms and exposed them to three initial concentrations of a glyphosate-based herbicide (0, 2 and 6.5 mg a.e./L glyphosate), and to the presence or absence of caged predators (dragonfly larvae). The type of experimental venue had a large effect on the outcome: The herbicide was less lethal to tadpoles reared in outdoor mesocosms than in the laboratory. Further, while the herbicide had a negative effect on development time and on body mass in the laboratory, tadpoles exposed to the herbicide in mesocosms were larger at metamorphosis and developed faster in comparison to those reared in the absence of the herbicide. The effect of the herbicide on morphological traits of tadpoles also differed between the two venues. Finally, in the presence of the herbicide, tadpoles tended to be more active and to stay closer to the bottom of laboratory containers, while tadpole behaviour shifted in the opposite direction in outdoor mesocosms. Our results demonstrate major discrepancies between results of a classic laboratory-based ecotoxicity test and outcomes of an experiment performed in outdoor mesocosms. Consequently, the use of standard laboratory tests may have to be reconsidered and their benefits carefully weighed against the difficulties of performing experiments under more natural conditions. Tests validating experimentally estimated

  4. DNA Commission of the International Society for Forensic Genetics: Recommendations on the validation of software programs performing biostatistical calculations for forensic genetics applications.

    PubMed

    Coble, M D; Buckleton, J; Butler, J M; Egeland, T; Fimmers, R; Gill, P; Gusmão, L; Guttman, B; Krawczak, M; Morling, N; Parson, W; Pinto, N; Schneider, P M; Sherry, S T; Willuweit, S; Prinz, M

    2016-11-01

    The use of biostatistical software programs to assist in data interpretation and calculate likelihood ratios is essential to forensic geneticists and part of the daily case work flow for both kinship and DNA identification laboratories. Previous recommendations issued by the DNA Commission of the International Society for Forensic Genetics (ISFG) covered the application of bio-statistical evaluations for STR typing results in identification and kinship cases, and this is now being expanded to provide best practices regarding validation and verification of the software required for these calculations. With larger multiplexes, more complex mixtures, and increasing requests for extended family testing, laboratories are relying more than ever on specific software solutions and sufficient validation, training and extensive documentation are of upmost importance. Here, we present recommendations for the minimum requirements to validate bio-statistical software to be used in forensic genetics. We distinguish between developmental validation and the responsibilities of the software developer or provider, and the internal validation studies to be performed by the end user. Recommendations for the software provider address, for example, the documentation of the underlying models used by the software, validation data expectations, version control, implementation and training support, as well as continuity and user notifications. For the internal validations the recommendations include: creating a validation plan, requirements for the range of samples to be tested, Standard Operating Procedure development, and internal laboratory training and education. To ensure that all laboratories have access to a wide range of samples for validation and training purposes the ISFG DNA commission encourages collaborative studies and public repositories of STR typing results. Published by Elsevier Ireland Ltd.

  5. Integrated Summary Report: Validation of Two Binding Assays ...

    EPA Pesticide Factsheets

    This Integrated Summary Report (ISR) summarizes, in a single document, the results from an international multi-laboratory validation study conducted for two in vitro estrogen receptor (ER) binding assays. These assays both use human recombinant estrogen receptor, alpha subtype (hrERα), to identify chemicals that may impact estrogen signaling through binding to the ER. The purpose of the ISR is to support the peer review of the findings obtained during the validation process.The two assays evaluated during this validation process are: The Freyberger-Wilson Assay (FW) using a full length human ER, and The Chemical Evaluation and Research Institute (CERI) Assay using a ligand-binding domain of the human ER.The two assays are mechanistically and functionally similar in that each measures the ability of a test chemical to competitively inhibit binding of [3H]17β-estradiol to the human recombinant ER. The essential elements of the FW and the CERI assays were developed at the laboratories of Bayer Pharma AG, Wuppertal, Germany (Freyberger et al., 2010) and CERI, Tokyo, Japan (Akahori et al., 2008), respectively.The ER competitive binding assay has long been in use, and is a well characterized approach, but historically uses rodent or other animal tissues as a source of the ER. Validation of the FW and CERI assays using human recombinant estrogen receptors ( subtype) will provide an updated alternative for the Agency’s current test guideline (OPPTS 89

  6. Determination of lipophilic toxins by LC/MS/MS: single-laboratory validation.

    PubMed

    Villar-González, Adriano; Rodríguez-Velasco, María Luisa; Gago-Martínez, Ana

    2011-01-01

    An LC/MS/MS method has been developed, assessed, and intralaboratory-validated for the analysis of the lipophilic toxins currently regulated by European Union legislation: okadaic acid (OA) and dinophysistoxins 1 and 2, including their ester forms; azaspiracids 1, 2, and 3; pectenotoxins 1 and 2; yessotoxin (YTX), and the analogs 45 OH-YTX, Homo YTX, and 45 OH-Homo YTX; as well as for the analysis of 13-desmetil-spirolide C. The method consists of duplicate sample extraction with methanol and direct analysis of the crude extract without further cleanup or concentration. Ester forms of OA and dinophysistoxins are detected as the parent ions after alkaline hydrolysis of the extract. The validation process of this method was performed using both fortified and naturally contaminated samples, and experiments were designed according to International Organization for Standardization, International Union of Pure and Applied Chemistry, and AOAC guidelines. With the exception of YTX in fortified samples, RSDr below 15% and RSDR were below 25%. Recovery values were between 77 and 95%, and LOQs were below 60 microg/kg. These data together with validation experiments for recovery, selectivity, robustness, traceability, and linearity, as well as uncertainty calculations, are presented in this paper.

  7. Comparative study of transient hydraulic tomography with varying parameterizations and zonations: Laboratory sandbox investigation

    NASA Astrophysics Data System (ADS)

    Luo, Ning; Zhao, Zhanfeng; Illman, Walter A.; Berg, Steven J.

    2017-11-01

    Transient hydraulic tomography (THT) is a robust method of aquifer characterization to estimate the spatial distributions (or tomograms) of both hydraulic conductivity (K) and specific storage (Ss). However, the highly-parameterized nature of the geostatistical inversion approach renders it computationally intensive for large-scale investigations. In addition, geostatistics-based THT may produce overly smooth tomograms when head data used to constrain the inversion is limited. Therefore, alternative model conceptualizations for THT need to be examined. To investigate this, we simultaneously calibrated different groundwater models with varying parameterizations and zonations using two cases of different pumping and monitoring data densities from a laboratory sandbox. Specifically, one effective parameter model, four geology-based zonation models with varying accuracy and resolution, and five geostatistical models with different prior information are calibrated. Model performance is quantitatively assessed by examining the calibration and validation results. Our study reveals that highly parameterized geostatistical models perform the best among the models compared, while the zonation model with excellent knowledge of stratigraphy also yields comparable results. When few pumping tests with sparse monitoring intervals are available, the incorporation of accurate or simplified geological information into geostatistical models reveals more details in heterogeneity and yields more robust validation results. However, results deteriorate when inaccurate geological information are incorporated. Finally, our study reveals that transient inversions are necessary to obtain reliable K and Ss estimates for making accurate predictions of transient drawdown events.

  8. Helping Students Evaluate the Validity of a Research Study.

    ERIC Educational Resources Information Center

    Morgan, George A.; Gliner, Jeffrey A.

    Students often have difficulty in evaluating the validity of a study. A conceptually and linguistically meaningful framework for evaluating research studies is proposed that is based on the discussion of internal and external validity of T. D. Cook and D. T. Campbell (1979). The proposal includes six key dimensions, three related to internal…

  9. Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I Follow-up Study cohort

    PubMed Central

    Gaziano, Thomas A; Young, Cynthia R; Fitzmaurice, Garrett; Atwood, Sidney; Gaziano, J Michael

    2008-01-01

    Summary Background Around 80% of all cardiovascular deaths occur in developing countries. Assessment of those patients at high risk is an important strategy for prevention. Since developing countries have limited resources for prevention strategies that require laboratory testing, we assessed if a risk prediction method that did not require any laboratory tests could be as accurate as one requiring laboratory information. Methods The National Health and Nutrition Examination Survey (NHANES) was a prospective cohort study of 14 407 US participants aged between 25–74 years at the time they were first examined (between 1971 and 1975). Our follow-up study population included participants with complete information on these surveys who did not report a history of cardiovascular disease (myocardial infarction, heart failure, stroke, angina) or cancer, yielding an analysis dataset N=6186. We compared how well either method could predict first-time fatal and non-fatal cardiovascular disease events in this cohort. For the laboratory-based model, which required blood testing, we used standard risk factors to assess risk of cardiovascular disease: age, systolic blood pressure, smoking status, total cholesterol, reported diabetes status, and current treatment for hypertension. For the non-laboratory-based model, we substituted body-mass index for cholesterol. Findings In the cohort of 6186, there were 1529 first-time cardiovascular events and 578 (38%) deaths due to cardiovascular disease over 21 years. In women, the laboratory-based model was useful for predicting events, with a c statistic of 0·829. The c statistic of the non-laboratory-based model was 0·831. In men, the results were similar (0·784 for the laboratory-based model and 0·783 for the non-laboratory-based model). Results were similar between the laboratory-based and non-laboratory-based models in both men and women when restricted to fatal events only. Interpretation A method that uses non-laboratory

  10. Variability of creatinine measurements in clinical laboratories: results from the CRIC study.

    PubMed

    Joffe, Marshall; Hsu, Chi-yuan; Feldman, Harold I; Weir, Matthew; Landis, J R; Hamm, L Lee

    2010-01-01

    Estimating equations using serum creatinine (SCr) are often used to assess glomerular filtration rate (GFR). Such creatinine (Cr)-based formulae may produce biased estimates of GFR when using Cr measurements that have not been calibrated to reference laboratories. In this paper, we sought to examine the degree of this variation in Cr assays in several laboratories associated with academic medical centers affiliated with the Chronic Renal Insufficiency Cohort (CRIC) Study; to consider how best to correct for this variation, and to quantify the impact of such corrections on eligibility for participation in CRIC. Variability of Cr is of particular concern in the conduct of CRIC, a large multicenter study of subjects with chronic renal disease, because eligibility for the study depends on Cr-based assessment of GFR. A library of 5 large volume plasma specimens from apheresis patients was assembled, representing levels of plasma Cr from 0.8 to 2.4 mg/dl. Samples from this library were used for measurement of Cr at each of the 14 CRIC laboratories repetitively over time. We used graphical displays and linear regression methods to examine the variability in Cr, and used linear regression to develop calibration equations. We also examined the impact of the various calibration equations on the proportion of subjects screened as potential participants who were actually eligible for the study. There was substantial variability in Cr assays across laboratories and over time. We developed calibration equations for each laboratory; these equations varied substantially among laboratories and somewhat over time in some laboratories. The laboratory site contributed the most to variability (51% of the variance unexplained by the specimen) and variation with time accounted for another 15%. In some laboratories, calibration equations resulted in differences in eligibility for CRIC of as much as 20%. The substantial variability in SCr assays across laboratories necessitates calibration

  11. Validity of the Digital Inclinometer and iPhone When Measuring Thoracic Spine Rotation.

    PubMed

    Bucke, Jonathan; Spencer, Simon; Fawcett, Louise; Sonvico, Lawrence; Rushton, Alison; Heneghan, Nicola R

    2017-09-01

      Spinal axial rotation is required for many functional and sporting activities. Eighty percent of axial rotation occurs in the thoracic spine. Existing measures of thoracic spine rotation commonly involve laboratory equipment, use a seated position, and include lumbar motion. A simple performance-based outcome measure would allow clinicians to evaluate isolated thoracic spine rotation. Currently, no valid measure exists.   To explore the criterion and concurrent validity of a digital inclinometer (DI) and iPhone Clinometer app (iPhone) for measuring thoracic spine rotation using the heel-sit position.   Controlled laboratory study.   University laboratory.   A total of 23 asymptomatic healthy participants (14 men, 9 women; age = 25.82 ± 4.28 years, height = 170.26 ± 8.01 cm, mass = 67.50 ± 9.46 kg, body mass index = 23.26 ± 2.79) were recruited from a student population.   We took DI and iPhone measurements of thoracic spine rotation in the heel-sit position concurrently with dual-motion analysis (laboratory measure) and ultrasound imaging of the underlying bony tissue motion (reference standard). To determine the criterion and concurrent validity, we used the Pearson product moment correlation coefficient (r, 2 tailed) and Bland-Altman plots.   The DI (r = 0.88, P < .001) and iPhone (r = 0.88, P < .001) demonstrated strong criterion validity. Both also had strong concurrent validity (r = 0.98, P < .001). Bland-Altman plots illustrated mean differences of 5.82° (95% confidence interval [CI] = 20.37°, -8.73°) and 4.94° (95% CI = 19.23°, -9.35°) between the DI and iPhone, respectively, and the reference standard and 0.87° (95% CI = 6.79°, -5.05°) between the DI and iPhone.   The DI and iPhone provided valid measures of thoracic spine rotation in the heel-sit position. Both can be used in clinical practice to assess thoracic spine rotation, which may be valuable when evaluating thoracic dysfunction.

  12. Bioanalysis of alectinib and metabolite M4 in human plasma, cross-validation and impact on PK assessment.

    PubMed

    Heinig, Katja; Miya, Kazuhiro; Kamei, Tomonori; Guerini, Elena; Fraier, Daniela; Yu, Li; Bansal, Surendra; Morcos, Peter N

    2016-07-01

    Alectinib is a novel anaplastic lymphoma kinase (ALK) inhibitor for treatment of patients with ALK-positive non-small-cell lung cancer who have progressed on or are intolerant to crizotinib. To support clinical development, concentrations of alectinib and metabolite M4 were determined in plasma from patients and healthy subjects. LC-MS/MS methods were developed and validated in two different laboratories: Chugai used separate assays for alectinib and M4 in a pivotal Phase I/II study while Roche established a simultaneous assay for both analytes for another pivotal study and all other studies. Cross-validation assessment revealed a bias between the two bioanalytical laboratories, which was confirmed with the clinical PK data between both pivotal studies using the different bioanalytical methods.

  13. Determination of Aristolochic Acid in Botanicals and Dietary Supplements by Liquid Chromatography with Ultraviolet Detection and by Liquid Chromatography/Mass Spectrometry: Single Laboratory Validation Confirmation

    PubMed Central

    Trujillo, William A.; Sorenson, Wendy R.; La Luzerne, Paul; Austad, John W.; Sullivan, Darryl

    2008-01-01

    The presence of aristolochic acid in some dietary supplements is a concern to regulators and consumers. A method has been developed, by initially using a reference method as a guide, during single laboratory validation (SLV) for the determination of aristolochic acid I, also known as aristolochic acid A, in botanical species and dietary supplements at concentrations of approximately 2 to 32 μg/g. Higher levels were determined by dilution to fit the standard curve. Through the SLV, the method was optimized for quantification by liquid Chromatography with ultraviolet detection (LC-UV) and LC/mass Spectrometry (MS) confirmation. The test samples were extracted with organic solvent and water, then injected on a reverse phase LC column. Quantification was achieved with linear regression using a laboratory automation system. The SLV study included systematically optimizing the LC-UV method with regard to test sample size, fine grinding of solids, and solvent extraction efficiency. These parameters were varied in increments (and in separate optimization studies), in order to ensure that each parameter was individually studied; the test results include corresponding tables of parameter variations. In addition, the chromatographic conditions were optimized with respect to injection volume and detection wavelength. Precision studies produced overall relative standard deviation values from 2.44 up to 8.26% for aristolochic acid I. Mean recoveries were between 100 and 103% at the 2 μg/g level, between 102 and 103% at the 10 μg/g level, and 104% at the 30 μg/g level. PMID:16915829

  14. Absorption in Sport: A Cross-Validation Study

    PubMed Central

    Koehn, Stefan; Stavrou, Nektarios A. M.; Cogley, Jeremy; Morris, Tony; Mosek, Erez; Watt, Anthony P.

    2017-01-01

    Absorption has been identified as readiness for experiences of deep involvement in the task. Conceptually, absorption is a key psychological construct, incorporating experiential, cognitive, and motivational components. Although, no operationalization of the construct has been provided to facilitate research in this area, the purpose of this research was the development and examination of the psychometric properties of a sport-specific measure of absorption that evolved from the use of the modified Tellegen Absorption Scale (MODTAS; Jamieson, 2005) in mainstream psychology. The study aimed to provide evidence of the psychometric properties, reliability, and validity of the Measure of Absorption in Sport Contexts (MASCs). The psychometric examination included a calibration sample from Scotland and a cross-validation sample from Australia using a cross-sectional design. The item pool was developed based on existing items from the modified Tellegen Absorption Scale (Jamieson, 2005). The MODTAS items were reworded and translated into a sport context. The Scottish sample consisted of 292 participants and the Australian sample of 314 participants. Congeneric model testing and confirmatory factor analysis for both samples and multi-group invariance testing across samples was used. In the cross-validation sample the MASC subscales showed acceptable internal consistency and construct reliability (≥0.70). Excellent fit indices were found for the final 18-item, six-factor measure in the cross-validation sample, χ(120)2 = 197.486, p < 0.001; CFI = 0.957; TLI = 0.945; RMSEA = 0.045; SRMR = 0.044. Multi-group invariance testing revealed no differences in item meaning, except for two items. The MASC and the Dispositional Flow Scale-2 showed moderate-to-strong positive correlations in both samples, r = 0.38, p < 0.001 and r = 0.42, p < 0.001, supporting the external validity of the MASC. This article provides initial evidence in support of the psychometric properties

  15. Does a dynamic chair increase office workers' movements? - Results from a combined laboratory and field study.

    PubMed

    Grooten, Wilhelmus J A; Äng, Björn O; Hagströmer, Maria; Conradsson, David; Nero, Håkan; Franzén, Erika

    2017-04-01

    Dynamic chairs have the potential to facilitate movements that could counteract health problems associated with sedentary office work. This study aimed to evaluate whether a dynamic chair can increase movements during desk-based office work. Fifteen healthy subjects performed desk-based office work using a dynamic office chair and compared to three other conditions in a movement laboratory. In a field study, the dynamic office chair was studied during three working days using accelerometry. Equivocal results showed that the dynamic chair increased upper body and chair movements as compared to the conventional chair, but lesser movements were found compared to standing. No differences were found between the conditions in the field study. A dynamic chair may facilitate movements in static desk-based office tasks, but the results were not consistent for all outcome measures. Validation of measuring protocols for assessing movements during desk-based office work is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Validation of a Multimarker Model for Assessing Risk of Type 2 Diabetes from a Five-Year Prospective Study of 6784 Danish People (Inter99)

    PubMed Central

    Urdea, Mickey; Kolberg, Janice; Wilber, Judith; Gerwien, Robert; Moler, Edward; Rowe, Michael; Jorgensen, Paul; Hansen, Torben; Pedersen, Oluf; Jørgensen, Torben; Borch-Johnsen, Knut

    2009-01-01

    Background Improved identification of subjects at high risk for development of type 2 diabetes would allow preventive interventions to be targeted toward individuals most likely to benefit. In previous research, predictive biomarkers were identified and used to develop multivariate models to assess an individual's risk of developing diabetes. Here we describe the training and validation of the PreDx™ Diabetes Risk Score (DRS) model in a clinical laboratory setting using baseline serum samples from subjects in the Inter99 cohort, a population-based primary prevention study of cardiovascular disease. Methods Among 6784 subjects free of diabetes at baseline, 215 subjects progressed to diabetes (converters) during five years of follow-up. A nested case-control study was performed using serum samples from 202 converters and 597 randomly selected nonconverters. Samples were randomly assigned to equally sized training and validation sets. Seven biomarkers were measured using assays developed for use in a clinical reference laboratory. Results The PreDx DRS model performed better on the training set (area under the curve [AUC] = 0.837) than fasting plasma glucose alone (AUC = 0.779). When applied to the sequestered validation set, the PreDx DRS showed the same performance (AUC = 0.838), thus validating the model. This model had a better AUC than any other single measure from a fasting sample. Moreover, the model provided further risk stratification among high-risk subpopulations with impaired fasting glucose or metabolic syndrome. Conclusions The PreDx DRS provides the absolute risk of diabetes conversion in five years for subjects identified to be “at risk” using the clinical factors. PMID:20144324

  17. Determination of Aflatoxins and Ochratoxin A in Traditional Turkish Concentrated Fruit Juice Products by Multi-Immunoaffinity Column Cleanup and LC Fluorescence Detection: Single-Laboratory Validation.

    PubMed

    Kaymak, Tugrul; Türker, Levent; Tulay, Hüseyin; Stroka, Joerg

    2018-04-27

    Background : Pekmez and pestil are traditional Turkish foods made from concentrated grapejuice, which can be contaminated with mycotoxins such as aflatoxins and ochratoxin A (OTA). Objective : To carry out a single-laboratory validation of a method to simultaneously determine aflatoxins B 1 , B₂, G 1 , and G₂ and ochratoxin A in pekmez and pestil. Methods : The homogenized sample is extracted with methanol-water (80 + 20) using a high-speed blender. The (sample) extract is filtered, diluted with phosphate-buffered saline solution, and applied to a multi-immunoaffinity column (AFLAOCHRA PREP®). Aflatoxins and ochratoxin A are removed with (neat) methanol and then directly analyzed by reversed-phase LC with fluorescence detection using post-column bromination (Kobra cell®). Results : Test portions of blank pekmez and pestil were spiked with a mixture of aflatoxins and ochratoxin A to give levels ranging from 2.6 to 10.4 μg/kg and 1.0-4.0 μg/kg, respectively. Recoveries for total aflatoxins and ochratoxin A ranged from 84 to 106% and 80-97%, respectively, for spiked samples. Based on results for spiked pekmez and pestil (30 replicates each at three levels), the repeatability RSD ranged from 1.6 to 12% and 2.7-11% for total aflatoxins and ochratoxin A, respectively. Conclusions : The method performance in terms of recovery, repeatability, and detection limits has been demonstrated to be suitable for use as an Official Method. Highlights : First immunoaffinity column method validated for simultaneous analysis of aflatoxins and ochratoxin A in pekmez and pestil. Suitability for use for official purposes in Turkey, demonstrated by single-laboratory validation. Co-occurrence of aflatoxins and OTA in mulberry and carob pekmez reported for the first time.

  18. Plans and Preliminary Results of Fundamental Studies of Ice Crystal Icing Physics in the NASA Propulsion Systems Laboratory

    NASA Technical Reports Server (NTRS)

    Struk, Peter; Tsao, Jen-Ching; Bartkus, Tadas

    2016-01-01

    This presentation accompanies the paper titled Plans and Preliminary Results of Fundamental Studies of Ice Crystal Icing Physics in the NASA Propulsion Systems Laboratory. NASA is evaluating whether PSL, in addition to full-engine and motor-driven-rig tests, can be used for more fundamental ice-accretion studies that simulate the different mixed-phase icing conditions along the core flow passage of a turbo-fan engine compressor. The data from such fundamental accretion tests will be used to help develop and validate models of the accretion process. This presentation (and accompanying paper) presents data from some preliminary testing performed in May 2015 which examined how a mixed-phase cloud could be generated at PSL using evaporative cooling in a warmer-than-freezing environment.

  19. Laboratory Education in New Zealand

    ERIC Educational Resources Information Center

    Borrmann, Thomas

    2008-01-01

    Laboratory work is one of the main forms of teaching used in chemistry, physics, biology and medicine. For many years researchers and teachers have argued in favor of or against this form of education. Student opinion could be a valuable tool for teachers to demonstrate the validity of such expensive and work intensive forms of education as…

  20. Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

    PubMed

    Carroll, Erica Eggers

    2016-01-01

    Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

  1. Verification, Validation and Sensitivity Studies in Computational Biomechanics

    PubMed Central

    Anderson, Andrew E.; Ellis, Benjamin J.; Weiss, Jeffrey A.

    2012-01-01

    Computational techniques and software for the analysis of problems in mechanics have naturally moved from their origins in the traditional engineering disciplines to the study of cell, tissue and organ biomechanics. Increasingly complex models have been developed to describe and predict the mechanical behavior of such biological systems. While the availability of advanced computational tools has led to exciting research advances in the field, the utility of these models is often the subject of criticism due to inadequate model verification and validation. The objective of this review is to present the concepts of verification, validation and sensitivity studies with regard to the construction, analysis and interpretation of models in computational biomechanics. Specific examples from the field are discussed. It is hoped that this review will serve as a guide to the use of verification and validation principles in the field of computational biomechanics, thereby improving the peer acceptance of studies that use computational modeling techniques. PMID:17558646

  2. Hospital blood bank information systems accurately reflect patient transfusion: results of a validation study.

    PubMed

    McQuilten, Zoe K; Schembri, Nikita; Polizzotto, Mark N; Akers, Christine; Wills, Melissa; Cole-Sinclair, Merrole F; Whitehead, Susan; Wood, Erica M; Phillips, Louise E

    2011-05-01

    Hospital transfusion laboratories collect information regarding blood transfusion and some registries gather clinical outcomes data without transfusion information, providing an opportunity to integrate these two sources to explore effects of transfusion on clinical outcomes. However, the use of laboratory information system (LIS) data for this purpose has not been validated previously. Validation of LIS data against individual patient records was undertaken at two major centers. Data regarding all transfusion episodes were analyzed over seven 24-hour periods. Data regarding 596 units were captured including 399 red blood cell (RBC), 95 platelet (PLT), 72 plasma, and 30 cryoprecipitate units. They were issued to: inpatient 221 (37.1%), intensive care 109 (18.3%), outpatient 95 (15.9%), operating theater 45 (7.6%), emergency department 27 (4.5%), and unrecorded 99 (16.6%). All products recorded by LIS as issued were documented as transfused to intended patients. Median time from issue to transfusion initiation could be calculated for 535 (89.8%) components: RBCs 16 minutes (95% confidence interval [CI], 15-18 min; interquartile range [IQR], 7-30 min), PLTs 20 minutes (95% CI, 15-22 min; IQR, 10-37 min), fresh-frozen plasma 33 minutes (95% CI, 14-83 min; IQR, 11-134 min), and cryoprecipitate 3 minutes (95% CI, -10 to 42 min; IQR, -15 to 116 min). Across a range of blood component types and destinations comparison of LIS data with clinical records demonstrated concordance. The difference between LIS timing data and patient clinical records reflects expected time to transport, check, and prepare transfusion but does not affect the validity of linkage for most research purposes. Linkage of clinical registries with LIS data can therefore provide robust information regarding individual patient transfusion. This enables analysis of joint data sets to determine the impact of transfusion on clinical outcomes. © 2010 American Association of Blood Banks.

  3. California Diploma Project Technical Report III: Validity Study--Validity Study of the Health Sciences and Medical Technology Standards

    ERIC Educational Resources Information Center

    McGaughy, Charis; Bryck, Rick; de Gonzalez, Alicia

    2012-01-01

    This study is a validity study of the recently revised version of the Health Science Standards. The purpose of this study is to understand how the Health Science Standards relate to college and career readiness, as represented by survey ratings submitted by entry-level college instructors of health science courses and industry representatives. For…

  4. Determination of quaternary ammonium compounds by potentiometric titration with an ionic surfactant electrode: single-laboratory validation.

    PubMed

    Price, Randi; Wan, Ping

    2010-01-01

    A potentiometric titration for determining the quaternary ammonium compounds (QAC) commonly found in antimicrobial products was validated by a single laboratory. Traditionally, QACs were determined by using a biphasic (chloroform and water) manual titration procedure. Because of safety considerations regarding chloroform, as well as the subjectivity of color indicator-based manual titration determinations, an automatic potentiometric titration procedure was tested with quaternary nitrogen product formulations. By using the Metrohm Titrando system coupled with an ionic surfactant electrode and an Ag/AgCl reference electrode, titrations were performed with various QAC-containing formulation products/matrixes; a standard sodium lauryl sulfate solution was used as the titrant. Results for the products tested are sufficiently reproducible and accurate for the purpose of regulatory product enforcement. The robustness of the method was measured by varying pH levels, as well as by comparing buffered versus unbuffered titration systems. A quantitation range of 1-1000 ppm quaternary nitrogen was established. Eight commercially available antimicrobial products covering a variety of matrixes were assayed; the results obtained were comparable to those obtained by the manual titration method. Recoveries of 94 to 104% were obtained for spiked samples.

  5. Semiconductor laser joint study program with Rome Laboratory

    NASA Astrophysics Data System (ADS)

    Schaff, William J.; Okeefe, Sean S.; Eastman, Lester F.

    1994-09-01

    A program to jointly study vertical-cavity surface emitting lasers (VCSEL) for high speed vertical optical interconnects (VOI) has been conducted under an ES&E between Rome Laboratory and Cornell University. Lasers were designed, grown, and fabricated at Cornell University. A VCSEL measurement laboratory has been designed, built, and utilized at Rome Laboratory. High quality VCSEL material was grown and characterized by fabricating conventional lateral cavity lasers that emitted at the design wavelength of 1.04 microns. The VCSEL's emit at 1.06 microns. Threshold currents of 16 mA at 4.8 volts were obtained for 30 microns diameter devices. Output powers of 5 mW were measured. This is 500 times higher power than from the light emitting diodes employed previously for vertical optical interconnects. A new form of compositional grading using a cosinusoidal function has been developed and is very successful for reducing diode series resistance for high speed interconnection applications. A flip-chip diamond package compatible with high speed operation of 16 VCSEL elements has been designed and characterized. A flip-chip device binding effort at Rome Laboratory was also designed and initiated. This report presents details of the one-year effort, including process recipes and results.

  6. Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation

    PubMed Central

    Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

    2018-01-01

    Background While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. PMID:29691203

  7. Managing laboratory automation in a changing pharmaceutical industry

    PubMed Central

    Rutherford, Michael L.

    1995-01-01

    The health care reform movement in the USA and increased requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented. PMID:18925014

  8. Measuring Nutrition Literacy in Spanish-Speaking Latinos: An Exploratory Validation Study.

    PubMed

    Gibbs, Heather D; Camargo, Juliana M T B; Owens, Sarah; Gajewski, Byron; Cupertino, Ana Paula

    2017-11-21

    Nutrition is important for preventing and treating chronic diseases highly prevalent among Latinos, yet no tool exists for measuring nutrition literacy among Spanish speakers. This study aimed to adapt the validated Nutrition Literacy Assessment Instrument for Spanish-speaking Latinos. This study was developed in two phases: adaptation and validity testing. Adaptation included translation, expert item content review, and interviews with Spanish speakers. For validity testing, 51 participants completed the Short Assessment of Health Literacy-Spanish (SAHL-S), the Nutrition Literacy Assessment Instrument in Spanish (NLit-S), and socio-demographic questionnaire. Validity and reliability statistics were analyzed. Content validity was confirmed with a Scale Content Validity Index of 0.96. Validity testing demonstrated NLit-S scores were strongly correlated with SAHL-S scores (r = 0.52, p < 0.001). Entire reliability was substantial at 0.994 (CI 0.992-0.996) and internal consistency was excellent (Cronbach's α = 0.92). The NLit-S demonstrates validity and reliability for measuring nutrition literacy among Spanish-speakers.

  9. An Exploratory Study of Objective Attainment in the Divergent Physics Laboratory.

    ERIC Educational Resources Information Center

    Lerch, Robert Donald

    Students enrolled in the introductory physics laboratory at New Mexico State University participated in this study. A stated set of objectives, developed by Dr. John M. Fowler of the Commission on College Physics, was used in the laboratory. This study attempted to measure student achievement based on the use of these objectives as opposed to the…

  10. HOMOLOGOUS MEASURES OF COGNITIVE FUNCTION IN HUMAN INFANTS AND LABORATORY ANIMALS TO IDENTIFY ENVIRONMENTAL HEALTH RISKS TO CHILDREN

    EPA Science Inventory

    The importance of including neurodevelopmental endpoints in environmental studies is clear. A validated measure of cognitive fucntion in human infants that also has a parallel test in laboratory animal studies will provide a valuable approach for largescale studies. Such a ho...

  11. Analysis of Urinary Biomarkers for Smoking Crack Cocaine: Results of a Danish Laboratory Study.

    PubMed

    Jeppesen, Hans Henrik; Busch-Nielsen, Malthe; Larsen, Anders Nørgaard; Breindahl, Torben

    2015-01-01

    Crack cocaine (free-base cocaine) smokers belong to a subgroup of marginalized drug users exposed to severe health risks and great social harm. Detection of the urinary, pyrolytic biomarker methylecgonidine (MED) and its metabolite ecgonidine (ED) secures an unambiguous confirmation of crack cocaine smoking. Although prevalence studies of cocaine based upon self-reporting may not be accurate, laboratory analysis is seldom used for neither diagnostic purpose nor early identification of crack cocaine smoking, which is far more severe than snorting cocaine. A new analytical method was validated for MED, ED and other relevant cocaine metabolites using automated liquid handling and column switching coupled to liquid chromatography and tandem mass spectrometry. Limit of quantification was 30 ng/mL for ED and MED. This method was applied in a laboratory study of urine samples (n = 110) from cocaine users in Denmark subjected to routine drugs-of-abuse testing. Crack cocaine smoking was confirmed by the presence of MED and/or ED. Eighty-four samples (76.4%) were found positive for crack cocaine smoking in this group of problematic cocaine users. MED was only detected in 5.9% of the positive samples. The study shows a prevalence 3-fold higher to that recently suggested by European Monitoring Centre for Drugs and Drug Addiction. We therefore advocate that the urinary biomarkers MED and ED are included in routine testing methods for clinical toxicology. This may lead to an earlier identification of crack cocaine smoking and possibly prevent a more severe drug use. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. 21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

  13. 21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

  14. 21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

  15. 21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

  16. Gene Expression-Based Survival Prediction in Lung Adenocarcinoma: A Multi-Site, Blinded Validation Study

    PubMed Central

    Shedden, Kerby; Taylor, Jeremy M.G.; Enkemann, Steve A.; Tsao, Ming S.; Yeatman, Timothy J.; Gerald, William L.; Eschrich, Steve; Jurisica, Igor; Venkatraman, Seshan E.; Meyerson, Matthew; Kuick, Rork; Dobbin, Kevin K.; Lively, Tracy; Jacobson, James W.; Beer, David G.; Giordano, Thomas J.; Misek, David E.; Chang, Andrew C.; Zhu, Chang Qi; Strumpf, Dan; Hanash, Samir; Shepherd, Francis A.; Ding, Kuyue; Seymour, Lesley; Naoki, Katsuhiko; Pennell, Nathan; Weir, Barbara; Verhaak, Roel; Ladd-Acosta, Christine; Golub, Todd; Gruidl, Mike; Szoke, Janos; Zakowski, Maureen; Rusch, Valerie; Kris, Mark; Viale, Agnes; Motoi, Noriko; Travis, William; Sharma, Anupama

    2009-01-01

    Although prognostic gene expression signatures for survival in early stage lung cancer have been proposed, for clinical application it is critical to establish their performance across different subject populations and in different laboratories. Here we report a large, training-testing, multi-site blinded validation study to characterize the performance of several prognostic models based on gene expression for 442 lung adenocarcinomas. The hypotheses proposed examined whether microarray measurements of gene expression either alone or combined with basic clinical covariates (stage, age, sex) can be used to predict overall survival in lung cancer subjects. Several models examined produced risk scores that substantially correlated with actual subject outcome. Most methods performed better with clinical data, supporting the combined use of clinical and molecular information when building prognostic models for early stage lung cancer. This study also provides the largest available set of microarray data with extensive pathological and clinical annotation for lung adenocarcinomas. PMID:18641660

  17. Individual differences in situation awareness: Validation of the Situationism Scale

    PubMed Central

    Roberts, Megan E.; Gibbons, Frederick X.; Gerrard, Meg; Klein, William M. P.

    2015-01-01

    This paper concerns the construct of lay situationism—an individual’s belief in the importance of a behavior’s context. Study 1 identified a 13-item Situationism Scale, which demonstrated good reliability and validity. In particular, higher situationism was associated with greater situation-control (strategies to manipulate the environment in order to avoid temptation). Subsequent laboratory studies indicated that people higher on the situationism subscales used greater situation-control by sitting farther from junk food (Study 2) and choosing to drink non-alcoholic beverages before a cognitive task (Study 3). Overall, findings provide preliminary support for the psychometric validity and predictive utility of the Situationism Scale and offer this individual difference construct as a means to expand self-regulation theory. PMID:25329242

  18. Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-Probes study of laboratory staffing at 98 institutions.

    PubMed

    Jones, Bruce A; Darcy, Teresa; Souers, Rhona J; Meier, Frederick A

    2012-02-01

    Publicly available information concerning laboratory staffing benchmarks is scarce. One of the few publications on this topic summarized the findings of a Q-Probes study performed in 2004. This publication reports a similar survey with data collected in 2010. To assess the relationship between staffing levels in specified laboratory sections and test volumes in these sections and quantify management span of control. The study defined 4 laboratory sections: anatomic pathology (including cytology), chemistry/hematology/immunology, microbiology, and transfusion medicine. It divided staff into 3 categories: management, nonmanagement (operational or bench staff), and doctoral (MD, PhD) supervisory staff. People in these categories were tabulated as full-time equivalents and exclusions specified. Tests were counted in uniform formats, specified for each laboratory section, according to Medicare rules for the bundling and unbundling of tests. Ninety-eight participating institutions provided data that showed significant associations between test volumes and staffing for all 4 sections. There was wide variation in productivity based on volume. There was no relationship between testing volume per laboratory section and management span of control. Higher productivity in chemistry/hematology/immunology was associated with a higher fraction of tests coming from nonacute care patients. In both the 2004 and 2010 studies, productivity was inseparably linked to test volume. Higher test volume was associated with higher productivity ratios in chemistry/hematology/immunology and transfusion medicine sections. The impact of various testing services on productivity is section-specific.

  19. Cyber Victim and Bullying Scale: A Study of Validity and Reliability

    ERIC Educational Resources Information Center

    Cetin, Bayram; Yaman, Erkan; Peker, Adem

    2011-01-01

    The purpose of this study is to develop a reliable and valid scale, which determines cyber victimization and bullying behaviors of high school students. Research group consisted of 404 students (250 male, 154 male) in Sakarya, in 2009-2010 academic years. In the study sample, mean age is 16.68. Content validity and face validity of the scale was…

  20. Region 9 Superfund Data Evaluation/Validation Guide

    EPA Pesticide Factsheets

    This guidance document is designed by EPARegion 9 Quality Assurance Office to provide assistance to project officers, Superfund contractors, and Superfund grantees in performing timely data evaluation and/or validation of laboratory data.

  1. New HPV Serology Laboratory Aims to Standardize Assays and Contribute to Vaccine Implementation and Access | Frederick National Laboratory for Cancer Research

    Cancer.gov

    A new international initiative, led by scientists at the Frederick National Laboratory for Cancer Research and several other institutions, is being launched to provide expertise and leadership on the development, validation, and standardization of hu

  2. Laboratory Experimental Design for a Glycomic Study.

    PubMed

    Ugrina, Ivo; Campbell, Harry; Vučković, Frano

    2017-01-01

    Proper attention to study design before, careful conduct of procedures during, and appropriate inference from results after scientific experiments are important in all scientific studies in order to ensure valid and sometimes definitive conclusions can be made. The design of experiments, also called experimental design, addresses the challenge of structuring and conducting experiments to answer the questions of interest as clearly and efficiently as possible.

  3. A feasibility study of returning clinically actionable somatic genomic alterations identified in a research laboratory.

    PubMed

    Arango, Natalia Paez; Brusco, Lauren; Mills Shaw, Kenna R; Chen, Ken; Eterovic, Agda Karina; Holla, Vijaykumar; Johnson, Amber; Litzenburger, Beate; Khotskaya, Yekaterina B; Sanchez, Nora; Bailey, Ann; Zheng, Xiaofeng; Horombe, Chacha; Kopetz, Scott; Farhangfar, Carol J; Routbort, Mark; Broaddus, Russell; Bernstam, Elmer V; Mendelsohn, John; Mills, Gordon B; Meric-Bernstam, Funda

    2017-06-27

    Molecular profiling performed in the research setting usually does not benefit the patients that donate their tissues. Through a prospective protocol, we sought to determine the feasibility and utility of performing broad genomic testing in the research laboratory for discovery, and the utility of giving treating physicians access to research data, with the option of validating actionable alterations in the CLIA environment. 1200 patients with advanced cancer underwent characterization of their tumors with high depth hybrid capture sequencing of 201 genes in the research setting. Tumors were also tested in the CLIA laboratory, with a standardized hotspot mutation analysis on an 11, 46 or 50 gene platform. 527 patients (44%) had at least one likely somatic mutation detected in an actionable gene using hotspot testing. With the 201 gene panel, 945 patients (79%) had at least one alteration in a potentially actionable gene that was undetected with the more limited CLIA panel testing. Sixty-four genomic alterations identified on the research panel were subsequently tested using an orthogonal CLIA assay. Of 16 mutations tested in the CLIA environment, 12 (75%) were confirmed. Twenty-five (52%) of 48 copy number alterations were confirmed. Nine (26.5%) of 34 patients with confirmed results received genotype-matched therapy. Seven of these patients were enrolled onto genotype-matched targeted therapy trials. Expanded cancer gene sequencing identifies more actionable genomic alterations. The option of CLIA validating research results can provide alternative targets for personalized cancer therapy.

  4. A surgical skills laboratory improves residents' knowledge and performance of episiotomy repair.

    PubMed

    Banks, Erika; Pardanani, Setul; King, Mary; Chudnoff, Scott; Damus, Karla; Freda, Margaret Comerford

    2006-11-01

    This study was undertaken to assess whether a surgical skills laboratory improves residents' knowledge and performance of episiotomy repair. Twenty-four first- and second-year residents were randomly assigned to either a surgical skills laboratory on episiotomy repair or traditional teaching alone. Pre- and posttests assessed basic knowledge. Blinded attending physicians assessed performance, evaluating residents on second-degree laceration/episiotomy repairs in the clinical setting with 3 validated tools: a task-specific checklist, global rating scale, and a pass-fail grade. Postgraduate year 1 (PGY-1) residents participating in the laboratory scored significantly better on all 3 surgical assessment tools: the checklist, the global score, and the pass/fail analysis. All the residents who had the teaching laboratory demonstrated significant improvements on knowledge and the skills checklist. PGY-2 residents did not benefit as much as PGY-1 residents. A surgical skills laboratory improved residents' knowledge and performance in the clinical setting. Improvement was greatest for PGY-1 residents.

  5. A multivariate assessment of the effect of the laboratory homework component of a microcomputer-based laboratory for a college freshman physics course

    NASA Astrophysics Data System (ADS)

    Ramlo, Susan E.

    Microcomputer-based laboratories (MBLs) have been defined as software that uses an electronic probe to collect information about a physical system and then converts that information into graphical systems in real-time. Realtime Physics Laboratories (RTP) are an example of laboratories that combine the use of MBLs with collaboration and guided-inquiry. RTP Mechanics Laboratories include both laboratory activities and laboratory homework for the first semester of college freshman physics courses. Prior research has investigated the effectiveness of the RTP laboratories as a package (laboratory activities with laboratory homework). In this study, an experimental-treatment had students complete both the RTP laboratory activity and the associated laboratory homework during the same laboratory period. Observations of this treatment indicated that students primarily consulted the laboratory instructor and referred to their completed laboratory activity while completing the homework in their collaborative groups. In the control-treatment, students completed the laboratory homework outside the laboratory period. Measures of force and motion conceptual understanding included the Force and Motion Conceptual Understanding (FMCE), a 47 multiple-choice question test. Analyses of the FMCE indicated that it is both a reliable and a valid measure of force and motion conceptual understanding. A distinct, five-factor structure for the FMCE post-test answers reflected specific concepts related to force and motion. However, the three FMCE pretest factors were less distinct. Analysis of the experimental-treatment, compared to a control-treatment, included multiple regression analysis with covariates of age, prior physics-classroom experience, and the three FMCE pretest factors. Criterion variables included each of the five post-test factors, the total laboratory homework score, and a group of seven exam questions. The results were all positive, in favor of the experimental

  6. COMPARABLE MEASURES OF COGNITIVE FUNCTION IN HUMAN INFANTS AND LABORATORY ANIMALS TO IDENTIFY ENVIRONMENTAL HEALTH RISKS TO CHILDREN

    EPA Science Inventory

    The importance of including neurodevelopmental end points in environmental studies is clear. A validated measure of cognitive function in human infants that also has a homologous or parallel test in laboratory animal studies will provide a valuable approach for large-scale studie...

  7. Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation.

    PubMed

    Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Rosser, B R Simon; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

    2018-04-24

    While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. This paper reports the challenges of survey validation inherent in a small Web-based health survey research. The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. ©James Dewitt, Benjamin Capistrant, Nidhi Kohli, B R Simon Rosser, Darryl Mitteldorf, Enyinnaya Merengwa, William West. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2018.

  8. Factors associated with rape as predictors of laboratory aggression against women.

    PubMed

    Malamuth, N M

    1983-08-01

    This study examined the relation between factors associated with "real"-world aggression against women and laboratory aggression. In the first phase of the research, assessment was made of the attitudes about aggression against women and of the sexual responsiveness to rape of 42 male subjects. In the second phase of the research, which subjects believed was a totally independent experiment, aggression was assessed within a Buss paradigm. It was found that the factors assessed in the first phase successfully predicted men's laboratory aggression in the second research phase. The data are interpreted as supporting the construct validity of (a) theory that suggests that common factors underlie varied acts of aggression against women, (b) the measures designed to predict aggressive tendencies, and (c) the methodology of assessing aggression within a laboratory context.

  9. Interlaboratory study for the validation of an ecotoxicological procedure to monitor the quality of septic sludge received at a wastewater treatment plant.

    PubMed

    Robidoux, P Y; Choucri, A; Bastien, C; Sunahara, G I; López-Gastey, J

    2001-01-01

    Septic tank sludge is regularly hauled to the Montreal Urban Community (MUC) wastewater treatment plant. It is then discharged and mixed with the wastewater inflow before entering the primary chemical treatment process. An ecotoxicological procedure integrating chemical and toxicological analyses has been recently developed and applied to screen for the illicit discharge of toxic substances in septic sludge. The toxicity tests used were the Microtox, the bacterial-respiration, and the lettuce (Lactuca sativa) root elongation tests. In order to validate the applicability of the proposed procedure, a two-year interlaboratory study was carried out. In general, the results obtained by two independent laboratories (MUC and the Centre d'expertise en analyse environnementale du Quebec) were comparable and reproducible. Some differences were found using the Microtox test. Organic (e.g., phenol and formaldehyde) and inorganic (e.g., nickel and cyanide) spiked septic sludge were detected with good reliability and high efficiency. The relative efficiency to detect spiked substances was > 70% and confirms the results of previous studies. In addition, the respiration test was the most efficient toxicological tool to detect spiked substances, whereas the Microtox was the least efficient (< 15%). Efficiencies to detect spiked contaminants were also similar for both laboratories. These results support previous data presented earlier and contribute to the validation of the ecotoxicological procedure used by the MUC to screen toxicity in septic sludge.

  10. A Unified Constitutive Model for Subglacial Till, Part II: Laboratory Tests, Disturbed State Modeling, and Validation for Two Subglacial Tills

    NASA Astrophysics Data System (ADS)

    Desai, C. S.; Sane, S. M.; Jenson, J. W.; Contractor, D. N.; Carlson, A. E.; Clark, P. U.

    2006-12-01

    This presentation, which is complementary to Part I (Jenson et al.), describes the application of the Disturbed State Concept (DSC) constitutive model to define the behavior of the deforming sediment (till) underlying glaciers and ice sheets. The DSC includes elastic, plastic, and creep strains, and microstructural changes leading to degradation, failure, and sometimes strengthening or healing. Here, we describe comprehensive laboratory experiments conducted on samples of two regionally significant tills deposited by the Laurentide Ice Sheet: the Tiskilwa Till and Sky Pilot Till. The tests are used to determine the parameters to calibrate the DSC model, which is validated with respect to the laboratory tests by comparing the predictions with test data used to find the parameters, and also comparing them with independent tests not used to find the parameters. Discussion of the results also includes comparison of the DSC model with the classical Mohr-Coulomb model, which has been commonly used for glacial tills. A numerical procedure based on finite element implementation of the DSC is used to simulate an idealized field problem, and its predictions are discussed. Based on these analyses, the unified DSC model is proposed to provide an improved model for subglacial tills compared to other models used commonly, and thus to provide the potential for improved predictions of ice sheet movements.

  11. Construct Validation Theory Applied to the Study of Personality Dysfunction

    PubMed Central

    Zapolski, Tamika C. B.; Guller, Leila; Smith, Gregory T.

    2013-01-01

    The authors review theory validation and construct validation principles as related to the study of personality dysfunction. Historically, personality disorders have been understood to be syndromes of heterogeneous symptoms. The authors argue that the syndrome approach to description results in diagnoses of unclear meaning and constrained validity. The alternative approach of describing personality dysfunction in terms of homogeneous dimensions of functioning avoids the problems of the syndromal approach and has been shown to provide more valid description and diagnosis. The authors further argue that description based on homogeneous dimensions of personality function/dysfunction is more useful, because it provides direct connections to validated treatments. PMID:22321263

  12. Determination of Chondroitin Sulfate Content in Raw Materials and Dietary Supplements by High-Performance Liquid Chromatography with UV Detection After Enzymatic Hydrolysis: Single-Laboratory Validation First Action 2015.11.

    PubMed

    Brunelle, Sharon L

    2016-01-01

    A previously validated method for determination of chondroitin sulfate in raw materials and dietary supplements was submitted to the AOAC Expert Review Panel (ERP) for Stakeholder Panel on Dietary Supplements Set 1 Ingredients (Anthocyanins, Chondroitin, and PDE5 Inhibitors) for consideration of First Action Official Methods(SM) status. The ERP evaluated the single-laboratory validation results against AOAC Standard Method Performance Requirements 2014.009. With recoveries of 100.8-101.6% in raw materials and 105.4-105.8% in finished products and precision of 0.25-1.8% RSDr within-day and 1.6-4.72% RSDr overall, the ERP adopted the method for First Action Official Methods status and provided recommendations for achieving Final Action status.

  13. Reliable Digit Span: A Systematic Review and Cross-Validation Study

    ERIC Educational Resources Information Center

    Schroeder, Ryan W.; Twumasi-Ankrah, Philip; Baade, Lyle E.; Marshall, Paul S.

    2012-01-01

    Reliable Digit Span (RDS) is a heavily researched symptom validity test with a recent literature review yielding more than 20 studies ranging in dates from 1994 to 2011. Unfortunately, limitations within some of the research minimize clinical generalizability. This systematic review and cross-validation study was conducted to address these…

  14. Internal validation of the RapidHIT® ID system.

    PubMed

    Wiley, Rachel; Sage, Kelly; LaRue, Bobby; Budowle, Bruce

    2017-11-01

    Traditionally, forensic DNA analysis has required highly skilled forensic geneticists in a dedicated laboratory to generate short tandem repeat (STR) profiles. STR profiles are routinely used either to associate or exclude potential donors of forensic biological evidence. The typing of forensic reference samples has become more demanding, especially with the requirement in some jurisdictions to DNA profile arrestees. The Rapid DNA (RDNA) platform, the RapidHIT ® ID (IntegenX ® , Pleasanton, CA), is a fully automated system capable of processing reference samples in approximately 90min with minimal human intervention. Thus, the RapidHIT ID instrument can be deployed to non-laboratory environments (e.g., booking stations) and run by trained atypical personnel such as law enforcement. In order to implement the RapidHIT ID platform, validation studies are needed to define the performance and limitations of the system. Internal validation studies were undertaken with four early-production RapidHIT ID units. Reliable and concordant STR profiles were obtained from reference buccal swabs. Throughout the study, no contamination was observed. The overall first-pass success rate with an "expert-like system" was 72%, which is comparable to another current RDNA platform commercially available. The system's second-pass success rate (involving manual interpretation on first-pass inconclusive results) increased to 90%. Inhibitors (i.e., coffee, smoking tobacco, and chewing tobacco) did not appear to affect typing by the instrument system; however, substrate (i.e., swab type) did impact typing success. Additionally, one desirable feature not available with other Rapid systems is that in the event of a system failed run, a swab can be recovered and subsequently re-analyzed in a new sample cartridge. Therefore, rarely should additional sampling or swab consumption be necessary. The RapidHIT ID system is a robust and reliable tool capable of generating complete STR profiles within

  15. Validation of a motor activity system by a robotically controlled vehicle and using standard reference compounds.

    PubMed

    Patterson, John P; Markgraf, Carrie G; Cirino, Maria; Bass, Alan S

    2005-01-01

    A series of experiments were undertaken to evaluate the accuracy, precision, specificity, and sensitivity of an automated, infrared photo beam-based open field motor activity system, the MotorMonitor v. 4.01, Hamilton-Kinder, LLC, for use in a good laboratory practices (GLP) Safety Pharmacology laboratory. This evaluation consisted of two phases: (1) system validation, employing known inputs using the EM-100 Controller Photo Beam Validation System, a robotically controlled vehicle representing a rodent and (2) biologic validation, employing groups of rats treated with the standard pharmacologic agents diazepam or D-amphetamine. The MotorMonitor's parameters that described the open-field activity of a subject were: basic movements, total distance, fine movements, x/y horizontal ambulations, rearing, and total rest time. These measurements were evaluated over a number of zones within each enclosure. System validation with the EM-100 Controller Photo Beam Validation System showed that all the parameters accurately and precisely measured what they were intended to measure, with the exception of fine movements and x/y ambulations. Biologic validation using the central nervous system depressant diazepam at 1, 2, or 5 mg/kg, i.p. produced the expected dose-dependent reduction in rat motor activity. In contrast, the central nervous system stimulant D-amphetamine produced the expected increases in rat motor activity at 0.1 and 1 mg/kg, i.p, demonstrating the specificity and sensitivity of the system. Taken together, these studies of the accuracy, precision, specificity, and sensitivity show the importance of both system and biologic validation in the evaluation of an automated open field motor activity system for use in a GLP compliant laboratory.

  16. Convergent Validity of and Bias in Maternal Reports of Child Emotion

    ERIC Educational Resources Information Center

    Durbin, C. Emily; Wilson, Sylia

    2012-01-01

    This study examined the convergent validity of maternal reports of child emotion in a sample of 190 children between the ages of 3 and 6. Children completed a battery of 10 emotion-eliciting laboratory tasks; their mothers and untrained naive observers rated child emotions (happiness, surprise, fear, sadness, and anger) following each task, and…

  17. Hiero-Dermato-Glyphics: Laboratory Study of the Skin

    ERIC Educational Resources Information Center

    Roark, Oakley F.

    1977-01-01

    Explains several laboratory exercises using the skin, including the mapping of receptors, counting of sweat glands, computation of total skin area, comparison of various animal skins, measurement of the palm triradius angle, and study of epidermal ridges (dermatoglyphics) in males and females. (CS)

  18. Laboratory Practices of Beginning Secondary Science Teachers: A Five-Year Study

    ERIC Educational Resources Information Center

    Wong, Sissy S.; Firestone, Jonah B.; Luft, Julie A.; Weeks, Charles B.

    2013-01-01

    During the beginning years of teaching, science teachers develop the knowledge and skills needed to design and implement science laboratories. In this regard, this quantitative study focused on the reported laboratory practices of 61 beginning secondary science teachers who participated in four different induction programs. The results…

  19. External validity of post-stroke interventional gait rehabilitation studies.

    PubMed

    Kafri, Michal; Dickstein, Ruth

    2017-01-01

    Gait rehabilitation is a major component of stroke rehabilitation, and is supported by extensive research. The objective of this review was to examine the external validity of intervention studies aimed at improving gait in individuals post-stroke. To that end, two aspects of these studies were assessed: subjects' exclusion criteria and the ecological validity of the intervention, as manifested by the intervention's technological complexity and delivery setting. Additionally, we examined whether the target population as inferred from the titles/abstracts is broader than the population actually represented by the reported samples. We systematically researched PubMed for intervention studies to improve gait post-stroke, working backwards from the beginning of 2014. Exclusion criteria, the technological complexity of the intervention (defined as either elaborate or simple), setting, and description of the target population in the titles/abstracts were recorded. Fifty-two studies were reviewed. The samples were exclusive, with recurrent stroke, co-morbidities, cognitive status, walking level, and residency being major reasons for exclusion. In one half of the studies, the intervention was elaborate. Descriptions of participants in the title/abstract in almost one half of the studies included only the diagnosis (stroke or comparable terms) and its stage (acute, subacute, and chronic). The external validity of a substantial number of intervention studies about rehabilitation of gait post-stroke appears to be limited by exclusivity of the samples as well as by deficiencies in ecological validity of the interventions. These limitations are not accurately reflected in the titles or abstracts of the studies.

  20. Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

    PubMed Central

    Hoerger, Thomas J.; Meadow, Ann

    1997-01-01

    Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors conclude that these conditions can be accommodated by available bidding design options and by careful selection of bidding markets. PMID:10180003

  1. Validity of smartphone pedometer applications.

    PubMed

    Orr, Krystn; Howe, Holly S; Omran, Janine; Smith, Kristina A; Palmateer, Tess M; Ma, Alvin E; Faulkner, Guy

    2015-11-30

    Given the widespread use of smartphone pedometer applications and the relatively limited number of published validity tests, this study examined the validity of three popular commercial smartphone pedometer applications (i.e., Accupedo, Moves, and Runtastic Pedometer). Convenience samples of males and females were recruited for laboratory tests [n = 11; mean: aged 24.18 years (±3.06)] and a free-living test [n = 18; mean: aged 28.78 years (±9.52)]. Five conditions were assessed: (a) 20-step test, (b) 40-step stair climbing, (c) treadmill walking and running at different speeds, (d) driving, and (e) 3-day free-living. The Yamax SW-200 pedometer and observed step counts were used as criterion measures. Analyses identified an unacceptable error percentage in all of the applications compared to the pedometer. Given the inaccuracy of these applications, caution is required in their promotion to the public for self-monitoring physical activity and in their use as tools for assessing physical activity in research trials.

  2. [Turkish validity and reliability study of fear of pain questionnaire-III].

    PubMed

    Ünver, Seher; Turan, Fatma Nesrin

    2018-01-01

    This study aimed to develop a Turkish version of the Fear of Pain Questionnaire-III developed by McNeil and Rainwater (1998) and examine its validity and reliability indicators. The study was conducted with 459 university students studying in the nursing department. The Turkish translation of the scale was conducted by language experts and the original scale owner. Expert opinions were taken for language validity, and the Lawshe's content validity ratio formula was used to calculate the content validity. Exploratory factor analysis was used to assess the construct validity. The factors were rotated using the Varimax rotation (orthogonal) method. For reliability indicators of the questionnaire, the internal consistency coefficient and test re-test reliability were utilized. Explanatory factor analyses using the three-factor model (explaining 50.5% of the total variance) revealed that the item factor loads varied were above the limit value of 0.30 which indicated that the questionnaire had good construct validity. The Cronbach's alpha value for the total questionnaire was 0.938, and test re-test value was 0.846 for the total scale. The Turkish version of the Fear of Pain Questionnaire-III had sufficiently high reliability and validity to be used as a tool in evaluating the fear of pain among the young Turkish population.

  3. Prediction of down-gradient impacts of DNAPL source depletion using tracer techniques: Laboratory and modeling validation

    NASA Astrophysics Data System (ADS)

    Jawitz, J. W.; Basu, N.; Chen, X.

    2007-05-01

    Interwell application of coupled nonreactive and reactive tracers through aquifer contaminant source zones enables quantitative characterization of aquifer heterogeneity and contaminant architecture. Parameters obtained from tracer tests are presented here in a Lagrangian framework that can be used to predict the dissolution of nonaqueous phase liquid (NAPL) contaminants. Nonreactive tracers are commonly used to provide information about travel time distributions in hydrologic systems. Reactive tracers have more recently been introduced as a tool to quantify the amount of NAPL contaminant present within the tracer swept volume. Our group has extended reactive tracer techniques to also characterize NAPL spatial distribution heterogeneity. By conceptualizing the flow field through an aquifer as a collection of streamtubes, the aquifer hydrodynamic heterogeneities may be characterized by a nonreactive tracer travel time distribution, and NAPL spatial distribution heterogeneity may be similarly described using reactive travel time distributions. The combined statistics of these distributions are used to derive a simple analytical solution for contaminant dissolution. This analytical solution, and the tracer techniques used for its parameterization, were validated both numerically and experimentally. Illustrative applications are presented from numerical simulations using the multiphase flow and transport simulator UTCHEM, and laboratory experiments of surfactant-enhanced NAPL remediation in two-dimensional flow chambers.

  4. Validation on milk and sprouts of EN ISO 16654:2001 - Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Escherichia coli O157.

    PubMed

    Tozzoli, Rosangela; Maugliani, Antonella; Michelacci, Valeria; Minelli, Fabio; Caprioli, Alfredo; Morabito, Stefano

    2018-05-08

    In 2006, the European Committee for standardisation (CEN)/Technical Committee 275 - Food analysis - Horizontal methods/Working Group 6 - Microbiology of the food chain (TC275/WG6), launched the project of validating the method ISO 16654:2001 for the detection of Escherichia coli O157 in foodstuff by the evaluation of its performance, in terms of sensitivity and specificity, through collaborative studies. Previously, a validation study had been conducted to assess the performance of the Method No 164 developed by the Nordic Committee for Food Analysis (NMKL), which aims at detecting E. coli O157 in food as well, and is based on a procedure equivalent to that of the ISO 16654:2001 standard. Therefore, CEN established that the validation data obtained for the NMKL Method 164 could be exploited for the ISO 16654:2001 validation project, integrated with new data obtained through two additional interlaboratory studies on milk and sprouts, run in the framework of the CEN mandate No. M381. The ISO 16654:2001 validation project was led by the European Union Reference Laboratory for Escherichia coli including VTEC (EURL-VTEC), which organized the collaborative validation study on milk in 2012 with 15 participating laboratories and that on sprouts in 2014, with 14 participating laboratories. In both studies, a total of 24 samples were tested by each laboratory. Test materials were spiked with different concentration of E. coli O157 and the 24 samples corresponded to eight replicates of three levels of contamination: zero, low and high spiking level. The results submitted by the participating laboratories were analyzed to evaluate the sensitivity and specificity of the ISO 16654:2001 method when applied to milk and sprouts. The performance characteristics calculated on the data of the collaborative validation studies run under the CEN mandate No. M381 returned sensitivity and specificity of 100% and 94.4%, respectively for the milk study. As for sprouts matrix, the sensitivity

  5. Laboratory studies of imitation/field studies of tradition: towards a synthesis in animal social learning.

    PubMed

    Galef, Bennett G

    2015-03-01

    Here I discuss: (1) historical precedents that have resulted in comparative psychologists accepting the two-action method as the "gold standard" in laboratory investigations of imitation learning, (2) evidence suggesting that the two-action procedure may not be adequate to answer questions concerning the role of imitation in the development of traditional behaviors of animals living in natural habitat, and (3) an alternative approach to the laboratory study of imitation that might increase the relevance of laboratory studies of imitation to the work of behavioral ecologists/primatologists interested in animal traditions and their relationship to human cumulative culture. This article is part of a Special Issue entitled: Tribute to Tom Zentall. Copyright © 2014 Elsevier B.V. All rights reserved.

  6. Validation Study of Unnotched Charpy and Taylor-Anvil Impact Experiments using Kayenta

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kamojjala, Krishna; Lacy, Jeffrey; Chu, Henry S.

    2015-03-01

    Validation of a single computational model with multiple available strain-to-failure fracture theories is presented through experimental tests and numerical simulations of the standardized unnotched Charpy and Taylor-anvil impact tests, both run using the same material model (Kayenta). Unnotched Charpy tests are performed on rolled homogeneous armor steel. The fracture patterns using Kayenta’s various failure options that include aleatory uncertainty and scale effects are compared against the experiments. Other quantities of interest include the average value of the absorbed energy and bend angle of the specimen. Taylor-anvil impact tests are performed on Ti6Al4V titanium alloy. The impact speeds of the specimenmore » are 321 m/s and 393 m/s. The goal of the numerical work is to reproduce the damage patterns observed in the laboratory. For the numerical study, the Johnson-Cook failure model is used as the ductile fracture criterion, and aleatory uncertainty is applied to rate-dependence parameters to explore its effect on the fracture patterns.« less

  7. Validity of administrative data claim-based methods for identifying individuals with diabetes at a population level.

    PubMed

    Southern, Danielle A; Roberts, Barbara; Edwards, Alun; Dean, Stafford; Norton, Peter; Svenson, Lawrence W; Larsen, Erik; Sargious, Peter; Lau, David C W; Ghali, William A

    2010-01-01

    This study assessed the validity of a widely-accepted administrative data surveillance methodology for identifying individuals with diabetes relative to three laboratory data reference standard definitions for diabetes. We used a combination of linked regional data (hospital discharge abstracts and physician data) and laboratory data to test the validity of administrative data surveillance definitions for diabetes relative to a laboratory data reference standard. The administrative discharge data methodology includes two definitions for diabetes: a strict administrative data definition of one hospitalization code or two physician claims indicating diabetes; and a more liberal definition of one hospitalization code or a single physician claim. The laboratory data, meanwhile, produced three reference standard definitions based on glucose levels +/- HbA1c levels. Sensitivities ranged from 68.4% to 86.9% for the administrative data definitions tested relative to the three laboratory data reference standards. Sensitivities were higher for the more liberal administrative data definition. Positive predictive values (PPV), meanwhile, ranged from 53.0% to 88.3%, with the liberal administrative data definition producing lower PPVs. These findings demonstrate the trade-offs of sensitivity and PPV for selecting diabetes surveillance definitions. Centralized laboratory data may be of value to future surveillance initiatives that use combined data sources to optimize case detection.

  8. A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24.

    PubMed

    Kojima, Hajime; Katoh, Masakazu; Shinoda, Shinsuke; Hagiwara, Saori; Suzuki, Tamie; Izumi, Runa; Yamaguchi, Yoshihiro; Nakamura, Maki; Kasahawa, Toshihiko; Shibai, Aya

    2014-07-01

    Three validation studies were conducted by the Japanese Society for Alternatives to Animal Experiments in order to assess the performance of a skin irritation assay using reconstructed human epidermis (RhE) LabCyte EPI-MODEL24 (LabCyte EPI-MODEL24 SIT) developed by the Japan Tissue Engineering Co., Ltd. (J-TEC), and the results of these studies were submitted to the Organisation for Economic Co-operation and Development (OECD) for the creation of a Test Guideline (TG). In the summary review report from the OECD, the peer review panel indicated the need to resolve an issue regarding the misclassification of 1-bromohexane. To this end, a rinsing operation intended to remove exposed chemicals was reviewed and the standard operating procedure (SOP) revised by J-TEC. Thereafter, in order to confirm general versatility of the revised SOP, a new validation management team was organized by the Japanese Center for the Validation of Alternative Methods (JaCVAM) to undertake a catch-up validation study that would compare the revised assay with similar in vitro skin irritation assays, per OECD TG No. 439 (2010). The catch-up validation and supplementary studies for LabCyte EPI-MODEL24 SIT using the revised SOPs were conducted at three laboratories. These results showed that the revised SOP of LabCyte EPI-MODEL24 SIT conformed more accurately to the classifications for skin irritation under the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS), thereby highlighting the importance of an optimized rinsing operation for the removal of exposed chemicals in obtaining consistent results from in vitro skin irritation assays. Copyright © 2013 John Wiley & Sons, Ltd.

  9. Evaluation of validation of a fully instrumented Hüttlin HKC 05-TJ laboratory-scale fluidized bed granulator.

    PubMed

    Wöstheinrich, K; Schmidt, P C

    2000-06-01

    The instrumentation and validation of a laboratory-scale fluidized bed apparatus is described. For continuous control of the process, the apparatus is instrumented with sensors for temperature, relative humidity (RH), and air velocity. Conditions of inlet air, fluidizing air, product, and exhaust air were determined. The temperature sensors were calibrated at temperatures of 0.0 degree C and 99.9 degrees C. The calibration of the humidity sensors covered the range from 12% RH to 98% RH using saturated electrolyte solutions. The calibration of the anemometer took place in a wind tunnel at defined air velocities. The calibrations led to satisfying results concerning sensitivity and precision. To evaluate the reproducibility of the process, 15 granules were prepared under identical conditions. The influence of the type of pump used for delivering the granulating liquid was investigated. Particle size distribution, bulk density, and tapped density were determined. Granules were tableted on a rotary press at four different compression force levels, followed by determination of tablet properties such as weight, crushing strength, and disintegration time. The apparatus was found to produce granules with good reproducibility concerning the granule and tablet properties.

  10. Development and single-laboratory validation of an HPLC method for the determination of cyclamate sweetener in foodstuffs.

    PubMed

    Scotter, M J; Castle, L; Roberts, D P T; Macarthur, R; Brereton, P A; Hasnip, S K; Katz, N

    2009-05-01

    A method for the determination of cyclamate has been developed and single-laboratory validated for a range of foodstuffs including carbonated and fruit-juice drinks, fruit preserves, spreads, and dairy desserts. The method uses the peroxide oxidation of cyclamate to cyclohexylamine followed by derivatization with trinitrobenzenesulfonic acid and analysis by a modified reversed-phase high-performance liquid chromatography-ultraviolet light (HPLC-UV). Cycloheptylamine is used as an internal standard. The limits of detection were in the range 1-20 mg kg(-1) and the analysis was linear up to 1300 mg kg(-1) cyclamic acid in foods and up to 67 mg l(-1) in beverages. Analytical recovery was between 82% and 123%, and results were recovery corrected. Precision was within experimentally predicted levels for all of the matrices tested and Horrat values for the combined standard uncertainty associated with the measurement of cyclamate between 0.4 (water-based drinks) and 1.7 (spreads). The method was used successfully to test three soft drink samples for homogeneity before analytical performance assessment. The method is recommended for use in monitoring compliance and for formal testing by collaborative trial.

  11. A Manpower Study of Technical Personnel in Hospital Clinical Laboratories. Final Report.

    ERIC Educational Resources Information Center

    Harkness, James P., And Others

    As one of the efforts related to closing the gap between the growing demands for clinical laboratory workers and the supply of well-trained workers, the volume and quality of laboratory procedures and the general characteristics of workers in North Carolina hospitals were studied. Approaches to the study included tests on "unknowns" by…

  12. [Tuberculosis Laboratory Surveillance Network (TuLSA) study group. The first step for national tuberculosis laboratory surveillance: Ankara, 2011].

    PubMed

    Sezen, Figen; Albayrak, Nurhan; Özkara, Şeref; Karagöz, Alper; Alp, Alpaslan; Duyar Ağca, Filiz; İnan Süer, Asiye; Müderris, Tuba; Ceyhan, İsmail; Durmaz, Rıza; Ertek, Mustafa

    2015-04-01

    The most effective method for monitoring country-level drug resistance frequency and to implement the necessary control measures is the establishment of a laboratory-based surveillance system. The aim of this study was to summarize the follow up trend of the drug-resistant tuberculosis (TB) cases, determine the load of resistance and evaluate the capacities of laboratories depending on laboratory quality assurance system for the installation work of National Tuberculosis Laboratory Surveillance Network (TuLSA) which has started in Ankara in 2011. TuLSA studies was carried out under the coordination of National Tuberculosis Reference Laboratory (NRL) with the participation of TB laboratories and dispensaries. Specimens of TB patients, reported from health institutions, were followed in TB laboratories, and the epidemiological information was collected from the dispensaries. One isolate per patient with the drug susceptibility test (DST) results were sent to NRL from TB laboratories and in NRL the isolates were rechecked with the genotypical (MTBDRplus, Hain Lifescience, Germany) and phenotypical (MGIT 960, BD, USA) DST methods. Molecular epidemiological analysis were also performed by spoligotyping and MIRU/VNTR. Second-line DST was applied to the isolates resistant to rifampin. A total of 1276 patients were reported between January 1st to December 31th 2011, and 335 cases were defined as "pulmonary TB from Ankara province". The mean age of those patients was 43.4 ± 20 years, and 67.5% were male. Three hundred seventeen (94.6%) patients were identified as new cases. The average sample number obtained from pulmonary TB cases was 3.26 ± 2.88, and 229 (68.3%) of them was culture positive. DST was applied to all culture positive isolates; 90.4% (207/229) of cases were susceptible to the five drugs tested (ethambutol, isoniazid, pyrazinamide, rifampicin, streptomycin). Eight (3.5%) of the isolates were multidrug-resistant (MDR-TB), while no extensively drug

  13. Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study.

    PubMed

    Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda

    2016-01-01

    Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules' performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2-4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved.

  14. Validation of GC and HPLC systems for residue studies

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Williams, M.

    1995-12-01

    For residue studies, GC and HPLC system performance must be validated prior to and during use. One excellent measure of system performance is the standard curve and associated chromatograms used to construct that curve. The standard curve is a model of system response to an analyte over a specific time period, and is prima facia evidence of system performance beginning at the auto sampler and proceeding through the injector, column, detector, electronics, data-capture device, and printer/plotter. This tool measures the performance of the entire chromatographic system; its power negates most of the benefits associated with costly and time-consuming validation ofmore » individual system components. Other measures of instrument and method validation will be discussed, including quality control charts and experimental designs for method validation.« less

  15. [Quality Management System in Pathological Laboratory].

    PubMed

    Koyatsu, Junichi; Ueda, Yoshihiko

    2015-07-01

    Even compared to other clinical laboratories, the pathological laboratory conducts troublesome work, and many of the work processes are also manual. Therefore, the introduction of the systematic management of administration is necessary. It will be a shortcut to use existing standards such as ISO 15189 for this purpose. There is no standard specialized for the pathological laboratory, but it is considered to be important to a pathological laboratory in particular. 1. Safety nianagement of the personnel and environmental conditions. Comply with laws and regulations concerning the handling of hazardous materials. 2. Pre-examination processes. The laboratory shall have documented procedures for the proper collection and handling of primary samples. Developed and documented criteria for acceptance or rejection of samples are applied. 3. Examination processes. Selection, verification, and validation of the examination procedures. Devise a system that can constantly monitor the traceability of the sample. 4. Post-examination processes. Storage, retention, and disposal of clinical samples. 5. Release of results. When examination results fall within established alert or critical intervals, immediately notify the physicians. The important point is to recognize the needs of the client and be aware that pathological diagnoses are always "the final diagnoses".

  16. 40 CFR 152.93 - Citation of a previously submitted valid study.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Data Submitters' Rights § 152.93 Citation of a previously submitted valid study. An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The... the original data submitter, the applicant may cite the study only in accordance with paragraphs (b...

  17. Turkish Version of Kolcaba's Immobilization Comfort Questionnaire: A Validity and Reliability Study.

    PubMed

    Tosun, Betül; Aslan, Özlem; Tunay, Servet; Akyüz, Aygül; Özkan, Hüseyin; Bek, Doğan; Açıksöz, Semra

    2015-12-01

    The purpose of this study was to determine the validity and reliability of the Turkish version of the Immobilization Comfort Questionnaire (ICQ). The sample used in this methodological study consisted of 121 patients undergoing lower extremity arthroscopy in a training and research hospital. The validity study of the questionnaire assessed language validity, structural validity and criterion validity. Structural validity was evaluated via exploratory factor analysis. Criterion validity was evaluated by assessing the correlation between the visual analog scale (VAS) scores (i.e., the comfort and pain VAS scores) and the ICQ scores using Spearman's correlation test. The Kaiser-Meyer-Olkin coefficient and Bartlett's test of sphericity were used to determine the suitability of the data for factor analysis. Internal consistency was evaluated to determine reliability. The data were analyzed with SPSS version 15.00 for Windows. Descriptive statistics were presented as frequencies, percentages, means and standard deviations. A p value ≤ .05 was considered statistically significant. A moderate positive correlation was found between the ICQ scores and the VAS comfort scores; a moderate negative correlation was found between the ICQ and the VAS pain measures in the criterion validity analysis. Cronbach α values of .75 and .82 were found for the first and second measurements, respectively. The findings of this study reveal that the ICQ is a valid and reliable tool for assessing the comfort of patients in Turkey who are immobilized because of lower extremity orthopedic problems. Copyright © 2015. Published by Elsevier B.V.

  18. Advances in Stereotype Threat Research on African Americans: Continuing Challenges to the Validity of Its Role in the Achievement Gap

    ERIC Educational Resources Information Center

    Whaley, Arthur L.

    2018-01-01

    Over the past two decades, there have been significant advances in stereotype threat research on African Americans. The current article reviews general issues of internal validity and external validity (or generalizability) beyond college laboratories in stereotype threat studies, and as they are revealed specifically in the context of advances in…

  19. European multicentre validation study of the accuracy of E/e' ratio in estimating invasive left ventricular filling pressure: EURO-FILLING study.

    PubMed

    Galderisi, Maurizio; Lancellotti, Patrizio; Donal, Erwan; Cardim, Nuno; Edvardsen, Thor; Habib, Gilbert; Magne, Julien; Maurer, Gerald; Popescu, Bogdan A

    2014-07-01

    The non-invasive estimation of left ventricular filling pressures (LVFPs) represents a main goal in the clinical setting. Current recommendations encourage the use of pulsed-wave Tissue Doppler for calculating the ratio between the preload-dependent transmitral E velocity and the average of septal and lateral early diastolic velocities (e') of the mitral annulus. Despite its wide use, real utility of the E/e' ratio has been recently challenged in patients with either very advanced heart failure or preserved left ventricular (LV) ejection fraction. However, only few studies performed the invasive and non-invasive estimation of LVFP simultaneously. The EURO-FILLING Study will validate the E/e' ratio (and additional non-invasive estimates) against simultaneously measured LVFP obtained by left heart catheterization in a multicentre study involving reference European echo laboratories collecting a wide population sample size of cardiac patients with and without heart failure. The EURO-FILLING study is a large, prospective observational study in which simultaneous assessment of invasive and non-invasive measurements of LVFP will be acquired in eight reference European centres. Centralized reading of the collected parameters will be performed in a core laboratory. Not only standardized echo Doppler measurements but also novel echo parameters such as LV global longitudinal strain and global atrial strain (obtainable by two-dimensional speckle tracking echocardiography) will be tested for predicting invasive measurements of LVFP. The EURO-FILLING study is expected to provide important information on non-invasive assessment of LVFP and to contribute to the standardization of this assessment in clinical practice. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  20. A Unified Model of Performance: Validation of its Predictions across Different Sleep/Wake Schedules

    PubMed Central

    Ramakrishnan, Sridhar; Wesensten, Nancy J.; Balkin, Thomas J.; Reifman, Jaques

    2016-01-01

    Study Objectives: Historically, mathematical models of human neurobehavioral performance developed on data from one sleep study were limited to predicting performance in similar studies, restricting their practical utility. We recently developed a unified model of performance (UMP) to predict the effects of the continuum of sleep loss—from chronic sleep restriction (CSR) to total sleep deprivation (TSD) challenges—and validated it using data from two studies of one laboratory. Here, we significantly extended this effort by validating the UMP predictions across a wide range of sleep/wake schedules from different studies and laboratories. Methods: We developed the UMP on psychomotor vigilance task (PVT) lapse data from one study encompassing four different CSR conditions (7 d of 3, 5, 7, and 9 h of sleep/night), and predicted performance in five other studies (from four laboratories), including different combinations of TSD (40 to 88 h), CSR (2 to 6 h of sleep/night), control (8 to 10 h of sleep/night), and nap (nocturnal and diurnal) schedules. Results: The UMP accurately predicted PVT performance trends across 14 different sleep/wake conditions, yielding average prediction errors between 7% and 36%, with the predictions lying within 2 standard errors of the measured data 87% of the time. In addition, the UMP accurately predicted performance impairment (average error of 15%) for schedules (TSD and naps) not used in model development. Conclusions: The unified model of performance can be used as a tool to help design sleep/wake schedules to optimize the extent and duration of neurobehavioral performance and to accelerate recovery after sleep loss. Citation: Ramakrishnan S, Wesensten NJ, Balkin TJ, Reifman J. A unified model of performance: validation of its predictions across different sleep/wake schedules. SLEEP 2016;39(1):249–262. PMID:26518594

  1. Corrections of clinical chemistry test results in a laboratory information system.

    PubMed

    Wang, Sihe; Ho, Virginia

    2004-08-01

    The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and

  2. Single-laboratory validation of a saponification method for the determination of four polycyclic aromatic hydrocarbons in edible oils by HPLC-fluorescence detection.

    PubMed

    Akdoğan, Abdullah; Buttinger, Gerhard; Wenzl, Thomas

    2016-01-01

    An analytical method is reported for the determination of four polycyclic aromatic hydrocarbons (benzo[a]pyrene (BaP), benz[a]anthracene (BaA), benzo[b]fluoranthene (BbF) and chrysene (CHR)) in edible oils (sesame, maize, sunflower and olive oil) by high-performance liquid chromatography. Sample preparation is based on three steps including saponification, liquid-liquid partitioning and, finally, clean-up by solid phase extraction on 2 g of silica. Guidance on single-laboratory validation of the proposed analysis method was taken from the second edition of the Eurachem guide on method validation. The lower level of the working range of the method was determined by the limits of quantification of the individual analytes, and the upper level was equal to 5.0 µg kg(-1). The limits of detection and quantification of the four PAHs ranged from 0.06 to 0.12 µg kg(-1) and from 0.13 to 0.24 µg kg(-1). Recoveries of more than 84.8% were achieved for all four PAHs at two concentration levels (2.5 and 5.0 µg kg(-1)), and expanded relative measurement uncertainties were below 20%. The performance of the validated method was in all aspects compliant with provisions set in European Union legislation for the performance of analytical methods employed in the official control of food. The applicability of the method to routine samples was evaluated based on a limited number of commercial edible oil samples.

  3. The sensitivity of laboratory tests assessing driving related skills to dose-related impairment of alcohol: A literature review.

    PubMed

    Jongen, S; Vuurman, E F P M; Ramaekers, J G; Vermeeren, A

    2016-04-01

    Laboratory tests assessing driving related skills can be useful as initial screening tools to assess potential drug induced impairment as part of a standardized behavioural assessment. Unfortunately, consensus about which laboratory tests should be included to reliably assess drug induced impairment has not yet been reached. The aim of the present review was to evaluate the sensitivity of laboratory tests to the dose dependent effects of alcohol, as a benchmark, on performance parameters. In total, 179 experimental studies were included. Results show that a cued go/no-go task and a divided attention test with primary tracking and secondary visual search were consistently sensitive to the impairing effects at medium and high blood alcohol concentrations. Driving performance assessed in a simulator was less sensitive to the effects of alcohol as compared to naturalistic, on-the-road driving. In conclusion, replicating results of several potentially useful tests and their predictive validity of actual driving impairment should deserve further research. In addition, driving simulators should be validated and compared head to head to naturalistic driving in order to increase construct validity. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study

    PubMed Central

    Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda

    2016-01-01

    Background Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules’ performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Methods Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. Results A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2–4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Conclusion Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved. PMID:26730980

  5. A comparison of traditional physical laboratory and computer-simulated laboratory experiences in relation to engineering undergraduate students' conceptual understandings of a communication systems topic

    NASA Astrophysics Data System (ADS)

    Javidi, Giti

    2005-07-01

    This study was designed to investigate an alternative to the use of traditional physical laboratory activities in a communication systems course. Specifically, this study examined whether as an alternative, computer simulation is as effective as physical laboratory activities in teaching college-level electronics engineering education students about the concepts of signal transmission, modulation and demodulation. Eighty undergraduate engineering students participated in the study, which was conducted at a southeastern four-year university. The students were randomly assigned to two groups. The groups were compared on understanding the concepts, remembering the concepts, completion time of the lab experiments and perception toward the laboratory experiments. The physical group's (n = 40) treatment was to conduct laboratory experiments in a physical laboratory. The students in this group used equipment in a controlled electronics laboratory. The Simulation group's (n = 40) treatment was to conduct similar experiments in a PC laboratory. The students in this group used a simulation program in a controlled PC lab. At the completion of the treatment, scores on a validated conceptual test were collected once after the treatment and again three weeks after the treatment. Attitude surveys and qualitative study were administered at the completion of the treatment. The findings revealed significant differences, in favor of the simulation group, between the two groups on both the conceptual post-test and the follow-up test. The findings also revealed significant correlation between simulation groups' attitude toward the simulation program and their post-test scores. Moreover, there was a significant difference between the two groups on their attitude toward their laboratory experience in favor of the simulation group. In addition, there was significant difference between the two groups on their lab completion time in favor of the simulation group. At the same time, the

  6. Clinical laboratory studies of disinfection with Sporicidin.

    PubMed Central

    Isenberg, H D

    1985-01-01

    The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

  7. An Experimental Study of a BSCS-Style Laboratory Approach for University General Biology.

    ERIC Educational Resources Information Center

    Leonard, William H.

    1983-01-01

    A Biological Sciences Curriculum Study (BSCS) inquiry approach for university general biology laboratory was tested against a well-established commercial program judged to be highly directive. The BSCS was found to be more effective in learning biology laboratory concepts than the commercial program as measured by a laboratory concepts test.…

  8. Safety in the Chemical Laboratory. Epidemiology of Accidents in Academic Chemistry Laboratories, Part 2. Accident Intervention Study, Legal Aspects, and Observations.

    ERIC Educational Resources Information Center

    Hellmann, Margaret A.; And Others

    1986-01-01

    Reports on a chemistry laboratory accident intervention study conducted throughout the state of Colorado. Addresses the results of an initial survey of institutions of higher learning. Discusses some legal aspects concerning academic chemistry accidents. Provides some observations about academic chemistry laboratory accidents on the whole. (TW)

  9. Tracer Studies In A Laboratory Beach Subjected To Waves

    EPA Science Inventory

    This work investigated the washout of dissolved nutrients from beaches due to waves by conducting tracer studies in a laboratory beach facility. The effects of waves were studied in the case where the beach was subjected to the tide, and that in which no tidal action was present...

  10. Preliminary study: Formaldehyde exposure in laboratories of Sharjah university in UAE

    PubMed Central

    Ahmed, Hafiz Omer

    2011-01-01

    Objectives Laboratory technicians, students, and instructors are at high risk, because they deal with chemicals including formaldehyde. Thus, this preliminary study was conducted to measure the concentration of formaldehyde in the laboratories of the University of Sharjah in UAE. Materials and Methods: Thirty-two air samples were collected and analyzed for formaldehyde using National Institute for Occupational Safety and Health (NIOSH) method 3500. In this method, formaldehyde reacts with chromotropic acid in the presence of sulfuric acid to form a colored solution. The absorbance of the colored solution is read in spectrophotometer at wavelength 580 nm and is proportional to the quantity of the formaldehyde in the solution. Results: For the anatomy laboratory and in the presence of the covered cadaver, the mean concentration of formaldehyde was found to be 0.100 ppm with a range of 0.095–0.105 ppm. Whereas for the other laboratories, the highest mean concentration of formaldehyde was 0.024 ppm in the general microbiology laboratory and the lowest mean concentration of formaldehyde was 0.001 ppm in the environmental health laboratory. The 8-hour (time-weighted average) concentration of formaldehyde was found to be ranging between 0.0003 ppm in environmental health laboratory and 0.026 ppm in the anatomy laboratory. Conclusions: The highest level of concentration of formaldehyde in the presence of the covered cadaver in anatomy laboratory exceeded the recommended ceiling standard established by USA-NIOSH which is 0.1 ppm, but below the ceiling standard established by American Conference of Governmental Industrial Hygienists which is 0.3 ppm. Thus, it is recommended that formaldehyde levels should be measured periodically specially during the dissection in the anatomy laboratory, and local exhaust ventilation system should be installed and personal protective equipment such as safety glass and gloves should be available and be used to prevent direct skin or eye

  11. The Development of Virtual Laboratory Using ICT for Physics in Senior High School

    NASA Astrophysics Data System (ADS)

    Masril, M.; Hidayati, H.; Darvina, Y.

    2018-04-01

    One of the problems found in the implementation of the curriculum in 2013 is not all competency skills can be performed well. Therefore, to overcome these problems, virtual laboratory designed to improve the mastery of concepts of physics. One of the design objectives virtual laboratories is to improve the quality of education and learning in physics in high school. The method used in this study is a research method development four D model with the definition phase, design phase, development phase, and dissemination phase. Research has reached the stage of development and has been tested valid specialist. The instrument used in the research is a questionnaire consisting of: 1) the material substance; 2) The display of visual communication; 3) instructional design; 4) the use of software; and 5) Linguistic. The research results is validity in general has been a very good category (85.6), so that the design of virtual labs designed can already be used in high school.

  12. Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges.

    PubMed

    Blank, Melissa D; Breland, Alison B; Cobb, Caroline O; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

    2016-10-01

    Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation.

  13. PLCO Ovarian Phase III Validation Study — EDRN Public Portal

    Cancer.gov

    Our preliminary data indicate that the performance of CA 125 as a screening test for ovarian cancer can be improved upon by additional biomarkers. With completion of one additional validation step, we will be ready to test the performance of a consensus marker panel in a phase III validation study. Given the original aims of the PLCO trial, we believe that the PLCO represents an ideal longitudinal cohort offering specimens for phase III validation of ovarian cancer biomarkers.

  14. Validating a Fidelity Scale to Understand Intervention Effects in Classroom-Based Studies

    ERIC Educational Resources Information Center

    Buckley, Pamela; Moore, Brooke; Boardman, Alison G.; Arya, Diana J.; Maul, Andrew

    2017-01-01

    K-12 intervention studies often include fidelity of implementation (FOI) as a mediating variable, though most do not report the validity of fidelity measures. This article discusses the critical need for validated FOI scales. To illustrate our point, we describe the development and validation of the Implementation Validity Checklist (IVC-R), an…

  15. Collaborative trial validation studies of real-time PCR-based GMO screening methods for detection of the bar gene and the ctp2-cp4epsps construct.

    PubMed

    Grohmann, Lutz; Brünen-Nieweler, Claudia; Nemeth, Anne; Waiblinger, Hans-Ulrich

    2009-10-14

    Polymerase Chain Reaction (PCR)-based screening methods targeting genetic elements commonly used in genetically modified (GM) plants are important tools for the detection of GM materials in food, feed, and seed samples. To expand and harmonize the screening capability of enforcement laboratories, the German Federal Office of Consumer Protection and Food Safety conducted collaborative trials for interlaboratory validation of real-time PCR methods for detection of the phosphinothricin acetyltransferase (bar) gene from Streptomyces hygroscopicus and a construct containing the 5-enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium tumefaciens sp. strain CP4 (ctp2-cp4epsps), respectively. To assess the limit of detection, precision, and accuracy of the methods, laboratories had to analyze two sets of 18 coded genomic DNA samples of events LLRice62 and MS8 with the bar method and NK603 and GT73 with the ctp2-cp4epsps method at analyte levels of 0, 0.02, and 0.1% GM content, respectively. In addition, standard DNAs were provided to the laboratories to generate calibration curves for copy number quantification of the bar and ctp2-cp4epsps target sequences present in the test samples. The study design and the results obtained are discussed with respect to the difficult issue of developing general guidelines and concepts for the collaborative trial validation of qualitative PCR screening methods.

  16. Dimensions of Intuition: First-Round Validation Studies

    ERIC Educational Resources Information Center

    Vrugtman, Rosanne

    2009-01-01

    This study utilized confirmatory factor analysis (CFA), canonical correlation analysis (CCA), regression analysis (RA), and correlation analysis (CA) for first-round validation of the researcher's Dimensions of Intuition (DOI) instrument. The DOI examined 25 personal characteristics and situations purportedly predictive of intuition. Data was…

  17. International Validation of Two Human Recombinant Estrogen ...

    EPA Pesticide Factsheets

    An international validation study has been successfully completed for 2 competitive binding assays using human recombinant ERa. Assays evaluated included the Freyberger-Wilson (FW) assay using a full length human ER, and the Chemical Evaluation and Research Institute (CERI) assay using a ligand-binding domain of the human ER. Twenty three compounds were tested in 6 laboratories for the FW assay and 5 for the CERJ assay, which included three controls (used with every run), 9 uncoded, and 14 coded chemicals across 3 subtasks. The overall goal of this validation study was to demonstrate the ability of each of the two assays to reliably classify the test chemicals as binders or non-binders. Laboratories had little trouble with the ER binders that produced a full binding curve when using either the CERI or FW assays. As is typical with all ER competitive binding assays, the weak binders proved to be more challenging. However, overall results from both the FW and CERI assays were consistent and in agreement with expected classifications regardless of the form of the hrER (i.e., full length ER versus an ER ligand binding domain) or the subtle differences in the protocols for conducting each assay. The reproducibility and accuracy for classification of chemicals as potential ER binders and non- binders using the FW and CERI hrER binding assays were comparable to that of the U.S.EPA’s existing ER binding test guideline OPPTS 890.1250, while providing an improved, highe

  18. Interlaboratory study of a liquid chromatography method for erythromycin: determination of uncertainty.

    PubMed

    Dehouck, P; Vander Heyden, Y; Smeyers-Verbeke, J; Massart, D L; Marini, R D; Chiap, P; Hubert, Ph; Crommen, J; Van de Wauw, W; De Beer, J; Cox, R; Mathieu, G; Reepmeyer, J C; Voigt, B; Estevenon, O; Nicolas, A; Van Schepdael, A; Adams, E; Hoogmartens, J

    2003-08-22

    Erythromycin is a mixture of macrolide antibiotics produced by Saccharopolyspora erythreas during fermentation. A new method for the analysis of erythromycin by liquid chromatography has previously been developed. It makes use of an Astec C18 polymeric column. After validation in one laboratory, the method was now validated in an interlaboratory study. Validation studies are commonly used to test the fitness of the analytical method prior to its use for routine quality testing. The data derived in the interlaboratory study can be used to make an uncertainty statement as well. The relationship between validation and uncertainty statement is not clear for many analysts and there is a need to show how the existing data, derived during validation, can be used in practice. Eight laboratories participated in this interlaboratory study. The set-up allowed the determination of the repeatability variance, s(2)r and the between-laboratory variance, s(2)L. Combination of s(2)r and s(2)L results in the reproducibility variance s(2)R. It has been shown how these data can be used in future by a single laboratory that wants to make an uncertainty statement concerning the same analysis.

  19. Feasibility study of an orbiting laboratory for testing CSI technology

    NASA Technical Reports Server (NTRS)

    Bicos, Andrew S.; Loboda, Gregory G.

    1993-01-01

    A concept for an orbiting laboratory for testing Controls-Structures Integration (CSI) technology is described. The CSI-Star concept reflects a lower cost, higher risk approach. The concept supports demonstration and validation testing for critical CSI technologies at a cost of $20M to $26M with a 1-year reliability of approximately 0.9. The Ball Aerospace QuickStar bus is the carrier for the CSI test article. QuickStar is launched as a secondary payload on the McDonnell Douglas Delta 2. The QuickStar/Delta 2 approach is flight proven. The CSI test article is a 20 foot, 1 Hz, truss beam which is deployed from the QuickStar bus. The test article is well instrumented for quality system identification. The laboratory provides three layers of active control consisting of global vibration suppression along the truss beam, vibration isolation between the beam and instrument platforms, and vibration compensation through the use of gimbaled platforms which point lasers relative to optical sensor targets. The configuration simulates the dynamics of multi-instrument science platforms such as those of the Earth Observation System (EOS) while maintaining strong ties to astrophysics missions such as the Optical Interferometer. Uplink/downlink services and a reprogrammable computer provide flexibility for long-term investigations by members of the CSI community (NASA, DoD, academia, and industry). CSI-Star fills the gap between short-term experiments, which have been conducted primarily on the Shuttle, and future science missions which require the technology. The on-orbit maturity of CSI technology must be established to obtain acceptance by project managers and to promote injection of the technology into future science missions.

  20. How toxic is coal ash? A laboratory toxicity case study

    DOE PAGES

    Sherrard, Rick M.; Carriker, Neil; Greeley, Jr., Mark Stephen

    2014-12-08

    Under a consent agreement among the Environmental Protection Agency (EPA) and proponents both for and against stricter regulation, EPA is to issue a new coal ash disposal rule by the end of 2014. Laboratory toxicity investigations often yield conservative estimates of toxicity because many standard test species are more sensitive than resident species, thus could provide information useful to the rule-making. However, few laboratory studies of coal ash toxicity are available; most studies reported in the literature are based solely on field investigations. In this paper, we describe a broad range of toxicity studies conducted for the Tennessee Valley Authoritymore » (TVA) Kingston ash spill, results of which help provide additional perspective on the toxicity of coal ash.« less

  1. Oxy-acetylene driven laboratory scale shock tubes for studying blast wave effects

    NASA Astrophysics Data System (ADS)

    Courtney, Amy C.; Andrusiv, Lubov P.; Courtney, Michael W.

    2012-04-01

    This paper describes the development and characterization of modular, oxy-acetylene driven laboratory scale shock tubes. Such tools are needed to produce realistic blast waves in a laboratory setting. The pressure-time profiles measured at 1 MHz using high-speed piezoelectric pressure sensors have relevant durations and show a true shock front and exponential decay characteristic of free-field blast waves. Descriptions are included for shock tube diameters of 27-79 mm. A range of peak pressures from 204 kPa to 1187 kPa (with 0.5-5.6% standard error of the mean) were produced by selection of the driver section diameter and distance from the shock tube opening. The peak pressures varied predictably with distance from the shock tube opening while maintaining both a true blast wave profile and relevant pulse duration for distances up to about one diameter from the shock tube opening. This shock tube design provides a more realistic blast profile than current compression-driven shock tubes, and it does not have a large jet effect. In addition, operation does not require specialized personnel or facilities like most blast-driven shock tubes, which reduces operating costs and effort and permits greater throughput and accessibility. It is expected to be useful in assessing the response of various sensors to shock wave loading; assessing the reflection, transmission, and absorption properties of candidate armor materials; assessing material properties at high rates of loading; assessing the response of biological materials to shock wave exposure; and providing a means to validate numerical models of the interaction of shock waves with structures. All of these activities have been difficult to pursue in a laboratory setting due in part to lack of appropriate means to produce a realistic blast loading profile.

  2. Test of Creative Imagination: Validity and Reliability Study

    ERIC Educational Resources Information Center

    Gundogan, Aysun; Ari, Meziyet; Gonen, Mubeccel

    2013-01-01

    The purpose of this study was to investigate validity and reliability of the test of creative imagination. This study was conducted with the participation of 1000 children, aged between 9-14 and were studying in six primary schools in the city center of Denizli Province, chosen by cluster ratio sampling. In the study, it was revealed that the…

  3. Adaptive Training and Education Research at the US Army Research Laboratory: Bibliography (2016-2017)

    DTIC Science & Technology

    2018-03-05

    Validation suite. Synthetic training environments. Service orientated architecture. Citation: Robson, E., Ray, F., Sinatra, A. M., & Sinatra, A. M. (2017...ARL-SR-0393 ● MAR 2018 US Army Research Laboratory Adaptive Training and Education Research at the US Army Research Laboratory... Training and Education Research at the US Army Research Laboratory: Bibliography (2016–2017) by Robert A Sottilare Human Research and

  4. Percent body fat estimations in college men using field and laboratory methods: a three-compartment model approach.

    PubMed

    Moon, Jordan R; Tobkin, Sarah E; Smith, Abbie E; Roberts, Michael D; Ryan, Eric D; Dalbo, Vincent J; Lockwood, Chris M; Walter, Ashley A; Cramer, Joel T; Beck, Travis W; Stout, Jeffrey R

    2008-04-21

    Methods used to estimate percent body fat can be classified as a laboratory or field technique. However, the validity of these methods compared to multiple-compartment models has not been fully established. The purpose of this study was to determine the validity of field and laboratory methods for estimating percent fat (%fat) in healthy college-age men compared to the Siri three-compartment model (3C). Thirty-one Caucasian men (22.5 +/- 2.7 yrs; 175.6 +/- 6.3 cm; 76.4 +/- 10.3 kg) had their %fat estimated by bioelectrical impedance analysis (BIA) using the BodyGram computer program (BIA-AK) and population-specific equation (BIA-Lohman), near-infrared interactance (NIR) (Futrex(R) 6100/XL), four circumference-based military equations [Marine Corps (MC), Navy and Air Force (NAF), Army (A), and Friedl], air-displacement plethysmography (BP), and hydrostatic weighing (HW). All circumference-based military equations (MC = 4.7% fat, NAF = 5.2% fat, A = 4.7% fat, Friedl = 4.7% fat) along with NIR (NIR = 5.1% fat) produced an unacceptable total error (TE). Both laboratory methods produced acceptable TE values (HW = 2.5% fat; BP = 2.7% fat). The BIA-AK, and BIA-Lohman field methods produced acceptable TE values (2.1% fat). A significant difference was observed for the MC and NAF equations compared to both the 3C model and HW (p < 0.006). Results indicate that the BP and HW are valid laboratory methods when compared to the 3C model to estimate %fat in college-age Caucasian men. When the use of a laboratory method is not feasible, BIA-AK, and BIA-Lohman are acceptable field methods to estimate %fat in this population.

  5. Self-administration of cocaine, cannabis and heroin in the human laboratory: benefits and pitfalls.

    PubMed

    Haney, Margaret

    2009-01-01

    The objective of this review is to describe self-administration procedures for modeling addiction to cocaine, cannabis and heroin in the human laboratory, the benefits and pitfalls of the approach, and the methodological issues unique to each drug. In addition, the predictive validity of the model for testing treatment medications will be addressed. The results show that all three drugs of abuse are reliably and robustly self-administered by non-treatment-seeking research volunteers. In terms of pharmacotherapies, cocaine use is extraordinarily difficult to disrupt either in the laboratory or in the clinic. A range of medications has been shown to significantly decrease cocaine's subjective effects and craving without decreasing either cocaine self-administration or cocaine abuse by patients. These negative data combined with recent positive findings with modafinil suggest that self-administration procedures are an important intermediary step between pre-clinical and clinical studies. In terms of cannabis, a recent study suggests that medications that improve sleep and mood during cannabis withdrawal decrease the resumption of marijuana self-administration in abstinent volunteers. Clinical data on patients seeking treatment for their marijuana use are needed to validate these laboratory findings. Finally, in contrast to cannabis or cocaine dependence, there are three efficacious Food and Drug Administration-approved medications to treat opioid dependence, all of which decrease both heroin self-administration and subjective effects in the human laboratory. In summary, self-administration procedures provide meaningful behavioral data in a small number of individuals. These studies contribute to our understanding of the variables maintaining cocaine, marijuana and heroin intake, and are important in guiding the development of more effective drug treatment programs.

  6. Integrated Summary Report: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa)

    EPA Science Inventory

    This Integrated Summary Report (ISR) summarizes, in a single document, the results from an international multi-laboratory validation study conducted for two in vitro estrogen receptor (ER) binding assays. These assays both use human recombinant estrogen receptor, alpha subtype (h...

  7. A reliability and validity study of the Palliative Performance Scale

    PubMed Central

    Ho, Francis; Lau, Francis; Downing, Michael G; Lesperance, Mary

    2008-01-01

    Background The Palliative Performance Scale (PPS) was first introduced in1996 as a new tool for measurement of performance status in palliative care. PPS has been used in many countries and has been translated into other languages. Methods This study evaluated the reliability and validity of PPS. A web-based, case scenarios study with a test-retest format was used to determine reliability. Fifty-three participants were recruited and randomly divided into two groups, each evaluating 11 cases at two time points. The validity study was based on the content validation of 15 palliative care experts conducted over telephone interviews, with discussion on five themes: PPS as clinical assessment tool, the usefulness of PPS, PPS scores affecting decision making, the problems in using PPS, and the adequacy of PPS instruction. Results The intraclass correlation coefficients for absolute agreement were 0.959 and 0.964 for Group 1, at Time-1 and Time-2; 0.951 and 0.931 for Group 2, at Time-1 and Time-2 respectively. Results showed that the participants were consistent in their scoring over the two times, with a mean Cohen's kappa of 0.67 for Group 1 and 0.71 for Group 2. In the validity study, all experts agreed that PPS is a valuable clinical assessment tool in palliative care. Many of them have already incorporated PPS as part of their practice standard. Conclusion The results of the reliability study demonstrated that PPS is a reliable tool. The validity study found that most experts did not feel a need to further modify PPS and, only two experts requested that some performance status measures be defined more clearly. Areas of PPS use include prognostication, disease monitoring, care planning, hospital resource allocation, clinical teaching and research. PPS is also a good communication tool between palliative care workers. PMID:18680590

  8. Conceptualization, Development and Validation of an Instrument for Investigating Elements of Undergraduate Physics Laboratory Learning Environments: The UPLLES (Undergraduate Physics Laboratory Learning Environment Survey)

    ERIC Educational Resources Information Center

    Thomas, Gregory P; Meldrum, Al; Beamish, John

    2013-01-01

    First-year undergraduate physics laboratories are important physics learning environments. However, there is a lack of empirically informed literature regarding how students perceive their overall laboratory learning experiences. Recipe formats persist as the dominant form of instructional design in these sites, and these formats do not adequately…

  9. Method for the Determination of Aconitum Alkaloids in Dietary Supplements and Raw Materials by Reversed-Phase Liquid Chromatography with Ultraviolet Detection and Confirmation by Tandem Mass Spectrometry: Single-Laboratory Validation

    PubMed Central

    Tang, Wai-Tong; Wong, Sui-Kay; Law, Tin-Yau; Pang, Kwok-Chu; Sin, Della; Tam, Yin-King

    2008-01-01

    A study of single-laboratory validation (SLV) of a reversed-phase liquid Chromatography (RP-LC) method was conducted for the determination of diester-diterpene Aconitum alkaloids, viz., aconitine, mesaconitine, and hypaconitine, in a variety of dietary supplements, including single-arid multiple-ingredient dry powder extracts, pills, capsules, and raw materials. The Aconitum alkaloids in the samples were extracted by diethyl ether in the presence of ammonia. After cleanup with solid-phase extraction to remove the matrix interferences, the alkaloids were determined by RP-LC with UV detection at 235 nm, and the results were confirmed by tandem mass Spectrometry. The linear responses for aconitine, mesaconitine, and hypaconitine based on the present LC system ranged from 0.5 to 200 μg/mL. Relative standard deviations of 2.0 to 6.9% were obtained from duplicate analysis of 6 test materials of different matrixes for the 3 Aconitum alkaloids performed by 2 analysts on 5 different days. The recoveries determined for supplements and raw materials spiked with 3 Aconitum alkaloids at levels of 2.5–10 μg/g were in the range of 86–99%. In view of the attainment of satisfactory results for accuracy, precision, and recovery in the SLV study, it is recommended that the method validation process proceed to a collaborative study. PMID:17225594

  10. Validation of biomarkers of food intake-critical assessment of candidate biomarkers.

    PubMed

    Dragsted, L O; Gao, Q; Scalbert, A; Vergères, G; Kolehmainen, M; Manach, C; Brennan, L; Afman, L A; Wishart, D S; Andres Lacueva, C; Garcia-Aloy, M; Verhagen, H; Feskens, E J M; Praticò, G

    2018-01-01

    Biomarkers of food intake (BFIs) are a promising tool for limiting misclassification in nutrition research where more subjective dietary assessment instruments are used. They may also be used to assess compliance to dietary guidelines or to a dietary intervention. Biomarkers therefore hold promise for direct and objective measurement of food intake. However, the number of comprehensively validated biomarkers of food intake is limited to just a few. Many new candidate biomarkers emerge from metabolic profiling studies and from advances in food chemistry. Furthermore, candidate food intake biomarkers may also be identified based on extensive literature reviews such as described in the guidelines for Biomarker of Food Intake Reviews (BFIRev). To systematically and critically assess the validity of candidate biomarkers of food intake, it is necessary to outline and streamline an optimal and reproducible validation process. A consensus-based procedure was used to provide and evaluate a set of the most important criteria for systematic validation of BFIs. As a result, a validation procedure was developed including eight criteria, plausibility, dose-response, time-response, robustness, reliability, stability, analytical performance, and inter-laboratory reproducibility. The validation has a dual purpose: (1) to estimate the current level of validation of candidate biomarkers of food intake based on an objective and systematic approach and (2) to pinpoint which additional studies are needed to provide full validation of each candidate biomarker of food intake. This position paper on biomarker of food intake validation outlines the second step of the BFIRev procedure but may also be used as such for validation of new candidate biomarkers identified, e.g., in food metabolomic studies.

  11. Estimating retention in HIV care accounting for patient transfers: A national laboratory cohort study in South Africa.

    PubMed

    Fox, Matthew P; Bor, Jacob; Brennan, Alana T; MacLeod, William B; Maskew, Mhairi; Stevens, Wendy S; Carmona, Sergio

    2018-06-01

    Systematic reviews have described high rates of attrition in patients with HIV receiving antiretroviral therapy (ART). However, migration and clinical transfer may lead to an overestimation of attrition (death and loss to follow-up). Using a newly linked national laboratory database in South Africa, we assessed national retention in South Africa's national HIV program. Patients receiving care in South Africa's national HIV program are monitored through regular CD4 count and viral load testing. South Africa's National Health Laboratory Service has maintained a database of all public-sector CD4 count and viral load results since 2004. We linked individual laboratory results to patients using probabilistic matching techniques, creating a national HIV cohort. Validation of our approach in comparison to a manually matched dataset showed 9.0% undermatching and 9.5% overmatching. We analyzed data on patients initiating ART in the public sector from April 1, 2004, to December 31, 2006, when ART initiation could be determined based on first viral load among those whose treatment followed guidelines. Attrition occurred on the date of a patient's last observed laboratory measure, allowing patients to exit and reenter care prior to that date. All patients had 6 potential years of follow-up, with an additional 2 years to have a final laboratory measurement to be retained at 6 years. Data were censored at December 31, 2012. We assessed (a) national retention including all laboratory tests regardless of testing facility and (b) initiating facility retention, where laboratory tests at other facilities were ignored. We followed 55,836 patients initiating ART between 2004 and 2006. At ART initiation, median age was 36 years (IQR: 30-43), median CD4 count was 150 cells/mm3 (IQR: 81-230), and 66.7% were female. Six-year initiating clinic retention was 29.1% (95% CI: 28.7%-29.5%). After allowing for transfers, national 6-year retention was 63.3% (95% CI: 62.9%-63.7%). Results differed

  12. Laboratory prototype for experimental validation of MR-guided radiofrequency head and neck hyperthermia

    NASA Astrophysics Data System (ADS)

    Paulides, M. M.; Bakker, J. F.; Hofstetter, L. W.; Numan, W. C. M.; Pellicer, R.; Fiveland, E. W.; Tarasek, M.; Houston, G. C.; van Rhoon, G. C.; Yeo, D. T. B.; Kotek, G.

    2014-05-01

    Clinical studies have established a strong benefit from adjuvant mild hyperthermia (HT) to radio- and chemotherapy for many tumor sites, including the head and neck (H&N). The recently developed HYPERcollar allows the application of local radiofrequency HT to tumors in the entire H&N. Treatment quality is optimized using electromagnetic and thermal simulators and, whenever placement risk is tolerable, assessed using invasively placed thermometers. To replace the current invasive procedure, we are investigating whether magnetic resonance (MR) thermometry can be exploited for continuous and 3D thermal dose assessment. In this work, we used our simulation tools to design an MR compatible laboratory prototype applicator. By simulations and measurements, we showed that the redesigned patch antennas are well matched to 50 Ω (S11<-10 dB). Simulations also show that, using 300 W input power, a maximum specific absorption rate (SAR) of 100 W kg-1 and a temperature increase of 4.5 °C in 6 min is feasible at the center of a cylindrical fat/muscle phantom. Temperature measurements using the MR scanner confirmed the focused heating capabilities and MR compatibility of the setup. We conclude that the laboratory applicator provides the possibility for experimental assessment of the feasibility of hybrid MR-HT in the H&N region. This versatile design allows rigorous analysis of MR thermometry accuracy in increasingly complex phantoms that mimic patients' anatomies and thermodynamic characteristics.

  13. VALUE - A Framework to Validate Downscaling Approaches for Climate Change Studies

    NASA Astrophysics Data System (ADS)

    Maraun, Douglas; Widmann, Martin; Gutiérrez, José M.; Kotlarski, Sven; Chandler, Richard E.; Hertig, Elke; Wibig, Joanna; Huth, Radan; Wilke, Renate A. I.

    2015-04-01

    VALUE is an open European network to validate and compare downscaling methods for climate change research. VALUE aims to foster collaboration and knowledge exchange between climatologists, impact modellers, statisticians, and stakeholders to establish an interdisciplinary downscaling community. A key deliverable of VALUE is the development of a systematic validation framework to enable the assessment and comparison of both dynamical and statistical downscaling methods. Here, we present the key ingredients of this framework. VALUE's main approach to validation is user-focused: starting from a specific user problem, a validation tree guides the selection of relevant validation indices and performance measures. Several experiments have been designed to isolate specific points in the downscaling procedure where problems may occur: what is the isolated downscaling skill? How do statistical and dynamical methods compare? How do methods perform at different spatial scales? Do methods fail in representing regional climate change? How is the overall representation of regional climate, including errors inherited from global climate models? The framework will be the basis for a comprehensive community-open downscaling intercomparison study, but is intended also to provide general guidance for other validation studies.

  14. VALUE: A framework to validate downscaling approaches for climate change studies

    NASA Astrophysics Data System (ADS)

    Maraun, Douglas; Widmann, Martin; Gutiérrez, José M.; Kotlarski, Sven; Chandler, Richard E.; Hertig, Elke; Wibig, Joanna; Huth, Radan; Wilcke, Renate A. I.

    2015-01-01

    VALUE is an open European network to validate and compare downscaling methods for climate change research. VALUE aims to foster collaboration and knowledge exchange between climatologists, impact modellers, statisticians, and stakeholders to establish an interdisciplinary downscaling community. A key deliverable of VALUE is the development of a systematic validation framework to enable the assessment and comparison of both dynamical and statistical downscaling methods. In this paper, we present the key ingredients of this framework. VALUE's main approach to validation is user- focused: starting from a specific user problem, a validation tree guides the selection of relevant validation indices and performance measures. Several experiments have been designed to isolate specific points in the downscaling procedure where problems may occur: what is the isolated downscaling skill? How do statistical and dynamical methods compare? How do methods perform at different spatial scales? Do methods fail in representing regional climate change? How is the overall representation of regional climate, including errors inherited from global climate models? The framework will be the basis for a comprehensive community-open downscaling intercomparison study, but is intended also to provide general guidance for other validation studies.

  15. Clinical protein science developments for patient monitoring in hospital central laboratories.

    PubMed

    Malm, Johan; Marko-Varga, György

    2016-12-01

    Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

  16. Determination of Flavonol Aglycones in Ginkgo biloba Dietary Supplement Crude Materials and Finished Products by High-Performance Liquid Chromatography: Single Laboratory Validation

    PubMed Central

    Gray, Dean; LeVanseler, Kerri; Pan, Meide

    2008-01-01

    A single laboratory validation (SLV) was completed for a method to determine the flavonol aglycones quercetin, kaempferol, and isorhamnetin in Ginkgo biloba products. The method calculates total glycosides based on these aglycones formed following acid hydrolysis. Nine matrixes were chosen for the study, including crude leaf material, standardized dry powder extract, single and multiple entity finished products, and ethanol and glycerol tinctures. For the 9 matrixes evaluated as part of this SLV, the method appeared to be selective and specific, with no observed interferences. The simplified 60 min oven heating hydrolysis procedure was effective for each of the matrixes studied, with no apparent or consistent differences between 60, 75, and 90 min at 90°C. A Youden ruggedness trial testing 7 factors with the potential to affect quantitative results showed that 2 factors (volume hydrolyzed and test sample extraction/hydrolysis weight) were the most important parameters for control during sample preparation. The method performed well in terms of precision, with 4 matrixes tested in triplicate over a 3-day period showing an overall repeatability (relative standard deviation, RSD) of 2.3%. Analysis of variance testing at α = 0.05 showed no significant differences among the within- or between-group sources of variation, although comparisons of within-day (Sw), between-day (Sb), and total (St) precision showed that a majority of the standard deviation came from within-day determinations for all matrixes. Accuracy testing at 2 levels (approximately 30 and 90% of the determined concentrations in standardized dry powder extract) from 2 complex negative control matrixes showed an overall 96% recovery and RSD of 1.0% for the high spike, and 94% recovery and RSD of 2.5% for the low spike. HorRat scores were within the limits for performance acceptability, ranging from 0.4 to 1.3. Based on the performance results presented herein, it is recommended that this method progress

  17. Laboratory Design for Microbiological Safety

    PubMed Central

    Phillips, G. Briggs; Runkle, Robert S.

    1967-01-01

    Of the large amount of funds spent each year in this country on construction and remodeling of biomedical research facilities, a significant portion is directed to laboratories handling infectious microorganisms. This paper is intended for the scientific administrators, architects, and engineers concerned with the design of new microbiological facilities. It develops and explains the concept of primary and secondary barriers for the containment of microorganisms. The basic objectives of a microbiological research laboratory, (i) protection of the experimenter and staff, (ii) protection of the surrounding community, and (iii) maintenance of experimental validity, are defined. In the design of a new infectious-disease research laboratory, early identification should be made of the five functional zones of the facility and their relation to each other. The following five zones and design criteria applicable to each are discussed: clean and transition, research area, animal holding and research area, laboratory support, engineering support. The magnitude of equipment and design criteria which are necessary to integrate these five zones into an efficient and safe facility are delineated. Images Fig. 1 Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8 Fig. 9 Fig. 10 Fig. 11 Fig. 12 Fig. 13 Fig. 14 Fig. 15 Fig. 16 Fig. 17 Fig. 18 Fig. 19 PMID:4961771

  18. Learning Environment, Attitudes and Achievement among Middle-School Science Students Using Inquiry-Based Laboratory Activities

    ERIC Educational Resources Information Center

    Wolf, Stephen J.; Fraser, Barry J.

    2008-01-01

    This study compared inquiry and non-inquiry laboratory teaching in terms of students' perceptions of the classroom learning environment, attitudes toward science, and achievement among middle-school physical science students. Learning environment and attitude scales were found to be valid and related to each other for a sample of 1,434 students in…

  19. Validation of a PCR-based method for the detection of various rendered materials in feedstuffs using a forensic DNA extraction kit.

    PubMed

    Myers, Michael J; Yancy, Haile F; Araneta, Michael; Armour, Jennifer; Derr, Janice; Hoostelaere, Lawrence A D; Farmer, Doris; Jackson, Falana; Kiessling, William M; Koch, Henry; Lin, Huahua; Liu, Yan; Mowlds, Gabrielle; Pinero, David; Riter, Ken L; Sedwick, John; Shen, Yuelian; Wetherington, June; Younkins, Ronsha

    2006-01-01

    positive control DNA samples could be detected with the ovine primers. The multispecies primer pair was validated in three laboratories for use with bovine meat and bone meal and lamb meal but not with PMBM. The three laboratories had an average accuracy of 98.9% for bovine meat and bone meal, 97.8% for lamb meal, and 63.3% for PMBM. When examined on an individual laboratory basis, one of these four laboratories could not identify a single feed sample containing PMBM by using the multispecies primer, whereas the other laboratory identified only one PMBM-fortified sample, suggesting that the limit of detection for PMBM with this primer pair is around 0.1% (wt/wt). The results of this study demonstrated that the DNA forensic kit can be used to extract DNA from animal feed, which can then be used for PCR analysis to detect animal-derived protein present in the feed sample.

  20. Can We Study Autonomous Driving Comfort in Moving-Base Driving Simulators? A Validation Study.

    PubMed

    Bellem, Hanna; Klüver, Malte; Schrauf, Michael; Schöner, Hans-Peter; Hecht, Heiko; Krems, Josef F

    2017-05-01

    To lay the basis of studying autonomous driving comfort using driving simulators, we assessed the behavioral validity of two moving-base simulator configurations by contrasting them with a test-track setting. With increasing level of automation, driving comfort becomes increasingly important. Simulators provide a safe environment to study perceived comfort in autonomous driving. To date, however, no studies were conducted in relation to comfort in autonomous driving to determine the extent to which results from simulator studies can be transferred to on-road driving conditions. Participants ( N = 72) experienced six differently parameterized lane-change and deceleration maneuvers and subsequently rated the comfort of each scenario. One group of participants experienced the maneuvers on a test-track setting, whereas two other groups experienced them in one of two moving-base simulator configurations. We could demonstrate relative and absolute validity for one of the two simulator configurations. Subsequent analyses revealed that the validity of the simulator highly depends on the parameterization of the motion system. Moving-base simulation can be a useful research tool to study driving comfort in autonomous vehicles. However, our results point at a preference for subunity scaling factors for both lateral and longitudinal motion cues, which might be explained by an underestimation of speed in virtual environments. In line with previous studies, we recommend lateral- and longitudinal-motion scaling factors of approximately 50% to 60% in order to obtain valid results for both active and passive driving tasks.

  1. An international study of how laboratories handle and evaluate patient samples after detecting an unexpected APTT prolongation.

    PubMed

    Ajzner, Éva; Rogic, Dunja; Meijer, Piet; Kristoffersen, Ann Helen; Carraro, Paolo; Sozmen, Eser; Faria, Ana Paula; Sandberg, Sverre

    2015-09-01

    An unexpectedly detected prolonged activated partial thromboplastin time (APTT) can be a harmless laboratory finding, but can also reflect a thrombotic tendency or a bleeding disorder. The assistance of laboratory professionals in the interpretation of an unexpectedly detected prolonged APTT (uAPTT) is often required. The way in which uAPTTs are evaluated in laboratories was assessed in this international study with the aim of determining whether laboratory professionals are able to fulfill this need. Postanalytical practices after uAPTT were investigated and the mixing study methodology (if used) was studied by circulating a case report with a questionnaire to staff in the invited laboratories. In addition, the interpretations of those staff regarding the presence or absence of inhibitors in three APTT mixing study scenarios were examined. Large within- and between-country variations were detected in both postanalytical practices and mixing study methodologies among the 990 responding laboratories, 90% of which were in 13 countries. Shortcomings regarding the investigation of uAPTTs leading to potentially incorrect or delayed clinical diagnoses were found in 88% of the laboratories. Of the laboratories to which the interpretative questions were sent, 49% interpreted all mixing study scenarios correctly. uAPTTs were investigated appropriately and all mixing study scenarios interpreted correctly in parallel in only 9.6% of the participating laboratories. The clinical requirement for the assistance of laboratory professionals in the interpretation of uAPTTs cannot be met at most of the participating laboratories. Laboratory professionals should be trained in the evaluation of ordinary laboratory tests, such as that for uAPTTs.

  2. Report of the Field and Laboratory Utilization Study Group. Appendix

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    None

    1975-12-01

    These appendices (ERDA organization and management, summary of other resources, and FLU study considerations/inputs) provide detailed and quantitative information in support of the findings and recommendations presented in the report of the field and laboratory utilization study group. (RWR)

  3. Total laboratory automation: Do stat tests still matter?

    PubMed

    Dolci, Alberto; Giavarina, Davide; Pasqualetti, Sara; Szőke, Dominika; Panteghini, Mauro

    2017-07-01

    During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  4. The science of laboratory and project management in regulated bioanalysis.

    PubMed

    Unger, Steve; Lloyd, Thomas; Tan, Melvin; Hou, Jingguo; Wells, Edward

    2014-05-01

    Pharmaceutical drug development is a complex and lengthy process, requiring excellent project and laboratory management skills. Bioanalysis anchors drug safety and efficacy with systemic and site of action exposures. Development of scientific talent and a willingness to innovate or adopt new technology is essential. Taking unnecessary risks, however, should be avoided. Scientists must strategically assess all risks and find means to minimize or negate them. Laboratory Managers must keep abreast of ever-changing technology. Investments in instrumentation and laboratory design are critical catalysts to efficiency and safety. Matrix management requires regular communication between Project Managers and Laboratory Managers. When properly executed, it aligns the best resources at the right times for a successful outcome. Attention to detail is a critical aspect that separates excellent laboratories. Each assay is unique and requires attention in its development, validation and execution. Methods, training and facilities are the foundation of a bioanalytical laboratory.

  5. Fun and Games: The Validity of Games for the Study of Conflict

    ERIC Educational Resources Information Center

    Schlenker, Barry R.; Bonoma, Thomas V.

    1978-01-01

    Examines claimed advantages and criticisms of the use of games in the study of social conflict, differentiating the advantages and criticisms into questions of internal validity, external validity, and ecological validity. Available from: Sage Publications, Inc., 275 South Beverly Drive, Beverly Hills, California 90212. (JG)

  6. Cold Agglutinin Disease; A Laboratory Challenge.

    PubMed

    Nikousefat, Zahra; Javdani, Moosa; Hashemnia, Mohammad; Haratyan, Abbas; Jalili, Ali

    2015-10-01

    Autoimmune haemolytic anemia (AIHA) is a complex process characterized by an immune reaction against red blood cell self-antigens. The analysis of specimens, drawn from patients with cold auto-immune hemolytic anemia is a difficult problem for automated hematology analyzer. This paper was written to alert technologists and pathologists to the presence of cold agglutinins and its effect on laboratory tests. A 72-year-old female presented to the Shafa laboratory for hematology profile evaluation. CBC indices showed invalid findings with the Sysmex automated hematology analyzer. Checking the laboratory process showed precipitation residue sticking to the sides of the tube. After warming the tubes, results become valid and the problem attributed to cold agglutinin disease. In this situation, aggregation of RBCs, which occurs at t < 30°C, causes invalid findings meanwhile working with automated hematology analyzer. Knowledge of this phenomenon can help prevent wasting too much time and make an early and accurate diagnosis.

  7. Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes.

    PubMed

    Wilson, Ian G; Smye, Michael; Wallace, Ian J C

    2016-02-01

    Accreditation to ISO/IEC 17025 is required for EC official food control and veterinary laboratories by Regulation (EC) No. 882/2004. Measurements in hospital laboratories and clinics are increasingly accredited to ISO/IEC 15189. Both of these management standards arose from command and control military standards for factory inspection during World War II. They rely on auditing of compliance and have not been validated internally as assessment bodies require of those they accredit. Neither have they been validated to criteria outside their own ideology such as the Cochrane principles of evidence-based medicine which might establish whether any benefit exceeds their cost. We undertook a retrospective meta-audit over 14 years of internal and external laboratory audits that checked compliance with ISO 17025 in a public health laboratory. Most noncompliances arose solely from clauses in the standard and would not affect users. No effect was likely from 91% of these. Fewer than 1% of noncompliances were likely to have consequences for the validity of results or quality of service. The ISO system of compliance auditing has the performance characteristics of a poor screening test. It adds substantially to costs and generates more noise (false positives) than informative signal. Ethical use of resources indicates that management standards should not be used unless proven to deliver the efficacy, effectiveness, and value required of modern healthcare interventions. © 2015 The Authors. MicrobiologyOpen published by John Wiley & Sons Ltd.

  8. Construct Validity of the Emotional Eating Scale Adapted for Children and Adolescents

    PubMed Central

    Vannucci, Anna; Tanofsky-Kraff, Marian; Shomaker, Lauren B.; Ranzenhofer, Lisa M.; Matheson, Brittany E.; Cassidy, Omni L.; Zocca, Jaclyn M.; Kozlosky, Merel; Yanovski, Susan Z.; Yanovski, Jack A.

    2012-01-01

    Background Emotional eating, defined as eating in response to a range of negative emotions, is common in youth. Yet, there are few easily administered and well-validated methods to assess emotional eating in pediatric populations. Objective The current study tested the construct validity of the Emotional Eating Scale Adapted for Children and Adolescents (EES-C) by examining its relationship to observed emotional eating at laboratory test meals. Method One hundred fifty-one youth (8-18 years) participated in two multi-item lunch buffet meals on separate days. They ate ad libitum after being instructed to “eat as much as you would at a normal meal” or to “let yourself go and eat as much as you want.” State negative affect was assessed immediately prior to each meal. The EES-C was completed three months, on average, prior to the first test meal. Results Among youth with high EES-C total scores, but not low EES-C scores, higher pre-meal state negative affect was related to greater total energy intake at both meals, with and without the inclusion of age, race, sex, and BMI-z as covariates (ps < 0.03). Discussion The EES-C demonstrates good construct validity for children and adolescents’ observed energy intake across laboratory test meals designed to capture both normal and disinhibited eating. Future research is required to evaluate the construct validity of the EES-C in the natural environment and the predictive validity of the EES-C longitudinally. PMID:22124451

  9. Cross-validation of generalised body composition equations with diverse young men and women: the Training Intervention and Genetics of Exercise Response (TIGER) Study

    USDA-ARS?s Scientific Manuscript database

    Generalised skinfold equations developed in the 1970s are commonly used to estimate laboratory-measured percentage fat (BF%). The equations were developed on predominately white individuals using Siri's two-component percentage fat equation (BF%-GEN). We cross-validated the Jackson-Pollock (JP) gene...

  10. Reliability and Validity of Ambulatory Cognitive Assessments

    PubMed Central

    Sliwinski, Martin J.; Mogle, Jacqueline A.; Hyun, Jinshil; Munoz, Elizabeth; Smyth, Joshua M.; Lipton, Richard B.

    2017-01-01

    Mobile technologies are increasingly used to measure cognitive function outside of traditional clinic and laboratory settings. Although ambulatory assessments of cognitive function conducted in people’s natural environments offer potential advantages over traditional assessment approaches, the psychometrics of cognitive assessment procedures have been understudied. We evaluated the reliability and construct validity of ambulatory assessments of working memory and perceptual speed administered via smartphones as part of an ecological momentary assessment (EMA) protocol in a diverse adult sample (N=219). Results indicated excellent between-person reliability (≥.97) for average scores, and evidence of reliable within-person variability across measurement occasions (.41–.53). The ambulatory tasks also exhibited construct validity, as evidence by their loadings on working memory and perceptual speed factors defined by the in-lab assessments. Our findings demonstrate that averaging across brief cognitive assessments made in uncontrolled naturalistic settings provide measurements that are comparable in reliability to assessments made in controlled laboratory environments. PMID:27084835

  11. Sensor data validation and reconstruction. Phase 1: System architecture study

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The sensor validation and data reconstruction task reviewed relevant literature and selected applicable validation and reconstruction techniques for further study; analyzed the selected techniques and emphasized those which could be used for both validation and reconstruction; analyzed Space Shuttle Main Engine (SSME) hot fire test data to determine statistical and physical relationships between various parameters; developed statistical and empirical correlations between parameters to perform validation and reconstruction tasks, using a computer aided engineering (CAE) package; and conceptually designed an expert system based knowledge fusion tool, which allows the user to relate diverse types of information when validating sensor data. The host hardware for the system is intended to be a Sun SPARCstation, but could be any RISC workstation with a UNIX operating system and a windowing/graphics system such as Motif or Dataviews. The information fusion tool is intended to be developed using the NEXPERT Object expert system shell, and the C programming language.

  12. The role of diagnostic laboratories in support of animal disease surveillance systems.

    PubMed

    Zepeda, C

    2007-01-01

    Diagnostic laboratories are an essential component of animal disease surveillance systems. To understand the occurrence of disease in populations, surveillance systems rely on random or targeted surveys using three approaches: clinical, serological and virological surveillance. Clinical surveillance is the basis for early detection of disease and is usually centered on the detection of syndromes and clinical findings requiring confirmation by diagnostic laboratories. Although most of the tests applied usually perform to an acceptable standard, several have not been properly validated in terms of their diagnostic sensitivity and specificity. Sensitivity and specificity estimates can vary according to local conditions and, ideally, should be determined by national laboratories where the tests are to be applied. The importance of sensitivity and specificity estimates in the design and interpretation of statistically based surveys and risk analysis is fundamental to establish appropriate disease control and prevention strategies. The World Organisation for Animal Health's (OIE) network of reference laboratories acts as centers of expertise for the diagnosis of OIE listed diseases and have a role in promoting the validation of OIE prescribed tests for international trade. This paper discusses the importance of the epidemiological evaluation of diagnostic tests and the role of the OIE Reference Laboratories and Collaborating Centres in this process.

  13. Laboratory and Space Plasma Studies

    NASA Astrophysics Data System (ADS)

    Hyman, Ellis

    1996-08-01

    The work performed by Science Applications International Corporation (SAIC), encompasses a wide range of topics in experimental, computational, and analytical laboratory and space plasma physics. The accomplishments described in this report have been in support of the programs of the Laser Plasma Branch (Code 6730) and other segments of the Plasma Physics Division at the Naval Research Laboratory (NRL) and cover the period 27 September 1993 to August 1, 1996. SAIC's efforts have been supported by sub-contracts or consulting agreements with Pulse Sciences, Inc., Clark Richardson, and Biskup Consulting Engineers, Pharos Technical Enterprises, Plex Corporation, Cornell University, Stevens Institute of Technology, the University of Connecticut, Plasma Materials and Technologies, Inc., and GaSonics International, Inc. In the following discussions section we will describe each of the topics investigated and the results obtained. Much of the research work has resulted in journal publications and NRL Memorandum Reports in which the investigation is described in detail. These reports are included as Appendices to this Final Report.

  14. Beyond-laboratory-scale prediction for channeling flows through subsurface rock fractures with heterogeneous aperture distributions revealed by laboratory evaluation

    NASA Astrophysics Data System (ADS)

    Ishibashi, Takuya; Watanabe, Noriaki; Hirano, Nobuo; Okamoto, Atsushi; Tsuchiya, Noriyoshi

    2015-01-01

    The present study evaluates aperture distributions and fluid flow characteristics for variously sized laboratory-scale granite fractures under confining stress. As a significant result of the laboratory investigation, the contact area in fracture plane was found to be virtually independent of scale. By combining this characteristic with the self-affine fractal nature of fracture surfaces, a novel method for predicting fracture aperture distributions beyond laboratory scale is developed. Validity of this method is revealed through reproduction of the results of laboratory investigation and the maximum aperture-fracture length relations, which are reported in the literature, for natural fractures. The present study finally predicts conceivable scale dependencies of fluid flows through joints (fractures without shear displacement) and faults (fractures with shear displacement). Both joint and fault aperture distributions are characterized by a scale-independent contact area, a scale-dependent geometric mean, and a scale-independent geometric standard deviation of aperture. The contact areas for joints and faults are approximately 60% and 40%. Changes in the geometric means of joint and fault apertures (µm), em, joint and em, fault, with fracture length (m), l, are approximated by em, joint = 1 × 102 l0.1 and em, fault = 1 × 103 l0.7, whereas the geometric standard deviations of both joint and fault apertures are approximately 3. Fluid flows through both joints and faults are characterized by formations of preferential flow paths (i.e., channeling flows) with scale-independent flow areas of approximately 10%, whereas the joint and fault permeabilities (m2), kjoint and kfault, are scale dependent and are approximated as kjoint = 1 × 10-12 l0.2 and kfault = 1 × 10-8 l1.1.

  15. Validation of streamflow measurements made with acoustic doppler current profilers

    USGS Publications Warehouse

    Oberg, K.; Mueller, D.S.

    2007-01-01

    The U.S. Geological Survey and other international agencies have collaborated to conduct laboratory and field validations of acoustic Doppler current profiler (ADCP) measurements of streamflow. Laboratory validations made in a large towing basin show that the mean differences between tow cart velocity and ADCP bottom-track and water-track velocities were -0.51 and -1.10%, respectively. Field validations of commercially available ADCPs were conducted by comparing streamflow measurements made with ADCPs to reference streamflow measurements obtained from concurrent mechanical current-meter measurements, stable rating curves, salt-dilution measurements, or acoustic velocity meters. Data from 1,032 transects, comprising 100 discharge measurements, were analyzed from 22 sites in the United States, Canada, Sweden, and The Netherlands. Results of these analyses show that broadband ADCP streamflow measurements are unbiased when compared to the reference discharges regardless of the water mode used for making the measurement. Measurement duration is more important than the number of transects for reducing the uncertainty of the ADCP streamflow measurement. ?? 2007 ASCE.

  16. Laboratory Based Case Studies: Closer to the Real World

    ERIC Educational Resources Information Center

    Dinan, Frank J.

    2005-01-01

    Case-based laboratories offer students the chance to approximate real science. Based on interesting stories that pose problems requiring experimental solutions, they avoid the cookbook approach characteristic of traditional undergraduate laboratory instruction. Instead, case-based laboratories challenge students to develop, as much as possible,…

  17. Gene-environment interactions and construct validity in preclinical models of psychiatric disorders.

    PubMed

    Burrows, Emma L; McOmish, Caitlin E; Hannan, Anthony J

    2011-08-01

    The contributions of genetic risk factors to susceptibility for brain disorders are often so closely intertwined with environmental factors that studying genes in isolation cannot provide the full picture of pathogenesis. With recent advances in our understanding of psychiatric genetics and environmental modifiers we are now in a position to develop more accurate animal models of psychiatric disorders which exemplify the complex interaction of genes and environment. Here, we consider some of the insights that have emerged from studying the relationship between defined genetic alterations and environmental factors in rodent models. A key issue in such animal models is the optimization of construct validity, at both genetic and environmental levels. Standard housing of laboratory mice and rats generally includes ad libitum food access and limited opportunity for physical exercise, leading to metabolic dysfunction under control conditions, and thus reducing validity of animal models with respect to clinical populations. A related issue, of specific relevance to neuroscientists, is that most standard-housed rodents have limited opportunity for sensory and cognitive stimulation, which in turn provides reduced incentive for complex motor activity. Decades of research using environmental enrichment has demonstrated beneficial effects on brain and behavior in both wild-type and genetically modified rodent models, relative to standard-housed littermate controls. One interpretation of such studies is that environmentally enriched animals more closely approximate average human levels of cognitive and sensorimotor stimulation, whereas the standard housing currently used in most laboratories models a more sedentary state of reduced mental and physical activity and abnormal stress levels. The use of such standard housing as a single environmental variable may limit the capacity for preclinical models to translate into successful clinical trials. Therefore, there is a need to

  18. Laboratory studies of in vivo fluorescence of phytoplankton

    NASA Technical Reports Server (NTRS)

    Brown, C. A., Jr.; Farmer, F. H.; Jarrett, O., Jr.; Staton, W. L.

    1978-01-01

    A lidar system is developed that uses four selected excitation wavelengths to induce chlorophyll 'a' fluorescence which is indicative of both the concentration and diversity of phytoplankton. The operating principles of the system and the results of measurements of phytoplankton fluorescence in a controlled laboratory environment are presented. A comparative study of results from lidar fluorosensor laboratory tank tests using representative species of phytoplankton in single and multispecies cultures from each of four color groups reveals that (1) there is good correlation between the fluorescence of chlorophyll 'a' remotely simulated and detected by the lidar system and in-situ measurements using four similar excitation wavelengths in a flow-through fluorometer; (2) good correlation exists between the total chlorophyll 'a' calculated from lidar-fluorosensor data and measurements obtained by the Strickland-Parsons method; and (3) the lidar fluorosensor can provide an index of population diversity.

  19. Sonographically Guided Plantaris Tendon Release: A Cadaveric Validation Study.

    PubMed

    Smith, Jay; Alfredson, Håkan; Masci, Lorenzo; Sellon, Jacob L; Woods, Charonn D

    2018-06-13

    The plantaris tendon (PT) has been implicated in the pathogenesis of symptoms in a subset of patients with Achilles region pain syndromes and has been traditionally managed via open surgical resection. Although the PT can be visualized on ultrasound, a minimally invasive technique for sonographically guided PT release has not been formally described. To validate a technique to perform sonographically guided PT release in an unembalmed cadaveric model. Prospective, cadaveric laboratory investigation. Procedural skills laboratory in a tertiary medical center. Twenty unembalmed cadaveric knee-ankle-foot specimens (10 right, 10 left; 6 male, 10 female) from 16 donors ages 55-96 years (mean 82.6 years) with BMI's of 14.1 to 33.2 kg/m 2 (mean 23.3 kg/m 2 ). Following simulated local anesthesia and sonographically guided hydrodissection of the plantaris tendon-Achilles tendon interval, a single experienced operator performed sonographically guided PT release on each specimen using an in-plane, lateral to medial approach, a commercially available, disposable 3.0 mm hook knife, and either a 17-5 MHz or 15-7 MHz linear array transducer. Each specimen was subsequently dissected to assess for PT release and iatrogenic injury. Status of the PT, Achilles tendon, and regional neurovascular structures as determined by dissection. All 20 PT releases were completed in a single attempt through a 3-5 mm incision. Dissection confirmed complete PT release in all specimens without damage to the adjacent Achilles tendon or regional neurovascular structures. Sonographically guided PT release is technically feasible and can be performed while avoiding injury to the Achilles tendon and regional neurovascular structures. Additional research is warranted to further define the role of sonographically guided PT release in patients with suspected PT-mediated Achilles region pain syndromes. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All

  20. The Jackson Career Explorer: Two Further Validity Studies

    ERIC Educational Resources Information Center

    Schermer, Julie Aitken

    2012-01-01

    The present report consists of two further validity studies using the Jackson Career Explorer (JCE), a short form and continuous version of the Jackson Vocational Interest Survey, measuring 34 interests. The first study examined the relationships between the JCE and five personality factors, from a sample of 528 individuals. The correlations found…

  1. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children.

    PubMed

    Vlieg-Boerstra, Berber J; Bijleveld, Charles M A; van der Heide, Sicco; Beusekamp, Berta J; Wolt-Plompen, Saskia A A; Kukler, Jeanet; Brinkman, Joep; Duiverman, Eric J; Dubois, Anthony E J

    2004-02-01

    The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. The purpose of this study was to develop and validate recipes for use in DBPCFCs in children by using allergenic foods, preferably in their usual edible form. Recipes containing milk, soy, cooked egg, raw whole egg, peanut, hazelnut, and wheat were developed. For each food, placebo and active test food recipes were developed that met the requirements of acceptable taste, allowance of a challenge dose high enough to elicit reactions in an acceptable volume, optimal matrix ingredients, and good matching of sensory properties of placebo and active test food recipes. Validation was conducted on the basis of sensory tests for difference by using the triangle test and the paired comparison test. Recipes were first tested by volunteers from the hospital staff and subsequently by a professional panel of food tasters in a food laboratory designed for sensory testing. Recipes were considered to be validated if no statistically significant differences were found. Twenty-seven recipes were developed and found to be valid by the volunteer panel. Of these 27 recipes, 17 could be validated by the professional panel. Sensory testing with appropriate statistical analysis allows for objective validation of challenge materials. We recommend the use of professional tasters in the setting of a food laboratory for best results.

  2. 29 CFR 1607.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... in the design of the study and their effects identified. (5) Statistical relationships. The degree of...; or such factors should be included in the design of the study and their effects identified. (f... arduous effort involving a series of research studies, which include criterion related validity studies...

  3. 29 CFR 1607.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... in the design of the study and their effects identified. (5) Statistical relationships. The degree of...; or such factors should be included in the design of the study and their effects identified. (f... arduous effort involving a series of research studies, which include criterion related validity studies...

  4. 29 CFR 1607.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... in the design of the study and their effects identified. (5) Statistical relationships. The degree of...; or such factors should be included in the design of the study and their effects identified. (f... arduous effort involving a series of research studies, which include criterion related validity studies...

  5. 29 CFR 1607.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... in the design of the study and their effects identified. (5) Statistical relationships. The degree of...; or such factors should be included in the design of the study and their effects identified. (f... arduous effort involving a series of research studies, which include criterion related validity studies...

  6. 29 CFR 1607.14 - Technical standards for validity studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... in the design of the study and their effects identified. (5) Statistical relationships. The degree of...; or such factors should be included in the design of the study and their effects identified. (f... arduous effort involving a series of research studies, which include criterion related validity studies...

  7. Rediscovery rate estimation for assessing the validation of significant findings in high-throughput studies.

    PubMed

    Ganna, Andrea; Lee, Donghwan; Ingelsson, Erik; Pawitan, Yudi

    2015-07-01

    It is common and advised practice in biomedical research to validate experimental or observational findings in a population different from the one where the findings were initially assessed. This practice increases the generalizability of the results and decreases the likelihood of reporting false-positive findings. Validation becomes critical when dealing with high-throughput experiments, where the large number of tests increases the chance to observe false-positive results. In this article, we review common approaches to determine statistical thresholds for validation and describe the factors influencing the proportion of significant findings from a 'training' sample that are replicated in a 'validation' sample. We refer to this proportion as rediscovery rate (RDR). In high-throughput studies, the RDR is a function of false-positive rate and power in both the training and validation samples. We illustrate the application of the RDR using simulated data and real data examples from metabolomics experiments. We further describe an online tool to calculate the RDR using t-statistics. We foresee two main applications. First, if the validation study has not yet been collected, the RDR can be used to decide the optimal combination between the proportion of findings taken to validation and the size of the validation study. Secondly, if a validation study has already been done, the RDR estimated using the training data can be compared with the observed RDR from the validation data; hence, the success of the validation study can be assessed. © The Author 2014. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  8. Tolerance of sexual harassment: a laboratory paradigm.

    PubMed

    Angelone, David J; Mitchell, Damon; Carola, Kara

    2009-12-01

    The present study attempted to develop a laboratory analogue for the study of tolerance for sexual harassment by using an online speed-dating paradigm. In that context, the relation between participants' sexual harassment attitudes, perpetrator attractiveness, perpetrator status, and perceived dating potential of the perpetrator were examined as factors influencing participants' tolerance of sexually harassing behavior. Participants were 128 female college students from a small northeastern public university. Results indicated that attractiveness, high social status, and attitudinal beliefs about sexual harassment were all predictive of tolerance for sexual harassment, providing preliminary support for the validity of this paradigm. In addition, participants' self reported likelihood to date a bogus male dating candidate was also predictive of tolerance for sexual harassment, over and above the aforementioned variables, suggesting that dating potential can play a role in perceptions of sexual harassment. Further, this experiment demonstrated that perceptions of sexual harassment can be assessed using the in vivo measurement of behavior. In addition, using an online environment not only provides a contemporary spin and adds a greater degree of external validity compared to other sexual harassment analogues, it also reduces any risk of potential physical sexual contact for participants.

  9. Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges

    PubMed Central

    Blank, Melissa D.; Breland, Alison B.; Cobb, Caroline O.; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

    2017-01-01

    Objective Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. Methods The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Results Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Conclusions Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation. PMID:28819633

  10. The Role of Slope in the Fill and Spill Process of Linked Submarine Minibasins. Model Validation and Numerical Runs at Laboratory Scale.

    NASA Astrophysics Data System (ADS)

    Bastianon, E.; Viparelli, E.; Cantelli, A.; Imran, J.

    2015-12-01

    Primarily motivated by applications to hydrocarbon exploration, submarine minibasins have been widely studied during recent decades to understand the physical phenomenon that characterizes their fill process. Minibasins were identified in seismic records in the Gulf of Mexico, Angola, Trinidad and Tobago, Ireland, Nigeria and also in outcrops (e.g., Tres Pasos Formation, southern Chile). The filling of minibasis is generally described as the 'fill-and-spill' process, i.e. turbidity currents enter, are reflected on the minibasin flanks, pond and deposit suspended sediment. As the minibasin fills the turbidity current spills on the lowermost zone of the basin flank -spill point - and start filling the next basin downdip. Different versions of this simplified model were used to interpret field and laboratory data but it is still unclear how the minibasin size compared to the magnitude of the turbidity currents, the position of each basin in the system, and the slope of the minibasin system affects the characteristics of the deposit (e.g., geometry, grain size). Here, we conduct a numerical study to investigate how the 'fill-and-spill' model changes with increase in slopes of the minibasin system. First, we validate our numerical results against laboratory experiment performed on two linked minibasins located on a horizontal platform by comparing measured and simulated deposit geometries, suspended sediment concentration profiles and grain sizes. We then perform numerical simulations by increasing the minibasin system slope: deposit and flow characteristics are compared with the case of horizontal platform to identify how the depositional processes change. For the numerical study we used a three-dimensional numerical model of turbidity currents that solves the Reynolds-averaged Navier-Stokes equations for dilute suspensions. Turbulence is modeled by a buoyancy-modified k-ɛ closure. The numerical model has a deforming bottom boundary, to model the changes in the bed

  11. Additional confirmation of the validity of laboratory simulation of cloud radiances

    NASA Technical Reports Server (NTRS)

    Davis, J. M.; Cox, S. K.

    1986-01-01

    The results of a laboratory experiment are presented that provide additional verification of the methodology adopted for simulation of the radiances reflected from fields of optically thick clouds using the Cloud Field Optical Simulator (CFOS) at Colorado State University. The comparison of these data with their theoretically derived counterparts indicates that the crucial mechanism of cloud-to-cloud radiance field interaction is accurately simulated in the CFOS experiments and adds confidence to the manner in which the optical depth is scaled.

  12. Improvement and validation of the method to determine neutral detergent fiber in feed.

    PubMed

    Hiraoka, Hisaaki; Fukunaka, Rie; Ishikuro, Eiichi; Enishi, Osamu; Goto, Tetsuhisa

    2012-10-01

    To improve the performance of the analytical method for neutral detergent fiber in feed with heat-stable α-amylase treatment (aNDFom), the process of adding heat-stable α-amylase, as well as other analytical conditions, were examined. In this new process, the starch in the samples was removed by adding amylase to neutral detergent (ND) solution twice, just after the start of heating and immediately after refluxing. We also examined the effects of the use of sodium sulfite, and drying and ashing conditions for aNDFom analysis by this modified amylase addition method. A collaborative study to validate this new method was carried out with 15 laboratories. These laboratories analyzed two samples, alfalfa pellet and dairy mixed feed, with blind duplicates. Ten laboratories used a conventional apparatus and five used a Fibertec(®) type apparatus. There were no significant differences in aNDFom values between these two refluxing apparatuses. The aNDFom values in alfalfa pellet and dairy mixed feed were 388 g/kg and 145 g/kg, the coefficients of variation for the repeatability and reproducibility (CV(r) and CV(R) ) were 1.3% and 2.9%, and the HorRat values were 0.8 and 1.1, respectively. This new method was validated with 5.8% uncertainty (k = 2) from the collaborative study. © 2012 The Authors. Animal Science Journal © 2012 Japanese Society of Animal Science.

  13. A program for the investigation of the Multibody Modeling, Verification, and Control Laboratory

    NASA Technical Reports Server (NTRS)

    Tobbe, Patrick A.; Christian, Paul M.; Rakoczy, John M.; Bulter, Marlon L.

    1993-01-01

    The Multibody Modeling, Verification, and Control (MMVC) Laboratory is under development at NASA MSFC in Huntsville, Alabama. The laboratory will provide a facility in which dynamic tests and analyses of multibody flexible structures representative of future space systems can be conducted. The purpose of the tests are to acquire dynamic measurements of the flexible structures undergoing large angle motions and use the data to validate the multibody modeling code, TREETOPS, developed under sponsorship of NASA. Advanced control systems design and system identification methodologies will also be implemented in the MMVC laboratory. This paper describes the ground test facility, the real-time control system, and the experiments. A top-level description of the TREETOPS code is also included along with the validation plan for the MMVC program. Dynamic test results from component testing are also presented and discussed. A detailed discussion of the test articles, which manifest the properties of large flexible space structures, is included along with a discussion of the various candidate control methodologies to be applied in the laboratory.

  14. Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

    PubMed

    Gu, Jun; Smith, Janice L; Dowling, Patricia K

    2017-01-01

    In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

  15. Percent body fat estimations in college men using field and laboratory methods: A three-compartment model approach

    PubMed Central

    Moon, Jordan R; Tobkin, Sarah E; Smith, Abbie E; Roberts, Michael D; Ryan, Eric D; Dalbo, Vincent J; Lockwood, Chris M; Walter, Ashley A; Cramer, Joel T; Beck, Travis W; Stout, Jeffrey R

    2008-01-01

    Background Methods used to estimate percent body fat can be classified as a laboratory or field technique. However, the validity of these methods compared to multiple-compartment models has not been fully established. The purpose of this study was to determine the validity of field and laboratory methods for estimating percent fat (%fat) in healthy college-age men compared to the Siri three-compartment model (3C). Methods Thirty-one Caucasian men (22.5 ± 2.7 yrs; 175.6 ± 6.3 cm; 76.4 ± 10.3 kg) had their %fat estimated by bioelectrical impedance analysis (BIA) using the BodyGram™ computer program (BIA-AK) and population-specific equation (BIA-Lohman), near-infrared interactance (NIR) (Futrex® 6100/XL), four circumference-based military equations [Marine Corps (MC), Navy and Air Force (NAF), Army (A), and Friedl], air-displacement plethysmography (BP), and hydrostatic weighing (HW). Results All circumference-based military equations (MC = 4.7% fat, NAF = 5.2% fat, A = 4.7% fat, Friedl = 4.7% fat) along with NIR (NIR = 5.1% fat) produced an unacceptable total error (TE). Both laboratory methods produced acceptable TE values (HW = 2.5% fat; BP = 2.7% fat). The BIA-AK, and BIA-Lohman field methods produced acceptable TE values (2.1% fat). A significant difference was observed for the MC and NAF equations compared to both the 3C model and HW (p < 0.006). Conclusion Results indicate that the BP and HW are valid laboratory methods when compared to the 3C model to estimate %fat in college-age Caucasian men. When the use of a laboratory method is not feasible, BIA-AK, and BIA-Lohman are acceptable field methods to estimate %fat in this population. PMID:18426582

  16. NREL and Army Validate Energy Savings for Net Zero Energy Installations |

    Science.gov Websites

    News | NREL and Army Validate Energy Savings for Net Zero Energy Installations News Release : NREL and Army Validate Energy Savings for Net Zero Energy Installations October 27, 2014 The U.S. Army (Army) has partnered with the Energy Department's National Renewable Energy Laboratory (NREL) to

  17. Brazilian validation of the Alberta Infant Motor Scale.

    PubMed

    Valentini, Nadia Cristina; Saccani, Raquel

    2012-03-01

    The Alberta Infant Motor Scale (AIMS) is a well-known motor assessment tool used to identify potential delays in infants' motor development. Although Brazilian researchers and practitioners have used the AIMS in laboratories and clinical settings, its translation to Portuguese and validation for the Brazilian population is yet to be investigated. This study aimed to translate and validate all AIMS items with respect to internal consistency and content, criterion, and construct validity. A cross-sectional and longitudinal design was used. A cross-cultural translation was used to generate a Brazilian-Portuguese version of the AIMS. In addition, a validation process was conducted involving 22 professionals and 766 Brazilian infants (aged 0-18 months). The results demonstrated language clarity and internal consistency for the motor criteria (motor development score, α=.90; prone, α=.85; supine, α=.92; sitting, α=.84; and standing, α=.86). The analysis also revealed high discriminative power to identify typical and atypical development (motor development score, P<.001; percentile, P=.04; classification criterion, χ(2)=6.03; P=.05). Temporal stability (P=.07) (rho=.85, P<.001) was observed, and predictive power (P<.001) was limited to the group of infants aged from 3 months to 9 months. Limited predictive validity was observed, which may have been due to the restricted time that the groups were followed longitudinally. In sum, the translated version of AIMS presented adequate validity and reliability.

  18. Assessing motivation orientations in schizophrenia: Scale development and validation

    PubMed Central

    Cooper, Shanna; Lavaysse, Lindsey M.; Gard, David E.

    2014-01-01

    Motivation deficits are common in several disorders including schizophrenia, and are an important factor in both functioning and treatment adherence. Self-Determination Theory (SDT), a leading macro-theory of motivation, has contributed a number of insights into how motivation is impaired in schizophrenia. Nonetheless, self-report measures of motivation appropriate for people with severe mental illness (including those that emphasize SDT) are generally lacking in literature. To fill this gap, we adapted and abbreviated the well-validated General Causality Orientation Scale for use with people with schizophrenia and with other severe mental disorders (GCOS-clinical populations; GCOS-CP). In Study 1, we tested the similarity of our measure to the existing GCOS (using a college sample) and then validated this new measure in a schizophrenia and healthy control sample (Study 2). Results from Study 1 (N=360) indicated that the GCOS-CP was psychometrically similar to the original GCOS and provided good convergent and discriminant validity. In Study 2, the GCOS-CP was given to individuals with (N=44) and without schizophrenia (N=42). In line with both laboratory-based and observer-based research, people with schizophrenia showed lower motivational autonomy and higher impersonal/amotivated orientations. Additional applications of the GCOS-CP are discussed. PMID:25454115

  19. Assessing motivation orientations in schizophrenia: Scale development and validation.

    PubMed

    Cooper, Shanna; Lavaysse, Lindsey M; Gard, David E

    2015-01-30

    Motivation deficits are common in several disorders including schizophrenia, and are an important factor in both functioning and treatment adherence. Self-Determination Theory (SDT), a leading macro-theory of motivation, has contributed a number of insights into how motivation is impaired in schizophrenia. Nonetheless, self-report measures of motivation appropriate for people with severe mental illness (including those that emphasize SDT) are generally lacking in the literature. To fill this gap, we adapted and abbreviated the well-validated General Causality Orientation Scale for use with people with schizophrenia and with other severe mental disorders (GCOS-clinical populations; GCOS-CP). In Study 1, we tested the similarity of our measure to the existing GCOS (using a college sample) and then validated this new measure in a schizophrenia and healthy control sample (Study 2). Results from Study 1 (N=360) indicated that the GCOS-CP was psychometrically similar to the original GCOS and provided good convergent and discriminant validity. In Study 2, the GCOS-CP was given to individuals with (N=44) and without schizophrenia (N=42). In line with both laboratory-based and observer-based research, people with schizophrenia showed lower motivational autonomy and higher impersonal/amotivated orientations. Additional applications of the GCOS-CP are discussed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Simultaneous Determination of 10 Ultratrace Elements in Infant Formula, Adult Nutritionals, and Milk Products by ICP/MS After Pressure Digestion: Single-Laboratory Validation.

    PubMed

    Dubascoux, Stephane; Nicolas, Marine; Rime, Celine Fragniere; Payot, Janique Richoz; Poitevin, Eric

    2015-01-01

    A single-laboratory validation (SLV) is presented for the simultaneous determination of 10 ultratrace elements (UTEs) including aluminum (Al), arsenic (As), cadmium (Cd), cobalt (Co), chromium (Cr), mercury (Hg), molybdenum (Mo), lead (Pb), selenium (Se), and tin (Sn) in infant formulas, adult nutritionals, and milk based products by inductively coupled plasma (ICP)/MS after acidic pressure digestion. This robust and routine multielemental method is based on several official methods with modifications of sample preparation using either microwave digestion or high pressure ashing and of analytical conditions using ICP/MS with collision cell technology. This SLV fulfills AOAC method performance criteria in terms of linearity, specificity, sensitivity, precision, and accuracy and fully answers most international regulation limits for trace contaminants and/or recommended nutrient levels established for 10 UTEs in targeted matrixes.