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.

Compliance program data management system for The Idaho National Engineering Laboratory/Environmental Protection Agency

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

Hertzler, C.L.; Poloski, J.P.; Bates, R.A.

1988-01-01

The Compliance Program Data Management System (DMS) developed at the Idaho National Engineering Laboratory (INEL) validates and maintains the integrity of data collected to support the Consent Order and Compliance Agreement (COCA) between the INEL and the Environmental Protection Agency (EPA). The system uses dBase III Plus programs and dBase III Plus in an interactive mode to enter, store, validate, manage, and retrieve analytical information provided on EPA Contract Laboratory Program (CLP) forms and CLP forms modified to accommodate 40 CFR 264 Appendix IX constituent analyses. Data analysis and presentation is performed utilizing SAS, a statistical analysis software program. Archivingmore » of data and results is performed at appropriate stages of data management. The DMS is useful for sampling and analysis programs where adherence to EPA CLP protocol, along with maintenance and retrieval of waste site investigation sampling results is desired or requested. 3 refs.« less

Validation of PV-RPM Code in the System Advisor Model.

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

Klise, Geoffrey Taylor; Lavrova, Olga; Freeman, Janine

2017-04-01

This paper describes efforts made by Sandia National Laboratories (SNL) and the National Renewable Energy Laboratory (NREL) to validate the SNL developed PV Reliability Performance Model (PV - RPM) algorithm as implemented in the NREL System Advisor Model (SAM). The PV - RPM model is a library of functions that estimates component failure and repair in a photovoltaic system over a desired simulation period. The failure and repair distributions in this paper are probabilistic representations of component failure and repair based on data collected by SNL for a PV power plant operating in Arizona. The validation effort focuses on whethermore » the failure and repair dist ributions used in the SAM implementation result in estimated failures that match the expected failures developed in the proof - of - concept implementation. Results indicate that the SAM implementation of PV - RPM provides the same results as the proof - of - concep t implementation, indicating the algorithms were reproduced successfully.« less

Invention and validation of an automated camera system that uses optical character recognition to identify patient name mislabeled samples.

PubMed

Hawker, Charles D; McCarthy, William; Cleveland, David; Messinger, Bonnie L

2014-03-01

Mislabeled samples are a serious problem in most clinical laboratories. Published error rates range from 0.39/1000 to as high as 1.12%. Standardization of bar codes and label formats has not yet achieved the needed improvement. The mislabel rate in our laboratory, although low compared with published rates, prompted us to seek a solution to achieve zero errors. To reduce or eliminate our mislabeled samples, we invented an automated device using 4 cameras to photograph the outside of a sample tube. The system uses optical character recognition (OCR) to look for discrepancies between the patient name in our laboratory information system (LIS) vs the patient name on the customer label. All discrepancies detected by the system's software then require human inspection. The system was installed on our automated track and validated with production samples. We obtained 1 009 830 images during the validation period, and every image was reviewed. OCR passed approximately 75% of the samples, and no mislabeled samples were passed. The 25% failed by the system included 121 samples actually mislabeled by patient name and 148 samples with spelling discrepancies between the patient name on the customer label and the patient name in our LIS. Only 71 of the 121 mislabeled samples detected by OCR were found through our normal quality assurance process. We have invented an automated camera system that uses OCR technology to identify potential mislabeled samples. We have validated this system using samples transported on our automated track. Full implementation of this technology offers the possibility of zero mislabeled samples in the preanalytic stage.

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.

Continued Development of Compact Multi-gas Monitor for Life Support Systems Control in Space

NASA Technical Reports Server (NTRS)

Delgado-Alonso, Jesús; Phillips, Straun; Chullen, Cinda; Quinn, Gregory

2016-01-01

Miniature optic gas sensors (MOGS) based on luminescent materials have shown great potential as alternatives to Near-Infrared-based gas sensor systems for the advanced space suit portable life support system (PLSS). The unique capability of MOGS for carbon dioxide and oxygen monitoring under wet conditions has been reported, as has the fast recovery of MOGS humidity sensors after long periods of being wet. Lower volume and power requirements are also potential advantages of MOGS over both traditional and advanced Non-Dispersive Infrared (NDIR) gas sensors, which have shown so far longer life than luminescent sensors. This paper presents the most recent results in the development and analytical validation of a compact multi-gas sensor unit based on luminescent sensors for the PLSS. Results of extensive testing are presented, including studies conducted at Intelligent Optical Systems laboratories, a United Technology Corporation Aerospace Systems (UTAS) laboratory, and a Johnson Space Center laboratory. The potential of this sensor technology for gas monitoring in PLSSs and other life support systems and the advantages and limitations found through detailed sensor validation are discussed.

Continued Development of Compact Multi-Gas Monitor for Life Support Systems Control in Space

NASA Technical Reports Server (NTRS)

Delgado, Jesus; Phillips, Straun; Chullen, Cinda

2015-01-01

Miniature optic gas sensors (MOGS) based on luminescent materials have shown great potential as alternatives to NIR-based gas sensor systems for the Portable Life Support System (PLSS). The unique capability of MOGS for carbon dioxide and oxygen monitoring under wet conditions has been reported, as has the fast recovery of MOGS humidity sensors after long periods of being wet. Lower volume and power requirements are also potential advantages of MOGS over both traditional and advanced Non-Dispersive Infrared (NDIR) gas sensors, which have shown so far longer life than luminescent sensors. In this paper we present the most recent results in the development and analytical validation of a compact multi-gas sensor unit based on luminescent sensors for the PLSS. Results of extensive testing are presented, including studies conducted at Intelligent Optical Systems laboratories, a United Technology Corporation Aerospace Systems (UTAS) laboratory, and a Johnson Space Center laboratory. The potential of this sensor technology for gas monitoring in PLSSs and other life support systems and the advantages and limitations found through detailed sensor validation are discussed.

Continued Development of Compact Multi-Gas Monitor for Life Support Systems Control in Space

NASA Technical Reports Server (NTRS)

Delgado-Alonso, Jesus; Phillips, Straun; Berry, David; DiCarmine, Paul; Chullen, Cinda; Quinn, Gregory

2016-01-01

Miniature optical gas sensors based on luminescent materials have shown great potential as alternatives to NIR-based gas sensor systems for the Portable Life Support System (PLSS). The unique capability of luminescent sensors for carbon dioxide and oxygen monitoring under wet conditions has been reported, as has the fast recovery of humidity sensors after long periods of being wet. Lower volume and power requirements are also potential advantages over both traditional and advanced non-dispersive infrared (NDIR) gas sensors, which have so far shown longer life than luminescent sensors. In this paper we present the most recent results in the development and analytical validation of a compact multi-gas sensor unit based on luminescent sensors for the PLSS. Results of extensive testing are presented, including studies conducted in Intelligent Optical Systems laboratories, a United Technologies Corporation Aerospace Systems (UTC) laboratory, and a Johnson Space Center laboratory. The potential of this sensor technology for gas monitoring in PLSSs and other life support systems, and the advantages and limitations found through detailed sensor validation are discussed.

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 more efficient extraction and quantification technology, an increase in the number of evidence samples tested using robotic/DNA IQ magnetic bead DNA extraction, a decrease in the number of negative samples amplified due to qPCR and implementation of a single multiplex amplification system. In addition, initial studies show the microcapillary array electrophoresis device (microCAE) evaluation results provide greater sensitivity and faster STR analysis output than current platforms.

Validating the Equilibrium Stage Model for an Azeotropic System in a Laboratorial Distillation Column

ERIC Educational Resources Information Center

Duarte, B. P. M.; Coelho Pinheiro, M. N.; Silva, D. C. M.; Moura, M. J.

2006-01-01

The experiment described is an excellent opportunity to apply theoretical concepts of distillation, thermodynamics of mixtures and process simulation at laboratory scale, and simultaneously enhance the ability of students to operate, control and monitor complex units.

System for Informatics in the Molecular Pathology Laboratory: An Open-Source End-to-End Solution for Next-Generation Sequencing Clinical Data Management.

PubMed

Kang, Wenjun; Kadri, Sabah; Puranik, Rutika; Wurst, Michelle N; Patil, Sushant A; Mujacic, Ibro; Benhamed, Sonia; Niu, Nifang; Zhen, Chao Jie; Ameti, Bekim; Long, Bradley C; Galbo, Filipo; Montes, David; Iracheta, Crystal; Gamboa, Venessa L; Lopez, Daisy; Yourshaw, Michael; Lawrence, Carolyn A; Aisner, Dara L; Fitzpatrick, Carrie; McNerney, Megan E; Wang, Y Lynn; Andrade, Jorge; Volchenboum, Samuel L; Furtado, Larissa V; Ritterhouse, Lauren L; Segal, Jeremy P

2018-04-24

Next-generation sequencing (NGS) diagnostic assays increasingly are becoming the standard of care in oncology practice. As the scale of an NGS laboratory grows, management of these assays requires organizing large amounts of information, including patient data, laboratory processes, genomic data, as well as variant interpretation and reporting. Although several Laboratory Information Systems and/or Laboratory Information Management Systems are commercially available, they may not meet all of the needs of a given laboratory, in addition to being frequently cost-prohibitive. Herein, we present the System for Informatics in the Molecular Pathology Laboratory, a free and open-source Laboratory Information System/Laboratory Information Management System for academic and nonprofit molecular pathology NGS laboratories, developed at the Genomic and Molecular Pathology Division at the University of Chicago Medicine. The System for Informatics in the Molecular Pathology Laboratory was designed as a modular end-to-end information system to handle all stages of the NGS laboratory workload from test order to reporting. We describe the features of the system, its clinical validation at the Genomic and Molecular Pathology Division at the University of Chicago Medicine, and its installation and testing within a different academic center laboratory (University of Colorado), and we propose a platform for future community co-development and interlaboratory data sharing. Copyright © 2018. Published by Elsevier Inc.

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

NREL Spectrum of Innovation

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

None

2011-02-25

There are many voices calling for a future of abundant clean energy. The choices are difficult and the challenges daunting. How will we get there? The National Renewable Energy Laboratory integrates the entire spectrum of innovation including fundamental science, market relevant research, systems integration, testing and validation, commercialization and deployment. The innovation process at NREL is interdependent and iterative. Many scientific breakthroughs begin in our own laboratories, but new ideas and technologies come to NREL at any point along the innovation spectrum to be validated and refined for commercial use.

NREL Spectrum of Innovation

ScienceCinema

None

2018-05-11

There are many voices calling for a future of abundant clean energy. The choices are difficult and the challenges daunting. How will we get there? The National Renewable Energy Laboratory integrates the entire spectrum of innovation including fundamental science, market relevant research, systems integration, testing and validation, commercialization and deployment. The innovation process at NREL is interdependent and iterative. Many scientific breakthroughs begin in our own laboratories, but new ideas and technologies come to NREL at any point along the innovation spectrum to be validated and refined for commercial use.

Development of Servo Motor Trainer for Basic Control System in Laboratory of Electrical Engineering Control System Faculty of Engineering Universitas Negeri Surabaya

NASA Astrophysics Data System (ADS)

Endryansyah; Wanarti Rusimamto, Puput; Ridianto, Adam; Sugiarto, Hariyadi

2018-04-01

In the Department of Electrical Engineering FT Unesa, there are 3 majors: S1 Electrical Engineering Education, S1 Electrical Engineering, and D3 Electrical Engineering. Courses the Basic System Settings go to in the curriculum of the three programs. Team lecturer college of basic system settings seek learning innovation, focused on the development of trainer to student practicum at the laboratory of systems control. Trainer developed is a servo motor along with the lab module that contains a wide variety of theories about the servo motor and guide the practicum. This research type is development research using methods Research & development (R & D). In which the steps are applied in this study is as follows: pay attention to the potential and existing problems, gather information and study the literature, design the product, validate the design, revise the design, a limited trial. The results of the validation of learning device in the form of modules and trainer obtained as follows: score validation of learning device is 3,64; score validation lab module Servo Motor is 3,47; and questionnaire responses of students is 3,73. The result of the whole validation value is located in the interval >of 3.25 s/d 4 with the category of “Very Valid”, so it can be concluded that all instruments have a level of validity “Very Valid” and worthy of use for further learning.

Pulverized solid injection system. Application to laboratory burners and pyrometric temperature measurements

NASA Astrophysics Data System (ADS)

Therssen, E.; Delfosse, L.

1995-08-01

The design and setting up of a pulverized solid injection system for use in laboratory burners is presented. The original dual system consists of a screw feeder coupled to an acoustic sower. This laboratory device allows a good regularity and stability of the particle-gas mixture transported to the burner in a large scale of mass powder and gas vector rate flow. The thermal history of the particles has been followed by optical measurements. The quality of the particle cloud injected in the burner has been validated by the good agreement between experimental and modeling particle temperature.

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...

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...

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...

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...

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...

Overview of a Proposed Flight Validation of Aerocapture System Technology for Planetary Missions

NASA Technical Reports Server (NTRS)

Keys, Andrew S.; Hall, Jeffery L.; Oh, David; Munk, Michelle M.

2006-01-01

Aerocapture System Technology for Planetary Missions is being proposed to NASA's New Millennium Program for flight aboard the Space Technology 9 (ST9) flight opportunity. The proposed ST9 aerocapture mission is a system-level flight validation of the aerocapture maneuver as performed by an instrumented, high-fidelity flight vehicle within a true in-space and atmospheric environment. Successful validation of the aerocapture maneuver will be enabled through the flight validation of an advanced guidance, navigation, and control system as developed by Ball Aerospace and two advanced Thermal Protection System (TPS) materials, Silicon Refined Ablative Material-20 (SRAM-20) and SRAM-14, as developed by Applied Research Associates (ARA) Ablatives Laboratory. The ST9 aerocapture flight validation will be sufficient for immediate infusion of these technologies into NASA science missions being proposed for flight to a variety of Solar System destinations possessing a significant planetary atmosphere.

NREL Spectrum of Clean Energy Innovation (Brochure)

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

Not Available

2011-09-01

This brochure describes the NREL Spectrum of Clean Energy Innovation, which includes analysis and decision support, fundamental science, market relevant research, systems integration, testing and validation, commercialization and deployment. Through deep technical expertise and an unmatched breadth of capabilities, the National Renewable Energy Laboratory (NREL) leads an integrated approach across the spectrum of renewable energy innovation. From scientific discovery to accelerating market deployment, NREL works in partnership with private industry to drive the transformation of our nation's energy systems. NREL integrates the entire spectrum of innovation, including fundamental science, market relevant research, systems integration, testing and validation, commercialization, and deployment.more » Our world-class analysis and decision support informs every point on the spectrum. The innovation process at NREL is inter-dependent and iterative. Many scientific breakthroughs begin in our own laboratories, but new ideas and technologies may come to NREL at any point along the innovation spectrum to be validated and refined for commercial use.« less

US DOE Regional Test Centers Program - 2016 Annual Report.

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

Stein, Joshua

The US Department of Energy’s Regional Test Center (RTC) program provides outdoor validation and bankability data for innovative solar technologies at five sites across the US representing a range of climate conditions. Data helps get new technologies to market faster and improves US industry competitiveness. Managed by Sandia National Laboratories and the National Renewable Energy Laboratory (NREL), the RTC program partners with US manufacturers of photovoltaic (PV) technologies, including modules, inverters, and balance-of-system equipment. The study is collaborative, with manufacturers (also known as RTC industry partners) and the national labs working together on a system design and validation strategy thatmore » meets a clearly defined set of performance and reliability objectives.« less

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 the forensic DNA typing laboratory or with proper training in decentralized environments by non-laboratory personnel. Copyright © 2017 Elsevier B.V. All rights reserved.

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...

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...

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...

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...

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...

BioMICADAS: Compact next generation AMS system for pharmaceutical science

NASA Astrophysics Data System (ADS)

Schulze-König, Tim; Dueker, Stephen R.; Giacomo, Jason; Suter, Martin; Vogel, John S.; Synal, Hans-Arno

2010-04-01

The next generation Accelerator Mass Spectrometer system specifically designed to address the needs of the growing pharmaceutical science market has passed validation testing. The system dubbed BioMICADAS is based on a previously developed compact carbon dating instrument, the MICADAS. Like its predecessor, it has an overall footprint of only 2.5 × 3 m 2 and uses a 200 kV high voltage platform for tandem based ion acceleration. The ion source can accommodate samples as graphite or gaseous CO 2. It is equipped with two independently operating vacuum locks, allowing continuous measurement sequence and providing a capacity of ˜20,000 samples per annum. A barcoded cathode tracking system allows data capture into Laboratory Information Management System (LIMS) for Good Laboratory Practices (GLP) regulated work. It can be housed in research laboratories alongside other complementary bioanalytical equipment and operated by general laboratory staff as the system is designed to be robust and user-friendly. The system has undergone rigorous validation over the range from 0.1 to 100 Modern Carbon, including accuracy, linearity, robustness, and precision experiments over the course of 7 months. It has been shipped and installed at the site of our collaborative partner, Vitalea Science in Davis, California. The installation process took ˜2 weeks from boxes to beam. The feasibility of the system to determine the absolute specific activity of biogenic samples was also shown by using the method of isotopic dilution.

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.

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.

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

Crystallization of aluminum hydroxide in the aluminum-air battery: Literature review, crystallizer design and results of integrated system tests

NASA Astrophysics Data System (ADS)

Maimoni, A.

1988-03-01

The literature on aluminum trihydroxide crystallization is reviewed and the implications of crystallization on the design and performance of the aluminum-air battery are illustrated. Results of research on hydrargillite crystallization under battery operating conditions at Alcoa Laboratories, Alcan Kingston Laboratories, and Lawrence Livermore National Laboratory are summarized and are applied to the design of an electrolyte management system using lamella settlers for clarification of the electrolyte and product separation. The design principles were validated in a series of experiments that, for the first time in the aluminum-air program, demonstrated continuous operation of an integrated system consisting of cells, crystallizer, and a product-removal system.

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

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.

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.

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

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...

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...

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...

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...

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...

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…

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

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.

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.

Preliminary Validation of Composite Material Constitutive Characterization

Treesearch

John G. Michopoulos; Athanasios lliopoulos; John C. Hermanson; Adrian C. Orifici; Rodney S. Thomson

2012-01-01

This paper is describing the preliminary results of an effort to validate a methodology developed for composite material constitutive characterization. This methodology involves using massive amounts of data produced from multiaxially tested coupons via a 6-DoF robotic system called NRL66.3 developed at the Naval Research Laboratory. The testing is followed by...

Breaking Out of the Lab: Measuring Real-Time Responses to Televised Political Content in Real-World Settings.

PubMed

Maier, Jürgen; Hampe, J Felix; Jahn, Nico

2016-01-01

Real-time response (RTR) measurement is an important technique for analyzing human processing of electronic media stimuli. Although it has been demonstrated that RTR data are reliable and internally valid, some argue that they lack external validity. The reason for this is that RTR measurement is restricted to a laboratory environment due to its technical requirements. This paper introduces a smartphone app that 1) captures real-time responses using the dial technique and 2) provides a solution for one of the most important problems in RTR measurement, the (automatic) synchronization of RTR data. In addition, it explores the reliability and validity of mobile RTR measurement by comparing the real-time reactions of two samples of young and well-educated voters to the 2013 German televised debate. Whereas the first sample participated in a classical laboratory study, the second sample was equipped with our mobile RTR system and watched the debate at home. Results indicate that the mobile RTR system yields similar results to the lab-based RTR measurement, providing evidence that laboratory studies using RTR are externally valid. In particular, the argument that the artificial reception situation creates artificial results has to be questioned. In addition, we conclude that RTR measurement outside the lab is possible. Hence, mobile RTR opens the door for large-scale studies to better understand the processing and impact of electronic media content.

Breaking Out of the Lab

PubMed Central

Maier, Jürgen; Hampe, J. Felix; Jahn, Nico

2016-01-01

Real-time response (RTR) measurement is an important technique for analyzing human processing of electronic media stimuli. Although it has been demonstrated that RTR data are reliable and internally valid, some argue that they lack external validity. The reason for this is that RTR measurement is restricted to a laboratory environment due to its technical requirements. This paper introduces a smartphone app that 1) captures real-time responses using the dial technique and 2) provides a solution for one of the most important problems in RTR measurement, the (automatic) synchronization of RTR data. In addition, it explores the reliability and validity of mobile RTR measurement by comparing the real-time reactions of two samples of young and well-educated voters to the 2013 German televised debate. Whereas the first sample participated in a classical laboratory study, the second sample was equipped with our mobile RTR system and watched the debate at home. Results indicate that the mobile RTR system yields similar results to the lab-based RTR measurement, providing evidence that laboratory studies using RTR are externally valid. In particular, the argument that the artificial reception situation creates artificial results has to be questioned. In addition, we conclude that RTR measurement outside the lab is possible. Hence, mobile RTR opens the door for large-scale studies to better understand the processing and impact of electronic media content. PMID:27274577

Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

PubMed

Fulga, Netta

2013-06-01

Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

The laboratory demonstration and signal processing of the inverse synthetic aperture imaging ladar

NASA Astrophysics Data System (ADS)

Gao, Si; Zhang, ZengHui; Xu, XianWen; Yu, WenXian

2017-10-01

This paper presents a coherent inverse synthetic-aperture imaging ladar(ISAL)system to obtain high resolution images. A balanced coherent optics system in laboratory is built with binary phase coded modulation transmit waveform which is different from conventional chirp. A whole digital signal processing solution is proposed including both quality phase gradient autofocus(QPGA) algorithm and cubic phase function(CPF) algorithm. Some high-resolution well-focused ISAL images of retro-reflecting targets are shown to validate the concepts. It is shown that high resolution images can be achieved and the influences from vibrations of platform involving targets and radar can be automatically compensated by the distinctive laboratory system and digital signal process.

Validation of the criteria for initiating the cleaning of heating, ventilation, and air-conditioning (HVAC) ductwork under real conditions.

PubMed

Lavoie, Jacques; Marchand, Geneviève; Cloutier, Yves; Lavoué, Jérôme

2011-08-01

Dust accumulation in the components of heating, ventilation, and air-conditioning (HVAC) systems is a potential source of contaminants. To date, very little information is available on recognized methods for assessing dust buildup in these systems. The few existing methods are either objective in nature, involving numerical values, or subjective in nature, based on experts' judgments. An earlier project aimed at assessing different methods of sampling dust in ducts was carried out in the laboratories of the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST). This laboratory study showed that all the sampling methods were practicable, provided that a specific surface-dust cleaning initiation criterion was used for each method. However, these conclusions were reached on the basis of ideal conditions in a laboratory using a reference dust. The objective of this present study was to validate these laboratory results in the field. To this end, the laboratory sampling templates were replicated in real ducts and the three sampling methods (the IRSST method, the method of the U.S. organization National Air Duct Cleaner Association [NADCA] and that of the French organization Association pour la Prévention et l'Étude de la Contamination [ASPEC]) were used simultaneously in a statistically representative number of systems. The air return and supply ducts were also compared. Cleaning initiation criteria under real conditions were found to be 6.0 mg/100 cm(2) using the IRSST method, 2.0 mg/100 cm(2) using the NADCA method, and 23 mg/100 cm(2) using the ASPEC method. In the laboratory study, the criteria using the same methods were 6.0 for the IRSST method, 2.0 for the NADCA method, and 3.0 for the ASPEC method. The laboratory criteria for the IRSST and NADCA methods were therefore validated in the field. The ASPEC criterion was the only one to change. The ASPEC method therefore allows for the most accurate evaluation of dust accumulation in HVAC ductwork. We therefore recommend using the latter method to objectively assess dust accumulation levels in HVAC ductwork.

Program Description: EDIT Program and Vendor Master Update, SWRL Financial System.

ERIC Educational Resources Information Center

Ikeda, Masumi

Computer routines to edit input data for the Southwest Regional Laboratory's (SWRL) Financial System are described. The program is responsible for validating input records, generating records for further system processing, and updating the Vendor Master File--a file containing the information necessary to support the accounts payable and…

Student-Centered Reliability, Concurrent Validity and Instructional Sensitivity in Scoring of Students' Concept Maps in a University Science Laboratory

ERIC Educational Resources Information Center

Kaya, Osman Nafiz; Kilic, Ziya

2004-01-01

Student-centered approach of scoring the concept maps consisted of three elements namely symbol system, individual portfolio and scoring scheme. We scored student-constructed concept maps based on 5 concept map criteria: validity of concepts, adequacy of propositions, significance of cross-links, relevancy of examples, and interconnectedness. With…

ENFIN--A European network for integrative systems biology.

PubMed

Kahlem, Pascal; Clegg, Andrew; Reisinger, Florian; Xenarios, Ioannis; Hermjakob, Henning; Orengo, Christine; Birney, Ewan

2009-11-01

Integration of biological data of various types and the development of adapted bioinformatics tools represent critical objectives to enable research at the systems level. The European Network of Excellence ENFIN is engaged in developing an adapted infrastructure to connect databases, and platforms to enable both the generation of new bioinformatics tools and the experimental validation of computational predictions. With the aim of bridging the gap existing between standard wet laboratories and bioinformatics, the ENFIN Network runs integrative research projects to bring the latest computational techniques to bear directly on questions dedicated to systems biology in the wet laboratory environment. The Network maintains internally close collaboration between experimental and computational research, enabling a permanent cycling of experimental validation and improvement of computational prediction methods. The computational work includes the development of a database infrastructure (EnCORE), bioinformatics analysis methods and a novel platform for protein function analysis FuncNet.

Verification and Validation of NASA-Supported Enhancements to the Near Real Time Harmful Algal Blooms Observing System (HABSOS)

NASA Technical Reports Server (NTRS)

Spruce, Joseph P.; Hall, Calllie; McPherson, Terry; Spiering, Bruce; Brown, Richard; Estep, Lee; Lunde, Bruce; Guest, DeNeice; Navard, Andy; Pagnutti, Mary;

TARDEC’s Victory Systems Integration Laboratory (SIL) is a Key Tool for Advancing Standardized Ground Vehicle Electronic Architecture

DTIC Science & Technology

2012-08-01

The first phase consisted of Shared Services , Threat Detection and Reporting, and the Remote Weapon Station (RWS) build up and validation. The...Awareness build up and validation. The first phase consisted of the development of the shared services or core services that are required by many...C4ISR/EW systems. The shared services include: time synchronization, position, direction of travel, and orientation. Time synchronization is

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.

[On the way to national reference system of laboratory medicine].

PubMed

Muravskaia, N P; Men'shikov, V V

2014-10-01

The application of standard samples and reference techniques of implementation of measurements is needed for a valid support of reliability of analyses applied in clinical diagnostic laboratories. They play role of landmarks under metrologic monitoring, calibration of devices and control of quality of results. The article presents analysis of shortcomings interfering with formation of national reference system in Russia harmonized with possibilities provided by international organizations. Among them are the joint Committee on metrologic monitoring in laboratory medicine under the auspices of the International Bureau of Weights and Measures, the International Federation of clinical chemistry and laboratory medicine, etc. The results of the recent development of national normative documents, standard samples and techniques assisted by the authors of article are considered. They are the first steps to organization of national reference system which would comprise all range of modern analytical technologies of laboratory medicine. The national and international measures are proposed to enhance the promptest resolving of task of organization of national reference system for laboratory medicine in the interests of increasing of effectiveness of medical care to citizen of Russia.

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.

A longitudinal evaluation of performance of automated BCR-ABL1 quantitation using cartridge-based detection system.

PubMed

Enjeti, Anoop; Granter, Neil; Ashraf, Asma; Fletcher, Linda; Branford, Susan; Rowlings, Philip; Dooley, Susan

2015-10-01

An automated cartridge-based detection system (GeneXpert; Cepheid) is being widely adopted in low throughput laboratories for monitoring BCR-ABL1 transcript in chronic myelogenous leukaemia. This Australian study evaluated the longitudinal performance specific characteristics of the automated system.The automated cartridge-based system was compared prospectively with the manual qRT-PCR-based reference method at SA Pathology, Adelaide, over a period of 2.5 years. A conversion factor determination was followed by four re-validations. Peripheral blood samples (n = 129) with international scale (IS) values within detectable range were selected for assessment. The mean bias, proportion of results within specified fold difference (2-, 3- and 5-fold), the concordance rate of major molecular remission (MMR) and concordance across a range of IS values on paired samples were evaluated.The initial conversion factor for the automated system was determined as 0.43. Except for the second re-validation, where a negative bias of 1.9-fold was detected, all other biases fell within desirable limits. A cartridge-specific conversion factor and efficiency value was introduced and the conversion factor was confirmed to be stable in subsequent re-validation cycles. Concordance with the reference method/laboratory at >0.1-≤10 IS was 78.2% and at ≤0.001 was 80%, compared to 86.8% in the >0.01-≤0.1 IS range. The overall and MMR concordance were 85.7% and 94% respectively, for samples that fell within ± 5-fold of the reference laboratory value over the entire period of study.Conversion factor and performance specific characteristics for the automated system were longitudinally stable in the clinically relevant range, following introduction by the manufacturer of lot specific efficiency values.

Concurrent Validity of a Portable Force Plate Using Vertical Jump Force-Time Characteristics.

PubMed

Lake, Jason; Mundy, Peter; Comfort, Paul; McMahon, John J; Suchomel, Timothy J; Carden, Patrick

2018-05-29

This study examined concurrent validity of countermovement vertical jump (CMJ) reactive strength index modified and force-time characteristics recorded using a one dimensional portable and laboratory force plate system. Twenty-eight men performed bilateral CMJs on two portable force plates placed on top of two in-ground force plates, both recording vertical ground reaction force at 1000 Hz. Time to take-off, jump height, reactive strength index modified, braking and propulsion impulse, mean net force, and duration were calculated from the vertical force from both force plate systems. Results from both systems were highly correlated (r≥.99). There were small (d<.12) but significant differences between their respective braking impulse, braking mean net force, propulsion impulse, and propulsion mean net force (p<.001). However, limits of agreement yielded a mean value of 1.7% relative to the laboratory force plate system (95% CL: .9% to 2.5%), indicating very good agreement across all of the dependent variables. The largest limits of agreement belonged to jump height (2.1%), time to take-off (3.4%), and reactive strength index modified (3.8%). The portable force plate system provides a valid method of obtaining reactive strength measures, and several underpinning force-time variables, from unloaded CMJ and practitioners can use both force plates interchangeably.

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.

The comparative immunology of wild and laboratory mice, Mus musculus domesticus

PubMed Central

Abolins, Stephen; King, Elizabeth C.; Lazarou, Luke; Weldon, Laura; Hughes, Louise; Drescher, Paul; Raynes, John G.; Hafalla, Julius C. R.; Viney, Mark E.; Riley, Eleanor M.

2017-01-01

The laboratory mouse is the workhorse of immunology, used as a model of mammalian immune function, but how well immune responses of laboratory mice reflect those of free-living animals is unknown. Here we comprehensively characterize serological, cellular and functional immune parameters of wild mice and compare them with laboratory mice, finding that wild mouse cellular immune systems are, comparatively, in a highly activated (primed) state. Associations between immune parameters and infection suggest that high level pathogen exposure drives this activation. Moreover, wild mice have a population of highly activated myeloid cells not present in laboratory mice. By contrast, in vitro cytokine responses to pathogen-associated ligands are generally lower in cells from wild mice, probably reflecting the importance of maintaining immune homeostasis in the face of intense antigenic challenge in the wild. These data provide a comprehensive basis for validating (or not) laboratory mice as a useful and relevant immunological model system. PMID:28466840

Performance model for grid-connected photovoltaic inverters.

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

Boyson, William Earl; Galbraith, Gary M.; King, David L.

2007-09-01

This document provides an empirically based performance model for grid-connected photovoltaic inverters used for system performance (energy) modeling and for continuous monitoring of inverter performance during system operation. The versatility and accuracy of the model were validated for a variety of both residential and commercial size inverters. Default parameters for the model can be obtained from manufacturers specification sheets, and the accuracy of the model can be further refined using measurements from either well-instrumented field measurements in operational systems or using detailed measurements from a recognized testing laboratory. An initial database of inverter performance parameters was developed based on measurementsmore » conducted at Sandia National Laboratories and at laboratories supporting the solar programs of the California Energy Commission.« less

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.

On Selecting Commercial Information Systems

PubMed Central

Möhr, J.R.; Sawinski, R.; Kluge, A.; Alle, W.

1984-01-01

As more commercial information systems become available, the methodology for their selection gains importance. An instances where the method employed for the selection of laboratory information systems was multilevel assessment. The method is described and the experience gained in the project is summarized and discussed. Evidence is provided that the employed method is comprehensive, reproducible, valid and economic.

A Hardware Platform for Characterizing and Validating 1-Dimensional Optical Systems

DTIC Science & Technology

2014-09-01

principle laboratory experiments, a bread -board sensor and data collection system was created to gather fuze data to postprocess after the event...merely differentiates this bistable memory category from dynamic random access memory [RAM], which must be periodically refreshed to retain data.) A

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

LLE 2008 annual report, October 2007 - September 2008

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

None

2009-01-31

The research program at the University of Rochester’s Laboratory for Laser Energetics (LLE) focuses on inertial confinement fusion (ICF) research supporting the goal of achieving ignition on the National Ignition Facility (NIF). This program includes the full use of the OMEGA EP Laser System. Within the National Ignition Campaign (NIC), LLE is the lead laboratory for the validation of the performance of cryogenic target implosions, essential to all forms of ICF ignition. LLE has taken responsibility for a number of critical elements within the Integrated Experimental Teams (IET’s) supporting the demonstration of indirect-drive ignition on the NIF and is themore » lead laboratory for the validation of the polardrive approach to ignition on the NIF. LLE is also developing, testing, and building a number of diagnostics to be deployed on the NIF for the NIC.« less

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.

Further Development and Validation of the frog Embryo Teratogenesis Assay - Xenopus (FETAX)

DTIC Science & Technology

1991-02-28

abnormalities.39 40 The teratogenic effects of serotonin in the laboratory rat include anophthalmia , hydrocephalus, exencephaly, omphalocoele and vacuolization...kinky tail. ZnSO4 in Xenopus, should be tested in parallel with hemangioma. anophthalmia and scoliosis). Skeletal a metabolic activation system to show...teratogenic effects of 0 serotonin in the laboratory rat include anophthalmia , hydrocephalus, exencephaly, omphalocele and vacuolization of myocardial cells.41

An Annotated Bibliography of Literature Integrating Organizational and Systems Theory

DTIC Science & Technology

1985-09-01

believed to be representative of current thinking on the problem as it is defined in this particular effort. 4. Abstracting For abstracting purposes...individual concept or isolated case which defies mathematical description or classical empirical validation) or nomothetic (pertaining to the abstract ...and to induce change in organizations - laboratory training. Laboratory training is a method used to promote changes in the learning process itself

Performance Evaluation of State of the Art Systems for Physical Activity Classification of Older Subjects Using Inertial Sensors in a Real Life Scenario: A Benchmark Study

PubMed Central

Awais, Muhammad; Palmerini, Luca; Bourke, Alan K.; Ihlen, Espen A. F.; Helbostad, Jorunn L.; Chiari, Lorenzo

2016-01-01

The popularity of using wearable inertial sensors for physical activity classification has dramatically increased in the last decade due to their versatility, low form factor, and low power requirements. Consequently, various systems have been developed to automatically classify daily life activities. However, the scope and implementation of such systems is limited to laboratory-based investigations. Furthermore, these systems are not directly comparable, due to the large diversity in their design (e.g., number of sensors, placement of sensors, data collection environments, data processing techniques, features set, classifiers, cross-validation methods). Hence, the aim of this study is to propose a fair and unbiased benchmark for the field-based validation of three existing systems, highlighting the gap between laboratory and real-life conditions. For this purpose, three representative state-of-the-art systems are chosen and implemented to classify the physical activities of twenty older subjects (76.4 ± 5.6 years). The performance in classifying four basic activities of daily life (sitting, standing, walking, and lying) is analyzed in controlled and free living conditions. To observe the performance of laboratory-based systems in field-based conditions, we trained the activity classification systems using data recorded in a laboratory environment and tested them in real-life conditions in the field. The findings show that the performance of all systems trained with data in the laboratory setting highly deteriorates when tested in real-life conditions, thus highlighting the need to train and test the classification systems in the real-life setting. Moreover, we tested the sensitivity of chosen systems to window size (from 1 s to 10 s) suggesting that overall accuracy decreases with increasing window size. Finally, to evaluate the impact of the number of sensors on the performance, chosen systems are modified considering only the sensing unit worn at the lower back. The results, similarly to the multi-sensor setup, indicate substantial degradation of the performance when laboratory-trained systems are tested in the real-life setting. This degradation is higher than in the multi-sensor setup. Still, the performance provided by the single-sensor approach, when trained and tested with real data, can be acceptable (with an accuracy above 80%). PMID:27973434

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

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.

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...

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...

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...

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...

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...

Brunn: an open source laboratory information system for microplates with a graphical plate layout design process.

PubMed

Alvarsson, Jonathan; Andersson, Claes; Spjuth, Ola; Larsson, Rolf; Wikberg, Jarl E S

2011-05-20

Compound profiling and drug screening generates large amounts of data and is generally based on microplate assays. Current information systems used for handling this are mainly commercial, closed source, expensive, and heavyweight and there is a need for a flexible lightweight open system for handling plate design, and validation and preparation of data. A Bioclipse plugin consisting of a client part and a relational database was constructed. A multiple-step plate layout point-and-click interface was implemented inside Bioclipse. The system contains a data validation step, where outliers can be removed, and finally a plate report with all relevant calculated data, including dose-response curves. Brunn is capable of handling the data from microplate assays. It can create dose-response curves and calculate IC50 values. Using a system of this sort facilitates work in the laboratory. Being able to reuse already constructed plates and plate layouts by starting out from an earlier step in the plate layout design process saves time and cuts down on error sources.

Manpower Requirements Report for FY (Fiscal Year) 1984.

DTIC Science & Technology

1983-02-01

capability to detect cannabis brings to seven the number of drugs detectable through urinaly- sis in the DoD system. While the detection and deterrence of... toxicology . The primary purpose of these con- ferences was validation of Legal sufficiency of the DoD laboratory system by the scientific community

Laboratory and numerical investigations of kinetic interface sensitive tracers transport for immiscible two-phase flow porous media systems

NASA Astrophysics Data System (ADS)

Tatomir, Alexandru Bogdan A. C.; Sauter, Martin

2017-04-01

A number of theoretical approaches estimating the interfacial area between two fluid phases are available (Schaffer et al.,2013). Kinetic interface sensitive (KIS) tracers are used to describe the evolution of fluid-fluid interfaces advancing in two phase porous media systems (Tatomir et al., 2015). Initially developed to offer answers about the supercritical (sc)CO2 plume movement and the efficiency of trapping in geological carbon storage reservoirs, KIS tracers are tested in dynamic controlled laboratory conditions. N-octane and water, analogue to a scCO2 - brine system, are used. The KIS tracer is dissolved in n-octane, which is injected as the non-wetting phase in a fully water saturated porous media column. The porous system is made up of spherical glass beads with sizes of 100-250 μm. Subsequently, the KIS tracer follows a hydrolysis reaction over the n-octane - water interface resulting in an acid and phenol which are both water soluble. The fluid-fluid interfacial area is described numerically with the help of constitutive-relationships derived from the Brooks-Corey model. The specific interfacial area is determined numerically from pore scale calculations, or from different literature sources making use of pore network model calculations (Joekar-Niasar et al., 2008). This research describes the design of the laboratory setup and compares the break-through curves obtained with the forward model and in the laboratory experiment. Furthermore, first results are shown in the attempt to validate the immiscible two phase flow reactive transport numerical model with dynamic laboratory column experiments. Keywords: Fluid-fluid interfacial area, KIS tracers, model validation, CCS, geological storage of CO2

Initial design and performance of the near surface unmanned aircraft system sensor suite in support of the GOES-R field campaign

NASA Astrophysics Data System (ADS)

Pearlman, Aaron J.; Padula, Francis; Shao, Xi; Cao, Changyong; Goodman, Steven J.

2016-09-01

One of the main objectives of the Geostationary Operational Environmental Satellite R-Series (GOES-R) field campaign is to validate the SI traceability of the Advanced Baseline Imager. The campaign plans include a feasibility demonstration study for new near surface unmanned aircraft system (UAS) measurement capability that is being developed to meet the challenges of validating geostationary sensors. We report our progress in developing our initial systems by presenting the design and preliminary characterization results of the sensor suite. The design takes advantage of off-the-shelf technologies and fiber-based optical components to make hemispheric directional measurements from a UAS. The characterization results - including laboratory measurements of temperature effects and polarization sensitivity - are used to refine the radiometric uncertainty budget towards meeting the validation objectives for the campaign. These systems will foster improved validation capabilities for the GOES-R field campaign and other next generation satellite systems.

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.

Geometric Calibration and Validation of Ultracam Aerial Sensors

NASA Astrophysics Data System (ADS)

Gruber, Michael; Schachinger, Bernhard; Muick, Marc; Neuner, Christian; Tschemmernegg, Helfried

2016-03-01

We present details of the calibration and validation procedure of UltraCam Aerial Camera systems. Results from the laboratory calibration and from validation flights are presented for both, the large format nadir cameras and the oblique cameras as well. Thus in this contribution we show results from the UltraCam Eagle and the UltraCam Falcon, both nadir mapping cameras, and the UltraCam Osprey, our oblique camera system. This sensor offers a mapping grade nadir component together with the four oblique camera heads. The geometric processing after the flight mission is being covered by the UltraMap software product. Thus we present details about the workflow as well. The first part consists of the initial post-processing which combines image information as well as camera parameters derived from the laboratory calibration. The second part, the traditional automated aerial triangulation (AAT) is the step from single images to blocks and enables an additional optimization process. We also present some special features of our software, which are designed to better support the operator to analyze large blocks of aerial images and to judge the quality of the photogrammetric set-up.

Empirical and Face Validity of Software Maintenance Defect Models Used at the Jet Propulsion Laboratory

NASA Technical Reports Server (NTRS)

Taber, William; Port, Dan

2014-01-01

At the Mission Design and Navigation Software Group at the Jet Propulsion Laboratory we make use of finite exponential based defect models to aid in maintenance planning and management for our widely used critical systems. However a number of pragmatic issues arise when applying defect models for a post-release system in continuous use. These include: how to utilize information from problem reports rather than testing to drive defect discovery and removal effort, practical model calibration, and alignment of model assumptions with our environment.

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.

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.

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.

Consistency and Reproducibility of Bioaerosol Delivery for Infectivity Studies on Mice

DTIC Science & Technology

2010-03-01

respiration, the most common being the common laboratory rat (strains of Rattus norvegicus) and mouse ( Mus musculus ). Animal respiratory systems are...validation U U U UU 92 Joseph D. Wander Reset CONSISTENCY AND REPRODUCIBILITY OF BIOAEROSOL DELIVERY FOR INFECTIVITY STUDIES ON MICE...design and construction phase of the project. The data from this thesis appear as part of the US Air Force Research Laboratory technical report AFRL

[Building and implementation of management system in laboratories of the National Institute of Hygiene].

PubMed

Rozbicka, Beata; Brulińska-Ostrowska, Elzbieta

2008-01-01

The rules of good laboratory practice have always been observed in the laboratories of National Institute of Hygiene (NIH) and the reliability of the results has been carefully cared after when performing tests for clients. In 2003 the laboratories performing analyses related to food safety were designated as the national reference laboratories. This, added to the necessity of compliance with work standards and requirements of EU legislation and to the need of confirmation of competence by an independent organisation, led to a decision to seek accreditation of Polish Centre of Accreditation (PCA). The following stages of building and implementation of management system were presented: training, modifications of Institute's organisational structure, elaboration of management system's documentation, renovation and refurbishment of laboratory facilities, implementation of measuring and test equipment's supervision, internal audits and management review. The importance of earlier experiences and achievements with regard to validation of analytical methods and guarding of the quality of the results through organisation and participation in proficiency tests was highlighted. Current status of accreditation of testing procedures used in NIH laboratories that perform analyses in the field of chemistry, microbiology, radiobiology and medical diagnostic tests was presented.

77 FR 29757 - Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... Discharge Elimination System (NPDES) program, issue permits with conditions designed to ensure compliance... completion of a full inter-laboratory validation study designed to fully characterize the performance of...

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.

Enabling digital pathology in the diagnostic setting: navigating through the implementation journey in an academic medical centre.

PubMed

Cheng, Chee Leong; Azhar, Rafay; Sng, Shi Hui Adeline; Chua, Yong Quan; Hwang, Jacqueline Siok Gek; Chin, Jennifer Poi Fun; Seah, Waih Khuen; Loke, Janel Chui Ling; Ang, Roy Hang Leng; Tan, Puay Hoon

2016-09-01

As digital pathology (DP) and whole slide imaging (WSI) technology advance and mature, there is an increasing drive to incorporate DP into the diagnostic environment. However, integration of DP into the diagnostic laboratory is a non-trivial task and filled with unexpected challenges unlike standalone implementations. We share our journey of implementing DP in the diagnostic laboratory setting, highlighting seven key guiding principles that drive the progression through implementation into deployment and beyond. The DP implementation with laboratory information system integration was completed in 8 months, including validation of the solution for diagnostic use in accordance with College of American Pathologists guidelines. We also conducted prospective validation via paired delivery of glass slides and WSI to our pathologists postdeployment. Common themes in our guiding principles included emphasis on workflow and being comprehensive in the approach, looking beyond pathologist user champions and expanding into an extended project team involving laboratory technicians, clerical/data room staff and archival staff. Concordance between glass slides and WSI ranged from 93% to 100% among various applications on validation. We also provided equal opportunities for every pathologist throughout the department to be competent and confident with DP through prospective validation, with overall concordance of 96% compared with glass slides, allowing appreciation of the advantages and limitations of WSI, hence enabling the use of DP as a useful diagnostic modality. Smooth integration of DP into the diagnostic laboratory is possible with careful planning, discipline and a systematic approach adhering to our guiding principles. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Low-cost extrapolation method for maximal LTE radio base station exposure estimation: test and validation.

PubMed

Verloock, Leen; Joseph, Wout; Gati, Azeddine; Varsier, Nadège; Flach, Björn; Wiart, Joe; Martens, Luc

2013-06-01

An experimental validation of a low-cost method for extrapolation and estimation of the maximal electromagnetic-field exposure from long-term evolution (LTE) radio base station installations are presented. No knowledge on downlink band occupation or service characteristics is required for the low-cost method. The method is applicable in situ. It only requires a basic spectrum analyser with appropriate field probes without the need of expensive dedicated LTE decoders. The method is validated both in laboratory and in situ, for a single-input single-output antenna LTE system and a 2×2 multiple-input multiple-output system, with low deviations in comparison with signals measured using dedicated LTE decoders.

Development of a Pyramid Wave-front Sensor

NASA Astrophysics Data System (ADS)

El Hadi, Kacem; Vignaux, Mael; Fusco, Thierry

2013-12-01

Within the framework of the E-ELT studies, several laboratories are involved on some instruments: HARMONY with its ATLAS adaptive optics [AO] system, EAGLE or EPICS. Most of the AO systems will probably integrate one or several pyramidal wavefront sensors, PWFS (R. Ragazzoni [1]). The coupling in an AO loop and the control in laboratory (then on sky) of this type of sensor is fundamental for the continuation of the projects related to OA systems on the E-ELT. LAM (Laboratory of Astrophysics of Marseille) is involved in particular in the VLT-SPHERE, ATLAS, EPICS projects. For the last few years, our laboratory has been carrying out different R&D activities in AO instrumentation for ELTs. An experimental AO bench is designed and being developed to allow the validation of new wave-front sensing and control concepts [2]. One the objectives of this bench, is the experimental validation of a pyramid WFS. Theoretical investigations on its behavior have been already made. The world's fastest and most sensitive camera system (OCAM2) has been recently developed at LAM (J.L Gach [3], First Light Imaging). Conjugating this advantage with the pyramid concept, we plan to demonstrate a home made Pyramid sensor for Adaptive Optics whose the speed and the precision are the key points. As a joint collaboration with ONERA and Shaktiware, our work aims at the optimization (measurement process, calibration and operation) in laboratory then on the sky of a pyramid sensor dedicated to the first generation instruments for ELTs. The sensor will be implemented on the ONERA ODISSEE AO bench combining thus a pyramid and a Shack-Hartmann wavefront sensors. What would give the possibility to compare strictly these two WFS types and make this bench unique in France and even in Europe. Experimental work on laboratory demonstration is undergoing. The status of our development will presented at the conference.

[The balanced scorecard used as a management tool in a clinical laboratory: internal business processes indicators].

PubMed

Salinas La Casta, Maria; Flores Pardo, Emilio; Uris Selles, Joaquín

2009-01-01

to propose a set of indicators as a management tool for a clinical laboratory, by using the balanced scorecard internal business processes perspective. indicators proposed are obtained from different sources; external proficiency testing of the Valencia Community Government, by means of internal surveys and laboratory information system registers. One year testing process proportion indicators results are showed. internal management indicators are proposed (process, appropriateness and proficiency testing). The process indicators results show gradual improvement since its establishment. after one years of using a conceptually solid Balanced Scorecard Internal business processes perspective indicators, the obtained results validate the usefulness as a laboratory management tool.

GNSS-Based Space Weather Systems Including COSMIC Ionospheric Measurements

NASA Technical Reports Server (NTRS)

Komjathy, Attila; Mandrake, Lukas; Wilson, Brian; Iijima, Byron; Pi, Xiaoqing; Hajj, George; Mannucci, Anthony J.

2006-01-01

The presentation outline includes University Corporation for Atmospheric Research (UCAR) and Jet Propulsion Laboratory (JPL) product comparisons, assimilating ground-based global positioning satellites (GPS) and COSMIC into JPL/University of Southern California (USC) Global Assimilative Ionospheric Model (GAIM), and JPL/USC GAIM validation. The discussion of comparisons examines Abel profiles and calibrated TEC. The JPL/USC GAIM validation uses Arecibo ISR, Jason-2 VTEC, and Abel profiles.

SCALE TSUNAMI Analysis of Critical Experiments for Validation of 233U Systems

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

Mueller, Don; Rearden, Bradley T

2009-01-01

Oak Ridge National Laboratory (ORNL) staff used the SCALE TSUNAMI tools to provide a demonstration evaluation of critical experiments considered for use in validation of current and anticipated operations involving {sup 233}U at the Radiochemical Development Facility (RDF). This work was reported in ORNL/TM-2008/196 issued in January 2009. This paper presents the analysis of two representative safety analysis models provided by RDF staff.

[CLIMATE CHANGE AND ALLERGIC AIRWAY DISEASE] OBSERVATIONAL,LABORATORY, AND MODELING STUDIES OF THE IMPACTS OF CLIMATE CHANGE ONALLERGIC AIRWAY DISEASE

EPA Science Inventory

Based on these data and preliminary studies, this proposal will be composed of a multiscale source-to-dose analysis approach for assessing the exposure interactions of environmental and biological systems. Once the entire modeling system is validated, it will run f...

WetLab-2: Wet Lab RNA SmartCycler Providing PCR Capability on ISS

NASA Technical Reports Server (NTRS)

Parra, Macarena; Schonfeld, Julie

2015-01-01

The WetLab-2 system will provide sample preparation and qRT-PCR analysis on-board the ISS, a capability to enable using the ISS as a real laboratory. The system will be validated on SpX-7, and is planned for its first PI use on SpX-9.

Characterization of a Low-Cost Multi-Parameter Sensor for Resource Applications: Preprint

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

Habte, Aron M; Sengupta, Manajit; Andreas, Afshin M

Low-cost multi-parameter sensing and measurement devices enable cost-effective monitoring of the functional, operational reliability, efficiency, and resiliency of the electrical grid. The National Renewable Research Laboratory (NREL) Solar Radiation Research Laboratory (SRRL), in collaboration with Arable Labs Inc., deployed Arable Lab's Mark multi-parameter sensor system. The unique suite of system sensors measures the down-welling and upwelling shortwave solar resource and longwave radiation, humidity, air temperature, and ground temperature. This study describes the shortwave calibration, characteriza-tion, and validation of measurement accuracy of this instrument by comparison with existing instruments that are part of NREL-SRRL's Baseline Measurement System.

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...

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...

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...

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...

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...

MIT Lincoln Laboratory 2011 Facts

DTIC Science & Technology

2011-01-01

currently valid OMB control number. 1. REPORT DATE 2011 2. REPORT TYPE 3. DATES COVERED 00-00-2011 to 00-00-2011 4. TITLE AND SUBTITLE MIT Lincoln...primary mission areas—space control ; air and missile defense; communication systems; intelligence, surveillance, and reconnaissance systems; advanced...electronics; tactical systems; homeland protection and chemical and biological defense; cyber security; and air traffic control . Two of the

An integrated user-oriented laboratory for verification of digital flight control systems: Features and capabilities

NASA Technical Reports Server (NTRS)

Defeo, P.; Doane, D.; Saito, J.

1982-01-01

A Digital Flight Control Systems Verification Laboratory (DFCSVL) has been established at NASA Ames Research Center. This report describes the major elements of the laboratory, the research activities that can be supported in the area of verification and validation of digital flight control systems (DFCS), and the operating scenarios within which these activities can be carried out. The DFCSVL consists of a palletized dual-dual flight-control system linked to a dedicated PDP-11/60 processor. Major software support programs are hosted in a remotely located UNIVAC 1100 accessible from the PDP-11/60 through a modem link. Important features of the DFCSVL include extensive hardware and software fault insertion capabilities, a real-time closed loop environment to exercise the DFCS, an integrated set of software verification tools, and a user-oriented interface to all the resources and capabilities.

Inspection Reliability of Nortec-30 Eddyscan System

DOT National Transportation Integrated Search

1995-08-01

This report is in MS Word 6.0/95 format. : A key task of the Aging Aircraft Nondestructive Inspection Validation Center : (AANC) at Sandia National Laboratories is to establish and apply a consistent : and systematic methodology to assess the reliabi...

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.

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…

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...

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...

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...

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...

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...

An Undergraduate Laboratory Experiment for Upper-Level Forensic Science, Biochemistry, or Molecular Biology Courses: Human DNA Amplification Using STR Single Locus Primers by Real-Time PCR with SYBR Green Detection

ERIC Educational Resources Information Center

Elkins, Kelly M.; Kadunc, Raelynn E.

2012-01-01

In this laboratory experiment, real-time polymerase chain reaction (real-time PCR) was conducted using published human TPOX single-locus DNA primers for validation and various student-designed short tandem repeat (STR) primers for Combined DNA Index System (CODIS) loci. SYBR Green was used to detect the amplification of the expected amplicons. The…

Comparison of calibration and standardization approaches for fluorescence guided imaging systems to benchtop fluorescence measurements in cellular systems

NASA Astrophysics Data System (ADS)

Litorja, Maritoni; DeRose, Paul

2018-02-01

Fluorescence measurements are a staple in biomedicine, from research and discovery to more recently, for fluorescenceguided imaging systems for diagnostics and surgery. Measurement validation for clinical imagers is a challenge as it is applied to many different optical systems and probe through matrices with different optical properties in a demanding field environment. In this paper we will present approaches to fluorescence calibration for a field system, in comparison to those used in laboratory instruments for cell measurements or benchtop fluorometers. We will present the common challenges and differences, and lessons from the standardization effort of laboratory fluorescence measurements. We will discuss the conceptually different pathways to measurement traceability, between counting moles of substance and measuring light.

Global harmonization of food safety regulations: perspectives from Japan after the Fukushima nuclear accident.

PubMed

Yoshida, Mitsuru

2014-08-01

Japanese food self-sufficiency was only 39% on the basis of kcal in 2012, so Japan relies heavily on imported food. Hence the necessity of having international rules on the regulation of food contaminants is important especially for countries like Japan that depend on food imports. A One-Stop-Testing system is desired, in which the test result obtained from a single testing laboratory is accepted as valid worldwide. To establish this system, laboratory accreditation under international standards is a necessary step. Furthermore, the importance of supply of reference materials for internal quality control and proficiency testing for external quality control of each laboratory's analytical system is reviewed in connection with the experience of radioactive nuclide contamination resulting from the Fukushima nuclear power plant accident in March 2011. © 2013 Society of Chemical Industry.

A National Residue Control Plan from the analytical perspective--the Brazilian case.

PubMed

Mauricio, Angelo de Q; Lins, Erick S; Alvarenga, Marcelo B

2009-04-01

Food safety is a strategic topic entailing not only national public health aspects but also competitiveness in international trade. An important component of any food safety program is the control and monitoring of residues posed by certain substances involved in food production. In turn, a National Residue Control Plan (NRCP) relies on an appropriate laboratory network, not only to generate analytical results, but also more broadly to verify and co-validate the controls built along the food production chain. Therefore laboratories operating under a NRCP should work in close cooperation with inspection bodies, fostering the critical alignment of the whole system with the principles of risk analysis. Beyond producing technically valid results, these laboratories should arguably be able to assist in the prediction and establishment of targets for official control. In pursuit of analytical excellence, the Brazilian government has developed a strategic plan for Official Agricultural Laboratories. Inserted in a national agenda for agricultural risk analysis, the plan has succeeded in raising laboratory budget by approximately 200%, it has started a rigorous program for personnel capacity-building, it has initiated strategic cooperation with international reference centres, and finally, it has completely renewed instrumental resources and rapidly triggered a program aimed at full laboratory compliance with ISO/IEC 17025 requirements.

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.

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.

Process material management in the Space Station environment

NASA Technical Reports Server (NTRS)

Perry, J. L.; Humphries, W. R.

1988-01-01

The Space Station will provide a unique facility for conducting material-processing and life-science experiments under microgravity conditions. These conditions place special requirements on the U.S. Laboratory for storing and transporting chemicals and process fluids, reclaiming water from selected experiments, treating and storing experiment wastes, and providing vacuum utilities. To meet these needs and provide a safe laboratory environment, the Process Material Management System (PMMS) is being developed. Preliminary design requirements and concepts related to the PMMS are addressed, and the MSFC PMMS breadboard test facility and a preliminary plan for validating the overall system design are discussed.

Model-Driven Test Generation of Distributed Systems

NASA Technical Reports Server (NTRS)

Easwaran, Arvind; Hall, Brendan; Schweiker, Kevin

2012-01-01

This report describes a novel test generation technique for distributed systems. Utilizing formal models and formal verification tools, spe cifically the Symbolic Analysis Laboratory (SAL) tool-suite from SRI, we present techniques to generate concurrent test vectors for distrib uted systems. These are initially explored within an informal test validation context and later extended to achieve full MC/DC coverage of the TTEthernet protocol operating within a system-centric context.

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.

Turbine Engine Testing.

DTIC Science & Technology

1981-01-01

per-rev, ring weighting factor, etc.) and with compression system design . A detailed description of the SAE methodology is provided in Ref. 1...offers insights into the practical application of experimental aeromechanical procedures and establishes the process of valid design assessment, avoiding...considerations given to the total engine system. Design Verification in the Experimental Laboratory Certain key parameters are influencing the design of modern

Evolution of a residue laboratory network and the management tools for monitoring its performance.

PubMed

Lins, E S; Conceição, E S; Mauricio, A De Q

2012-01-01

Since 2005 the National Residue & Contaminants Control Plan (NRCCP) in Brazil has been considerably enhanced, increasing the number of samples, substances and species monitored, and also the analytical detection capability. The Brazilian laboratory network was forced to improve its quality standards in order to comply with the NRCP's own evolution. Many aspects such as the limits of quantification (LOQs), the quality management systems within the laboratories and appropriate method validation are in continuous improvement, generating new scenarios and demands. Thus, efficient management mechanisms for monitoring network performance and its adherence to the established goals and guidelines are required. Performance indicators associated to computerised information systems arise as a powerful tool to monitor the laboratories' activity, making use of different parameters to describe this activity on a day-to-day basis. One of these parameters is related to turnaround times, and this factor is highly affected by the way each laboratory organises its management system, as well as the regulatory requirements. In this paper a global view is presented of the turnaround times related to the type of analysis, laboratory, number of samples per year, type of matrix, country region and period of the year, all these data being collected from a computerised system called SISRES. This information gives a solid background to management measures aiming at the improvement of the service offered by the laboratory network.

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

UAS-Systems Integration, Validation, and Diagnostics Simulation Capability

NASA Technical Reports Server (NTRS)

Buttrill, Catherine W.; Verstynen, Harry A.

2014-01-01

As part of the Phase 1 efforts of NASA's UAS-in-the-NAS Project a task was initiated to explore the merits of developing a system simulation capability for UAS to address airworthiness certification requirements. The core of the capability would be a software representation of an unmanned vehicle, including all of the relevant avionics and flight control system components. The specific system elements could be replaced with hardware representations to provide Hardware-in-the-Loop (HWITL) test and evaluation capability. The UAS Systems Integration and Validation Laboratory (UAS-SIVL) was created to provide a UAS-systems integration, validation, and diagnostics hardware-in-the-loop simulation capability. This paper discusses how SIVL provides a robust and flexible simulation framework that permits the study of failure modes, effects, propagation paths, criticality, and mitigation strategies to help develop safety, reliability, and design data that can assist with the development of certification standards, means of compliance, and design best practices for civil UAS.

A Simple and Low-Cost Monitoring System to Investigate Environmental Conditions in a Biological Research Laboratory.

PubMed

Gurdita, Akshay; Vovko, Heather; Ungrin, Mark

2016-01-01

Basic equipment such as incubation and refrigeration systems plays a critical role in nearly all aspects of the traditional biological research laboratory. Their proper functioning is therefore essential to ensure reliable and repeatable experimental results. Despite this fact, in many academic laboratories little attention is paid to validating and monitoring their function, primarily due to the cost and/or technical complexity of available commercial solutions. We have therefore developed a simple and low-cost monitoring system that combines a "Raspberry Pi" single-board computer with USB-connected sensor interfaces to track and log parameters such as temperature and pressure, and send email alert messages as appropriate. The system is controlled by open-source software, and we have also generated scripts to automate software setup so that no background in programming is required to install and use it. We have applied it to investigate the behaviour of our own equipment, and present here the results along with the details of the monitoring system used to obtain them.

Peak Power Control with an Energy Management System

DTIC Science & Technology

2013-03-01

Rectifier - Dr. Giovanna Oriti %initial conditions file for model ec3150_software_lab4.mdl ampl=29*sqrt(2); fund=60; ws=2*pi*fund; Ls =200e-6...original % Ls =2e-4; %reduced source inductance Rs=5e-3; Rload=10; Cdc=1100e-6; %-----H-Bridge Model ----- %EC3150 Software lab#5 - H-bridge...using a Simulink model and an experimental laboratory setup. The Simulink model and EMS functionality are validated with the laboratory experiments

Computer-assisted enzyme immunoassays and simplified immunofluorescence assays: applications for the diagnostic laboratory and the veterinarian's office.

PubMed

Jacobson, R H; Downing, D R; Lynch, T J

1982-11-15

A computer-assisted enzyme-linked immunosorbent assay (ELISA) system, based on kinetics of the reaction between substrate and enzyme molecules, was developed for testing large numbers of sera in laboratory applications. Systematic and random errors associated with conventional ELISA technique were identified leading to results formulated on a statistically validated, objective, and standardized basis. In a parallel development, an inexpensive system for field and veterinary office applications contained many of the qualities of the computer-assisted ELISA. This system uses a fluorogenic indicator (rather than the enzyme-substrate interaction) in a rapid test (15 to 20 minutes' duration) which promises broad application in serodiagnosis.

Remote Sensing Product Verification and Validation at the NASA Stennis Space Center

NASA Technical Reports Server (NTRS)

Stanley, Thomas M.

2005-01-01

Remote sensing data product verification and validation (V&V) is critical to successful science research and applications development. People who use remote sensing products to make policy, economic, or scientific decisions require confidence in and an understanding of the products' characteristics to make informed decisions about the products' use. NASA data products of coarse to moderate spatial resolution are validated by NASA science teams. NASA's Stennis Space Center (SSC) serves as the science validation team lead for validating commercial data products of moderate to high spatial resolution. At SSC, the Applications Research Toolbox simulates sensors and targets, and the Instrument Validation Laboratory validates critical sensors. The SSC V&V Site consists of radiometric tarps, a network of ground control points, a water surface temperature sensor, an atmospheric measurement system, painted concrete radial target and edge targets, and other instrumentation. NASA's Applied Sciences Directorate participates in the Joint Agency Commercial Imagery Evaluation (JACIE) team formed by NASA, the U.S. Geological Survey, and the National Geospatial-Intelligence Agency to characterize commercial systems and imagery.

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.

Overview of the MEDLI Project

NASA Technical Reports Server (NTRS)

Gazarik, Michael J.; Hwang, Helen; Little, Alan; Cheatwood, Neil; Wright, Michael; Herath, Jeff

2007-01-01

The Mars Science Laboratory Entry, Descent, and Landing Instrumentation (MEDLI) Project's objectives are to measure aerothermal environments, sub-surface heatshield material response, vehicle orientation, and atmospheric density for the atmospheric entry and descent phases of the Mars Science Laboratory (MSL) entry vehicle. The flight science objectives of MEDLI directly address the largest uncertainties in the ability to design and validate a robust Mars entry system, including aerothermal, aerodynamic and atmosphere models, and thermal protection system (TPS) design. The instrumentation suite will be installed in the heatshield of the MSL entry vehicle. The acquired data will support future Mars entry and aerocapture missions by providing measured atmospheric data to validate Mars atmosphere models and clarify the design margins for future Mars missions. MEDLI thermocouple and recession sensor data will significantly improve the understanding of aeroheating and TPS performance uncertainties for future missions. MEDLI pressure data will permit more accurate trajectory reconstruction, as well as separation of aerodynamic and atmospheric uncertainties in the hypersonic and supersonic regimes. This paper provides an overview of the project including the instrumentation design, system architecture, and expected measurement response.

Overview of the MEDLI Project

NASA Technical Reports Server (NTRS)

Gazarik, Michael J.; Little, Alan; Cheatwood, F. Neil; Wright, Michael J.; Herath, Jeff A.; Martinez, Edward R.; Munk, Michelle; Novak, Frank J.; Wright, Henry S.

2008-01-01

The Mars Science Laboratory Entry, Descent, and Landing Instrumentation (MEDLI) Project s objectives are to measure aerothermal environments, sub-surface heatshield material response, vehicle orientation, and atmospheric density for the atmospheric entry and descent phases of the Mars Science Laboratory (MSL) entry vehicle. The flight science objectives of MEDLI directly address the largest uncertainties in the ability to design and validate a robust Mars entry system, including aerothermal, aerodynamic and atmosphere models, and thermal protection system (TPS) design. The instrumentation suite will be installed in the heatshield of the MSL entry vehicle. The acquired data will support future Mars entry and aerocapture missions by providing measured atmospheric data to validate Mars atmosphere models and clarify the design margins for future Mars missions. MEDLI thermocouple and recession sensor data will significantly improve the understanding of aeroheating and TPS performance uncertainties for future missions. MEDLI pressure data will permit more accurate trajectory reconstruction, as well as separation of aerodynamic and atmospheric uncertainties in the hypersonic and supersonic regimes. This paper provides an overview of the project including the instrumentation design, system architecture, and expected measurement response.

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

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

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

A rigorous approach to facilitate and guarantee the correctness of the genetic testing management in human genome information systems.

PubMed

Araújo, Luciano V; Malkowski, Simon; Braghetto, Kelly R; Passos-Bueno, Maria R; Zatz, Mayana; Pu, Calton; Ferreira, João E

2011-12-22

Recent medical and biological technology advances have stimulated the development of new testing systems that have been providing huge, varied amounts of molecular and clinical data. Growing data volumes pose significant challenges for information processing systems in research centers. Additionally, the routines of genomics laboratory are typically characterized by high parallelism in testing and constant procedure changes. This paper describes a formal approach to address this challenge through the implementation of a genetic testing management system applied to human genome laboratory. We introduced the Human Genome Research Center Information System (CEGH) in Brazil, a system that is able to support constant changes in human genome testing and can provide patients updated results based on the most recent and validated genetic knowledge. Our approach uses a common repository for process planning to ensure reusability, specification, instantiation, monitoring, and execution of processes, which are defined using a relational database and rigorous control flow specifications based on process algebra (ACP). The main difference between our approach and related works is that we were able to join two important aspects: 1) process scalability achieved through relational database implementation, and 2) correctness of processes using process algebra. Furthermore, the software allows end users to define genetic testing without requiring any knowledge about business process notation or process algebra. This paper presents the CEGH information system that is a Laboratory Information Management System (LIMS) based on a formal framework to support genetic testing management for Mendelian disorder studies. We have proved the feasibility and showed usability benefits of a rigorous approach that is able to specify, validate, and perform genetic testing using easy end user interfaces.

A rigorous approach to facilitate and guarantee the correctness of the genetic testing management in human genome information systems

PubMed Central

2011-01-01

Background Recent medical and biological technology advances have stimulated the development of new testing systems that have been providing huge, varied amounts of molecular and clinical data. Growing data volumes pose significant challenges for information processing systems in research centers. Additionally, the routines of genomics laboratory are typically characterized by high parallelism in testing and constant procedure changes. Results This paper describes a formal approach to address this challenge through the implementation of a genetic testing management system applied to human genome laboratory. We introduced the Human Genome Research Center Information System (CEGH) in Brazil, a system that is able to support constant changes in human genome testing and can provide patients updated results based on the most recent and validated genetic knowledge. Our approach uses a common repository for process planning to ensure reusability, specification, instantiation, monitoring, and execution of processes, which are defined using a relational database and rigorous control flow specifications based on process algebra (ACP). The main difference between our approach and related works is that we were able to join two important aspects: 1) process scalability achieved through relational database implementation, and 2) correctness of processes using process algebra. Furthermore, the software allows end users to define genetic testing without requiring any knowledge about business process notation or process algebra. Conclusions This paper presents the CEGH information system that is a Laboratory Information Management System (LIMS) based on a formal framework to support genetic testing management for Mendelian disorder studies. We have proved the feasibility and showed usability benefits of a rigorous approach that is able to specify, validate, and perform genetic testing using easy end user interfaces. PMID:22369688

A Nonparametric Statistical Approach to the Validation of Computer Simulation Models

DTIC Science & Technology

1985-11-01

Ballistic Research Laboratory, the Experimental Design and Analysis Branch of the Systems Engineering and Concepts Analysis Division was funded to...2 Winter. E M. Wisemiler. D P. azd UjiharmJ K. Venrgcation ad Validatiot of Engineering Simulatiots with Minimal D2ta." Pmeedinr’ of the 1976 Summer...used by numerous authors. Law%6 has augmented their approach with specific suggestions for each of the three stage’s: 1. develop high face-validity

The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: phase 1.

PubMed Central

Kanno, J; Onyon, L; Haseman, J; Fenner-Crisp, P; Ashby, J; Owens, W

2001-01-01

The Organisation for Economic Co-operation and Development has completed the first phase of an international validation program for the rodent uterotrophic bioassay. This uterotrophic bioassay is intended to identify the in vivo activity of compounds that are suspected agonists or antagonists of estrogen. This information could, for example, be used to help prioritize positive compounds for further testing. Using draft protocols, we tested and compared two model systems, the immature female rat and the adult ovariectomized rat. Data from 19 participating laboratories using a high-potency reference agonist, ethinyl estradiol (EE), and an antagonist, ZM 189,154, indicate no substantive performance differences between models. All laboratories and all protocols successfully detected increases in uterine weights using EE in phase 1. These significant uterine weight increases were achieved under a variety of experimental conditions (e.g., strain, diet, housing protocol, bedding, vehicle). For each protocol, there was generally good agreement among laboratories with regard to the actual EE doses both in producing the first significant increase in uterine weights and achieving the maximum uterine response. Furthermore, the Hill equation appears to model the dose response satisfactorily and indicates general agreement based on calculated effective dose (ED)(10) and ED(50) within and among laboratories. The feasibility of an antagonist assay was also successfully demonstrated. Therefore, both models appear robust, reproducible, and transferable across laboratories for high-potency estrogen agonists such as EE. For the next phase of the OECD validation program, both models will be tested against a battery of weak, partial estrogen agonists. PMID:11564613

Recommended Research Directions for Improving the Validation of Complex Systems Models.

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

Vugrin, Eric D.; Trucano, Timothy G.; Swiler, Laura Painton

Improved validation for models of complex systems has been a primary focus over the past year for the Resilience in Complex Systems Research Challenge. This document describes a set of research directions that are the result of distilling those ideas into three categories of research -- epistemic uncertainty, strong tests, and value of information. The content of this document can be used to transmit valuable information to future research activities, update the Resilience in Complex Systems Research Challenge's roadmap, inform the upcoming FY18 Laboratory Directed Research and Development (LDRD) call and research proposals, and facilitate collaborations between Sandia and externalmore » organizations. The recommended research directions can provide topics for collaborative research, development of proposals, workshops, and other opportunities.« less

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.

LIMS user acceptance testing.

PubMed

Klein, Corbett S

2003-01-01

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

Digital Fly-By-Wire Flight Control Validation Experience

NASA Technical Reports Server (NTRS)

Szalai, K. J.; Jarvis, C. R.; Krier, G. E.; Megna, V. A.; Brock, L. D.; Odonnell, R. N.

1978-01-01

The experience gained in digital fly-by-wire technology through a flight test program being conducted by the NASA Dryden Flight Research Center in an F-8C aircraft is described. The system requirements are outlined, along with the requirements for flight qualification. The system is described, including the hardware components, the aircraft installation, and the system operation. The flight qualification experience is emphasized. The qualification process included the theoretical validation of the basic design, laboratory testing of the hardware and software elements, systems level testing, and flight testing. The most productive testing was performed on an iron bird aircraft, which used the actual electronic and hydraulic hardware and a simulation of the F-8 characteristics to provide the flight environment. The iron bird was used for sensor and system redundancy management testing, failure modes and effects testing, and stress testing in many cases with the pilot in the loop. The flight test program confirmed the quality of the validation process by achieving 50 flights without a known undetected failure and with no false alarms.

Validity of a portable glucose, total cholesterol, and triglycerides multi-analyzer in adults.

PubMed

Coqueiro, Raildo da Silva; Santos, Mateus Carmo; Neto, João de Souza Leal; Queiroz, Bruno Morbeck de; Brügger, Nelson Augusto Jardim; Barbosa, Aline Rodrigues

2014-07-01

This study investigated the accuracy and precision of the Accutrend Plus system to determine blood glucose, total cholesterol, and plasma triglycerides in adults and evaluated its efficiency in measuring these blood variables. The sample consisted of 53 subjects (≥ 18 years). For blood variable laboratory determination, venous blood samples were collected and processed in a Labmax 240 analyzer. To measure blood variables with the Accutrend Plus system, samples of capillary blood were collected. In the analysis, the following tests were included: Wilcoxon and Student's t-tests for paired samples, Lin's concordance coefficient, Bland-Altman method, receiver operating characteristic curve, McNemar test, and k statistics. The results show that the Accutrend Plus system provided significantly higher values (p ≤ .05) of glucose and triglycerides but not of total cholesterol (p > .05) as compared to the values determined in the laboratory. However, the system showed good reproducibility (Lin's coefficient: glucose = .958, triglycerides = .992, total cholesterol = .940) and high concordance with the laboratory method (Lin's coefficient: glucose = .952, triglycerides = .990, total cholesterol = .944) and high sensitivity (glucose = 80.0%, triglycerides = 90.5%, total cholesterol = 84.4%) and specificity (glucose = 100.0%, triglycerides = 96.9%, total cholesterol = 95.2%) in the discrimination of high values of the three blood variables analyzed. It could be concluded that despite the tendency to overestimate glucose and triglyceride levels, a portable multi-analyzer is a valid alternative for the monitoring of metabolic disorders and cardiovascular risk factors. © The Author(s) 2013.

Validation Test Report for the Arctic Cap Nowcast/Forecast System as a Fractures/Leads and Polynyas Product

DTIC Science & Technology

2015-05-26

and Lipscomb, 2004) to describe the ice dynamics and compute strain rates. It incorporates the standard ridging scheme of Thorndike et al. (1975...Forecast System (ACNFS). NRL/MR/7320—10- 9287, Naval Research Laboratory, Stennis Space Center, MS, 55 pp. Thorndike , A.S., D.A. Rothrock, G.A. Maykut, and

Proceedings of the Twenty-Third Annual Software Engineering Workshop

NASA Technical Reports Server (NTRS)

1999-01-01

The Twenty-third Annual Software Engineering Workshop (SEW) provided 20 presentations designed to further the goals of the Software Engineering Laboratory (SEL) of the NASA-GSFC. The presentations were selected on their creativity. The sessions which were held on 2-3 of December 1998, centered on the SEL, Experimentation, Inspections, Fault Prediction, Verification and Validation, and Embedded Systems and Safety-Critical Systems.

MIT Lincoln Laboratory 2010 Facts

DTIC Science & Technology

2010-03-01

currently valid OMB control number. 1. REPORT DATE 2010 2. REPORT TYPE 3. DATES COVERED 00-00-2010 to 00-00-2010 4. TITLE AND SUBTITLE MIT Lincoln...space control ; air and missile defense; communications and information technology; intelligence, surveillance, and reconnaissance systems...advanced electronics; tactical systems; homeland protection and biological/chemical defense; and air traffic control . Two of the Laboratory’s principal

Soil properties differently influence estimates of soil CO2 efflux from three chamber-based measurement systems

Treesearch

John R. Butnor; Kurt H. Johnsen; Chris A. Maier

2005-01-01

Soil C02 efflux is a major component of net ecosystem productivity (NEP) of forest systems. Combining data from multiple researchers for larger-scale modeling and assessment will only be valid if their methodologies provide directly comparable results. We conducted a series of laboratory and field tests to assess the presence and magnitude of...

Calculated criticality for sup 235 U/graphite systems using the VIM Monte Carlo code

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

Collins, P.J.; Grasseschi, G.L.; Olsen, D.N.

1992-01-01

Calculations for highly enriched uranium and graphite systems gained renewed interest recently for the new production modular high-temperature gas-cooled reactor (MHTGR). Experiments to validate the physics calculations for these systems are being prepared for the Transient Reactor Test Facility (TREAT) reactor at Argonne National Laboratory (ANL-West) and in the Compact Nuclear Power Source facility at Los Alamos National Laboratory. The continuous-energy Monte Carlo code VIM, or equivalently the MCNP code, can utilize fully detailed models of the MHTGR and serve as benchmarks for the approximate multigroup methods necessary in full reactor calculations. Validation of these codes and their associated nuclearmore » data did not exist for highly enriched {sup 235}U/graphite systems. Experimental data, used in development of more approximate methods, dates back to the 1960s. The authors have selected two independent sets of experiments for calculation with the VIM code. The carbon-to-uranium (C/U) ratios encompass the range of 2,000, representative of the new production MHTGR, to the ratio of 10,000 in the fuel of TREAT. Calculations used the ENDF/B-V data.« less

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.

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.

An elevated plus-maze in mixed reality for studying human anxiety-related behavior.

PubMed

Biedermann, Sarah V; Biedermann, Daniel G; Wenzlaff, Frederike; Kurjak, Tim; Nouri, Sawis; Auer, Matthias K; Wiedemann, Klaus; Briken, Peer; Haaker, Jan; Lonsdorf, Tina B; Fuss, Johannes

2017-12-21

A dearth of laboratory tests to study actual human approach-avoidance behavior has complicated translational research on anxiety. The elevated plus-maze (EPM) is the gold standard to assess approach-avoidance behavior in rodents. Here, we translated the EPM to humans using mixed reality through a combination of virtual and real-world elements. In two validation studies, we observed participants' anxiety on a behavioral, physiological, and subjective level. Participants reported higher anxiety on open arms, avoided open arms, and showed an activation of endogenous stress systems. Participants' with high anxiety exhibited higher avoidance. Moreover, open arm avoidance was moderately predicted by participants' acrophobia and sensation seeking, with opposing influences. In a randomized, double blind, placebo controlled experiment, GABAergic stimulation decreased avoidance of open arms while alpha-2-adrenergic antagonism increased avoidance. These findings demonstrate cross-species validity of open arm avoidance as a translational measure of anxiety. We thus introduce the first ecologically valid assay to track actual human approach-avoidance behavior under laboratory conditions.

Developing Electronic Health Record Algorithms That Accurately Identify Patients With Systemic Lupus Erythematosus.

PubMed

Barnado, April; Casey, Carolyn; Carroll, Robert J; Wheless, Lee; Denny, Joshua C; Crofford, Leslie J

2017-05-01

To study systemic lupus erythematosus (SLE) in the electronic health record (EHR), we must accurately identify patients with SLE. Our objective was to develop and validate novel EHR algorithms that use International Classification of Diseases, Ninth Revision (ICD-9), Clinical Modification codes, laboratory testing, and medications to identify SLE patients. We used Vanderbilt's Synthetic Derivative, a de-identified version of the EHR, with 2.5 million subjects. We selected all individuals with at least 1 SLE ICD-9 code (710.0), yielding 5,959 individuals. To create a training set, 200 subjects were randomly selected for chart review. A subject was defined as a case if diagnosed with SLE by a rheumatologist, nephrologist, or dermatologist. Positive predictive values (PPVs) and sensitivity were calculated for combinations of code counts of the SLE ICD-9 code, a positive antinuclear antibody (ANA), ever use of medications, and a keyword of "lupus" in the problem list. The algorithms with the highest PPV were each internally validated using a random set of 100 individuals from the remaining 5,759 subjects. The algorithm with the highest PPV at 95% in the training set and 91% in the validation set was 3 or more counts of the SLE ICD-9 code, ANA positive (≥1:40), and ever use of both disease-modifying antirheumatic drugs and steroids, while excluding individuals with systemic sclerosis and dermatomyositis ICD-9 codes. We developed and validated the first EHR algorithm that incorporates laboratory values and medications with the SLE ICD-9 code to identify patients with SLE accurately. © 2016, American College of Rheumatology.

Hierarchical clustering method for improved prostate cancer imaging in diffuse optical tomography

NASA Astrophysics Data System (ADS)

Kavuri, Venkaiah C.; Liu, Hanli

2013-03-01

We investigate the feasibility of trans-rectal near infrared (NIR) based diffuse optical tomography (DOT) for early detection of prostate cancer using a transrectal ultrasound (TRUS) compatible imaging probe. For this purpose, we designed a TRUS-compatible, NIR-based image system (780nm), in which the photo diodes were placed on the trans-rectal probe. DC signals were recorded and used for estimating the absorption coefficient. We validated the system using laboratory phantoms. For further improvement, we also developed a hierarchical clustering method (HCM) to improve the accuracy of image reconstruction with limited prior information. We demonstrated the method using computer simulations laboratory phantom experiments.

Validation and verification of the laser range safety tool (LRST)

NASA Astrophysics Data System (ADS)

Kennedy, Paul K.; Keppler, Kenneth S.; Thomas, Robert J.; Polhamus, Garrett D.; Smith, Peter A.; Trevino, Javier O.; Seaman, Daniel V.; Gallaway, Robert A.; Crockett, Gregg A.

2003-06-01

The U.S. Dept. of Defense (DOD) is currently developing and testing a number of High Energy Laser (HEL) weapons systems. DOD range safety officers now face the challenge of designing safe methods of testing HEL's on DOD ranges. In particular, safety officers need to ensure that diffuse and specular reflections from HEL system targets, as well as direct beam paths, are contained within DOD boundaries. If both the laser source and the target are moving, as they are for the Airborne Laser (ABL), a complex series of calculations is required and manual calculations are impractical. Over the past 5 years, the Optical Radiation Branch of the Air Force Research Laboratory (AFRL/HEDO), the ABL System Program Office, Logicon-RDA, and Northrup-Grumman, have worked together to develop a computer model called teh Laser Range Safety Tool (LRST), specifically designed for HEL reflection hazard analyses. The code, which is still under development, is currently tailored to support the ABL program. AFRL/HEDO has led an LRST Validation and Verification (V&V) effort since 1998, in order to determine if code predictions are accurate. This paper summarizes LRST V&V efforts to date including: i) comparison of code results with laboratory measurements of reflected laser energy and with reflection measurements made during actual HEL field tests, and ii) validation of LRST's hazard zone computations.

Sleep-Wake Evaluation from Whole-Night Non-Contact Audio Recordings of Breathing Sounds

PubMed Central

Dafna, Eliran; Tarasiuk, Ariel; Zigel, Yaniv

2015-01-01

Study Objectives To develop and validate a novel non-contact system for whole-night sleep evaluation using breathing sounds analysis (BSA). Design Whole-night breathing sounds (using ambient microphone) and polysomnography (PSG) were simultaneously collected at a sleep laboratory (mean recording time 7.1 hours). A set of acoustic features quantifying breathing pattern were developed to distinguish between sleep and wake epochs (30 sec segments). Epochs (n = 59,108 design study and n = 68,560 validation study) were classified using AdaBoost classifier and validated epoch-by-epoch for sensitivity, specificity, positive and negative predictive values, accuracy, and Cohen's kappa. Sleep quality parameters were calculated based on the sleep/wake classifications and compared with PSG for validity. Setting University affiliated sleep-wake disorder center and biomedical signal processing laboratory. Patients One hundred and fifty patients (age 54.0±14.8 years, BMI 31.6±5.5 kg/m2, m/f 97/53) referred for PSG were prospectively and consecutively recruited. The system was trained (design study) on 80 subjects; validation study was blindly performed on the additional 70 subjects. Measurements and Results Epoch-by-epoch accuracy rate for the validation study was 83.3% with sensitivity of 92.2% (sleep as sleep), specificity of 56.6% (awake as awake), and Cohen's kappa of 0.508. Comparing sleep quality parameters of BSA and PSG demonstrate average error of sleep latency, total sleep time, wake after sleep onset, and sleep efficiency of 16.6 min, 35.8 min, and 29.6 min, and 8%, respectively. Conclusions This study provides evidence that sleep-wake activity and sleep quality parameters can be reliably estimated solely using breathing sound analysis. This study highlights the potential of this innovative approach to measure sleep in research and clinical circumstances. PMID:25710495

Validity and reliability of the PowerTap mobile cycling powermeter when compared with the SRM Device.

PubMed

Bertucci, W; Duc, S; Villerius, V; Pernin, J N; Grappe, F

2005-12-01

The SRM power measuring crank system is nowadays a popular device for cycling power output (PO) measurements in the field and in laboratories. The PowerTap (CycleOps, Madison, USA) is a more recent and less well-known device that allows mobile PO measurements of cycling via the rear wheel hub. The aim of this study is to test the validity and reliability of the PowerTap by comparing it with the most accurate (i.e. the scientific model) of the SRM system. The validity of the PowerTap is tested during i) sub-maximal incremental intensities (ranging from 100 to 420 W) on a treadmill with different pedalling cadences (45 to 120 rpm) and cycling positions (standing and seated) on different grades, ii) a continuous sub-maximal intensity lasting 30 min, iii) a maximal intensity (8-s sprint), and iiii) real road cycling. The reliability is assessed by repeating ten times the sub-maximal incremental and continuous tests. The results show a good validity of the PowerTap during sub-maximal intensities between 100 and 450 W (mean PO difference -1.2 +/- 1.3 %) when it is compared to the scientific SRM model, but less validity for the maximal PO during sprint exercise, where the validity appears to depend on the gear ratio. The reliability of the PowerTap during the sub-maximal intensities is similar to the scientific SRM model (the coefficient of variation is respectively 0.9 to 2.9 % and 0.7 to 2.1 % for PowerTap and SRM). The PowerTap must be considered as a suitable device for PO measurements during sub-maximal real road cycling and in sub-maximal laboratory tests.

Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

NASA Astrophysics Data System (ADS)

Cucu, Daniela; Woods, Mike

2008-08-01

The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee. According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures. When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results). Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results. Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance.

Risk score for first-screening of prevalent undiagnosed chronic kidney disease in Peru: the CRONICAS-CKD risk score.

PubMed

Carrillo-Larco, Rodrigo M; Miranda, J Jaime; Gilman, Robert H; Medina-Lezama, Josefina; Chirinos-Pacheco, Julio A; Muñoz-Retamozo, Paola V; Smeeth, Liam; Checkley, William; Bernabe-Ortiz, Antonio

2017-11-29

Chronic Kidney Disease (CKD) represents a great burden for the patient and the health system, particularly if diagnosed at late stages. Consequently, tools to identify patients at high risk of having CKD are needed, particularly in limited-resources settings where laboratory facilities are scarce. This study aimed to develop a risk score for prevalent undiagnosed CKD using data from four settings in Peru: a complete risk score including all associated risk factors and another excluding laboratory-based variables. Cross-sectional study. We used two population-based studies: one for developing and internal validation (CRONICAS), and another (PREVENCION) for external validation. Risk factors included clinical- and laboratory-based variables, among others: sex, age, hypertension and obesity; and lipid profile, anemia and glucose metabolism. The outcome was undiagnosed CKD: eGFR < 60 ml/min/1.73m 2 . We tested the performance of the risk scores using the area under the receiver operating characteristic (ROC) curve, sensitivity, specificity, positive/negative predictive values and positive/negative likelihood ratios. Participants in both studies averaged 57.7 years old, and over 50% were females. Age, hypertension and anemia were strongly associated with undiagnosed CKD. In the external validation, at a cut-off point of 2, the complete and laboratory-free risk scores performed similarly well with a ROC area of 76.2% and 76.0%, respectively (P = 0.784). The best assessment parameter of these risk scores was their negative predictive value: 99.1% and 99.0% for the complete and laboratory-free, respectively. The developed risk scores showed a moderate performance as a screening test. People with a score of ≥ 2 points should undergo further testing to rule out CKD. Using the laboratory-free risk score is a practical approach in developing countries where laboratories are not readily available and undiagnosed CKD has significant morbidity and mortality.

Simulation studies for the evaluation of health information technologies: experiences and results.

PubMed

Ammenwerth, Elske; Hackl, Werner O; Binzer, Kristine; Christoffersen, Tue E H; Jensen, Sanne; Lawton, Kitta; Skjoet, Peter; Nohr, Christian

It is essential for new health information technologies (IT) to undergo rigorous evaluations to ensure they are effective and safe for use in real-world situations. However, evaluation of new health IT is challenging, as field studies are often not feasible when the technology being evaluated is not sufficiently mature. Laboratory-based evaluations have also been shown to have insufficient external validity. Simulation studies seem to be a way to bridge this gap. The aim of this study was to evaluate, using a simulation methodology, the impact of a new prototype of an electronic medication management system on the appropriateness of prescriptions and drug-related activities, including laboratory test ordering or medication changes. This article presents the results of a controlled simulation study with 50 simulation runs, including ten doctors and five simulation patients, and discusses experiences and lessons learnt while conducting the study. Although the new electronic medication management system showed tendencies to improve medication safety when compared with the standard system, this tendency was not significant. Altogether, five distinct situations were identified where the new medication management system did help to improve medication safety. This simulation study provided a good compromise between internal validity and external validity. However, several challenges need to be addressed when undertaking simulation evaluations including: preparation of adequate test cases; training of participants before using unfamiliar applications; consideration of time, effort and costs of conducting the simulation; technical maturity of the evaluated system; and allowing adequate preparation of simulation scenarios and simulation setting. Simulation studies are an interesting but time-consuming approach, which can be used to evaluate newly developed health IT systems, particularly those systems that are not yet sufficiently mature to undergo field evaluation studies.

A Tool for Automatic Verification of Real-Time Expert Systems

NASA Technical Reports Server (NTRS)

Traylor, B.; Schwuttke, U.; Quan, A.

1994-01-01

The creation of an automated, user-driven tool for expert system development, validation, and verification is curretly onoging at NASA's Jet Propulsion Laboratory. In the new age of faster, better, cheaper missions, there is an increased willingness to utilize embedded expert systems for encapsulating and preserving mission expertise in systems which combine conventional algorithmic processing and artifical intelligence. The once-questioned role of automation in spacecraft monitoring is now becoming one of increasing importance.

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

PubMed

Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

2015-01-15

Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.

Design and validation of the eyesafe ladar testbed (ELT) using the LadarSIM system simulator

NASA Astrophysics Data System (ADS)

Neilsen, Kevin D.; Budge, Scott E.; Pack, Robert T.; Fullmer, R. Rees; Cook, T. Dean

2009-05-01

The development of an experimental full-waveform LADAR system has been enhanced with the assistance of the LadarSIM system simulation software. The Eyesafe LADAR Test-bed (ELT) was designed as a raster scanning, single-beam, energy-detection LADAR with the capability of digitizing and recording the return pulse waveform at up to 2 GHz for 3D off-line image formation research in the laboratory. To assist in the design phase, the full-waveform LADAR simulation in LadarSIM was used to simulate the expected return waveforms for various system design parameters, target characteristics, and target ranges. Once the design was finalized and the ELT constructed, the measured specifications of the system and experimental data captured from the operational sensor were used to validate the behavior of the system as predicted during the design phase. This paper presents the methodology used, and lessons learned from this "design, build, validate" process. Simulated results from the design phase are presented, and these are compared to simulated results using measured system parameters and operational sensor data. The advantages of this simulation-based process are also presented.

DAIDALUS: Detect and Avoid Alerting Logic for Unmanned Systems

NASA Technical Reports Server (NTRS)

Munoz, Cesar; Narkawicz, Anthony; Hagen, George; Upchurch, Jason; Dutle, Aaron; Consiglio, Maria; Chamberlain, James

2015-01-01

This paper presents DAIDALUS (Detect and Avoid Alerting Logic for Unmanned Systems), a reference implementation of a detect and avoid concept intended to support the integration of Unmanned Aircraft Systems into civil airspace. DAIDALUS consists of self-separation and alerting algorithms that provide situational awareness to UAS remote pilots. These algorithms have been formally specified in a mathematical notation and verified for correctness in an interactive theorem prover. The software implementation has been verified against the formal models and validated against multiple stressing cases jointly developed by the US Air Force Research Laboratory, MIT Lincoln Laboratory, and NASA. The DAIDALUS reference implementation is currently under consideration for inclusion in the appendices to the Minimum Operational Performance Standards for Unmanned Aircraft Systems presently being developed by RTCA Special Committee 228.

Robotics in biomedical chromatography and electrophoresis.

PubMed

Fouda, H G

1989-08-11

The ideal laboratory robot can be viewed as "an indefatigable assistant capable of working continuously for 24 h a day with constant efficiency". The development of a system approaching that promise requires considerable skill and time commitment, a thorough understanding of the capabilities and limitations of the robot and its specialized modules and an intimate knowledge of the functions to be automated. The robot need not emulate every manual step. Effective substitutes for difficult steps must be devised. The future of laboratory robots depends not only on technological advances in other fields, but also on the skill and creativity of chromatographers and other scientists. The robot has been applied to automate numerous biomedical chromatography and electrophoresis methods. The quality of its data can approach, and in some cases exceed, that of manual methods. Maintaining high data quality during continuous operation requires frequent maintenance and validation. Well designed robotic systems can yield substantial increase in the laboratory productivity without a corresponding increase in manpower. They can free skilled personnel from mundane tasks and can enhance the safety of the laboratory environment. The integration of robotics, chromatography systems and laboratory information management systems permits full automation and affords opportunities for unattended method development and for future incorporation of artificial intelligence techniques and the evolution of expert systems. Finally, humanoid attributes aside, robotic utilization in the laboratory should not be an end in itself. The robot is a useful tool that should be utilized only when it is prudent and cost-effective to do so.

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…

Managing Complexity in the MSL/Curiosity Entry, Descent, and Landing Flight Software and Avionics Verification and Validation Campaign

NASA Technical Reports Server (NTRS)

Stehura, Aaron; Rozek, Matthew

2013-01-01

The complexity of the Mars Science Laboratory (MSL) mission presented the Entry, Descent, and Landing systems engineering team with many challenges in its Verification and Validation (V&V) campaign. This paper describes some of the logistical hurdles related to managing a complex set of requirements, test venues, test objectives, and analysis products in the implementation of a specific portion of the overall V&V program to test the interaction of flight software with the MSL avionics suite. Application-specific solutions to these problems are presented herein, which can be generalized to other space missions and to similar formidable systems engineering problems.

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

Characterization of a Low-Cost Multiparameter Sensor for Solar Resource Applications

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

Habte, Aron M; Sengupta, Manajit; Andreas, Afshin M

Low-cost, multiparameter sensing and measurement devices enable cost-effective monitoring of the functional, operational reliability, efficiency, and resiliency of the electric grid. The National Renewable Research Laboratory (NREL) Solar Radiation Research Laboratory (SRRL), in collaboration with Arable Labs, Inc., deployed Arable Lab's Mark multiparameter sensor system. The device measures the downwelling and upwelling shortwave solar resource and longwave radiation, humidity, air temperature, and ground temperature. The system is also equipped with six downward-and upward-facing narrowband spectrometer channels that measure spectral radiation and surface spectral reflectance. This study describes the shortwave calibration, characterization, and validation of measurement accuracy of this instrument bymore » comparison with existing instruments that are part of NREL-SRRL's Baseline Measurement System.« less

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.

A Wildfire Behavior Modeling System at Los Alamos National Laboratory for Operational Applications

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

S.W. Koch; R.G.Balice

2004-11-01

To support efforts to protect facilities and property at Los Alamos National Laboratory from damages caused by wildfire, we completed a multiyear project to develop a system for modeling the behavior of wildfires in the Los Alamos region. This was accomplished by parameterizing the FARSITE wildfire behavior model with locally gathered data representing topography, fuels, and weather conditions from throughout the Los Alamos region. Detailed parameterization was made possible by an extensive monitoring network of permanent plots, weather towers, and other data collection facilities. We also incorporated a database of lightning strikes that can be used individually as repeatable ignitionmore » points or can be used as a group in Monte Carlo simulation exercises and in other randomization procedures. The assembled modeling system was subjected to sensitivity analyses and was validated against documented fires, including the Cerro Grande Fire. The resulting modeling system is a valuable tool for research and management. It also complements knowledge based on professional expertise and information gathered from other modeling technologies. However, the modeling system requires frequent updates of the input data layers to produce currently valid results, to adapt to changes in environmental conditions within the Los Alamos region, and to allow for the quick production of model outputs during emergency operations.« less

A Thermal Management System Using Ammonium Carbamate as an Endothermic Heat Sink (POSTPRINT)

DTIC Science & Technology

2017-04-01

Niedbalski and Soumya S. Patnaik Mechanical and Thermal Systems Branch Power and Control Division Douglas J. Johnson and Jamie S. Ervin University...failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE...and Control Division Air Force Research Laboratory, Aerospace Systems Directorate Wright-Patterson Air Force Base, OH 45433-7542 Air Force Materiel

Network of movement and proximity sensors for monitoring upper-extremity motor activity after stroke: proof of principle.

PubMed

Sokal, Brad; Uswatte, Gitendra; Barman, Joydip; Brewer, Michael; Byrom, Ezekiel; Latten, Jessica; Joseph, Jeethu; Serafim, Camila; Ghaffari, Touraj; Sarkar, Nilanjan

2014-03-01

To test the convergent validity of an objective method, Sensor-Enabled Radio-frequency Identification System for Monitoring Arm Activity (SERSMAA), that distinguishes between functional and nonfunctional activity. Cross-sectional study. Laboratory. Participants (N=25) were ≥0.2 years poststroke (median, 9) with a wide range of severity of upper-extremity hemiparesis. Not applicable. After stroke, laboratory tests of the motor capacity of the more-affected arm poorly predict spontaneous use of that arm in daily life. However, available subjective methods for measuring everyday arm use are vulnerable to self-report biases, whereas available objective methods only provide information on the amount of activity without regard to its relation with function. The SERSMAA consists of a proximity-sensor receiver on the more-affected arm and multiple units placed on objects. Functional activity is signaled when the more-affected arm is close to an object that is moved. Participants were videotaped during a laboratory simulation of an everyday activity, that is, setting a table with cups, bowls, and plates instrumented with transmitters. Observers independently coded the videos in 2-second blocks with a validated system for classifying more-affected arm activity. There was a strong correlation (r=.87, P<.001) between time that the more-affected arm was used for handling objects according to the SERSMAA and functional activity according to the observers. The convergent validity of SERSMAA for measuring more-affected arm functional activity after stroke was supported in a simulation of everyday activity. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Autonomous Vehicle Systems Laboratory Research Capability Expansion Program

DTIC Science & Technology

2017-12-03

currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. University of the Incarnate Word 4301 Broadway, Box #T-2 San Antonio...autonomous control , collaboration, and decision-making in unstructured, dynamic, and uncertain nonlinear environments for autonomous ground and air...vehicle systems. To fulfill the research goal, the PI has initiated fundamental research in the areas of autonomous rotorcraft control and

Validation approach for a fast and simple targeted screening method for 75 antibiotics in meat and aquaculture products using LC-MS/MS.

PubMed

Dubreil, Estelle; Gautier, Sophie; Fourmond, Marie-Pierre; Bessiral, Mélaine; Gaugain, Murielle; Verdon, Eric; Pessel, Dominique

2017-04-01

An approach is described to validate a fast and simple targeted screening method for antibiotic analysis in meat and aquaculture products by LC-MS/MS. The strategy of validation was applied for a panel of 75 antibiotics belonging to different families, i.e., penicillins, cephalosporins, sulfonamides, macrolides, quinolones and phenicols. The samples were extracted once with acetonitrile, concentrated by evaporation and injected into the LC-MS/MS system. The approach chosen for the validation was based on the Community Reference Laboratory (CRL) guidelines for the validation of screening qualitative methods. The aim of the validation was to prove sufficient sensitivity of the method to detect all the targeted antibiotics at the level of interest, generally the maximum residue limit (MRL). A robustness study was also performed to test the influence of different factors. The validation showed that the method is valid to detect and identify 73 antibiotics of the 75 antibiotics studied in meat and aquaculture products at the validation levels.

PONDS Watering System for Veggie

NASA Image and Video Library

2018-03-07

Tomato plants are growing inside a laboratory at the Space Station Processing Facility at NASA’s Kennedy Space Center in Florida. The plant growth is being tested in the Veggie Passive Orbital Nutrient Delivery System (PONDS). Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Veggie Passive Orbital Nutrient Delivery System (PONDS)

NASA Image and Video Library

2018-02-27

Project scientists, place seeds in Veggie Passive Orbital Nutrient Delivery System (PONDS) units inside a laboratory at the Space Station Processing Facility at NASA’s Kennedy Space Center in Florida. Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-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…

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

A Simple and Low-Cost Monitoring System to Investigate Environmental Conditions in a Biological Research Laboratory

PubMed Central

Gurdita, Akshay; Vovko, Heather; Ungrin, Mark

2016-01-01

Basic equipment such as incubation and refrigeration systems plays a critical role in nearly all aspects of the traditional biological research laboratory. Their proper functioning is therefore essential to ensure reliable and repeatable experimental results. Despite this fact, in many academic laboratories little attention is paid to validating and monitoring their function, primarily due to the cost and/or technical complexity of available commercial solutions. We have therefore developed a simple and low-cost monitoring system that combines a “Raspberry Pi” single-board computer with USB-connected sensor interfaces to track and log parameters such as temperature and pressure, and send email alert messages as appropriate. The system is controlled by open-source software, and we have also generated scripts to automate software setup so that no background in programming is required to install and use it. We have applied it to investigate the behaviour of our own equipment, and present here the results along with the details of the monitoring system used to obtain them. PMID:26771659

NASA-LaRc Flight-Critical Digital Systems Technology Workshop

NASA Technical Reports Server (NTRS)

Meissner, C. W., Jr. (Editor); Dunham, J. R. (Editor); Crim, G. (Editor)

1989-01-01

The outcome is documented of a Flight-Critical Digital Systems Technology Workshop held at NASA-Langley December 13 to 15 1988. The purpose of the workshop was to elicit the aerospace industry's view of the issues which must be addressed for the practical realization of flight-critical digital systems. The workshop was divided into three parts: an overview session; three half-day meetings of seven working groups addressing aeronautical and space requirements, system design for validation, failure modes, system modeling, reliable software, and flight test; and a half-day summary of the research issues presented by the working group chairmen. Issues that generated the most consensus across the workshop were: (1) the lack of effective design and validation methods with support tools to enable engineering of highly-integrated, flight-critical digital systems, and (2) the lack of high quality laboratory and field data on system failures especially due to electromagnetic environment (EME).

High-Temperature Strain Sensing for Aerospace Applications

NASA Technical Reports Server (NTRS)

Piazza, Anthony; Richards, Lance W.; Hudson, Larry D.

2008-01-01

Thermal protection systems (TPS) and hot structures are utilizing advanced materials that operate at temperatures that exceed abilities to measure structural performance. Robust strain sensors that operate accurately and reliably beyond 1800 F are needed but do not exist. These shortcomings hinder the ability to validate analysis and modeling techniques and hinders the ability to optimize structural designs. This presentation examines high-temperature strain sensing for aerospace applications and, more specifically, seeks to provide strain data for validating finite element models and thermal-structural analyses. Efforts have been made to develop sensor attachment techniques for relevant structural materials at the small test specimen level and to perform laboratory tests to characterize sensor and generate corrections to apply to indicated strains. Areas highlighted in this presentation include sensors, sensor attachment techniques, laboratory evaluation/characterization of strain measurement, and sensor use in large-scale structures.

Recovery Act. Development and Validation of an Advanced Stimulation Prediction Model for Enhanced Geothermal System

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

Gutierrez, Marte

The research project aims to develop and validate an advanced computer model that can be used in the planning and design of stimulation techniques to create engineered reservoirs for Enhanced Geothermal Systems. The specific objectives of the proposal are to: 1) Develop a true three-dimensional hydro-thermal fracturing simulator that is particularly suited for EGS reservoir creation. 2) Perform laboratory scale model tests of hydraulic fracturing and proppant flow/transport using a polyaxial loading device, and use the laboratory results to test and validate the 3D simulator. 3) Perform discrete element/particulate modeling of proppant transport in hydraulic fractures, and use the resultsmore » to improve understand of proppant flow and transport. 4) Test and validate the 3D hydro-thermal fracturing simulator against case histories of EGS energy production. 5) Develop a plan to commercialize the 3D fracturing and proppant flow/transport simulator. The project is expected to yield several specific results and benefits. Major technical products from the proposal include: 1) A true-3D hydro-thermal fracturing computer code that is particularly suited to EGS, 2) Documented results of scale model tests on hydro-thermal fracturing and fracture propping in an analogue crystalline rock, 3) Documented procedures and results of discrete element/particulate modeling of flow and transport of proppants for EGS applications, and 4) Database of monitoring data, with focus of Acoustic Emissions (AE) from lab scale modeling and field case histories of EGS reservoir creation.« less

Recovery Act. Development and Validation of an Advanced Stimulation Prediction Model for Enhanced Geothermal Systems

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

Gutierrez, Marte

2013-12-31

This research project aims to develop and validate an advanced computer model that can be used in the planning and design of stimulation techniques to create engineered reservoirs for Enhanced Geothermal Systems. The specific objectives of the proposal are to; Develop a true three-dimensional hydro-thermal fracturing simulator that is particularly suited for EGS reservoir creation; Perform laboratory scale model tests of hydraulic fracturing and proppant flow/transport using a polyaxial loading device, and use the laboratory results to test and validate the 3D simulator; Perform discrete element/particulate modeling of proppant transport in hydraulic fractures, and use the results to improve understandmore » of proppant flow and transport; Test and validate the 3D hydro-thermal fracturing simulator against case histories of EGS energy production; and Develop a plan to commercialize the 3D fracturing and proppant flow/transport simulator. The project is expected to yield several specific results and benefits. Major technical products from the proposal include; A true-3D hydro-thermal fracturing computer code that is particularly suited to EGS; Documented results of scale model tests on hydro-thermal fracturing and fracture propping in an analogue crystalline rock; Documented procedures and results of discrete element/particulate modeling of flow and transport of proppants for EGS applications; and Database of monitoring data, with focus of Acoustic Emissions (AE) from lab scale modeling and field case histories of EGS reservoir creation.« less

[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".

Development, validation and operating room-transfer of a six-step laparoscopic training program for the vesicourethral anastomosis.

PubMed

Klein, Jan; Teber, Dogu; Frede, Tom; Stock, Christian; Hruza, Marcel; Gözen, Ali; Seemann, Othmar; Schulze, Michael; Rassweiler, Jens

2013-03-01

Development and full validation of a laparoscopic training program for stepwise learning of a reproducible application of a standardized laparoscopic anastomosis technique and integration into the clinical course. The training of vesicourethral anastomosis (VUA) was divided into six simple standardized steps. To fix the objective criteria, four experienced surgeons performed the stepwise training protocol. Thirty-eight participants with no previous laparoscopic experience were investigated in their training performance. The times needed to manage each training step and the total training time were recorded. The integration into the clinical course was investigated. The training results and the corresponding steps during laparoscopic radical prostatectomy (LRP) were analyzed. Data analysis of corresponding operating room (OR) sections of 793 LRP was performed. Based on the validity, criteria were determined. In the laboratory section, a significant reduction of OR time for every step was seen in all participants. Coordination: 62%; longitudinal incision: 52%; inverted U-shape incision: 43%; plexus: 47%. Anastomosis catheter model: 38%. VUA: 38%. The laboratory section required a total time of 29 hours (minimum: 16 hours; maximum: 42 hours). All participants had shorter execution times in the laboratory than under real conditions. The best match was found within the VUA model. To perform an anastomosis under real conditions, 25% more time was needed. By using the training protocol, the performance of the VUA is comparable to that of an surgeon with experience of about 50 laparoscopic VUA. Data analysis proved content, construct, and prognostic validity. The use of stepwise training approaches enables a surgeon to learn and reproduce complex reconstructive surgical tasks: eg, the VUA in a safe environment. The validity of the designed system is given at all levels and should be used as a standard in the clinical surgical training in laparoscopic reconstructive urology.

Use of the Cultex® Radial Flow System as an in vitro exposure method to assess acute pulmonary toxicity of fine dusts and nanoparticles with special focus on the intra- and inter-laboratory reproducibility.

PubMed

Steinritz, Dirk; Möhle, Niklas; Pohl, Christine; Papritz, Mirko; Stenger, Bernhard; Schmidt, Annette; Kirkpatrick, Charles James; Thiermann, Horst; Vogel, Richard; Hoffmann, Sebastian; Aufderheide, Michaela

2013-12-05

Exposure of the respiratory tract to airborne particles (including metal-dusts and nano-particles) is considered as a serious health hazard. For a wide range of substances basic knowledge about the toxic properties and the underlying pathomechanisms is lacking or even completely missing. Legislation demands the toxicological characterization of all chemicals placed on the market until 2018 (REACH). As toxicological in vivo data are rare with regard to acute lung toxicity or exhibit distinct limitations (e.g. inter-species differences) and legislation claims the reduction of animal experiments in general ("3R" principle), profound in vitro models have to be established and characterized to meet these requirements. In this paper we characterize a recently introduced advanced in vitro exposure system (Cultex® RFS) showing a great similarity to the physiological in vivo exposure situation for the assessment of acute pulmonary toxicity of airborne materials. Using the Cultex® RFS, human lung epithelial cells (A549 cells) were exposed to different concentrations of airborne metal dusts (nano- and microscale particles) at the air-liquid-interface (ALI). Cell viability (WST-1 assay) as a parameter of toxicity was assessed 24h after exposure with special focus on the intra- and inter-laboratory (three independent laboratories) reproducibility. Our results show the general applicability of the Cultex® RFS with regard to the requirements of the ECVAM (European Centre for the Validation of Alternative Methods) principles on test validity underlining its robustness and stability. Intra- and inter-laboratory reproducibility can be considered as sufficient if predefined quality criteria are respected. Special attention must be paid to the pure air controls that turned out to be a critical parameter for a rational interpretation of the results. Our results are encouraging and future work is planned to improve the inter-laboratory reproducibility, to consolidate the results so far and to develop a valid prediction model. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Portable automated imaging in complex ceramics with a microwave interference scanning system

NASA Astrophysics Data System (ADS)

Goitia, Ryan M.; Schmidt, Karl F.; Little, Jack R.; Ellingson, William A.; Green, William; Franks, Lisa P.

2013-01-01

An improved portable microwave interferometry system has been automated to permit rapid examination of components with minimal operator attendance. Functionalities include stereo and multiplexed, frequency-modulated at multiple frequencies, producing layered volumetric images of complex ceramic structures. The technique has been used to image composite ceramic armor and ceramic matrix composite components, as well as other complex dielectric materials. The system utilizes Evisive Scan microwave interference scanning technique. Validation tests include artificial and in-service damage of ceramic armor, surrogates and ceramic matrix composite samples. Validation techniques include micro-focus x-ray and computed tomography imaging. The microwave interference scanning technique has demonstrated detection of cracks, interior laminar features and variations in material properties such as density. The image yields depth information through phase angle manipulation, and shows extent of feature and relative dielectric property information. It requires access to only one surface, and no coupling medium. Data are not affected by separation of layers of dielectric material, such as outer over-wrap. Test panels were provided by the US Army Research Laboratory, and the US Army Tank Automotive Research, Development and Engineering Center (TARDEC), who with the US Air Force Research Laboratory have supported this work.

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.

High resolution imaging

NASA Astrophysics Data System (ADS)

Goody, R.; Papaliolios, C.; Beletic, J.

1986-09-01

Diffraction-limited telescopic observations were obtained of solar system objects and a program of research into Uranus, Neptune, Pluto and the asteroids based upon the data obtained was persued. Two camera systems appropriate for this work were developed. Most importantly, the PAPA photon address camera was developed and proven. Algorithms were developed for both phase and amplitude recovery and were validated on theoretical and laboratory data and to a limited extent on telescopic data. A laboratory simulator was constructed that was used for development but is also available for controlled investigation of image reconstruction. During 1985 two successful expeditions were made to Hawaii and Cerro Tololo and a large body of data on Pluto, Uranus, Neptune and two asteroids are on tape.

High resolution imaging

NASA Technical Reports Server (NTRS)

Goody, R.; Papaliolios, C.; Beletic, J.

1986-01-01

Diffraction-limited telescopic observations were obtained of solar system objects and a program of research into Uranus, Neptune, Pluto and the asteroids based upon the data obtained was persued. Two camera systems appropriate for this work were developed. Most importantly, the PAPA photon address camera was developed and proven. Algorithms were developed for both phase and amplitude recovery and were validated on theoretical and laboratory data and to a limited extent on telescopic data. A laboratory simulator was constructed that was used for development but is also available for controlled investigation of image reconstruction. During 1985 two successful expeditions were made to Hawaii and Cerro Tololo and a large body of data on Pluto, Uranus, Neptune and two asteroids are on tape.

The Biomarker Knowledge System Informatics Pilot Project Supplement To The Biomarker Development Laboratory at Moffitt (Bedlam) — EDRN Public Portal

Cancer.gov

The Biomarker Knowledge System Informatics Pilot Project goal will develop network interfaces among databases that contain information about existing clinical populations and biospecimens and data relating to those specimens that are important in biomarker assay validation. This protocol comprises one of two that will comprise the Moffitt participation in the Biomarker Knowledge System Informatics Pilot Project. THIS PROTOCOL (58) is the Sput-Epi Database.

ARC Cell Science Validation (CS-V) Payload Overview

NASA Technical Reports Server (NTRS)

Gilkerson, Nikita

2017-01-01

Automated cell biology system for laboratory and International Space Station (ISS) National Laboratory research. Enhanced cell culture platform that provides undisturbed culture maintenance, including feedback temperature control, medical grade gas supply, perfusion nutrient delivery and removal of waste, and automated experiment manipulations. Programmable manipulations include: media feeds change out, injections, fraction collections, fixation, flow rate, and temperature modification within a one-piece sterile barrier flow path. Cassette provides 3 levels of containment and allows Crew access to the bioculture chamber and flow path assembly for experiment initiation, refurbishment, or sample retrieval and preservation.

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.

Do we really need in-situ bioassays?

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

Salazar, M.H.; Salazar, S.M.

1995-12-31

In-situ bioassays are needed to validate the results from laboratory testing and to understand biological interactions. Standard laboratory protocols provide reproducible test results, and the precision of those tests can be mathematically defined. Significant correlations between toxic substances and levels of response (bioaccumulation and bioeffects) have also been demonstrated with natural field populations and suggest that the laboratory results can accurately predict field responses. An equal number of studies have shown a lack of correlation between laboratory bioassay results and responses of natural field populations. The best way to validate laboratory results is with manipulative field testing; i.e., in-situ bioassaysmore » with caged organisms. Bioaccumulation in transplanted bivalves has probably been the most frequently used form of an in-situ bioassay. The authors have refined those methods to include synoptic measurements of bioaccumulation and growth. Growth provides an easily-measured bioeffects endpoint and a means of calibrating bioaccumulation. Emphasis has been on minimizing the size range of test animals, repetitive measurements of individuals and standardization of test protocols for a variety of applications. They are now attempting to standardize criteria for accepting and interpreting data in the same way that laboratory bioassays have been standardized. Others have developed methods for in-situ bioassays using eggs, larvae, unicellular organisms, crustaceans, benthic invertebrates, bivalves, and fish. In the final analysis, the in-situ approach could be considered as an exposure system where any clinical measurements are possible. The most powerful approach would be to use the same species in laboratory and field experiments with the same endpoints.« less

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

Koh, J. H.; Ng, E. Y. K.; Robertson, Amy

As part of a collaboration of the National Renewable Energy Laboratory (NREL) and SWAY AS, NREL installed scientific wind, wave, and motion measurement equipment on the spar-type 1/6.5th-scale prototype SWAY floating offshore wind system. The equipment enhanced SWAY's data collection and allowed SWAY to verify the concept and NREL to validate a FAST model of the SWAY design in an open-water condition. Nanyang Technological University (NTU), in collaboration with NREL, assisted with the validation. This final report gives an overview of the SWAY prototype and NREL and NTU's efforts to validate a model of the system. The report provides amore » summary of the different software tools used in the study, the modeling strategies, and the development of a FAST model of the SWAY prototype wind turbine, including justification of the modeling assumptions. Because of uncertainty in system parameters and modeling assumptions due to the complexity of the design, several system properties were tuned to better represent the system and improve the accuracy of the simulations. Calibration was performed using data from a static equilibrium test and free-decay tests.« less

Can smartwatches replace smartphones for posture tracking?

PubMed

Mortazavi, Bobak; Nemati, Ebrahim; VanderWall, Kristina; Flores-Rodriguez, Hector G; Cai, Jun Yu Jacinta; Lucier, Jessica; Naeim, Arash; Sarrafzadeh, Majid

2015-10-22

This paper introduces a human posture tracking platform to identify the human postures of sitting, standing or lying down, based on a smartwatch. This work develops such a system as a proof-of-concept study to investigate a smartwatch's ability to be used in future remote health monitoring systems and applications. This work validates the smartwatches' ability to track the posture of users accurately in a laboratory setting while reducing the sampling rate to potentially improve battery life, the first steps in verifying that such a system would work in future clinical settings. The algorithm developed classifies the transitions between three posture states of sitting, standing and lying down, by identifying these transition movements, as well as other movements that might be mistaken for these transitions. The system is trained and developed on a Samsung Galaxy Gear smartwatch, and the algorithm was validated through a leave-one-subject-out cross-validation of 20 subjects. The system can identify the appropriate transitions at only 10 Hz with an F-score of 0.930, indicating its ability to effectively replace smart phones, if needed.

Creation and Validation of Sintered PTFE BRDF Targets & Standards

PubMed Central

Durell, Christopher; Scharpf, Dan; McKee, Greg; L’Heureux, Michelle; Georgiev, Georgi; Obein, Gael; Cooksey, Catherine

2016-01-01

Sintered polytetrafluoroethylene (PTFE) is an extremely stable, near-perfect Lambertian reflecting diffuser and calibration standard material that has been used by national labs, space, aerospace and commercial sectors for over two decades. New uncertainty targets of 2 % on-orbit absolute validation in the Earth Observing Systems community have challenged the industry to improve is characterization and knowledge of almost every aspect of radiometric performance (space and ground). Assuming “near perfect” reflectance for angular dependent measurements is no longer going to suffice for many program needs. The total hemispherical spectral reflectance provides a good mark of general performance; but, without the angular characterization of bidirectional reflectance distribution function (BRDF) measurements, critical data is missing from many applications and uncertainty budgets. Therefore, traceable BRDF measurement capability is needed to characterize sintered PTFE’s angular response and provide a full uncertainty profile to users. This paper presents preliminary comparison measurements of the BRDF of sintered PTFE from several laboratories to better quantify the BRDF of sintered PTFE, assess the BRDF measurement comparability between laboratories, and improve estimates of measurement uncertainties under laboratory conditions. PMID:26900206

Creation and Validation of Sintered PTFE BRDF Targets & Standards.

PubMed

Durell, Christopher; Scharpf, Dan; McKee, Greg; L'Heureux, Michelle; Georgiev, Georgi; Obein, Gael; Cooksey, Catherine

2015-09-21

Sintered polytetrafluoroethylene (PTFE) is an extremely stable, near-perfect Lambertian reflecting diffuser and calibration standard material that has been used by national labs, space, aerospace and commercial sectors for over two decades. New uncertainty targets of 2 % on-orbit absolute validation in the Earth Observing Systems community have challenged the industry to improve is characterization and knowledge of almost every aspect of radiometric performance (space and ground). Assuming "near perfect" reflectance for angular dependent measurements is no longer going to suffice for many program needs. The total hemispherical spectral reflectance provides a good mark of general performance; but, without the angular characterization of bidirectional reflectance distribution function (BRDF) measurements, critical data is missing from many applications and uncertainty budgets. Therefore, traceable BRDF measurement capability is needed to characterize sintered PTFE's angular response and provide a full uncertainty profile to users. This paper presents preliminary comparison measurements of the BRDF of sintered PTFE from several laboratories to better quantify the BRDF of sintered PTFE, assess the BRDF measurement comparability between laboratories, and improve estimates of measurement uncertainties under laboratory conditions.

HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance.

PubMed

Carozzi, Francesca Maria; Del Mistro, Annarosa; Cuschieri, Kate; Frayle, Helena; Sani, Cristina; Burroni, Elena

2016-03-01

This review aims to highlight the importance of Quality Assurance for Laboratories performing HPV test for Cervical Cancer Screening. An HPV test, to be used as primary screening test, must be validated according to international criteria, based on comparison of its clinical accuracy to HC2 or GP5+/6+ PCR-EIA tests. The number of validated platforms is increasing and appropriate Quality Assurance Programs (QAPs) which can interrogate longitudinal robustness and quality are paramount. This document describes the following topics: (1) the characteristics of an HPV laboratory and the personnel training needs, to ensure an elevated quality of the entire process and the optimal use of the resources; (2) the Quality Assurance, as both internal (IQA) and external quality assessment (EQA) systems, to be implemented and performed, and the description of the existing EQAs, including limitations; (3) general considerations for an optimal EQA program for hrHPV primary screening Due to the importance of Quality Assurance for this field, international efforts are necessary to improve QA International Collaboration. Copyright © 2015 Elsevier B.V. All rights reserved.

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.

Cold Climate Foundation Retrofit Experimental Hygrothermal Performance. Cloquet Residential Research Facility Laboratory Results

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

Goldberg, Louise F.; Harmon, Anna C.

2015-04-09

This project was funded jointly by the National Renewable Energy Laboratory (NREL) and Oak Ridge National Laboratory (ORNL). ORNL focused on developing a full basement wall system experimental database to enable others to validate hygrothermal simulation codes. NREL focused on testing the moisture durability of practical basement wall interior insulation retrofit solutions for cold climates. The project has produced a physically credible and reliable long-term hygrothermal performance database for retrofit foundation wall insulation systems in zone 6 and 7 climates that are fully compliant with the performance criteria in the 2009 Minnesota Energy Code. These data currently span the periodmore » from November 10, 2012 through May 31, 2014 and are anticipated to be extended through November 2014. The experimental data were configured into a standard format that can be published online and that is compatible with standard commercially available spreadsheet and database software.« less

PR-PR: Cross-Platform Laboratory Automation System

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

Linshiz, G; Stawski, N; Goyal, G

To enable protocol standardization, sharing, and efficient implementation across laboratory automation platforms, we have further developed the PR-PR open-source high-level biology-friendly robot programming language as a cross-platform laboratory automation system. Beyond liquid-handling robotics, PR-PR now supports microfluidic and microscopy platforms, as well as protocol translation into human languages, such as English. While the same set of basic PR-PR commands and features are available for each supported platform, the underlying optimization and translation modules vary from platform to platform. Here, we describe these further developments to PR-PR, and demonstrate the experimental implementation and validation of PR-PR protocols for combinatorial modified Goldenmore » Gate DNA assembly across liquid-handling robotic, microfluidic, and manual platforms. To further test PR-PR cross-platform performance, we then implement and assess PR-PR protocols for Kunkel DNA mutagenesis and hierarchical Gibson DNA assembly for microfluidic and manual platforms.« less

Towards a laboratory breadboard for PEGASE, the DARWIN pathfinder

NASA Astrophysics Data System (ADS)

Cassaing, F.; Le Duigou, J.-M.; Sorrente, B.; Fleury, B.; Gorius, N.; Brachet, F.; Buisset, C.; Ollivier, M.; Hénault, F.; Mourard, D.; Rabbia, Y.; Delpech, M.; Guidotti, P.-Y.; Léger, A.; Barillot, M.; Rouan, D.; Rousset, G.

2017-11-01

PEGASE, a spaceborne mission proposed to the CNES, is a 2-aperture interferometer for nulling and interferometric imaging. PEGASE is composed of 3 free-flying satellites (2 siderostats and 1 beam combiner) with baselines from 50 to 500 m. The goals of PEGASE are the spectroscopy of hot Jupiter (Pegasides) and brown dwarves, the exploration of the inner part of protoplanetary disks and the validation in real space conditions of nulling and visibility interferometry with formation flying. During a phase-0 study performed in 2005 at CNES, ONERA and in the laboratories, the critical subsystems of the optical payload have been investigated and a preliminary system integration has been performed. These subsystems are mostly the broadband (2.5-5 μm) nuller and the cophasing system (visible) dedicated to the real-time control of the OPD/tip/tilt inside the payload. A laboratory breadboard of the payload is under definition and should be built in 2007.

PR-PR: cross-platform laboratory automation system.

PubMed

Linshiz, Gregory; Stawski, Nina; Goyal, Garima; Bi, Changhao; Poust, Sean; Sharma, Monica; Mutalik, Vivek; Keasling, Jay D; Hillson, Nathan J

2014-08-15

To enable protocol standardization, sharing, and efficient implementation across laboratory automation platforms, we have further developed the PR-PR open-source high-level biology-friendly robot programming language as a cross-platform laboratory automation system. Beyond liquid-handling robotics, PR-PR now supports microfluidic and microscopy platforms, as well as protocol translation into human languages, such as English. While the same set of basic PR-PR commands and features are available for each supported platform, the underlying optimization and translation modules vary from platform to platform. Here, we describe these further developments to PR-PR, and demonstrate the experimental implementation and validation of PR-PR protocols for combinatorial modified Golden Gate DNA assembly across liquid-handling robotic, microfluidic, and manual platforms. To further test PR-PR cross-platform performance, we then implement and assess PR-PR protocols for Kunkel DNA mutagenesis and hierarchical Gibson DNA assembly for microfluidic and manual platforms.

Infrastructure for Personalized Medicine at Partners HealthCare

PubMed Central

Weiss, Scott T.; Shin, Meini Sumbada

2016-01-01

Partners HealthCare Personalized Medicine (PPM) is a center within the Partners HealthCare system (founded by Massachusetts General Hospital and Brigham and Women’s Hospital) whose mission is to utilize genetics and genomics to improve the care of patients in a cost effective manner. PPM consists of five interconnected components: (1) Laboratory for Molecular Medicine (LMM), a CLIA laboratory performing genetic testing for patients world-wide; (2) Translational Genomics Core (TGC), a core laboratory providing genomic platforms for Partners investigators; (3) Partners Biobank, a biobank of samples (DNA, plasma and serum) for 50,000 Consented Partners patients; (4) Biobank Portal, an IT infrastructure and viewer to bring together genotypes, samples, phenotypes (validated diagnoses, radiology, and clinical chemistry) from the electronic medical record to Partners investigators. These components are united by (5) a common IT system that brings researchers, clinicians, and patients together for optimal research and patient care. PMID:26927187

The Midland fiber-optic analog transmission system development project (FATS)

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

Baumgart, J.S.; Anaya, R.; Morris, G.

1988-07-01

This report was written to document the overall effort related to the development and testing of the various components comprising the fiber optic analog transmission system (FATS) and to the validation of the FATS itself. The overall project was approached as a joint effort between the Los Alamos National Laboratory; the Atomic Weapons Research Establishment (AWRE); and EGandG Energy Measurements. The ultimate goal of the project was to develop a system, based on laser diodes and a streak camera system, to measure alpha. Although the FATS was not fielded on the MIDLAND event, in the course of the project wemore » did in fact answer technology questions identified on previous experiments and develop a better understanding of system needs. We hope that the information contained in this report will provide a basis for planning future experiments, as well as defining the direction for additional laboratory measurements. 94 figs.« less

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 changed to strengthen HER2 validation practices.

Seed Placement into Veggie Pods

NASA Image and Video Library

2018-02-27

Veggie Passive Orbital Nutrient Delivery System (PONDS) units are being prepared for seed planting inside a laboratory at the Space Station Processing Facility at NASA's Kennedy Space Center in Florida. Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Seed Placement into Veggie Pods

NASA Image and Video Library

2018-02-27

Seeds are being planted in Veggie Passive Orbital Nutrient Delivery System (PONDS) units inside a laboratory at the Space Station Processing Facility at NASA’s Kennedy Space Center in Florida. Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Laboratory Validation of the Sand Fly Fever Virus Antigen Assay

DTIC Science & Technology

2015-12-01

several commercially available assays from VecTOR Test Systems Inc. for malaria, West Nile virus, Rift Valley fever virus, dengue , chikungunya, and...Sabin AB. 1955. Recent advances in our knowledge of dengue and sandfly fever. Am J Trop Med Hyg 4:198–207. Sather GE. 1970. Catalogue of arthropod

SATURATION MEASUREMENT OF IMMISCIBLE FLUIDS IN 2-D STATIC SYSTEMS: VALIDATION BY LIGHT TRANSMISSION VISUALIZATION (SAN FRANCISCO, CA)

EPA Science Inventory

This study is a part of an ongoing research project that aims at assessing the environmental benefits of DNAPL removal. The laboratory part of the research project is to examine the functional relationship between DNAPL architecture, mass removal and contaminant mass flux in 2-D ...

Analysis of Bright Harvest Remote Analysis for Residential Solar Installations

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

Nangle, John; Simon, Joseph

Bright Harvest provides remote shading analysis and design products for residential PV system installers. The National Renewable Energy Laboratory (NREL) through the NREL Commercialization Assistance Program, completed comparative assessments between on-site measurements and remotely calculated values to validate the accuracy of Bright Harvest’s remote shading and power generation.

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

PubMed

Tazawa, Yoshiaki

2016-01-01

On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.

Direct total and free testosterone measurement by liquid chromatography tandem mass spectrometry across two different platforms.

PubMed

Rhea, Jeanne M; French, Deborah; Molinaro, Ross J

2013-05-01

To develop and validate liquid chromatography tandem mass spectrometry (LC-MS/MS) methods for the direct measurement of total and free testosterone in patient samples on two different analytical systems. An API 4000 and 5000 triple quadropoles were used and compared; the former is reported to be 3-5 times less sensitive, as was used to set the quantitation limits. Free testosterone was separated from the protein-bound fraction by equilibrium dialysis followed by derivatization. Either free or total testosterone, and a deuterated internal standard (d3-testosterone) were extracted by liquid-liquid extraction. The validation results were compared to two different clinical laboratories. The use of d2-testosterone was found to be unacceptable for our method. The total testosterone LC-MS/MS methods on both systems were linear over a wide concentration range of 1.5-2000ng/dL. Free testosterone was measured directly using equilibrium dialysis coupled LC-MS/MS and linear over the concentration range of 2.5-2500pg/mL. Good correlation (total testosterone, R(2)=0.96; free testosterone, R(2)=0.98) was observed between our LC-MS/MS systems and comparator laboratory. However, differences in absolute values for both free and total testosterone measurements were observed while a comparison to a second published LC-MS/MS method showed excellent correlation. Free and total testosterone measurements correlated well with clinical observations. To our knowledge, this is the first published validation of free and total testosterone methods across two analytical systems of different analytical sensitivities. A less sensitive system does not sacrifice analytical or clinical sensitivity to directly measure free and total testosterone in patient samples. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Evolution of an International External Quality Assurance Model To Support Laboratory Investigation of Streptococcus pneumoniae, Developed for the SIREVA Project in Latin America, from 1993 to 2005▿

PubMed Central

Lovgren, Marguerite; Talbot, James A.; Brandileone, Maria Cristina; Casagrande, Silvana T.; Agudelo, Clara Inés; Castañeda, Elizabeth; Regueira, Mabel; Corso, Alejandra; Heitmann, Ingrid; Maldonado, Aurora; Echániz-Avilés, Gabriela; Soto-Noguerón, Araceli; Hortal, María; Camou, Teresa; Gabastou, Jean-Marc; Fabio, José Luis Di

2007-01-01

In 1993 the Pan American Health Organization initiated a laboratory-based surveillance system, called the SIREVA project, to learn about Streptococcus pneumoniae invasive disease in Latin American children. In 1994, National Laboratories in six countries were trained to perform serotyping and antibiotic susceptibility testing using broth microdilution to determine the MIC for specified antibiotics. An international External Quality Assurance (EQA) program was developed to monitor and support ongoing laboratory performance. The EQA program was coordinated by the National Centre for Streptococcus (NCS), Edmonton, Canada, and included external proficiency testing (EPT) and a validation process requiring regular submission of a sample of isolates from each laboratory to the NCS for verification of the serotype and MIC. In 1999, the EQA program was decentralized to use three of the original laboratories as regional quality control centers to address operational concerns and to accommodate the growth of the laboratory network to more than 20 countries including the Caribbean region. The overall EPT serotyping accuracies for phase I (1993 to 1998) and phase II (1999 to 2005) were 88.0 and 93.8%, respectively; the MIC correlations within ±1 log2 dilution of the expected result were 83.0 and 91.0% and the interpretive category agreements were 89.1 and 95.3%. Overall, the validation process serotyping accuracies for phases I and II were 81.9 and 88.1%, respectively, 80.4 and 90.5% for MIC agreement, and 85.8 and 94.3% for category agreement. These results indicate a high level of testing accuracy in participating National Laboratories and a sustained increase in EQA participation in Latin America and the Caribbean. PMID:17687007

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 categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

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.

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.

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

[Monitoring nosocomial infections using a laboratory-based system].

PubMed

Montella, F; Gallo, S; Leacche, G; Macchia, G

1998-01-01

In this paper we report the results of a nosocomial infections surveillance system "Laboratory Based". The system started in August 1995 at San Giovanni Hospital, Rome. All the specimens sent to the Microbiology Laboratory have been registered using a computerized input form. 12,204 forms, attributable to patients between 0 and 97 years (median 43 years) resulted evaluable. The global rate of incidence of nosocomial infection was, in the study period, 16 per one thousand person/day. The rate of incidence, when stratified for the medical, surgical and emergency boards, was, respectively, 19 per one thousand person/day in the medical facilities, 15 per one thousand person/day in surgical and 17 per one thousand person/year in emergency facilities. The nosocomial infections incidence correlated well with the age of the patients and the time of bed stay. The bulk of infections were localized to the respiratory apparatus. Localization to urinary apparatus and sepsis follow. The isolated microbes were (38%) gram-negative microbes; the 38% of the isolates are gram-negative microbes and the 24% are Mycetes. Our data validate the surveillance system in a great hospital of Rome metropolitan area.

Technology readiness levels for the new millennium program

NASA Technical Reports Server (NTRS)

Moynihan, P. I.; Minning, C. P.; Stocky, J. F.

2003-01-01

NASA's New Millennium Program (NMP) seeks to advance space exploration by providing an in-space validating mechanism to verify the maturity of promising advanced technologies that cannot be adequately validated with Earth-based testing alone. In meeting this objective, NMP uses NASA Technology Readiness Levels (TRL) as key indicators of technology advancement and assesses development progress against this generalized metric. By providing an opportunity for in-space validation, NMP can mature a suitable advanced technology from TRL 4 (component and/or breadboard validation in laboratory environment) to a TRL 7 (system prototype demonstrated in an Earth-based space environment). Spaceflight technology comprises a myriad of categories, types, and functions, and as each individual technology emerges, a consistent interpretation of its specific state of technological advancement relative to other technologies is problematic.

Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.

PubMed

Rebelo, Sofia P; Dehne, Eva-Maria; Brito, Catarina; Horland, Reyk; Alves, Paula M; Marx, Uwe

2016-01-01

Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stability for longer periods of time. The reproducibility attained with bioreactor operations is, per se, an advantage for the validation of safety assessment. Regulatory agencies have gradually altered the validation concept from exhaustive "product" to rigorous and detailed process characterization, valuing reproducibility as a standard for validation. "Human-on-a-chip" technologies applying micro-physiological systems to the in vitro combination of miniaturized human organ equivalents into functional human micro-organisms are nowadays thought to be the most elaborate solution created to date. They target the replacement of the current most complex models-laboratory animals. Therefore, we provide here a road map towards the validation of such "human-on-a-chip" models and qualification of their respective bioreactor and microchip equipment along a path currently used for the respective animal models.

Intergrated Systems Biology Approach for Ovarian Cancer Biomarker Discovery — EDRN Public Portal

Cancer.gov

The overall objective is to validate serum protein markers for early diagnosis of ovarian cancer with the ultimate goal being to develop a multiparametric panel consisting of 2-4 novel markers with 10 known markers for phase 3 analysis. In phase 1, we will screen for markers able to pass a threshold of 98% specificity and 30% sensitivity in a cohort of 300 women. Markers that pass phase 1 validation will be investigated in a phase 2 PRoBE cohort with a 98% specificity and 70% sensitivity cut-off. Finally, markers that pass phase 2 validation will be evaluated in EDRN CVC laboratory specimens with a cut-off of > 98% specificity and 90% sensitivity.

PONDS Watering System for Veggie

NASA Image and Video Library

2018-03-07

Tomato plants are growing under red and blue LED lights in a growth chamber inside a laboratory at the Space Station Processing Facility at NASA’s Kennedy Space Center in Florida. The plant growth is being tested in the Veggie Passive Orbital Nutrient Delivery System (PONDS). Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

PONDS Watering System for Veggie

NASA Image and Video Library

2018-03-07

Howard Levine, Ph.D., a research scientist at NASA's Kennedy Space Center in Florida, reviews the growth of several tomato plants in a laboratory in the Space Station Processing Facility. The tomato plants are growing in the Veggie Passive Orbital Nutrient Delivery System (PONDS). Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Characterisation methods for the hyperspectral sensor HySpex at DLR's calibration home base

NASA Astrophysics Data System (ADS)

Baumgartner, Andreas; Gege, Peter; Köhler, Claas; Lenhard, Karim; Schwarzmaier, Thomas

2012-09-01

The German Aerospace Center's (DLR) Remote Sensing Technology Institute (IMF) operates a laboratory for the characterisation of imaging spectrometers. Originally designed as Calibration Home Base (CHB) for the imaging spectrometer APEX, the laboratory can be used to characterise nearly every airborne hyperspectral system. Characterisation methods will be demonstrated exemplarily with HySpex, an airborne imaging spectrometer system from Norsk Elektro Optikks A/S (NEO). Consisting of two separate devices (VNIR-1600 and SWIR-320me) the setup covers the spectral range from 400 nm to 2500 nm. Both airborne sensors have been characterised at NEO. This includes measurement of spectral and spatial resolution and misregistration, polarisation sensitivity, signal to noise ratios and the radiometric response. The same parameters have been examined at the CHB and were used to validate the NEO measurements. Additionally, the line spread functions (LSF) in across and along track direction and the spectral response functions (SRF) for certain detector pixels were measured. The high degree of lab automation allows the determination of the SRFs and LSFs for a large amount of sampling points. Despite this, the measurement of these functions for every detector element would be too time-consuming as typical detectors have 105 elements. But with enough sampling points it is possible to interpolate the attributes of the remaining pixels. The knowledge of these properties for every detector element allows the quantification of spectral and spatial misregistration (smile and keystone) and a better calibration of airborne data. Further laboratory measurements are used to validate the models for the spectral and spatial properties of the imaging spectrometers. Compared to the future German spaceborne hyperspectral Imager EnMAP, the HySpex sensors have the same or higher spectral and spatial resolution. Therefore, airborne data will be used to prepare for and validate the spaceborne system's data.

Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.

PubMed

Patel, Jayshree; Mulhall, Brian; Wolf, Heinz; Klohr, Steven; Guazzo, Dana Morton

2011-01-01

A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product in a parenteral vial package system. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Method development and optimization challenge studies incorporated artificially defective packages representing a range of glass vial wall and sealing surface defects, as well as various elastomeric stopper defects. Method validation required 3 days of random-order replicate testing of a test sample population of negative-control, no-defect packages and positive-control, with-defect packages. Positive-control packages were prepared using vials each with a single hole laser-drilled through the glass vial wall. Hole creation and hole size certification was performed by Lenox Laser. Validation study results successfully demonstrated the vacuum decay leak test method's ability to accurately and reliably detect those packages with laser-drilled holes greater than or equal to approximately 5 μm in nominal diameter. All development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work. A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated to detect defects in stoppered vial packages containing lyophilized product for injection. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Test method validation study results proved the method capable of detecting holes laser-drilled through the glass vial wall greater than or equal to 5 μm in nominal diameter. Total test time is less than 1 min per package. All method development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work.

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.

Space research on organs and tissues

NASA Technical Reports Server (NTRS)

Tischler, Marc E.; Morey-Holton, Emily

1992-01-01

The effects of microgravity on various physiological systems are reviewed focusing on muscle, bone, cardiovascular, pulmonary, neurovestibular, liver, and endocrine systems. It is noted that certain alterations of organs and tissues caused by microgravity are not reproducible in earth-bound animal or human models. Thus space research on organs and tissues is essential for both validating the earth-bound models used in laboratories and studying the adaptations to weightlessness which cannot be mimicked on earth.

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 Clinical Oncology/College of American Pathologists guidelines have been implemented, gaps remain in validation of HER2 IHC testing.

Developmental validation of the PowerPlex(®) Fusion 6C System.

PubMed

Ensenberger, Martin G; Lenz, Kristy A; Matthies, Learden K; Hadinoto, Gregory M; Schienman, John E; Przech, Angela J; Morganti, Michael W; Renstrom, Daniel T; Baker, Victoria M; Gawrys, Kori M; Hoogendoorn, Marlijn; Steffen, Carolyn R; Martín, Pablo; Alonso, Antonio; Olson, Hope R; Sprecher, Cynthia J; Storts, Douglas R

2016-03-01

The PowerPlex(®) Fusion 6C System is a 27-locus, six-dye, multiplex that includes all markers in the expanded CODIS core loci and increases overlap with STR database standards throughout the world. Additionally, it contains two, rapidly mutating, Y-STRs and is capable of both casework and database workflows, including direct amplification. A multi-laboratory developmental validation study was performed on the PowerPlex(®) Fusion 6C System. Here, we report the results of that study which followed SWGDAM guidelines and includes data for: species specificity, sensitivity, stability, precision, reproducibility and repeatability, case-type samples, concordance, stutter, DNA mixtures, and PCR-based procedures. Where appropriate we report data from both extracted DNA samples and direct amplification samples from various substrates and collection devices. Samples from all studies were separated on both Applied Biosystems 3500 series and 6-dye capable 3130 series Genetic Analyzers and data is reported for each. Together, the data validate the design and demonstrate the performance of the PowerPlex(®) Fusion 6C System. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Cooperative Collision Avoidance Technology Demonstration Data Analysis Report

NASA Technical Reports Server (NTRS)

2007-01-01

This report details the National Aeronautics and Space Administration (NASA) Access 5 Project Office Cooperative Collision Avoidance (CCA) Technology Demonstration for unmanned aircraft systems (UAS) conducted from 21 to 28 September 2005. The test platform chosen for the demonstration was the Proteus Optionally Piloted Vehicle operated by Scaled Composites, LLC, flown out of the Mojave Airport, Mojave, CA. A single intruder aircraft, a NASA Gulf stream III, was used during the demonstration to execute a series of near-collision encounter scenarios. Both aircraft were equipped with Traffic Alert and Collision Avoidance System-II (TCAS-II) and Automatic Dependent Surveillance Broadcast (ADS-B) systems. The objective of this demonstration was to collect flight data to support validation efforts for the Access 5 CCA Work Package Performance Simulation and Systems Integration Laboratory (SIL). Correlation of the flight data with results obtained from the performance simulation serves as the basis for the simulation validation. A similar effort uses the flight data to validate the SIL architecture that contains the same sensor hardware that was used during the flight demonstration.

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.

Introduction of the Bethesda System to Mainland China with a Web-based tutorial.

PubMed

Yuan, Qin; Chang, Alexander Russell; Ng, Ho Keung

2003-01-01

To validate the use of a Web-based tutorial to introduce the Bethesda System (TBS) to Mainland Chinese laboratories. Digitized color images of the diagnostic features in 20 Pap smears were displayed on a Web page. Participants were asked to give each smear a diagnosis using the reporting nomenclature employed in their laboratory or one that was familiar to them. This was followed by teaching images of each smear accompanied by text in English and Chinese that highlighted important features for making a diagnosis using TBS. Participants then reviewed the 20 original Pap smears and rendered a diagnosis using TBS. Pathologists and cytotechnologists at 17 laboratories located in 10 cities completed the exercise. The average diagnostic accuracy for the 20 Pap smears before and after the tutorial was 76% and 88%, respectively. Web-based tutorials can be used for disseminating cytologic information to widely dispersed laboratories in China and help enhance the practice of cytology, currently an underutilized diagnostic technique. However, such difficulties as lack of Internet connections in the laboratory, outdated computers and a lack of interest in cytology need to be overcome to ensure success.

Development of analytical methodologies to assess recalcitrant pesticide bioremediation in biobeds at laboratory scale.

PubMed

Rivero, Anisleidy; Niell, Silvina; Cerdeiras, M Pía; Heinzen, Horacio; Cesio, María Verónica

2016-06-01

To assess recalcitrant pesticide bioremediation it is necessary to gradually increase the complexity of the biological system used in order to design an effective biobed assembly. Each step towards this effective biobed design needs a suitable, validated analytical methodology that allows a correct evaluation of the dissipation and bioconvertion. Low recovery yielding methods could give a false idea of a successful biodegradation process. To address this situation, different methods were developed and validated for the simultaneous determination of endosulfan, its main three metabolites, and chlorpyrifos in increasingly complex matrices where the bioconvertor basidiomycete Abortiporus biennis could grow. The matrices were culture media, bran, and finally a laboratory biomix composed of bran, peat and soil. The methodology for the analysis of the first evaluated matrix has already been reported. The methodologies developed for the other two systems are presented in this work. The targeted analytes were extracted from fungi growing over bran in semisolid media YNB (Yeast Nitrogen Based) with acetonitrile using shaker assisted extraction, The salting-out step was performed with MgSO4 and NaCl, and the extracts analyzed by GC-ECD. The best methodology was fully validated for all the evaluated analytes at 1 and 25mgkg(-1) yielding recoveries between 72% and 109% and RSDs <11% in all cases. The application of this methodology proved that A. biennis is able to dissipate 94% of endosulfan and 87% of chlorpyrifos after 90 days. Having assessed that A. biennis growing over bran can metabolize the studied pesticides, the next step faced was the development and validation of an analytical procedure to evaluate the analytes in a laboratory scale biobed composed of 50% of bran, 25% of peat and 25% of soil together with fungal micelium. From the different procedures assayed, only ultrasound assisted extraction with ethyl acetate allowed recoveries between 80% and 110% with RSDs <18%. Linearity, recovery, precision, matrix effect and LODs/LOQs of each method were studied for all the analytes: endosulfan isomers (α & β) and its metabolites (endosulfan sulfate, ether and diol) as well as for chlorpyrifos. In the first laboratory evaluation of these biobeds endosulfan was bioconverted up to 87% and chlorpyrifos more than 79% after 27 days. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

Telepathology in cytopathology: challenges and opportunities.

PubMed

Collins, Brian T

2013-01-01

Telepathology in cytopathology is becoming more commonly utilized, and newer technologic infrastructures afford the laboratory a variety of options. The options and design of a telepathology system are driven by the clinical needs. This is primarily focused on providing rapid on-site evaluation service for fine needle aspiration. The clinical requirements and needs of a system are described. Available tools to design and implement a telepathology system are covered, including methods of image capture, network connectivity and remote viewing options. The primary telepathology method currently used and described involves the delivery via a network connection of a live video image to a remote site which is passively viewed by an internet web-based browser. By utilizing live video information and a voice connection to the on-site location, the remote viewer can collect clinical information and direct their view of the slides. Telepathology systems for use in cytopathology can be designed and implemented with commercially available infrastructure. It is necessary for the laboratory to validate the designed system and adhere to the required regulatory requirements. Telepathology for cytopathology can be reliably utilized by adapting existing technology, and newer advances hold great promise for further applications in the cytopathology laboratory. Copyright © 2013 S. Karger AG, Basel.

Building a Better Grid, in Partnership with the OMNETRIC Group and Siemens

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

Waight, Jim; Grover, Shailendra; Wiedetz, Clark

In collaboration with Siemens and the National Renewable Energy Laboratory (NREL), OMNETRIC Group developed a distributed control hierarchy—based on an open field message bus (OpenFMB) framework—that allows control decisions to be made at the edge of the grid. The technology was validated and demonstrated at NREL’s Energy Systems Integration Facility.

Flight instrument and telemetry response and its inversion

NASA Technical Reports Server (NTRS)

Weinberger, M. R.

1971-01-01

Mathematical models of rate gyros, servo accelerometers, pressure transducers, and telemetry systems were derived and their parameters were obtained from laboratory tests. Analog computer simulations were used extensively for verification of the validity for fast and large input signals. An optimal inversion method was derived to reconstruct input signals from noisy output signals and a computer program was prepared.

Application of the BioMek 2000 Laboratory Automation Workstation and the DNA IQ System to the extraction of forensic casework samples.

PubMed

Greenspoon, Susan A; Ban, Jeffrey D; Sykes, Karen; Ballard, Elizabeth J; Edler, Shelley S; Baisden, Melissa; Covington, Brian L

2004-01-01

Robotic systems are commonly utilized for the extraction of database samples. However, the application of robotic extraction to forensic casework samples is a more daunting task. Such a system must be versatile enough to accommodate a wide range of samples that may contain greatly varying amounts of DNA, but it must also pose no more risk of contamination than the manual DNA extraction methods. This study demonstrates that the BioMek 2000 Laboratory Automation Workstation, used in combination with the DNA IQ System, is versatile enough to accommodate the wide range of samples typically encountered by a crime laboratory. The use of a silica coated paramagnetic resin, as with the DNA IQ System, facilitates the adaptation of an open well, hands off, robotic system to the extraction of casework samples since no filtration or centrifugation steps are needed. Moreover, the DNA remains tightly coupled to the silica coated paramagnetic resin for the entire process until the elution step. A short pre-extraction incubation step is necessary prior to loading samples onto the robot and it is at this step that most modifications are made to accommodate the different sample types and substrates commonly encountered with forensic evidentiary samples. Sexual assault (mixed stain) samples, cigarette butts, blood stains, buccal swabs, and various tissue samples were successfully extracted with the BioMek 2000 Laboratory Automation Workstation and the DNA IQ System, with no evidence of contamination throughout the extensive validation studies reported here.

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

A method trial was initiated to validate the use of a commercial DNA forensic kit to extract DNA from animal feed as part of a PCR-based method. Four different PCR primer pairs (one bovine pair, one porcine pair, one ovine primer pair, and one multispecies pair) were also evaluated. Each laboratory was required to analyze a total of 120 dairy feed samples either not fortified (control, true negative) or fortified with bovine meat and bone meal, porcine meat and bone meal (PMBM), or lamb meal. Feeds were fortified with the animal meals at a concentration of 0.1% (wt/wt). Ten laboratories participated in this trial, and each laboratory was required to evaluate two different primer pairs, i.e., each PCR primer pair was evaluated by five different laboratories. The method was considered to be validated for a given animal source when three or more laboratories achieved at least 97% accuracy (29 correct of 30 samples for 96.7% accuracy, rounded up to 97%) in detecting the fortified samples for that source. Using this criterion, the method was validated for the bovine primer because three laboratories met the criterion, with an average accuracy of 98.9%. The average false-positive rate was 3.0% in these laboratories. A fourth laboratory was 80% accurate in identifying the samples fortified with bovine meat and bone meal. A fifth laboratory was not able to consistently extract the DNA from the feed samples and did not achieve the criterion for accuracy for either the bovine or multispecies PCR primers. For the porcine primers, the method was validated, with four laboratories meeting the criterion for accuracy with an average accuracy of 99.2%. The fifth laboratory had a 93.3% accuracy outcome for the porcine primer. Collectively, these five laboratories had a 1.3% false-positive rate for the porcine primer. No laboratory was able to meet the criterion for accuracy with the ovine primers, most likely because of problems with the synthesis of the primer pair; none of the 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.

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

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.

Benefits of an automated GLP final report preparation software solution.

PubMed

Elvebak, Larry E

2011-07-01

The final product of analytical laboratories performing US FDA-regulated (or GLP) method validation and bioanalysis studies is the final report. Although there are commercial-off-the-shelf (COTS) software/instrument systems available to laboratory managers to automate and manage almost every aspect of the instrumental and sample-handling processes of GLP studies, there are few software systems available to fully manage the GLP final report preparation process. This lack of appropriate COTS tools results in the implementation of rather Byzantine and manual processes to cobble together all the information needed to generate a GLP final report. The manual nature of these processes results in the need for several iterative quality control and quality assurance events to ensure data accuracy and report formatting. The industry is in need of a COTS solution that gives laboratory managers and study directors the ability to manage as many portions as possible of the GLP final report writing process and the ability to generate a GLP final report with the click of a button. This article describes the COTS software features needed to give laboratory managers and study directors such a solution.

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.

Validity and repeatability of inertial measurement units for measuring gait parameters.

PubMed

Washabaugh, Edward P; Kalyanaraman, Tarun; Adamczyk, Peter G; Claflin, Edward S; Krishnan, Chandramouli

2017-06-01

Inertial measurement units (IMUs) are small wearable sensors that have tremendous potential to be applied to clinical gait analysis. They allow objective evaluation of gait and movement disorders outside the clinic and research laboratory, and permit evaluation on large numbers of steps. However, repeatability and validity data of these systems are sparse for gait metrics. The purpose of this study was to determine the validity and between-day repeatability of spatiotemporal metrics (gait speed, stance percent, swing percent, gait cycle time, stride length, cadence, and step duration) as measured with the APDM Opal IMUs and Mobility Lab system. We collected data on 39 healthy subjects. Subjects were tested over two days while walking on a standard treadmill, split-belt treadmill, or overground, with IMUs placed in two locations: both feet and both ankles. The spatiotemporal measurements taken with the IMU system were validated against data from an instrumented treadmill, or using standard clinical procedures. Repeatability and minimally detectable change (MDC) of the system was calculated between days. IMUs displayed high to moderate validity when measuring most of the gait metrics tested. Additionally, these measurements appear to be repeatable when used on the treadmill and overground. The foot configuration of the IMUs appeared to better measure gait parameters; however, both the foot and ankle configurations demonstrated good repeatability. In conclusion, the IMU system in this study appears to be both accurate and repeatable for measuring spatiotemporal gait parameters in healthy young adults. Copyright © 2017 Elsevier B.V. All rights reserved.

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

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.

Seed Placement into Veggie Pods

NASA Image and Video Library

2018-02-27

From left, Matthew Romeyn and Dr. Ye Zhang, project scientists, place seeds in Veggie Passive Orbital Nutrient Delivery System (PONDS) units inside a laboratory at the Space Station Processing Facility at NASA’s Kennedy Space Center in Florida. Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Seed Placement into Veggie Pods

NASA Image and Video Library

2018-02-27

Dr. Ye Zhang, a project scientists, places seeds in Veggie Passive Orbital Nutrient Delivery System (PONDS) units inside a laboratory at the Space Station Processing Facility at NASA's Kennedy Space Center in Florida. Veggie PONDS is a direct follow-on to the Veg-01 and Veg-03 hardware and plant growth validation tests. The primary goal of this newly developed plant growing system, Veggie PONDS, is to demonstrate uniform plant growth. PONDS units have features that are designed to mitigate microgravity effects on water distribution, increase oxygen exchange and provide sufficient room for root zone growth. PONDS is planned for use during Veg-04 and Veg-05 on the International Space Station after the Veggie PONDS Validation flights on SpaceX-14 and OA-9.

Validation of an automated system for aliquoting of HIV-1 Env-pseudotyped virus stocks.

PubMed

Schultz, Anke; Germann, Anja; Fuss, Martina; Sarzotti-Kelsoe, Marcella; Ozaki, Daniel A; Montefiori, David C; Zimmermann, Heiko; von Briesen, Hagen

2018-01-01

The standardized assessments of HIV-specific immune responses are of main interest in the preclinical and clinical stage of HIV-1 vaccine development. In this regard, HIV-1 Env-pseudotyped viruses play a central role for the evaluation of neutralizing antibody profiles and are produced according to Good Clinical Laboratory Practice- (GCLP-) compliant manual and automated procedures. To further improve and complete the automated production cycle an automated system for aliquoting HIV-1 pseudovirus stocks has been implemented. The automation platform consists of a modified Tecan-based system including a robot platform for handling racks containing 48 cryovials, a Decapper, a tubing pump and a safety device consisting of ultrasound sensors for online liquid level detection of each individual cryovial. With the aim to aliquot the HIV-1 pseudoviruses in an automated manner under GCLP-compliant conditions a validation plan was developed where the acceptance criteria-accuracy, precision as well as the specificity and robustness-were defined and summarized. By passing the validation experiments described in this article the automated system for aliquoting has been successfully validated. This allows the standardized and operator independent distribution of small-scale and bulk amounts of HIV-1 pseudovirus stocks with a precise and reproducible outcome to support upcoming clinical vaccine trials.

Validation of an automated system for aliquoting of HIV-1 Env-pseudotyped virus stocks

PubMed Central

Schultz, Anke; Germann, Anja; Fuss, Martina; Sarzotti-Kelsoe, Marcella; Ozaki, Daniel A.; Montefiori, David C.; Zimmermann, Heiko

2018-01-01

The standardized assessments of HIV-specific immune responses are of main interest in the preclinical and clinical stage of HIV-1 vaccine development. In this regard, HIV-1 Env-pseudotyped viruses play a central role for the evaluation of neutralizing antibody profiles and are produced according to Good Clinical Laboratory Practice- (GCLP-) compliant manual and automated procedures. To further improve and complete the automated production cycle an automated system for aliquoting HIV-1 pseudovirus stocks has been implemented. The automation platform consists of a modified Tecan-based system including a robot platform for handling racks containing 48 cryovials, a Decapper, a tubing pump and a safety device consisting of ultrasound sensors for online liquid level detection of each individual cryovial. With the aim to aliquot the HIV-1 pseudoviruses in an automated manner under GCLP-compliant conditions a validation plan was developed where the acceptance criteria—accuracy, precision as well as the specificity and robustness—were defined and summarized. By passing the validation experiments described in this article the automated system for aliquoting has been successfully validated. This allows the standardized and operator independent distribution of small-scale and bulk amounts of HIV-1 pseudovirus stocks with a precise and reproducible outcome to support upcoming clinical vaccine trials. PMID:29300769

Body fluid matrix evaluation on a Roche cobas 8000 system.

PubMed

Owen, William E; Thatcher, Mindy L; Crabtree, Karolyn J; Greer, Ryan W; Strathmann, Frederick G; Straseski, Joely A; Genzen, Jonathan R

2015-09-01

Chemical analysis of body fluids is commonly requested by physicians. Because most commercial FDA-cleared clinical laboratory assays are not validated by diagnostic manufacturers for "non-serum" and "non-plasma" specimens, laboratories may need to complete additional validation studies to comply with regulatory requirements regarding body fluid testing. The objective of this report is to perform recovery studies to evaluate potential body fluid matrix interferences for commonly requested chemistry analytes. Using an IRB-approved protocol, previously collected clinical body fluid specimens (biliary/hepatic, cerebrospinal, dialysate, drain, pancreatic, pericardial, peritoneal, pleural, synovial, and vitreous) were de-identified and frozen (-20°C) until experiments were performed. Recovery studies (spiking with high concentration serum, control, and/or calibrator) were conducted using 10% spiking solution by volume; n=5 specimens per analyte/body fluid investigated. Specimens were tested on a Roche cobas 8000 system (c502, c702, e602, and ISE modules). In all 80 analyte/body fluid combinations investigated (including amylase, total bilirubin, urea nitrogen, carbohydrate antigen 19-9, carcinoembryonic antigen, cholesterol, chloride, creatinine, glucose, potassium, lactate dehydrogenase, lipase, rheumatoid factor, sodium, total protein, triglycerides, and uric acid), the average percent recovery was within predefined acceptable limits (less than ±10% from the calculated ideal recovery). The present study provides evidence against the presence of any systematic matrix interference in the analyte/body fluid combinations investigated on the Roche cobas 8000 system. Such findings support the utility of ongoing body fluid validation initiatives conducted to maintain compliance with regulatory requirements. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

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.

Evaluation of the repeatability and reproducibility of a suite of qPCR based microbial source tracking methods

EPA Science Inventory

Many PCR-based methods for microbial source tracking (MST) have been developed and validated within individual research laboratories. Inter-laboratory validation of these methods, however, has been minimal, and the effects of protocol standardization regimes have not been thor...

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

Chemical and microbiological experimentation for development of environmental control and life support systems

NASA Technical Reports Server (NTRS)

Whitman, G. A.; Wilson, M. E.; Cole, H. E.; Traweek, M.

1992-01-01

Microbiological techniques are under study with a view to the identification of viable microorganisms in liquid cultures, improve the identification of stressed organisms, and determine the biocidal activity of iodine and other chemicals on isolates from recycled water. A quality-assurance program has been implemented to validate data employed in making decisions concerning engineering and human health and safety. Analytical laboratory refinements will strongly aid the development of environmental control and life-support systems.

A Resonant Synchronous Vibration Based Approach for Rotor Imbalance Detection

NASA Technical Reports Server (NTRS)

Luo, Huangeng; Rodriquez, Hector; Hallman, Darren; Lewicki, David G.

2006-01-01

This paper presents a methodology of detecting rotor imbalances, such as mass imbalance and crack-induced imbalance, using shaft synchronous vibrations. An iterative scheme is developed to identify parameters from measured synchronous vibration data. A detection system is integrated by using state-of-the-art commercial analysis equipment. A laboratory rotor test rig is used to verify the system integration and algorithm validation. A real engine test has been carried out and the results are reported.

A monitor for the laboratory evaluation of control integrity in digital control systems operating in harsh electromagnetic environments

NASA Technical Reports Server (NTRS)

Belcastro, Celeste M.; Fischl, Robert; Kam, Moshe

1992-01-01

This paper presents a strategy for dynamically monitoring digital controllers in the laboratory for susceptibility to electromagnetic disturbances that compromise control integrity. The integrity of digital control systems operating in harsh electromagnetic environments can be compromised by upsets caused by induced transient electrical signals. Digital system upset is a functional error mode that involves no component damage, can occur simultaneously in all channels of a redundant control computer, and is software dependent. The motivation for this work is the need to develop tools and techniques that can be used in the laboratory to validate and/or certify critical aircraft controllers operating in electromagnetically adverse environments that result from lightning, high-intensity radiated fields (HIRF), and nuclear electromagnetic pulses (NEMP). The detection strategy presented in this paper provides dynamic monitoring of a given control computer for degraded functional integrity resulting from redundancy management errors, control calculation errors, and control correctness/effectiveness errors. In particular, this paper discusses the use of Kalman filtering, data fusion, and statistical decision theory in monitoring a given digital controller for control calculation errors.

Designing Mission Operations for the Gravity Recovery and Interior Laboratory Mission

NASA Technical Reports Server (NTRS)

Havens, Glen G.; Beerer, Joseph G.

2012-01-01

NASA's Gravity Recovery and Interior Laboratory (GRAIL) mission, to understand the internal structure and thermal evolution of the Moon, offered unique challenges to mission operations. From launch through end of mission, the twin GRAIL orbiters had to be operated in parallel. The journey to the Moon and into the low science orbit involved numerous maneuvers, planned on tight timelines, to ultimately place the orbiters into the required formation-flying configuration necessary. The baseline GRAIL mission is short, only 9 months in duration, but progressed quickly through seven very unique mission phases. Compressed into this short mission timeline, operations activities and maneuvers for both orbiters had to be planned and coordinated carefully. To prepare for these challenges, development of the GRAIL Mission Operations System began in 2008. Based on high heritage multi-mission operations developed by NASA's Jet Propulsion Laboratory and Lockheed Martin, the GRAIL mission operations system was adapted to meet the unique challenges posed by the GRAIL mission design. This paper describes GRAIL's system engineering development process for defining GRAIL's operations scenarios and generating requirements, tracing the evolution from operations concept through final design, implementation, and validation.

Cryosphere Science Outreach using the NASA/JPL Virtual Earth System Laboratory

NASA Astrophysics Data System (ADS)

Larour, E. Y.; Cheng, D. L. C.; Quinn, J.; Halkides, D. J.; Perez, G. L.

2016-12-01

Understanding the role of Cryosphere Science within the larger context of Sea Level Rise is both a technical and educational challenge that needs to be addressed if the public at large is to truly understand the implications and consequences of Climate Change. Within this context, we propose a new approach in which scientific tools are used directly inside a mobile/website platform geared towards Education/Outreach. Here, we apply this approach by using the Ice Sheet System Model, a state of the art Cryosphere model developed at NASA, and integrated within a Virtual Earth System Laboratory, with the goal to outreach Cryosphere science to K-12 and College level students. The approach mixes laboratory experiments, interactive classes/lessons on a website, and a simplified interface to a full-fledged instance of ISSM to validate the classes/lessons. This novel approach leverages new insights from the Outreach/Educational community and the interest of new generations in web based technologies and simulation tools, all of it delivered in a seamlessly integrated web platform, relying on a state of the art climate model and live simulations.

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.

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.

Analysis of Aurora's Performance Simulation Engine for Three Systems

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

Freeman, Janine; Simon, Joseph

2015-07-07

Aurora Solar Inc. is building a cloud-based optimization platform to automate the design, engineering, and permit generation process of solar photovoltaic (PV) installations. They requested that the National Renewable Energy Laboratory (NREL) validate the performance of the PV system performance simulation engine of Aurora Solar’s solar design platform, Aurora. In previous work, NREL performed a validation of multiple other PV modeling tools 1, so this study builds upon that work by examining all of the same fixed-tilt systems with available module datasheets that NREL selected and used in the aforementioned study. Aurora Solar set up these three operating PV systemsmore » in their modeling platform using NREL-provided system specifications and concurrent weather data. NREL then verified the setup of these systems, ran the simulations, and compared the Aurora-predicted performance data to measured performance data for those three systems, as well as to performance data predicted by other PV modeling tools.« less

Validation of Contact-Free Sleep Monitoring Device with Comparison to Polysomnography

PubMed Central

Tal, Asher; Shinar, Zvika; Shaki, David; Codish, Shlomi; Goldbart, Aviv

2017-01-01

Study Objectives: To validate a contact-free system designed to achieve maximal comfort during long-term sleep monitoring, together with high monitoring accuracy. Methods: We used a contact-free monitoring system (EarlySense, Ltd., Israel), comprising an under-the-mattress piezoelectric sensor and a smartphone application, to collect vital signs and analyze sleep. Heart rate (HR), respiratory rate (RR), body movement, and calculated sleep-related parameters from the EarlySense (ES) sensor were compared to data simultaneously generated by the gold standard, polysomnography (PSG). Subjects in the sleep laboratory underwent overnight technician-attended full PSG, whereas subjects at home were recorded for 1 to 3 nights with portable partial PSG devices. Data were compared epoch by epoch. Results: A total of 63 subjects (85 nights) were recorded under a variety of sleep conditions. Compared to PSG, the contact-free system showed similar values for average total sleep time (TST), % wake, % rapid eye movement, and % non-rapid eye movement sleep, with 96.1% and 93.3% accuracy of continuous measurement of HR and RR, respectively. We found a linear correlation between TST measured by the sensor and TST determined by PSG, with a coefficient of 0.98 (R = 0.87). Epoch-by-epoch comparison with PSG in the sleep laboratory setting revealed that the system showed sleep detection sensitivity, specificity, and accuracy of 92.5%, 80.4%, and 90.5%, respectively. Conclusions: TST estimates with the contact-free sleep monitoring system were closely correlated with the gold-standard reference. This system shows good sleep staging capability with improved performance over accelerometer-based apps, and collects additional physiological information on heart rate and respiratory rate. Citation: Tal A, Shinar Z, Shaki D, Codish S, Goldbart A. Validation of contact-free sleep monitoring device with comparison to polysomnography. J Clin Sleep Med. 2017;13(3):517–522. PMID:27998378

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.

The development and validation of an activity monitoring system for use in measurement of posture of childbearing women during first stage of labor.

PubMed

Martin, Caroline J Hollins; Kenney, Laurence; Pratt, Thomas; Granat, Malcolm H

2015-01-01

There is limited understanding of the type and extent of maternal postures that midwives should encourage or support during labor. The aims of this study were to identify a set of postures and movements commonly seen during labor, to develop an activity monitoring system for use during labor, and to validate this system design. Volunteer student midwives simulated maternal activity during labor in a laboratory setting. Participants (N = 15) wore monitors adhered to the left thigh and left shank, and adopted 13 common postures of laboring women for 3 minutes each. Simulated activities were recorded using a video camera. Postures and movements were coded from the video, and statistical analysis conducted of agreement between coded video data and outputs of the activity monitoring system. Excellent agreement between the 2 raters of the video recordings was found (Cohen's κ = 0.95). Both sensitivity and specificity of the activity monitoring system were greater than 80% for standing, lying, kneeling, and sitting (legs dangling). This validated system can be used to measure elected activity of laboring women and report on effects of postures on length of first stage, pain experience, birth satisfaction, and neonatal condition. This validated maternal posture-monitoring system is available as a reference-and for use by researchers who wish to develop research in this area. © 2015 by the American College of Nurse-Midwives.

Predictive Model and Methodology for Heat Treatment Distortion Final Report CRADA No. TC-298-92

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

Nikkel, D. J.; McCabe, J.

This project was a multi-lab, multi-partner CRADA involving LLNL, Los Alamos National Laboratory, Sandia National Laboratories, Oak Ridge National Laboratory, Martin Marietta Energy Systems and the industrial partner, The National Center of Manufacturing Sciences (NCMS). A number of member companies of NCMS participated including General Motors Corporation, Ford Motor Company, The Torrington Company, Gear Research, the Illinois Institute of Technology Research Institute, and Deformation Control Technology •. LLNL was the lead laboratory for metrology technology used for validation of the computational tool/methodology. LLNL was also the lead laboratory for the development of the software user interface , for the computationalmore » tool. This report focuses on the participation of LLNL and NCMS. The purpose of the project was to develop a computational tool/methodology that engineers would use to predict the effects of heat treatment on the _size and shape of industrial parts made of quench hardenable alloys. Initially, the target application of the tool was gears for automotive power trains.« less

Determination of calcium, copper, iron, magnesium, manganese, potassium, phosphorus, sodium, and zinc in fortified food products by microwave digestion and inductively coupled plasma-optical emission spectrometry: single-laboratory validation and ring trial.

PubMed

Poitevin, Eric

2012-01-01

A single-laboratory validation (SLV) and a ring trial (RT) were undertaken to determine nine nutritional elements in food products by inductively coupled plasma-optical emission spectrometry in order to modernize AOAC Official Method 984.27. The improvements involved extension of the scope to all food matrixes (including infant formula), optimized microwave digestion, selected analytical lines, internal standardization, and ion buffering. Simultaneous determination of nine elements (calcium, copper, iron, potassium, magnesium, manganese, sodium, phosphorus, and zinc) was made in food products. Sample digestion was performed through wet digestion of food samples by microwave technology with either closed- or open-vessel systems. Validation was performed to characterize the method for selectivity, sensitivity, linearity, accuracy, precision, recovery, ruggedness, and uncertainty. The robustness and efficiency of this method was proven through a successful RT using experienced independent food industry laboratories. Performance characteristics are reported for 13 certified and in-house reference materials, populating the AOAC triangle food sectors, which fulfilled AOAC criteria and recommendations for accuracy (trueness, recovery, and z-scores) and precision (repeatability and reproducibility RSD, and HorRat values) regarding SLVs and RTs. This multielemental method is cost-efficient, time-saving, accurate, and fit-for-purpose according to ISO 17025 Norm and AOAC acceptability criteria, and is proposed as an extended updated version of AOAC Official Method 984.27 for fortified food products, including infant formula.

Improvement of AOAC Official Method 984.27 for the determination of nine nutritional elements in food products by Inductively coupled plasma-atomic emission spectroscopy after microwave digestion: single-laboratory validation and ring trial.

PubMed

Poitevin, Eric; Nicolas, Marine; Graveleau, Laetitia; Richoz, Janique; Andrey, Daniel; Monard, Florence

2009-01-01

A single-laboratory validation (SLV) and a ring trial (RT) were undertaken to determine nine nutritional elements in food products by inductively coupled plasma-atomic emission spectroscopy in order to improve and update AOAC Official Method 984.27. The improvements involved optimized microwave digestion, selected analytical lines, internal standardization, and ion buffering. Simultaneous determination of nine elements (calcium, copper, iron, potassium, magnesium, manganese, sodium, phosphorus, and zinc) was made in food products. Sample digestion was performed through wet digestion of food samples by microwave technology with either closed or open vessel systems. Validation was performed to characterize the method for selectivity, sensitivity, linearity, accuracy, precision, recovery, ruggedness, and uncertainty. The robustness and efficiency of this method was proved through a successful internal RT using experienced food industry laboratories. Performance characteristics are reported for 13 certified and in-house reference materials, populating the AOAC triangle food sectors, which fulfilled AOAC criteria and recommendations for accuracy (trueness, recovery, and z-scores) and precision (repeatability and reproducibility RSD and HorRat values) regarding SLV and RT. This multielemental method is cost-efficient, time-saving, accurate, and fit-for-purpose according to ISO 17025 Norm and AOAC acceptability criteria, and is proposed as an improved version of AOAC Official Method 984.27 for fortified food products, including infant formula.

Identification of Curie temperature distributions in magnetic particulate systems

NASA Astrophysics Data System (ADS)

Waters, J.; Berger, A.; Kramer, D.; Fangohr, H.; Hovorka, O.

2017-09-01

This paper develops a methodology for extracting the Curie temperature distribution from magnetisation versus temperature measurements which are realizable by standard laboratory magnetometry. The method is integral in nature, robust against various sources of measurement noise, and can be adopted to a wide range of granular magnetic materials and magnetic particle systems. The validity and practicality of the method is demonstrated using large-scale Monte-Carlo simulations of an Ising-like model as a proof of concept, and general conclusions are drawn about its applicability to different classes of systems and experimental conditions.

First industrial strength multi-axial Robotic testing campaign for composite material characterization

Treesearch

John G. Michopoulos; John C. Hermanson; Athanasios Iliopoulos

2012-01-01

In this paper we are reporting on the first successful campaign of systematic, automated and massive multiaxial tests for composite material constitutive characterization. The 6 degrees of freedom system developed at the Naval Research Laboratory (NRL) called NRL66.3, was used for this task. This was the inaugural run that served as the validation of the...

Experimental Validation of PALM - A System for Precise Aircraft Location

DTIC Science & Technology

1975-04-29

resulting ellipse on an airport plan view. In Fig. 8, we plot this upper bound for two cases at runway 13L at JFK airport . The two cases are: 1. Aircraft...Laboratory have shown that within a 30-mile range of JFK airport in New York there are likely to be as many as 55 transponder equipped aircraft. For

Midwest Structural Sciences Center, 2006-2013

DTIC Science & Technology

2013-09-01

for Technology High Speed Systems Division Air Force Research Laboratory This report is published in the interest of scientific and...also be used for making predictions of future flights. 2 Approved for public release; distribution unlimited. Fig. 1.1: Development of future high ...methods were developed to provide validation quality data for coupled high temperature and acoustic loading environments, and to quantitatively study

Tap Testing Hammer using Unmanned Aerial Systems (UASs)

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

Mason, JaMein DeShon; Ayorinde, Emmanuel Temiloluwa; Mascarenas, David Dennis

This is the final poster for a Student Symposium at Los Alamos National Laboratory. This research describes the development, validation, and testing of a remote concrete tapping mechanism enabled by UAS. The conclusion is the following: The results quantify for the first time concrete tapping data collected remotely with UAS, enabling cost-effective, safer and sustainable upgrade prioritization of railroad bridges inventories.

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.

42 CFR 493.602 - Scope of subpart.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.602 Scope of subpart. This... (the PHS Act) and the Federal validation of accredited laboratories and of CLIA-exempt laboratories...

42 CFR 493.602 - Scope of subpart.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.602 Scope of subpart. This... (the PHS Act) and the Federal validation of accredited laboratories and of CLIA-exempt laboratories...

Advanced Hybrid Propulsion and Energy Management System for High Efficiency, Off Highway, 240 Ton Class, Diesel Electric Haul Trucks

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

Richter, Tim; Slezak, Lee; Johnson, Chris

2008-12-31

The objective of this project is to reduce the fuel consumption of off-highway vehicles, specifically large tonnage mine haul trucks. A hybrid energy storage and management system will be added to a conventional diesel-electric truck that will allow capture of braking energy normally dissipated in grid resistors as heat. The captured energy will be used during acceleration and motoring, reducing the diesel engine load, thus conserving fuel. The project will work towards a system validation of the hybrid system by first selecting an energy storage subsystem and energy management subsystem. Laboratory testing at a subscale level will evaluate these selectionsmore » and then a full-scale laboratory test will be performed. After the subsystems have been proven at the full-scale lab, equipment will be mounted on a mine haul truck and integrated with the vehicle systems. The integrated hybrid components will be exercised to show functionality, capability, and fuel economy impacts in a mine setting.« less

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...

[Pursuit of economic efficiency in the hospital laboratory--full automatic re-test system of clinical chemistry, hematology, immunology and cost control system].

PubMed

Chiba, M

2000-10-01

Further business improvement is requested due to finance-based fluctuation and the influence of the revision in the medical treatment law. Therefore, new laboratories are needed. To achieving this in our hospital, economic efficiency is being pursued. The first issue is the use of space, the second issue is labor-saving. The third issue is the simplification of business procedures. There is individual quality control by the zonal verification method that we developed, as well as the quality control of the batch method using controlled substances. The four issue is cost control. By controlling the delivery and use of reagents and materials including the term of validity control, we made an effort to abolition defective stock. The fifth issue is correspondence to circulation style society. The disposal of laboratory garbage is a major issue. We controlled garbage that occurs unnecessarily. Furthermore, we are improving the demand for reagents that exceeds the specification and use reagent containers.

Evaluation of heterotrophic plate and chromogenic agar colony counting in water quality laboratories.

PubMed

Hallas, Gary; Monis, Paul

2015-01-01

The enumeration of bacteria using plate-based counts is a core technique used by food and water microbiology testing laboratories. However, manual counting of bacterial colonies is both time and labour intensive, can vary between operators and also requires manual entry of results into laboratory information management systems, which can be a source of data entry error. An alternative is to use automated digital colony counters, but there is a lack of peer-reviewed validation data to allow incorporation into standards. We compared the performance of digital counting technology (ProtoCOL3) against manual counting using criteria defined in internationally recognized standard methods. Digital colony counting provided a robust, standardized system suitable for adoption in a commercial testing environment. The digital technology has several advantages:•Improved measurement of uncertainty by using a standard and consistent counting methodology with less operator error.•Efficiency for labour and time (reduced cost).•Elimination of manual entry of data onto LIMS.•Faster result reporting to customers.

Clinically expedient reporting of rapid diagnostic test information.

PubMed

Doern, G V

1986-03-01

With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.

Experiment plans to study preignition processes of a pool fire in low gravity. M.S. Thesis - 1988 Final Report

NASA Technical Reports Server (NTRS)

Schiller, David N.

1989-01-01

Science requirements are specified to guide experimental studies of transient heat transfer and fluid flow in an enclosure containing a two-layer gas-and-liquid system heated unevenly from above. Specifications are provided for experiments in three separate settings: (1) a normal gravity laboratory, (2) the NASA-LeRC Drop towers, and (3) a space-based laboratory (e.g., Shuttle, Space Station). A rationale is developed for both minimum and desired requirement levels. The principal objective of the experimental effort is to validate a computational model of the enclosed liquid fuel pool during the preignition phase and to determine via measurement the role of gravity on the behavior of the system. Preliminary results of single-phase normal gravity experiments and simulations are also presented.

Hawaiian Electric Advanced Inverter Grid Support Function Laboratory Validation and Analysis

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

Nelson, Austin; Nagarajan, Adarsh; Prabakar, Kumar

The objective for this test plan was to better understand how to utilize the performance capabilities of advanced inverter functions to allow the interconnection of distributed energy resource (DER) systems to support the new Customer Self-Supply, Customer Grid-Supply, and other future DER programs. The purpose of this project was: 1) to characterize how the tested grid supportive inverters performed the functions of interest, 2) to evaluate the grid supportive inverters in an environment that emulates the dynamics of O'ahu's electrical distribution system, and 3) to gain insight into the benefits of the grid support functions on selected O'ahu island distributionmore » feeders. These goals were achieved through laboratory testing of photovoltaic inverters, including power hardware-in-the-loop testing.« less

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.

Predicting the performance uncertainty of a 1-MW pilot-scale carbon capture system after hierarchical laboratory-scale calibration and validation

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

Xu, Zhijie; Lai, Canhai; Marcy, Peter William

2017-05-01

A challenging problem in designing pilot-scale carbon capture systems is to predict, with uncertainty, the adsorber performance and capture efficiency under various operating conditions where no direct experimental data exist. Motivated by this challenge, we previously proposed a hierarchical framework in which relevant parameters of physical models were sequentially calibrated from different laboratory-scale carbon capture unit (C2U) experiments. Specifically, three models of increasing complexity were identified based on the fundamental physical and chemical processes of the sorbent-based carbon capture technology. Results from the corresponding laboratory experiments were used to statistically calibrate the physical model parameters while quantifying some of theirmore » inherent uncertainty. The parameter distributions obtained from laboratory-scale C2U calibration runs are used in this study to facilitate prediction at a larger scale where no corresponding experimental results are available. In this paper, we first describe the multiphase reactive flow model for a sorbent-based 1-MW carbon capture system then analyze results from an ensemble of simulations with the upscaled model. The simulation results are used to quantify uncertainty regarding the design’s predicted efficiency in carbon capture. In particular, we determine the minimum gas flow rate necessary to achieve 90% capture efficiency with 95% confidence.« less

Mars Science Laboratory (MSL) Entry, Descent, and Landing Instrumentation (MEDLI): Complete Flight Data Set

NASA Technical Reports Server (NTRS)

Cheatwood, F. McNeil; Bose, Deepak; Karlgaard, Christopher D.; Kuhl, Christopher A.; Santos, Jose A.; Wright, Michael J.

2014-01-01

The Mars Science Laboratory (MSL) entry vehicle (EV) successfully entered the Mars atmosphere and landed the Curiosity rover safely on the surface of the planet in Gale crater on August 6, 2012. MSL carried the MSL Entry, Descent, and Landing (EDL) Instrumentation (MEDLI). MEDLI delivered the first in-depth understanding of the Mars entry environments and the response of the entry vehicle to those environments. MEDLI was comprised of three major subsystems: the Mars Entry Atmospheric Data System (MEADS), the MEDLI Integrated Sensor Plugs (MISP), and the Sensor Support Electronics (SSE). Ultimately, the entire MEDLI sensor suite consisting of both MEADS and MISP provided measurements that were used for trajectory reconstruction and engineering validation of aerodynamic, atmospheric, and thermal protection system (TPS) models in addition to Earth-based systems testing procedures. This report contains in-depth hardware descriptions, performance evaluation, and data information of the three MEDLI subsystems.

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.

Optoelectronic devices product assurance guideline for space application

NASA Astrophysics Data System (ADS)

Bensoussan, A.; Vanzi, M.

2017-11-01

New opportunities are emerging for the implementation of hardware sub-systems based on OptoElectronic Devices (OED) for space application. Since the end of this decade the main players for space systems namely designers and users including Industries, Agencies, Manufacturers and Laboratories are strongly demanding of adequate strategies to qualify and validate new optoelectronics products and sub-systems [1]. The long term space application mission will require to address either inter-satellite link (free space communication, positioning systems, tracking) or intra-satellite connectivity/flexibility/reconfigurability or high volume of data transfer between equipment installed into payload.

An alternative to the balance error scoring system: using a low-cost balance board to improve the validity/reliability of sports-related concussion balance testing.

PubMed

Chang, Jasper O; Levy, Susan S; Seay, Seth W; Goble, Daniel J

2014-05-01

Recent guidelines advocate sports medicine professionals to use balance tests to assess sensorimotor status in the management of concussions. The present study sought to determine whether a low-cost balance board could provide a valid, reliable, and objective means of performing this balance testing. Criterion validity testing relative to a gold standard and 7 day test-retest reliability. University biomechanics laboratory. Thirty healthy young adults. Balance ability was assessed on 2 days separated by 1 week using (1) a gold standard measure (ie, scientific grade force plate), (2) a low-cost Nintendo Wii Balance Board (WBB), and (3) the Balance Error Scoring System (BESS). Validity of the WBB center of pressure path length and BESS scores were determined relative to the force plate data. Test-retest reliability was established based on intraclass correlation coefficients. Composite scores for the WBB had excellent validity (r = 0.99) and test-retest reliability (R = 0.88). Both the validity (r = 0.10-0.52) and test-retest reliability (r = 0.61-0.78) were lower for the BESS. These findings demonstrate that a low-cost balance board can provide improved balance testing accuracy/reliability compared with the BESS. This approach provides a potentially more valid/reliable, yet affordable, means of assessing sports-related concussion compared with current methods.

Electrohydraulic Forming of Near-Net Shape Automotive Panels

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

Golovaschenko, Sergey F.

2013-09-26

The objective of this project was to develop the electrohydraulic forming (EHF) process as a near-net shape automotive panel manufacturing technology that simultaneously reduces the energy embedded in vehicles and the energy consumed while producing automotive structures. Pulsed pressure is created via a shockwave generated by the discharge of high voltage capacitors through a pair of electrodes in a liquid-filled chamber. The shockwave in the liquid initiated by the expansion of the plasma channel formed between two electrodes propagates towards the blank and causes the blank to be deformed into a one-sided die cavity. The numerical model of the EHFmore » process was validated experimentally and was successfully applied to the design of the electrode system and to a multi-electrode EHF chamber for full scale validation of the process. The numerical model was able to predict stresses in the dies during pulsed forming and was validated by the experimental study of the die insert failure mode for corner filling operations. The electrohydraulic forming process and its major subsystems, including durable electrodes, an EHF chamber, a water/air management system, a pulse generator and integrated process controls, were validated to be capable to operate in a fully automated, computer controlled mode for forming of a portion of a full-scale sheet metal component in laboratory conditions. Additionally, the novel processes of electrohydraulic trimming and electrohydraulic calibration were demonstrated at a reduced-scale component level. Furthermore, a hybrid process combining conventional stamping with EHF was demonstrated as a laboratory process for a full-scale automotive panel formed out of AHSS material. The economic feasibility of the developed EHF processes was defined by developing a cost model of the EHF process in comparison to the conventional stamping process.« less

Long-term predictions using natural analogues

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

Ewing, R.C.

1995-09-01

One of the unique and scientifically most challenging aspects of nuclear waste isolation is the extrapolation of short-term laboratory data (hours to years) to the long time periods (10{sup 3}-10{sup 5} years) required by regulatory agencies for performance assessment. The direct validation of these extrapolations is not possible, but methods must be developed to demonstrate compliance with government regulations and to satisfy the lay public that there is a demonstrable and reasonable basis for accepting the long-term extrapolations. Natural systems (e.g., {open_quotes}natural analogues{close_quotes}) provide perhaps the only means of partial {open_quotes}validation,{close_quotes} as well as data that may be used directlymore » in the models that are used in the extrapolation. Natural systems provide data on very large spatial (nm to km) and temporal (10{sup 3}-10{sup 8} years) scales and in highly complex terranes in which unknown synergisms may affect radionuclide migration. This paper reviews the application (and most importantly, the limitations) of data from natural analogue systems to the {open_quotes}validation{close_quotes} of performance assessments.« less

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

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

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.

Abstract - Cooperative Research and Development Agreement between Applied Spectra, Inc. and National Energy Technology Laboratory

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

McIntyre, Dustin L.; Russo, Richard

Applied Spectra, as our industrial collaborator, is helping us develop our downhole LIBS sensor. Our part of the collaboration is the design, construction, and validation of the miniaturized fiber coupled laser whereas Applied Spectra will be providing technical guidance and control/analysis software. This will allow our system which is traditionally operated by a person to be automated in both data collection and analysis. This will allow our system to significantly increase its TRL.

An interactive HTML ocean nowcast GUI based on Perl and JavaScript

NASA Astrophysics Data System (ADS)

Sakalaukus, Peter J.; Fox, Daniel N.; Louise Perkins, A.; Smedstad, Lucy F.

1999-02-01

We describe the use of Hyper Text Markup Language (HTML), JavaScript code, and Perl I/O to create and validate forms in an Internet-based graphical user interface (GUI) for the Naval Research Laboratory (NRL) Ocean models and Assimilation Demonstration System (NOMADS). The resulting nowcast system can be operated from any compatible browser across the Internet, for although the GUI was prepared in a Netscape browser, it used no Netscape extensions. Code available at: http://www.iamg.org/CGEditor/index.htm

Fiber-Optic Sensing System: Overview, Development and Deployment in Flight at NASA

NASA Technical Reports Server (NTRS)

Chan, Hon Man; Parker, Allen R.; Piazza, Anthony; Richards, W. Lance

2015-01-01

An overview of the research and technological development of the fiber-optic sensing system (FOSS) at the National Aeronautics and Space Administration Armstrong Flight Research Center (NASA AFRC) is presented. Theory behind fiber Bragg grating (FBG) sensors, as well as interrogation technique based on optical frequency domain reflectometry (OFDR) is discussed. Assessment and validation of FOSS as an accurate measurement tool for structural health monitoring is realized in the laboratory environment as well as large-scale flight deployment.

Development and validation of an anti-N3 indirect immunofluorescent antibody test to be used as a companion diagnostic test in the framework of a "DIVA" vaccination strategy for avian influenza infections in poultry.

PubMed

Cattoli, Giovanni; Milani, Adelaide; Bettini, Francesca; Serena Beato, Maria; Mancin, Marzia; Terregino, Calogero; Capua, Ilaria

2006-04-01

Avian influenza (AI) infections have become of growing importance both for animal and human health. Vaccination has become a recommended tool to support eradication efforts and limit the economic losses caused by this disease. The "DIVA" system, using a vaccine containing a heterologous neuraminidase to the field virus, has been shown to be an effective tool in increasing the resistance of birds to field challenge, preventing clinical signs and reducing viral shedding in the environment. The companion diagnostic test to the vaccine, however, has been only partially validated in the field against one subtype of neuraminidase (N1). The present paper presents the results of a full laboratory and field validation of the diagnostic test developed to detect antibodies to the N3 subtype of AI in vaccinated and unvaccinated chickens and turkeys. Antibody kinetic studies conducted in the laboratory have shown that antibodies to the N protein may be detected earlier than antibodies to the haemagglutinin. The data derived from this extensive validation trial indicate the excellent capability of this assay in detecting the presence of active AI infection at an early stage in both unvaccinated and vaccinated birds and the lack of interference with vaccine-induced antibodies.

Multiyear Plan for Validation of EnergyPlus Multi-Zone HVAC System Modeling using ORNL's Flexible Research Platform

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

Im, Piljae; Bhandari, Mahabir S.; New, Joshua Ryan

This document describes the Oak Ridge National Laboratory (ORNL) multiyear experimental plan for validation and uncertainty characterization of whole-building energy simulation for a multi-zone research facility using a traditional rooftop unit (RTU) as a baseline heating, ventilating, and air conditioning (HVAC) system. The project’s overarching objective is to increase the accuracy of energy simulation tools by enabling empirical validation of key inputs and algorithms. Doing so is required to inform the design of increasingly integrated building systems and to enable accountability for performance gaps between design and operation of a building. The project will produce documented data sets that canmore » be used to validate key functionality in different energy simulation tools and to identify errors and inadequate assumptions in simulation engines so that developers can correct them. ASHRAE Standard 140, Method of Test for the Evaluation of Building Energy Analysis Computer Programs (ASHRAE 2004), currently consists primarily of tests to compare different simulation programs with one another. This project will generate sets of measured data to enable empirical validation, incorporate these test data sets in an extended version of Standard 140, and apply these tests to the Department of Energy’s (DOE) EnergyPlus software (EnergyPlus 2016) to initiate the correction of any significant deficiencies. The fitness-for-purpose of the key algorithms in EnergyPlus will be established and demonstrated, and vendors of other simulation programs will be able to demonstrate the validity of their products. The data set will be equally applicable to validation of other simulation engines as well.« less

Bigfoot Field Manual, Version 2.1

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

Campbell, J.L.; Burrows, S.; Gower, S.T.

1999-09-01

The BigFoot Project is funded by the Earth Science Enterprise to collect and organize data to be used in the National Aeronautics and Space Administration's Earth Observing System (EOS) Validation Program. The data collected by the BigFoot Project are unique in being ground-based observations coincident with satellite overpasses. In addition to collecting data, the BigFoot project will develop and test new algorithms for scaling point measurements to the same spatial scales as the EOS satellite products. This BigFoot Field Manual will be used to achieve completeness and consistency of data collected at four initial BigFoot sites and at future sitesmore » that may collect similar validation data. Therefore, validation datasets submitted to the Oak Ridge National Laboratory Distributed Active Archive Center that have been compiled in a manner consistent with the field manual will be especially valuable in the validation program.« less

Artificial Neural Network Approach in Laboratory Test Reporting:  Learning Algorithms.

PubMed

Demirci, Ferhat; Akan, Pinar; Kume, Tuncay; Sisman, Ali Riza; Erbayraktar, Zubeyde; Sevinc, Suleyman

2016-08-01

In the field of laboratory medicine, minimizing errors and establishing standardization is only possible by predefined processes. The aim of this study was to build an experimental decision algorithm model open to improvement that would efficiently and rapidly evaluate the results of biochemical tests with critical values by evaluating multiple factors concurrently. The experimental model was built by Weka software (Weka, Waikato, New Zealand) based on the artificial neural network method. Data were received from Dokuz Eylül University Central Laboratory. "Training sets" were developed for our experimental model to teach the evaluation criteria. After training the system, "test sets" developed for different conditions were used to statistically assess the validity of the model. After developing the decision algorithm with three iterations of training, no result was verified that was refused by the laboratory specialist. The sensitivity of the model was 91% and specificity was 100%. The estimated κ score was 0.950. This is the first study based on an artificial neural network to build an experimental assessment and decision algorithm model. By integrating our trained algorithm model into a laboratory information system, it may be possible to reduce employees' workload without compromising patient safety. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Space Technology-7 Disturbance Reduction System Precision Control Flight Validation Experiment Control System Design

NASA Technical Reports Server (NTRS)

O'Donnell, James R.; Hsu, Oscar C.; Maghami, Peirman G.; Markley, F. Landis

2006-01-01

As originally proposed, the Space Technology-7 Disturbance Reduction System (DRS) project, managed out of the Jet Propulsion Laboratory, was designed to validate technologies required for future missions such as the Laser Interferometer Space Antenna (LISA). The two technologies to be demonstrated by DRS were Gravitational Reference Sensors (GRSs) and Colloidal MicroNewton Thrusters (CMNTs). Control algorithms being designed by the Dynamic Control System (DCS) team at the Goddard Space Flight Center would control the spacecraft so that it flew about a freely-floating GRS test mass, keeping it centered within its housing. For programmatic reasons, the GRSs were descoped from DRS. The primary goals of the new mission are to validate the performance of the CMNTs and to demonstrate precise spacecraft position control. DRS will fly as a part of the European Space Agency (ESA) LISA Pathfinder (LPF) spacecraft along with a similar ESA experiment, the LISA Technology Package (LTP). With no GRS, the DCS attitude and drag-free control systems make use of the sensor being developed by ESA as a part of the LTP. The control system is designed to maintain the spacecraft s position with respect to the test mass, to within 10 nm/the square root of Hz over the DRS science frequency band of 1 to 30 mHz.

Internal validation of the DNAscan/ANDE™ Rapid DNA Analysis™ platform and its associated PowerPlex® 16 high content DNA biochip cassette for use as an expert system with reference buccal swabs.

PubMed

Moreno, Lilliana I; Brown, Alice L; Callaghan, Thomas F

2017-07-01

Rapid DNA platforms are fully integrated systems capable of producing and analyzing short tandem repeat (STR) profiles from reference sample buccal swabs in less than two hours. The technology requires minimal user interaction and experience making it possible for high quality profiles to be generated outside an accredited laboratory. The automated production of point of collection reference STR profiles could eliminate the time delay for shipment and analysis of arrestee samples at centralized laboratories. Furthermore, point of collection analysis would allow searching against profiles from unsolved crimes during the normal booking process once the infrastructure to immediately search the Combined DNA Index System (CODIS) database from the booking station is established. The DNAscan/ANDE™ Rapid DNA Analysis™ System developed by Network Biosystems was evaluated for robustness and reliability in the production of high quality reference STR profiles for database enrollment and searching applications. A total of 193 reference samples were assessed for concordance of the CODIS 13 loci. Studies to evaluate contamination, reproducibility, precision, stutter, peak height ratio, noise and sensitivity were also performed. The system proved to be robust, consistent and dependable. Results indicated an overall success rate of 75% for the 13 CODIS core loci and more importantly no incorrect calls were identified. The DNAscan/ANDE™ could be confidently used without human interaction in both laboratory and non-laboratory settings to generate reference profiles. Published by Elsevier B.V.

A Capable and Temporary Test Facility on a Shoestring Budget: The MSL Touchdown Test Facility

NASA Technical Reports Server (NTRS)

White, Christopher V.; Frankovich, John K.; Yates, Philip; Wells, George, Jr.; Robert, Losey

2008-01-01

The Mars Science Laboratory mission (MSL) has undertaken a developmental Touchdown Test Program that utilizes a full-scale rover vehicle and an overhead winch system to replicate the skycrane landing event. Landing surfaces consisting of flat and sloped granular media, planar, rigid surfaces, and various combinations of rocks and slopes were studied. Information gathered from these tests was vital for validating the rover analytical model, validating certain design or system behavior assumptions, and for exploring events and phenomenon that are either very difficult or too costly to model in a credible way. This paper describes this test program, with a focus on the creation of test facility, daily test operations, and some of the challenges faced and lessons learned along the way.

Retina Image Analysis and Ocular Telehealth: The Oak Ridge National Laboratory-Hamilton Eye Institute Case Study

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

Karnowski, Thomas Paul; Giancardo, Luca; Li, Yaquin

2013-01-01

Automated retina image analysis has reached a high level of maturity in recent years, and thus the question of how validation is performed in these systems is beginning to grow in importance. One application of retina image analysis is in telemedicine, where an automated system could enable the automated detection of diabetic retinopathy and other eye diseases as a low-cost method for broad-based screening. In this work we discuss our experiences in developing a telemedical network for retina image analysis, including our progression from a manual diagnosis network to a more fully automated one. We pay special attention to howmore » validations of our algorithm steps are performed, both using data from the telemedicine network and other public databases.« less

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.

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.

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

Nuclear Energy Knowledge and Validation Center (NEKVaC) Needs Workshop Summary Report

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

Gougar, Hans

2015-02-01

The Department of Energy (DOE) has made significant progress developing simulation tools to predict the behavior of nuclear systems with greater accuracy and of increasing our capability to predict the behavior of these systems outside of the standard range of applications. These analytical tools require a more complex array of validation tests to accurately simulate the physics and multiple length and time scales. Results from modern simulations will allow experiment designers to narrow the range of conditions needed to bound system behavior and to optimize the deployment of instrumentation to limit the breadth and cost of the campaign. Modern validation,more » verification and uncertainty quantification (VVUQ) techniques enable analysts to extract information from experiments in a systematic manner and provide the users with a quantified uncertainty estimate. Unfortunately, the capability to perform experiments that would enable taking full advantage of the formalisms of these modern codes has progressed relatively little (with some notable exceptions in fuels and thermal-hydraulics); the majority of the experimental data available today is the "historic" data accumulated over the last decades of nuclear systems R&D. A validated code-model is a tool for users. An unvalidated code-model is useful for code developers to gain understanding, publish research results, attract funding, etc. As nuclear analysis codes have become more sophisticated, so have the measurement and validation methods and the challenges that confront them. A successful yet cost-effective validation effort requires expertise possessed only by a few, resources possessed only by the well-capitalized (or a willing collective), and a clear, well-defined objective (validating a code that is developed to satisfy the need(s) of an actual user). To that end, the Idaho National Laboratory established the Nuclear Energy Knowledge and Validation Center to address the challenges of modern code validation and to manage the knowledge from past, current, and future experimental campaigns. By pulling together the best minds involved in code development, experiment design, and validation to establish and disseminate best practices and new techniques, the Nuclear Energy Knowledge and Validation Center (NEKVaC or the ‘Center’) will be a resource for industry, DOE Programs, and academia validation efforts.« less

Design and validation of a wind tunnel system for odour sampling on liquid area sources.

PubMed

Capelli, L; Sironi, S; Del Rosso, R; Céntola, P

2009-01-01

The aim of this study is to describe the methods adopted for the design and the experimental validation of a wind tunnel, a sampling system suitable for the collection of gaseous samples on passive area sources, which allows to simulate wind action on the surface to be monitored. The first step of the work was the study of the air velocity profiles. The second step of the work consisted in the validation of the sampling system. For this purpose, the odour concentration of some air samples collected by means of the wind tunnel was measured by dynamic olfactometry. The results of the air velocity measurements show that the wind tunnel design features enabled the achievement of a uniform and homogeneous air flow through the hood. Moreover, the laboratory tests showed a very good correspondence between the odour concentration values measured at the wind tunnel outlet and the odour concentration values predicted by the application of a specific volatilization model, based on the Prandtl boundary layer theory. The agreement between experimental and theoretical trends demonstrate that the studied wind tunnel represents a suitable sampling system for the simulation of specific odour emission rates from liquid area sources without outward flow.

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...

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...

RELAP-7 Software Verification and Validation Plan

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

Smith, Curtis L.; Choi, Yong-Joon; Zou, Ling

This INL plan comprehensively describes the software for RELAP-7 and documents the software, interface, and software design requirements for the application. The plan also describes the testing-based software verification and validation (SV&V) process—a set of specially designed software models used to test RELAP-7. The RELAP-7 (Reactor Excursion and Leak Analysis Program) code is a nuclear reactor system safety analysis code being developed at Idaho National Laboratory (INL). The code is based on the INL’s modern scientific software development framework – MOOSE (Multi-Physics Object-Oriented Simulation Environment). The overall design goal of RELAP-7 is to take advantage of the previous thirty yearsmore » of advancements in computer architecture, software design, numerical integration methods, and physical models. The end result will be a reactor systems analysis capability that retains and improves upon RELAP5’s capability and extends the analysis capability for all reactor system simulation scenarios.« less

Impact Testing on Reinforced Carbon-Carbon Flat Panels with Ice Projectiles for the Space Shuttle Return to Flight Program

NASA Technical Reports Server (NTRS)

Melis, Matthew E.; Revilock, Duane M.; Pereira, Michael J.; Lyle, Karen H.

2009-01-01

Following the tragedy of the Orbiter Columbia (STS-107) on February 1, 2003, a major effort commenced to develop a better understanding of debris impacts and their effect on the space shuttle subsystems. An initiative to develop and validate physics-based computer models to predict damage from such impacts was a fundamental component of this effort. To develop the models it was necessary to physically characterize reinforced carbon-carbon (RCC) along with ice and foam debris materials, which could shed on ascent and impact the orbiter RCC leading edges. The validated models enabled the launch system community to use the impact analysis software LS-DYNA (Livermore Software Technology Corp.) to predict damage by potential and actual impact events on the orbiter leading edge and nose cap thermal protection systems. Validation of the material models was done through a three-level approach: Level 1--fundamental tests to obtain independent static and dynamic constitutive model properties of materials of interest, Level 2--subcomponent impact tests to provide highly controlled impact test data for the correlation and validation of the models, and Level 3--full-scale orbiter leading-edge impact tests to establish the final level of confidence for the analysis methodology. This report discusses the Level 2 test program conducted in the NASA Glenn Research Center (GRC) Ballistic Impact Laboratory with ice projectile impact tests on flat RCC panels, and presents the data observed. The Level 2 testing consisted of 54 impact tests in the NASA GRC Ballistic Impact Laboratory on 6- by 6-in. and 6- by 12-in. flat plates of RCC and evaluated three types of debris projectiles: Single-crystal, polycrystal, and "soft" ice. These impact tests helped determine the level of damage generated in the RCC flat plates by each projectile and validated the use of the ice and RCC models for use in LS-DYNA.

Impact Testing on Reinforced Carbon-Carbon Flat Panels With BX-265 and PDL-1034 External Tank Foam for the Space Shuttle Return to Flight Program

NASA Technical Reports Server (NTRS)

Melis, Matthew E.; Revilock, Duane M.; Pereira, Michael J.; Lyle, Karen H.

2009-01-01

Following the tragedy of the Orbiter Columbia (STS-107) on February 1, 2003, a major effort commenced to develop a better understanding of debris impacts and their effect on the space shuttle subsystems. An initiative to develop and validate physics-based computer models to predict damage from such impacts was a fundamental component of this effort. To develop the models it was necessary to physically characterize reinforced carbon-carbon (RCC) along with ice and foam debris materials, which could shed on ascent and impact the orbiter RCC leading edges. The validated models enabled the launch system community to use the impact analysis software LS-DYNA (Livermore Software Technology Corp.) to predict damage by potential and actual impact events on the orbiter leading edge and nose cap thermal protection systems. Validation of the material models was done through a three-level approach: Level 1-fundamental tests to obtain independent static and dynamic constitutive model properties of materials of interest, Level 2-subcomponent impact tests to provide highly controlled impact test data for the correlation and validation of the models, and Level 3-full-scale orbiter leading-edge impact tests to establish the final level of confidence for the analysis methodology. This report discusses the Level 2 test program conducted in the NASA Glenn Research Center (GRC) Ballistic Impact Laboratory with external tank foam impact tests on flat RCC panels, and presents the data observed. The Level 2 testing consisted of 54 impact tests in the NASA GRC Ballistic Impact Laboratory on 6- by 6-in. and 6- by 12-in. flat plates of RCC and evaluated two types of debris projectiles: BX-265 and PDL-1034 external tank foam. These impact tests helped determine the level of damage generated in the RCC flat plates by each projectile and validated the use of the foam and RCC models for use in LS-DYNA.

A comparison of the BAX system method to the U.S. Food and Drug Administration's Bacteriological Analytical Manual and International Organization for Standardization reference methods for the detection of Salmonella in a variety of soy ingredients.

PubMed

Belete, Tamrat; Crowley, Erin; Bird, Patrick; Gensic, Joseph; Wallace, F Morgan

2014-10-01

The performances of two DuPont BAX System PCR assays for detecting Salmonella on a variety of low-moisture soy ingredients were evaluated against the U. S. Food and Drug Administration's Bacteriological Analytical Manual (FDA BAM) method or the International Organization for Standardization (ISO) 6579 reference method. These evaluations were conducted as a single laboratory validation at an ISO 17025 accredited third-party laboratory. Validations were conducted on five soy ingredients: isolated soy protein (ISP), soy fiber, fluid soy lecithin, deoiled soy lecithin, and soy nuggets, using a paired-study design. The ISP was analyzed as both 25- and 375-g composite test portions, whereas all other sample matrices were analyzed as 375-g composite test portions. To evaluate 25-g test portions of ISP, the test material was inoculated using Salmonella enterica subsp. enterica serovar Mbandaka (Q Laboratories isolate 11031.1). Salmonella enterica subsp. enterica serovar Tennessee (Q Laboratories isolate 11031.3) was used for all other trials. For each trial of the method comparison, 25 samples were analyzed for each matrix: 5 uninoculated controls and 20 samples inoculated at low levels (0.2 to 2 CFU per test portion) that were targeted to achieve fractionally positive results (25 to 75%). Using McNemar's chi-square analysis, no significant difference at P ≥ 0.05 (χ(2) ≤ 3.84) was observed between the number of positives obtained by the BAX System and the reference methods for all five test matrices evaluated. These studies indicate that the BAX System PCR assays, in combination with the single buffered peptone water primary enrichment and subsequent brain heart infusion regrowth step, demonstrate equivalent sensitivity and robustness compared with the FDA BAM and ISO reference methods for both 25- and 375-g composite samples. Moreover, there was no observed reduction of sensitivity in the larger 375-g composite samples for all five matrices.

A Model-based Health Monitoring and Diagnostic System for the UH-60 Helicopter. Appendix D

NASA Technical Reports Server (NTRS)

Patterson-Hine, Ann; Hindson, William; Sanderfer, Dwight; Deb, Somnath; Domagala, Chuck

2001-01-01

Model-based reasoning techniques hold much promise in providing comprehensive monitoring and diagnostics capabilities for complex systems. We are exploring the use of one of these techniques, which utilizes multi-signal modeling and the TEAMS-RT real-time diagnostic engine, on the UH-60 Rotorcraft Aircrew Systems Concepts Airborne Laboratory (RASCAL) flight research aircraft. We focus on the engine and transmission systems, and acquire sensor data across the 1553 bus as well as by direct analog-to-digital conversion from sensors to the QHuMS (Qualtech health and usage monitoring system) computer. The QHuMS computer uses commercially available components and is rack-mounted in the RASCAL facility. A multi-signal model of the transmission and engine subsystems enables studies of system testability and analysis of the degree of fault isolation available with various instrumentation suites. The model and examples of these analyses will be described and the data architectures enumerated. Flight tests of this system will validate the data architecture and provide real-time flight profiles to be further analyzed in the laboratory.

An automation-assisted generic approach for biological sample preparation and LC-MS/MS method validation.

PubMed

Zhang, Jie; Wei, Shimin; Ayres, David W; Smith, Harold T; Tse, Francis L S

2011-09-01

Although it is well known that automation can provide significant improvement in the efficiency of biological sample preparation in quantitative LC-MS/MS analysis, it has not been widely implemented in bioanalytical laboratories throughout the industry. This can be attributed to the lack of a sound strategy and practical procedures in working with robotic liquid-handling systems. Several comprehensive automation assisted procedures for biological sample preparation and method validation were developed and qualified using two types of Hamilton Microlab liquid-handling robots. The procedures developed were generic, user-friendly and covered the majority of steps involved in routine sample preparation and method validation. Generic automation procedures were established as a practical approach to widely implement automation into the routine bioanalysis of samples in support of drug-development programs.

Avionics systems integration technology

NASA Technical Reports Server (NTRS)

Stech, George; Williams, James R.

1988-01-01

A very dramatic and continuing explosion in digital electronics technology has been taking place in the last decade. The prudent and timely application of this technology will provide Army aviation the capability to prevail against a numerically superior enemy threat. The Army and NASA have exploited this technology explosion in the development and application of avionics systems integration technology for new and future aviation systems. A few selected Army avionics integration technology base efforts are discussed. Also discussed is the Avionics Integration Research Laboratory (AIRLAB) that NASA has established at Langley for research into the integration and validation of avionics systems, and evaluation of advanced technology in a total systems context.

42 CFR 493.646 - Payment of fees.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.646 Payment of fees. (a) Except for CLIA-exempt laboratories, all laboratories are notified in writing by HHS or its designee of... been paid. (b) For State-exempt laboratories, HHS estimates the cost of conducting validation surveys...

Characterization of Aerodynamic Interactions with the Mars Science Laboratory Reaction Control System Using Computation and Experiment

NASA Technical Reports Server (NTRS)

Schoenenberger, Mark; VanNorman, John; Rhode, Matthew; Paulson, John

2013-01-01

On August 5 , 2012, the Mars Science Laboratory (MSL) entry capsule successfully entered Mars' atmosphere and landed the Curiosity rover in Gale Crater. The capsule used a reaction control system (RCS) consisting of four pairs of hydrazine thrusters to fly a guided entry. The RCS provided bank control to fly along a flight path commanded by an onboard computer and also damped unwanted rates due to atmospheric disturbances and any dynamic instabilities of the capsule. A preliminary assessment of the MSL's flight data from entry showed that the capsule flew much as predicted. This paper will describe how the MSL aerodynamics team used engineering analyses, computational codes and wind tunnel testing in concert to develop the RCS system and certify it for flight. Over the course of MSL's development, the RCS configuration underwent a number of design iterations to accommodate mechanical constraints, aeroheating concerns and excessive aero/RCS interactions. A brief overview of the MSL RCS configuration design evolution is provided. Then, a brief description is presented of how the computational predictions of RCS jet interactions were validated. The primary work to certify that the RCS interactions were acceptable for flight was centered on validating computational predictions at hypersonic speeds. A comparison of computational fluid dynamics (CFD) predictions to wind tunnel force and moment data gathered in the NASA Langley 31-Inch Mach 10 Tunnel was the lynch pin to validating the CFD codes used to predict aero/RCS interactions. Using the CFD predictions and experimental data, an interaction model was developed for Monte Carlo analyses using 6-degree-of-freedom trajectory simulation. The interaction model used in the flight simulation is presented.

Cryosphere Science Outreach using the Ice Sheet System Model and a Virtual Ice Sheet Laboratory

NASA Astrophysics Data System (ADS)

Cheng, D. L. C.; Halkides, D. J.; Larour, E. Y.

2015-12-01

Understanding the role of Cryosphere Science within the larger context of Sea Level Rise is both a technical and educational challenge that needs to be addressed if the public at large is to trulyunderstand the implications and consequences of Climate Change. Within this context, we propose a new approach in which scientific tools are used directly inside a mobile/website platform geared towards Education/Outreach. Here, we apply this approach by using the Ice Sheet System Model, a state of the art Cryosphere model developed at NASA, and integrated within a Virtual Ice Sheet Laboratory, with the goal is to outreach Cryospherescience to K-12 and College level students. The approach mixes laboratory experiments, interactive classes/lessons on a website, and a simplified interface to a full-fledged instance of ISSM to validate the classes/lessons. This novel approach leverages new insights from the Outreach/Educational community and the interest of new generations in web based technologies and simulation tools, all of it delivered in a seamlessly integrated web platform. This work was performed at the California Institute of Technology's Jet Propulsion Laboratory undera contract with the National Aeronautics and Space Administration's Cryosphere Science Program.

International Research and Development in Systems Biology

DTIC Science & Technology

2005-10-01

Poolla K., P. Khargonekar, A. Tikku, J. Krause , and K. Nagpal. 1994. A Time-Domain Approach to Model Validation. IEEE Trans Automat Contr 39: 951...Another European researcher modeling chemotaxis and cell motility is Wolfgang Alt (Bonn, Germany), although the panel did not visit his laboratory...Center/Hepatocyte Project Heidelberg, Germany Otmar Wiestler, Siegfried Neumann, Ursula Klingmüller, Willi Jager, Wolfgang Driever, Matthias Reuss

Development of a Hand Held Thromboelastograph

DTIC Science & Technology

2015-01-01

documents will be referenced during the Entegrion PCM System design, verification and validation activities. EN 61010 -1:2010 (Edition3.0) Safety...requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements. EN 61010 -2-101:2002 Safety...IPC-A-610E Acceptability of Electronic Assemblies IPC 7711/21B Rework, Modification and Repair of Electronic Assemblies. IEC 62304:2006/AC:2008

Using Optimization to Improve NASA Extravehicular Activity Planning

DTIC Science & Technology

2012-09-01

Mission Operations Directorate NASA National Aeronautics and Space Administration NBL Neutral Buoyancy Laboratory ORU Orbital Replacement Unit PET...training is conducted in the Neutral Buoyancy Lab ( NBL ) for full dress rehearsal. The active response gravity offload system is a facility that helps...three NBL runs are dedicated to task and timeline duration validation in normal circumstances, with the possibility of more if the tasks and procedures

HyPEP FY06 Report: Models and Methods

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

DOE report

2006-09-01

The Department of Energy envisions the next generation very high-temperature gas-cooled reactor (VHTR) as a single-purpose or dual-purpose facility that produces hydrogen and electricity. The Ministry of Science and Technology (MOST) of the Republic of Korea also selected VHTR for the Nuclear Hydrogen Development and Demonstration (NHDD) Project. This research project aims at developing a user-friendly program for evaluating and optimizing cycle efficiencies of producing hydrogen and electricity in a Very-High-Temperature Reactor (VHTR). Systems for producing electricity and hydrogen are complex and the calculations associated with optimizing these systems are intensive, involving a large number of operating parameter variations andmore » many different system configurations. This research project will produce the HyPEP computer model, which is specifically designed to be an easy-to-use and fast running tool for evaluating nuclear hydrogen and electricity production facilities. The model accommodates flexible system layouts and its cost models will enable HyPEP to be well-suited for system optimization. Specific activities of this research are designed to develop the HyPEP model into a working tool, including (a) identifying major systems and components for modeling, (b) establishing system operating parameters and calculation scope, (c) establishing the overall calculation scheme, (d) developing component models, (e) developing cost and optimization models, and (f) verifying and validating the program. Once the HyPEP model is fully developed and validated, it will be used to execute calculations on candidate system configurations. FY-06 report includes a description of reference designs, methods used in this study, models and computational strategies developed for the first year effort. Results from computer codes such as HYSYS and GASS/PASS-H used by Idaho National Laboratory and Argonne National Laboratory, respectively will be benchmarked with HyPEP results in the following years.« less

A validated finite element model of a soft artificial muscle motor

NASA Astrophysics Data System (ADS)

Tse, Tony Chun H.; O'Brien, Benjamin; McKay, Thomas; Anderson, Iain A.

2011-04-01

The Biomimetics Laboratory has developed a soft artificial muscle motor based on Dielectric Elastomers. The motor, 'Flexidrive', is light-weight and has low system complexity. It works by gripping and turning a shaft with a soft gear, like we would with our fingers. The motor's performance depends on many factors, such as actuation waveform, electrode patterning, geometries and contact tribology between the shaft and gear. We have developed a finite element model (FEM) of the motor as a study and design tool. Contact interaction was integrated with previous material and electromechanical coupling models in ABAQUS. The model was experimentally validated through a shape and blocked force analysis.

iPathology cockpit diagnostic station: validation according to College of American Pathologists Pathology and Laboratory Quality Center recommendation at the Hospital Trust and University of Verona.

PubMed

Brunelli, Matteo; Beccari, Serena; Colombari, Romano; Gobbo, Stefano; Giobelli, Luca; Pellegrini, Andrea; Chilosi, Marco; Lunardi, Maria; Martignoni, Guido; Scarpa, Aldo; Eccher, Albino

2014-01-01

Validation of digital whole slide images is crucial to ensure that diagnostic performance is at least equivalent to that of glass slides and light microscopy. The College of American Pathologists Pathology and Laboratory Quality Center recently developed recommendations for internal digital pathology system validation. Following these guidelines we sought to validate the performance of a digital approach for routine diagnosis by using an iPad and digital control widescreen-assisted workstation through a pilot study. From January 2014, 61 histopathological slides were scanned by ScanScope Digital Slides Scanner (Aperio, Vista, CA). Two independent pathologists performed diagnosis on virtual slides in front of a widescreen by using two computer devices (ImageScope viewing software) located to different Health Institutions (AOUI Verona) connected by local network and a remote image server using an iPad tablet (Aperio, Vista, CA), after uploading the Citrix receiver for iPad. Quality indicators related to image characters and work-flow of the e-health cockpit enterprise system were scored based on subjective (high vs poor) perception. The images were re-evaluated two weeks apart. The whole glass slides encountered 10 liver: hepatocarcinoma, 10 renal carcinoma, 10 gastric carcinoma and 10 prostate biopsies: adenocarcinoma, 5 excisional skin biopsies: melanoma, 5 lymph-nodes: lymphoma. 6 immuno- and 5 special stains were available for intra- and internet remote viewing. Scan times averaged two minutes and 54 seconds per slide (standard deviation 2 minutes 34 seconds). Megabytes ranged from 256 to 680 (mean 390) per slide storage. Reliance on glass slide, image quality (resolution and color fidelity), slide navigation time, simultaneous viewers in geographically remote locations were considered of high performance score. Side by side comparisons between diagnosis performed on tissue glass slides versus widescreen were excellent showing an almost perfect concordance (0.81, kappa index). We validated our institutional digital pathology system for routine diagnostic facing with whole slide images in a cockpit enterprise digital system or iPad tablet. Computer widescreens are better for diagnosing scanned glass slide that iPad. For urgent requests, iPad may be used. Legal aspects have to be soon faced with to permit the clinical use of this technology in a manner that does not compromise patient care.

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-treatment. However, the results were significant only with the criterions of the FMCE post-test factor "Concepts Regarding Newton's First and Second Laws" and the laboratory homework score. The interaction between the treatments and prior physics-classroom experience was not significant. Implications of the qualitative and quantitative findings are discussed.

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.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part IV - postanalytic considerations.

PubMed

Barnett, David; Louzao, Raaul; Gambell, Peter; De, Jitakshi; Oldaker, Teri; Hanson, Curtis A

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called home brew assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations. © 2013 International Clinical Cytometry Society.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues.

PubMed

Davis, Bruce H; Dasgupta, Amar; Kussick, Steven; Han, Jin-Yeong; Estrellado, Annalee

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part II - Preanalytical issues. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

Artificial intelligence techniques for monitoring dangerous infections.

PubMed

Lamma, Evelina; Mello, Paola; Nanetti, Anna; Riguzzi, Fabrizio; Storari, Sergio; Valastro, Gianfranco

2006-01-01

The monitoring and detection of nosocomial infections is a very important problem arising in hospitals. A hospital-acquired or nosocomial infection is a disease that develops after admission into the hospital and it is the consequence of a treatment, not necessarily a surgical one, performed by the medical staff. Nosocomial infections are dangerous because they are caused by bacteria which have dangerous (critical) resistance to antibiotics. This problem is very serious all over the world. In Italy, almost 5-8% of the patients admitted into hospitals develop this kind of infection. In order to reduce this figure, policies for controlling infections should be adopted by medical practitioners. In order to support them in this complex task, we have developed a system, called MERCURIO, capable of managing different aspects of the problem. The objectives of this system are the validation of microbiological data and the creation of a real time epidemiological information system. The system is useful for laboratory physicians, because it supports them in the execution of the microbiological analyses; for clinicians, because it supports them in the definition of the prophylaxis, of the most suitable antibi-otic therapy and in monitoring patients' infections; and for epidemiologists, because it allows them to identify outbreaks and to study infection dynamics. In order to achieve these objectives, we have adopted expert system and data mining techniques. We have also integrated a statistical module that monitors the diffusion of nosocomial infections over time in the hospital, and that strictly interacts with the knowledge based module. Data mining techniques have been used for improving the system knowledge base. The knowledge discovery process is not antithetic, but complementary to the one based on manual knowledge elicitation. In order to verify the reliability of the tasks performed by MERCURIO and the usefulness of the knowledge discovery approach, we performed a test based on a dataset of real infection events. In the validation task MERCURIO achieved an accuracy of 98.5%, a sensitivity of 98.5% and a specificity of 99%. In the therapy suggestion task, MERCURIO achieved very high accuracy and specificity as well. The executed test provided many insights to experts, too (we discovered some of their mistakes). The knowledge discovery approach was very effective in validating part of the MERCURIO knowledge base, and also in extending it with new validation rules, confirmed by interviewed microbiologists and specific to the hospital laboratory under consideration.

NCI Awards 18 Grants to Continue the Early Detection Research Network (EDRN) Biomarkers Effort | Division of Cancer Prevention

Cancer.gov

The NCI has awarded 18 grants to continue the Early Detection Research Network (EDRN), a national infrastructure that supports the integrated development, validation, and clinical application of biomarkers for the early detection of cancer. The awards fund 7 Biomarker Developmental Laboratories, 8 Clinical Validation Centers, 2 Biomarker Reference Laboratories, and a Data

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.

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

Rainer, Leo I.; Hoeschele, Marc A.; Apte, Michael G.

This report addresses the results of detailed monitoring completed under Program Element 6 of Lawrence Berkeley National Laboratory's High Performance Commercial Building Systems (HPCBS) PIER program. The purpose of the Energy Simulations and Projected State-Wide Energy Savings project is to develop reasonable energy performance and cost models for high performance relocatable classrooms (RCs) across California climates. A key objective of the energy monitoring was to validate DOE2 simulations for comparison to initial DOE2 performance projections. The validated DOE2 model was then used to develop statewide savings projections by modeling base case and high performance RC operation in the 16 Californiamore » climate zones. The primary objective of this phase of work was to utilize detailed field monitoring data to modify DOE2 inputs and generate performance projections based on a validated simulation model. Additional objectives include the following: (1) Obtain comparative performance data on base case and high performance HVAC systems to determine how they are operated, how they perform, and how the occupants respond to the advanced systems. This was accomplished by installing both HVAC systems side-by-side (i.e., one per module of a standard two module, 24 ft by 40 ft RC) on the study RCs and switching HVAC operating modes on a weekly basis. (2) Develop projected statewide energy and demand impacts based on the validated DOE2 model. (3) Develop cost effectiveness projections for the high performance HVAC system in the 16 California climate zones.« less

Thermodynamic limit for synthesis of metastable inorganic materials.

PubMed

Aykol, Muratahan; Dwaraknath, Shyam S; Sun, Wenhao; Persson, Kristin A

2018-04-01

Realizing the growing number of possible or hypothesized metastable crystalline materials is extremely challenging. There is no rigorous metric to identify which compounds can or cannot be synthesized. We present a thermodynamic upper limit on the energy scale, above which the laboratory synthesis of a polymorph is highly unlikely. The limit is defined on the basis of the amorphous state, and we validate its utility by effectively classifying more than 700 polymorphs in 41 common inorganic material systems in the Materials Project for synthesizability. The amorphous limit is highly chemistry-dependent and is found to be in complete agreement with our knowledge of existing polymorphs in these 41 systems, whether made by the nature or in a laboratory. Quantifying the limits of metastability for realizable compounds, the approach is expected to find major applications in materials discovery.

Ethernet-based smart networked elements (sensors and actuators)

NASA Astrophysics Data System (ADS)

Mata, Carlos T.; Perotti, José M.; Oostdyk, Rebecca L.; Lucena, Angel

2006-05-01

This paper outlines the present design approach for the Ethernet-Based Smart Networked Elements (SNE) being developed by NASA's Instrumentation Branch and the Advanced Electronics and Technology Development Laboratory of ASRC Aerospace Corporation at Kennedy Space Center (KSC). The SNEs are being developed as part of the Integrated Intelligent Health Management System (IIHMS), jointly developed by Stennis Space Center (SSC), KSC, and Marshall Space Flight Center (MSFC). SNEs are sensors/actuators with embedded intelligence, capable of networking among themselves and with higher-level systems (external processors and controllers) to provide not only instrumentation data but also associated data validity qualifiers. NASA KSC has successfully developed and preliminarily demonstrated this new generation of SNEs. SNEs that collect pressure, strain, and temperature measurements (including cryogenic temperature ranges) have been developed and tested in the laboratory and are ready for demonstration in the field.

Thermodynamic limit for synthesis of metastable inorganic materials

PubMed Central

2018-01-01

Realizing the growing number of possible or hypothesized metastable crystalline materials is extremely challenging. There is no rigorous metric to identify which compounds can or cannot be synthesized. We present a thermodynamic upper limit on the energy scale, above which the laboratory synthesis of a polymorph is highly unlikely. The limit is defined on the basis of the amorphous state, and we validate its utility by effectively classifying more than 700 polymorphs in 41 common inorganic material systems in the Materials Project for synthesizability. The amorphous limit is highly chemistry-dependent and is found to be in complete agreement with our knowledge of existing polymorphs in these 41 systems, whether made by the nature or in a laboratory. Quantifying the limits of metastability for realizable compounds, the approach is expected to find major applications in materials discovery. PMID:29725618

Development of a head impact monitoring "Intelligent Mouthguard".

PubMed

Hedin, Daniel S; Gibson, Paul L; Bartsch, Adam J; Samorezov, Sergey

2016-08-01

The authors present the development and laboratory system-level testing of an impact monitoring "Intelligent Mouthguard" intended to help with identification of potentially concussive head impacts and cumulative head impact dosage. The goal of Intelligent Mouthguard is to provide an indicator of potential concussion risk, and help caregiver identify athletes needing sideline concussion protocol testing. Intelligent Mouthguard may also help identify individuals who are at higher risk based on historical dosage. Intelligent Mouthguard integrates inertial sensors to provide 3-degree of freedom linear and rotational kinematics. The electronics are fully integrated into a custom mouthguard that couples tightly to the upper teeth. The combination of tight coupling and highly accurate sensor data means the Intelligent Mouthguard meets the National Football League (NFL) Level I validity specification based on laboratory system-level test data presented in this study.

Integrating standard operating procedures and industry notebook standards to evaluate students in laboratory courses.

PubMed

Wallert, Mark A; Provost, Joseph J

2014-01-01

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers. © 2013 by The International Union of Biochemistry and Molecular Biology.

Helical Face Gear Development Under the Enhanced Rotorcraft Drive System Program

NASA Technical Reports Server (NTRS)

Heath, Gregory F.; Slaughter, Stephen C.; Fisher, David J.; Lewicki, David G.; Fetty, Jason

2011-01-01

U.S. Army goals for the Enhanced Rotorcraft Drive System Program are to achieve a 40 percent increase in horsepower to weight ratio, a 15 dB reduction in drive system generated noise, 30 percent reduction in drive system operating, support, and acquisition cost, and 75 percent automatic detection of critical mechanical component failures. Boeing s technology transition goals are that the operational endurance level of the helical face gearing and related split-torque designs be validated to a TRL 6, and that analytical and manufacturing tools be validated. Helical face gear technology is being developed in this project to augment, and transition into, a Boeing AH-64 Block III split-torque face gear main transmission stage, to yield increased power density and reduced noise. To date, helical face gear grinding development on Northstar s new face gear grinding machine and pattern-development tests at the NASA Glenn/U.S. Army Research Laboratory have been completed and are described.

Sliding mode disturbance observer-based control of a twin rotor MIMO system.

PubMed

Rashad, Ramy; El-Badawy, Ayman; Aboudonia, Ahmed

2017-07-01

This work proposes a robust tracking controller for a helicopter laboratory setup known as the twin rotor MIMO system (TRMS) using an integral sliding mode controller. To eliminate the discontinuity in the control signal, the controller is augmented by a sliding mode disturbance observer. The actuator dynamics is handled using a backstepping approach which is applicable due to the continuous chattering-free nature of the command signals generated using the disturbance observer based controller. To avoid the complexity of analytically differentiating the command signals, a first order sliding mode differentiator is used. Stability analysis of the closed loop system and the ultimate boundedness of the tracking error is proved using Lyapunov stability arguments. The proposed controller is validated by several simulation studies and is compared to other schemes in the literature. Experimental results using a hardware-in-the-loop system validate the robustness and effectiveness of the proposed controller. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

A Multi-Purpose, Detector-Based Photometric Calibration System for Luminous Intensity, Illuminance and Luminance

NASA Astrophysics Data System (ADS)

Lam, Brenda H. S.; Yang, Steven S. L.; Chau, Y. C.

2018-02-01

A multi-purpose detector based calibration system for luminous intensity, illuminance and luminance has been developed at the Government of the Hong Kong Special Administrative Region, Standards and Calibration Laboratory (SCL). In this paper, the measurement system and methods are described. The measurement models and contributory uncertainties were validated using the Guide to the Expression of Uncertainty in Measurement (GUM) framework and Supplement 1 to the GUM - Propagation of distributions using a Monte Carlo method in accordance with the JCGM 100:2008 and JCGM 101:2008 at the intended precision level.

Performance and Durability of Environmental Barrier Coatings on SiC/SiC Ceramic Matrix Composites

NASA Technical Reports Server (NTRS)

Zhu, Dongming; Harder, Bryan; Bhatt, Ramakrishna

2016-01-01

This presentation highlights advanced environmental barrier coating (EBC) and SiC-SiC Ceramic Matrix Composites (CMC) systems for next generation turbine engines. The emphasis will be placed on fundamental coating and CMC property evaluations; and the integrated system performance and degradation mechanisms in simulated laboratory turbine engine testing environments. Long term durability tests in laser rig simulated high heat flux the rmomechanical creep and fatigue loading conditions will also be presented. The results can help improve the future EBC-CMC system designs, validating the advanced EBC-CMC technologies for hot section turbine engine applications.

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…

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.

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.

Evaluation of the national Notifiable Diseases Surveillance System for dengue fever in Taiwan, 2010-2012.

PubMed

McKerr, Caoimhe; Lo, Yi-Chun; Edeghere, Obaghe; Bracebridge, Sam

2015-03-01

In Taiwan, around 1,500 cases of dengue fever are reported annually and incidence has been increasing over time. A national web-based Notifiable Diseases Surveillance System (NDSS) has been in operation since 1997 to monitor incidence and trends and support case and outbreak management. We present the findings of an evaluation of the NDSS to ascertain the extent to which dengue fever surveillance objectives are being achieved. We extracted the NDSS data on all laboratory-confirmed dengue fever cases reported during 1 January 2010 to 31 December 2012 to assess and describe key system attributes based on the Centers for Disease Control and Prevention surveillance evaluation guidelines. The system's structure and processes were delineated and operational staff interviewed using a semi-structured questionnaire. Crude and age-adjusted incidence rates were calculated and key demographic variables were summarised to describe reporting activity. Data completeness and validity were described across several variables. Of 5,072 laboratory-confirmed dengue fever cases reported during 2010-2012, 4,740 (93%) were reported during July to December. The system was judged to be simple due to its minimal reporting steps. Data collected on key variables were correctly formatted and usable in > 90% of cases, demonstrating good data completeness and validity. The information collected was considered relevant by users with high acceptability. Adherence to guidelines for 24-hour reporting was 99%. Of 720 cases (14%) recorded as travel-related, 111 (15%) had an onset >14 days after return, highlighting the potential for misclassification. Information on hospitalization was missing for 22% of cases. The calculated PVP was 43%. The NDSS for dengue fever surveillance is a robust, well maintained and acceptable system that supports the collection of complete and valid data needed to achieve the surveillance objectives. The simplicity of the system engenders compliance leading to timely and accurate reporting. Completeness of hospitalization information could be further improved to allow assessment of severity of illness. To minimize misclassification, an algorithm to accurately classify travel cases should be established.

Characterization of the neutron irradiation system for use in the Low-Dose-Rate Irradiation Facility at Sandia National Laboratories.

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

Franco, Manuel

The objective of this work was to characterize the neutron irradiation system consisting of americium-241 beryllium (241AmBe) neutron sources placed in a polyethylene shielding for use at Sandia National Laboratories (SNL) Low Dose Rate Irradiation Facility (LDRIF). With a total activity of 0.3 TBq (9 Ci), the source consisted of three recycled 241AmBe sources of different activities that had been combined into a single source. The source in its polyethylene shielding will be used in neutron irradiation testing of components. The characterization of the source-shielding system was necessary to evaluate the radiation environment for future experiments. Characterization of the sourcemore » was also necessary because the documentation for the three component sources and their relative alignment within the Special Form Capsule (SFC) was inadequate. The system consisting of the source and shielding was modeled using Monte Carlo N-Particle transport code (MCNP). The model was validated by benchmarking it against measurements using multiple techniques. To characterize the radiation fields over the full spatial geometry of the irradiation system, it was necessary to use a number of instruments of varying sensitivities. First, the computed photon radiography assisted in determining orientation of the component sources. With the capsule properly oriented inside the shielding, the neutron spectra were measured using a variety of techniques. A N-probe Microspec and a neutron Bubble Dosimeter Spectrometer (BDS) set were used to characterize the neutron spectra/field in several locations. In the third technique, neutron foil activation was used to ascertain the neutron spectra. A high purity germanium (HPGe) detector was used to characterize the photon spectrum. The experimentally measured spectra and the MCNP results compared well. Once the MCNP model was validated to an adequate level of confidence, parametric analyses was performed on the model to optimize for potential experimental configurations and neutron spectra for component irradiation. The final product of this work is a MCNP model validated by measurements, an overall understanding of neutron irradiation system including photon/neutron transport and effective dose rates throughout the system, and possible experimental configurations for future irradiation of components.« less

[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.

Internal quality control: best practice.

PubMed

Kinns, Helen; Pitkin, Sarah; Housley, David; Freedman, Danielle B

2013-12-01

There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

Atmosphere behavior in gas-closed mouse-algal systems - An experimental and modelling study

NASA Technical Reports Server (NTRS)

Averner, M. M.; Moore, B., III; Bartholomew, I.; Wharton, R.

1984-01-01

A NASA-sponsored research program initiated using mathematical modelling and laboratory experimentation aimed at examining the gas-exchange characteristics of artificial animal/plant systems closed to the ambient atmosphere is studied. The development of control techniques and management strategies for maintaining the atmospheric levels of carbon dioxide and oxygen at physiological levels is considered. A mathematical model simulating the behavior of a gas-closed mouse-algal system under varying environmental conditions is described. To verify and validate the model simulations, an analytical system with which algal growth and gas exchange characteristics can be manipulated and measured is designed, fabricated, and tested. The preliminary results are presented.

CSI computer system/remote interface unit acceptance test results

NASA Technical Reports Server (NTRS)

Sparks, Dean W., Jr.

1992-01-01

The validation tests conducted on the Control/Structures Interaction (CSI) Computer System (CCS)/Remote Interface Unit (RIU) is discussed. The CCS/RIU consists of a commercially available, Langley Research Center (LaRC) programmed, space flight qualified computer and a flight data acquisition and filtering computer, developed at LaRC. The tests were performed in the Space Structures Research Laboratory (SSRL) and included open loop excitation, closed loop control, safing, RIU digital filtering, and RIU stand alone testing with the CSI Evolutionary Model (CEM) Phase-0 testbed. The test results indicated that the CCS/RIU system is comparable to ground based systems in performing real-time control-structure experiments.

Flight Validation of Mars Mission Technologies

NASA Technical Reports Server (NTRS)

Eberspeaker, P. J.

2000-01-01

Effective exploration and characterization of Mars will require the deployment of numerous surface probes, tethered balloon stations and free-flying balloon systems as well as larger landers and orbiting satellite systems. Since launch opportunities exist approximately every two years it is extremely critical that each and every mission maximize its potential for success. This will require significant testing of each system in an environment that simulates the actual operational environment as closely as possible. Analytical techniques and laboratory testing goes a long way in mitigating the inherent risks associated with space exploration, however they fall sort of accurately simulating the unpredictable operational environment in which these systems must function.

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.

A miniaturised image based fluorescence detection system for point-of-care-testing of cocaine abuse

NASA Astrophysics Data System (ADS)

Walczak, Rafał; Krüger, Jan; Moynihan, Shane

2015-08-01

In this paper, we describe a miniaturised image-based fluorescence detection system and demonstrate its viability as a highly sensitive tool for point-of-care-analysis of drugs of abuse in human sweat with a focus on monitor individuals for drugs of abuse. Investigations of miniaturised and low power optoelectronic configurations and methodologies for real-time image analysis were successfully carried out. The miniaturised fluorescence detection system was validated against a reference detection system under controlled laboratory conditions by analysing spiked sweat samples in dip stick and then strip with sample pad. As a result of the validation studies, a 1 ng mL-1 limit of detection of cocaine in sweat and full agreement of test results with the reference detection system can be reported. Results of the investigations open the way towards a detection system that integrates a hand-held fluorescence reader and a wearable skinpatch, and which can collect and in situ analyse sweat for the presence of cocaine at any point for up to tenths hours.

Multi-Evaporator Miniature Loop Heat Pipe for Small Spacecraft Thermal Control. Part 1; New Technologies and Validation Approach

NASA Technical Reports Server (NTRS)

Ku, Jentung; Ottenstein, Laura; Douglas, Donya; Hoang, Triem

2010-01-01

Under NASA s New Millennium Program Space Technology 8 (ST 8) Project, four experiments Thermal Loop, Dependable Microprocessor, SAILMAST, and UltraFlex - were conducted to advance the maturity of individual technologies from proof of concept to prototype demonstration in a relevant environment , i.e. from a technology readiness level (TRL) of 3 to a level of 6. This paper presents the new technologies and validation approach of the Thermal Loop experiment. The Thermal Loop is an advanced thermal control system consisting of a miniature loop heat pipe (MLHP) with multiple evaporators and multiple condensers designed for future small system applications requiring low mass, low power, and compactness. The MLHP retains all features of state-of-the-art loop heat pipes (LHPs) and offers additional advantages to enhance the functionality, performance, versatility, and reliability of the system. Details of the thermal loop concept, technical advances, benefits, objectives, level 1 requirements, and performance characteristics are described. Also included in the paper are descriptions of the test articles and mathematical modeling used for the technology validation. An MLHP breadboard was built and tested in the laboratory and thermal vacuum environments for TRL 4 and TRL 5 validations, and an MLHP proto-flight unit was built and tested in a thermal vacuum chamber for the TRL 6 validation. In addition, an analytical model was developed to simulate the steady state and transient behaviors of the MLHP during various validation tests. Capabilities and limitations of the analytical model are also addressed.

Benchmark Simulations of the Thermal-Hydraulic Responses during EBR-II Inherent Safety Tests using SAM

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

Hu, Rui; Sumner, Tyler S.

2016-04-17

An advanced system analysis tool SAM is being developed for fast-running, improved-fidelity, and whole-plant transient analyses at Argonne National Laboratory under DOE-NE’s Nuclear Energy Advanced Modeling and Simulation (NEAMS) program. As an important part of code development, companion validation activities are being conducted to ensure the performance and validity of the SAM code. This paper presents the benchmark simulations of two EBR-II tests, SHRT-45R and BOP-302R, whose data are available through the support of DOE-NE’s Advanced Reactor Technology (ART) program. The code predictions of major primary coolant system parameter are compared with the test results. Additionally, the SAS4A/SASSYS-1 code simulationmore » results are also included for a code-to-code comparison.« less

A mobile sensing system for structural health monitoring: design and validation

NASA Astrophysics Data System (ADS)

Zhu, Dapeng; Yi, Xiaohua; Wang, Yang; Lee, Kok-Meng; Guo, Jiajie

2010-05-01

This paper describes a new approach using mobile sensor networks for structural health monitoring. Compared with static sensors, mobile sensor networks offer flexible system architectures with adaptive spatial resolutions. The paper first describes the design of a mobile sensing node that is capable of maneuvering on structures built with ferromagnetic materials. The mobile sensing node can also attach/detach an accelerometer onto/from the structural surface. The performance of the prototype mobile sensor network has been validated through laboratory experiments. Two mobile sensing nodes are adopted for navigating on a steel portal frame and providing dense acceleration measurements. Transmissibility function analysis is conducted to identify structural damage using data collected by the mobile sensing nodes. This preliminary work is expected to spawn transformative changes in the use of mobile sensors for future structural health monitoring.

Computer-aided sperm analysis (CASA) in the medical laboratory: CASA in diagnostic andrology and assisted conception.

PubMed

Tomlinson, Mathew J; Naeem, Asad

2018-03-21

CASA has been used in reproductive medicine and pathology laboratories for over 25 years, yet the 'fertility industry' generally remains sceptical and has avoided automation, despite clear weaknesses in manual semen analysis. Early implementers had difficulty in validating CASA-Mot instruments against recommended manual methods (haemocytometer) due to the interference of seminal debris and non-sperm cells, which also affects the accuracy of grading motility. Both the inability to provide accurate sperm counts and a lack of consensus as to the value of sperm kinematic parameters appear to have continued to have a negative effect on CASA-Mot's reputation. One positive interpretation from earlier work is that at least one or more measures of sperm velocity adds clinical value to the semen analysis, and these are clearly more objective than any manual motility analysis. Moreover, recent CASA-Mot systems offer simple solutions to earlier problems in eliminating artefacts and have been successfully validated for sperm concentration; as a result, they should be viewed with more confidence in relation to motility grading. Sperm morphology and DNA testing both require an evidence-based consensus and a well-validated (reliable, reproducible) assay to be developed before automation of either can be of real clinical benefit.

Validity of the Instrumented Push and Release Test to Quantify Postural Responses in Persons With Multiple Sclerosis.

PubMed

El-Gohary, Mahmoud; Peterson, Daniel; Gera, Geetanjali; Horak, Fay B; Huisinga, Jessie M

2017-07-01

To test the validity of wearable inertial sensors to provide objective measures of postural stepping responses to the push and release clinical test in people with multiple sclerosis. Cross-sectional study. University medical center balance disorder laboratory. Total sample N=73; persons with multiple sclerosis (PwMS) n=52; healthy controls n=21. Stepping latency, time and number of steps required to reach stability, and initial step length were calculated using 3 inertial measurement units placed on participants' lumbar spine and feet. Correlations between inertial sensor measures and measures obtained from the laboratory-based systems were moderate to strong and statistically significant for all variables: time to release (r=.992), latency (r=.655), time to stability (r=.847), time of first heel strike (r=.665), number of steps (r=.825), and first step length (r=.592). Compared with healthy controls, PwMS demonstrated a longer time to stability and required a larger number of steps to reach stability. The instrumented push and release test is a valid measure of postural responses in PwMS and could be used as a clinical outcome measures for patient care decisions or for clinical trials aimed at improving postural control in PwMS. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The EnzymeTracker: an open-source laboratory information management system for sample tracking.

PubMed

Triplet, Thomas; Butler, Gregory

2012-01-26

In many laboratories, researchers store experimental data on their own workstation using spreadsheets. However, this approach poses a number of problems, ranging from sharing issues to inefficient data-mining. Standard spreadsheets are also error-prone, as data do not undergo any validation process. To overcome spreadsheets inherent limitations, a number of proprietary systems have been developed, which laboratories need to pay expensive license fees for. Those costs are usually prohibitive for most laboratories and prevent scientists from benefiting from more sophisticated data management systems. In this paper, we propose the EnzymeTracker, a web-based laboratory information management system for sample tracking, as an open-source and flexible alternative that aims at facilitating entry, mining and sharing of experimental biological data. The EnzymeTracker features online spreadsheets and tools for monitoring numerous experiments conducted by several collaborators to identify and characterize samples. It also provides libraries of shared data such as protocols, and administration tools for data access control using OpenID and user/team management. Our system relies on a database management system for efficient data indexing and management and a user-friendly AJAX interface that can be accessed over the Internet. The EnzymeTracker facilitates data entry by dynamically suggesting entries and providing smart data-mining tools to effectively retrieve data. Our system features a number of tools to visualize and annotate experimental data, and export highly customizable reports. It also supports QR matrix barcoding to facilitate sample tracking. The EnzymeTracker was designed to be easy to use and offers many benefits over spreadsheets, thus presenting the characteristics required to facilitate acceptance by the scientific community. It has been successfully used for 20 months on a daily basis by over 50 scientists. The EnzymeTracker is freely available online at http://cubique.fungalgenomics.ca/enzymedb/index.html under the GNU GPLv3 license.

The EnzymeTracker: an open-source laboratory information management system for sample tracking

PubMed Central

2012-01-01

Background In many laboratories, researchers store experimental data on their own workstation using spreadsheets. However, this approach poses a number of problems, ranging from sharing issues to inefficient data-mining. Standard spreadsheets are also error-prone, as data do not undergo any validation process. To overcome spreadsheets inherent limitations, a number of proprietary systems have been developed, which laboratories need to pay expensive license fees for. Those costs are usually prohibitive for most laboratories and prevent scientists from benefiting from more sophisticated data management systems. Results In this paper, we propose the EnzymeTracker, a web-based laboratory information management system for sample tracking, as an open-source and flexible alternative that aims at facilitating entry, mining and sharing of experimental biological data. The EnzymeTracker features online spreadsheets and tools for monitoring numerous experiments conducted by several collaborators to identify and characterize samples. It also provides libraries of shared data such as protocols, and administration tools for data access control using OpenID and user/team management. Our system relies on a database management system for efficient data indexing and management and a user-friendly AJAX interface that can be accessed over the Internet. The EnzymeTracker facilitates data entry by dynamically suggesting entries and providing smart data-mining tools to effectively retrieve data. Our system features a number of tools to visualize and annotate experimental data, and export highly customizable reports. It also supports QR matrix barcoding to facilitate sample tracking. Conclusions The EnzymeTracker was designed to be easy to use and offers many benefits over spreadsheets, thus presenting the characteristics required to facilitate acceptance by the scientific community. It has been successfully used for 20 months on a daily basis by over 50 scientists. The EnzymeTracker is freely available online at http://cubique.fungalgenomics.ca/enzymedb/index.html under the GNU GPLv3 license. PMID:22280360

Good Practices in Forensic Toxicology.

PubMed

Drummer, Olaf H

2017-01-01

This manuscript provides an overview for analysts, medical and scientific investigators, and laboratory administrators, the range of factors that should be considered to implement best practice forensic toxicology. These include laboratory influence over the collection of specimens, their proper transport and chain-of-custody before arrival in the laboratory. In addition, the laboratory needs to ensure properly trained staff use suitably validated and documented analytical procedures that meet the intended purpose and type of case in an accredited or suitably quality oriented management system. To assist the investigating officers laboratory results require an interpretation over their possible significance when sufficient details are available over the circumstances of the case. This requires a thorough understanding of the various factors that influence concentrations of substances and ultimately their likely physiological effect. These include consideration of the route of ingestion, influence over chronicity of usage on tissue concentrations and tolerance, possible combined drug effects or likely adverse reactions and consideration of relevant genetic factors that may have influenced pharmacokinetic or pharmacodynamic response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Benefits of a Recombination-Proficient Escherichia coli System for Adaptive Laboratory Evolution.

PubMed

Peabody, George; Winkler, James; Fountain, Weston; Castro, David A; Leiva-Aravena, Enzo; Kao, Katy C

2016-11-15

Adaptive laboratory evolution typically involves the propagation of organisms asexually to select for mutants with the desired phenotypes. However, asexual evolution is prone to competition among beneficial mutations (clonal interference) and the accumulation of hitchhiking and neutral mutations. The benefits of horizontal gene transfer toward overcoming these known disadvantages of asexual evolution were characterized in a strain of Escherichia coli engineered for superior sexual recombination (genderless). Specifically, we experimentally validated the capacity of the genderless strain to reduce the mutational load and recombine beneficial mutations. We also confirmed that inclusion of multiple origins of transfer influences both the frequency of genetic exchange throughout the chromosome and the linkage of donor DNA. We built a simple kinetic model to estimate recombination frequency as a function of transfer size and relative genotype enrichment in batch transfers; the model output correlated well with the experimental data. Our results provide strong support for the advantages of utilizing the genderless strain over its asexual counterpart during adaptive laboratory evolution for generating beneficial mutants with reduced mutational load. Over 80 years ago Fisher and Muller began a debate on the origins of sexual recombination. Although many aspects of sexual recombination have been examined at length, experimental evidence behind the behaviors of recombination in many systems and the means to harness it remain elusive. In this study, we sought to experimentally validate some advantages of recombination in typically asexual Escherichia coli and determine if a sexual strain of E. coli can become an effective tool for strain development. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Benefits of a Recombination-Proficient Escherichia coli System for Adaptive Laboratory Evolution

PubMed Central

Peabody, George; Winkler, James; Fountain, Weston; Castro, David A.; Leiva-Aravena, Enzo

2016-01-01

ABSTRACT Adaptive laboratory evolution typically involves the propagation of organisms asexually to select for mutants with the desired phenotypes. However, asexual evolution is prone to competition among beneficial mutations (clonal interference) and the accumulation of hitchhiking and neutral mutations. The benefits of horizontal gene transfer toward overcoming these known disadvantages of asexual evolution were characterized in a strain of Escherichia coli engineered for superior sexual recombination (genderless). Specifically, we experimentally validated the capacity of the genderless strain to reduce the mutational load and recombine beneficial mutations. We also confirmed that inclusion of multiple origins of transfer influences both the frequency of genetic exchange throughout the chromosome and the linkage of donor DNA. We built a simple kinetic model to estimate recombination frequency as a function of transfer size and relative genotype enrichment in batch transfers; the model output correlated well with the experimental data. Our results provide strong support for the advantages of utilizing the genderless strain over its asexual counterpart during adaptive laboratory evolution for generating beneficial mutants with reduced mutational load. IMPORTANCE Over 80 years ago Fisher and Muller began a debate on the origins of sexual recombination. Although many aspects of sexual recombination have been examined at length, experimental evidence behind the behaviors of recombination in many systems and the means to harness it remain elusive. In this study, we sought to experimentally validate some advantages of recombination in typically asexual Escherichia coli and determine if a sexual strain of E. coli can become an effective tool for strain development. PMID:27613685

Validation of the Emotiv EPOC® EEG gaming system for measuring research quality auditory ERPs

PubMed Central

Mousikou, Petroula; Mahajan, Yatin; de Lissa, Peter; Thie, Johnson; McArthur, Genevieve

2013-01-01

Background. Auditory event-related potentials (ERPs) have proved useful in investigating the role of auditory processing in cognitive disorders such as developmental dyslexia, specific language impairment (SLI), attention deficit hyperactivity disorder (ADHD), schizophrenia, and autism. However, laboratory recordings of auditory ERPs can be lengthy, uncomfortable, or threatening for some participants – particularly children. Recently, a commercial gaming electroencephalography (EEG) system has been developed that is portable, inexpensive, and easy to set up. In this study we tested if auditory ERPs measured using a gaming EEG system (Emotiv EPOC®, www.emotiv.com) were equivalent to those measured by a widely-used, laboratory-based, research EEG system (Neuroscan). Methods. We simultaneously recorded EEGs with the research and gaming EEG systems, whilst presenting 21 adults with 566 standard (1000 Hz) and 100 deviant (1200 Hz) tones under passive (non-attended) and active (attended) conditions. The onset of each tone was marked in the EEGs using a parallel port pulse (Neuroscan) or a stimulus-generated electrical pulse injected into the O1 and O2 channels (Emotiv EPOC®). These markers were used to calculate research and gaming EEG system late auditory ERPs (P1, N1, P2, N2, and P3 peaks) and the mismatch negativity (MMN) in active and passive listening conditions for each participant. Results. Analyses were restricted to frontal sites as these are most commonly reported in auditory ERP research. Intra-class correlations (ICCs) indicated that the morphology of the research and gaming EEG system late auditory ERP waveforms were similar across all participants, but that the research and gaming EEG system MMN waveforms were only similar for participants with non-noisy MMN waveforms (N = 11 out of 21). Peak amplitude and latency measures revealed no significant differences between the size or the timing of the auditory P1, N1, P2, N2, P3, and MMN peaks. Conclusions. Our findings suggest that the gaming EEG system may prove a valid alternative to laboratory ERP systems for recording reliable late auditory ERPs (P1, N1, P2, N2, and the P3) over the frontal cortices. In the future, the gaming EEG system may also prove useful for measuring less reliable ERPs, such as the MMN, if the reliability of such ERPs can be boosted to the same level as late auditory ERPs. PMID:23638374

Validation of the Emotiv EPOC(®) EEG gaming system for measuring research quality auditory ERPs.

PubMed

Badcock, Nicholas A; Mousikou, Petroula; Mahajan, Yatin; de Lissa, Peter; Thie, Johnson; McArthur, Genevieve

2013-01-01

Background. Auditory event-related potentials (ERPs) have proved useful in investigating the role of auditory processing in cognitive disorders such as developmental dyslexia, specific language impairment (SLI), attention deficit hyperactivity disorder (ADHD), schizophrenia, and autism. However, laboratory recordings of auditory ERPs can be lengthy, uncomfortable, or threatening for some participants - particularly children. Recently, a commercial gaming electroencephalography (EEG) system has been developed that is portable, inexpensive, and easy to set up. In this study we tested if auditory ERPs measured using a gaming EEG system (Emotiv EPOC(®), www.emotiv.com) were equivalent to those measured by a widely-used, laboratory-based, research EEG system (Neuroscan). Methods. We simultaneously recorded EEGs with the research and gaming EEG systems, whilst presenting 21 adults with 566 standard (1000 Hz) and 100 deviant (1200 Hz) tones under passive (non-attended) and active (attended) conditions. The onset of each tone was marked in the EEGs using a parallel port pulse (Neuroscan) or a stimulus-generated electrical pulse injected into the O1 and O2 channels (Emotiv EPOC(®)). These markers were used to calculate research and gaming EEG system late auditory ERPs (P1, N1, P2, N2, and P3 peaks) and the mismatch negativity (MMN) in active and passive listening conditions for each participant. Results. Analyses were restricted to frontal sites as these are most commonly reported in auditory ERP research. Intra-class correlations (ICCs) indicated that the morphology of the research and gaming EEG system late auditory ERP waveforms were similar across all participants, but that the research and gaming EEG system MMN waveforms were only similar for participants with non-noisy MMN waveforms (N = 11 out of 21). Peak amplitude and latency measures revealed no significant differences between the size or the timing of the auditory P1, N1, P2, N2, P3, and MMN peaks. Conclusions. Our findings suggest that the gaming EEG system may prove a valid alternative to laboratory ERP systems for recording reliable late auditory ERPs (P1, N1, P2, N2, and the P3) over the frontal cortices. In the future, the gaming EEG system may also prove useful for measuring less reliable ERPs, such as the MMN, if the reliability of such ERPs can be boosted to the same level as late auditory ERPs.

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…

Assessment of Bioremediation Technologies: Focus on Technologies Suitable for Field-Level Demonstrations and Applicable to DoD Contaminants.

DTIC Science & Technology

1995-06-01

include leachate collection systems and some form of aeration. The reactor is set up on an impermeable liner to prevent contaminant migration. Treatment...Bioremediation Microbial Mats Phytoremediation /construc- ted wetlands White Rot Fungus Full scale commercial technology for treatment of hydro...validation Phytoremediation / Constructed Wetlands Some scaled up batch demonstrations. Primarily laboratory scale. White Rot Fungus Pilot scale

The Use of Transfer Radiometers in Validating the Visible through Shortwave Infrared Calibrations of Radiance Sources Used by Instruments in NASA's Earth Observing System

NASA Technical Reports Server (NTRS)

Butler, James J.; Barnes, Robert A.

2002-01-01

The detection and study of climate change over a time frame of decades requires successive generations of satellite, airborne, and ground-based instrumentation carefully calibrated against a common radiance scale. In NASA s Earth Observing System (EOS) program, the pre-launch radiometric calibration of these instruments in the wavelength region from 400 nm to 2500 nm is accomplished using internally illuminated integrating spheres and diffuse reflectance panels illuminated by irradiance standard lamps. Since 1995, the EOS Calibration Program operating within the EOS Project Science Office (PSO) has enlisted the expertise of national standards laboratories and government and university metrology laboratories in an effort to validate the radiance scales assigned to sphere and panel radiance sources by EOS instrument calibration facilities. This state-of-the-art program has been accomplished using ultra-stable transfer radiometers independently calibrated by the above participating institutions. In ten comparisons since February 1995, the agreement between the radiance measurements of the transfer radiometers is plus or minus 1.80% at 411 nm, plus or minus 1.31% at 552.5 nm, plus or minus 1.32% at 868.0 nm, plus or minus 2.54% at 1622nm, and plus or minus 2.81% at 2200nm (sigma =1).

Multi-Evaporator Miniature Loop Heat Pipe for Small Spacecraft Thermal Control. Part 2; Validation Results

NASA Technical Reports Server (NTRS)

Ku, Jentung; Ottenstein, Laura; Douglas, Donya; Hoang, Triem

2010-01-01

Under NASA s New Millennium Program Space Technology 8 (ST 8) Project, Goddard Space Fight Center has conducted a Thermal Loop experiment to advance the maturity of the Thermal Loop technology from proof of concept to prototype demonstration in a relevant environment , i.e. from a technology readiness level (TRL) of 3 to a level of 6. The thermal Loop is an advanced thermal control system consisting of a miniature loop heat pipe (MLHP) with multiple evaporators and multiple condensers designed for future small system applications requiring low mass, low power, and compactness. The MLHP retains all features of state-of-the-art loop heat pipes (LHPs) and offers additional advantages to enhance the functionality, performance, versatility, and reliability of the system. An MLHP breadboard was built and tested in the laboratory and thermal vacuum environments for the TRL 4 and TRL 5 validations, respectively, and an MLHP proto-flight unit was built and tested in a thermal vacuum chamber for the TRL 6 validation. In addition, an analytical model was developed to simulate the steady state and transient behaviors of the MLHP during various validation tests. The MLHP demonstrated excellent performance during experimental tests and the analytical model predictions agreed very well with experimental data. All success criteria at various TRLs were met. Hence, the Thermal Loop technology has reached a TRL of 6. This paper presents the validation results, both experimental and analytical, of such a technology development effort.

Comparison of pneumatic tube system with manual transport for routine chemistry, hematology, coagulation and blood gas tests.

PubMed

Pupek, Alex; Matthewson, Beverly; Whitman, Erin; Fullarton, Rachel; Chen, Yu

2017-08-28

The pneumatic tube system (PTS) is commonly used in modern clinical laboratories to provide quick specimen delivery. However, its impact on sample integrity and laboratory testing results are still debatable. In addition, each PTS installation and configuration is unique to its institution. We sought to validate our Swisslog PTS by comparing routine chemistry, hematology, coagulation and blood gas test results and sample integrity indices between duplicate samples transported either manually or by PTS. Duplicate samples were delivered to the core laboratory manually by human courier or via the Swisslog PTS. Head-to-head comparisons of 48 routine chemistry, hematology, coagulation and blood gas laboratory tests, and three sample integrity indices were conducted on 41 healthy volunteers and 61 adult patients. The PTS showed no impact on sample hemolysis, lipemia, or icterus indices (all p<0.05). Although alkaline phosphatase, total bilirubin and hemoglobin reached statistical significance (p=0.009, 0.027 and 0.012, respectively), all had very low average bias which ranged from 0.01% to 2%. Potassium, total hemoglobin and percent deoxyhemoglobin were statistically significant for the neonatal capillary tube study (p=0.011, 0.033 and 0.041, respectively) but no biases greater than ±4% were identified for these parameters. All observed differences of these 48 laboratory tests were not clinically significant. The modern PTS investigated in this study is acceptable for reliable sample delivery for routine chemistry, hematology, coagulation and blood gas (in syringe and capillary tube) laboratory tests.

Strain gauge validation experiments for the Sandia 34-meter VAWT (Vertical Axis Wind Turbine) test bed

NASA Astrophysics Data System (ADS)

Sutherland, Herbert J.

1988-08-01

Sandia National Laboratories has erected a research oriented, 34- meter diameter, Darrieus vertical axis wind turbine near Bushland, Texas. This machine, designated the Sandia 34-m VAWT Test Bed, is equipped with a large array of strain gauges that have been placed at critical positions about the blades. This manuscript details a series of four-point bend experiments that were conducted to validate the output of the blade strain gauge circuits. The output of a particular gauge circuit is validated by comparing its output to equivalent gauge circuits (in this stress state) and to theoretical predictions. With only a few exceptions, the difference between measured and predicted strain values for a gauge circuit was found to be of the order of the estimated repeatability for the measurement system.

Review of the current state of whole slide imaging in pathology

PubMed Central

Pantanowitz, Liron; Valenstein, Paul N.; Evans, Andrew J.; Kaplan, Keith J.; Pfeifer, John D.; Wilbur, David C.; Collins, Laura C.; Colgan, Terence J.

2011-01-01

Whole slide imaging (WSI), or “virtual” microscopy, involves the scanning (digitization) of glass slides to produce “digital slides”. WSI has been advocated for diagnostic, educational and research purposes. When used for remote frozen section diagnosis, WSI requires a thorough implementation period coupled with trained support personnel. Adoption of WSI for rendering pathologic diagnoses on a routine basis has been shown to be successful in only a few “niche” applications. Wider adoption will most likely require full integration with the laboratory information system, continuous automated scanning, high-bandwidth connectivity, massive storage capacity, and more intuitive user interfaces. Nevertheless, WSI has been reported to enhance specific pathology practices, such as scanning slides received in consultation or of legal cases, of slides to be used for patient care conferences, for quality assurance purposes, to retain records of slides to be sent out or destroyed by ancillary testing, and for performing digital image analysis. In addition to technical issues, regulatory and validation requirements related to WSI have yet to be adequately addressed. Although limited validation studies have been published using WSI there are currently no standard guidelines for validating WSI for diagnostic use in the clinical laboratory. This review addresses the current status of WSI in pathology related to regulation and validation, the provision of remote and routine pathologic diagnoses, educational uses, implementation issues, and the cost-benefit analysis of adopting WSI in routine clinical practice. PMID:21886892

Re-evaluation of Spent Nuclear Fuel Assay Data for the Three Mile Island Unit 1 Reactor and Application to Code Validation

DOE PAGES

Gauld, Ian C.; Giaquinto, J. M.; Delashmitt, J. S.; ...

2016-01-01

Destructive radiochemical assay measurements of spent nuclear fuel rod segments from an assembly irradiated in the Three Mile Island unit 1 (TMI-1) pressurized water reactor have been performed at Oak Ridge National Laboratory (ORNL). Assay data are reported for five samples from two fuel rods of the same assembly. The TMI-1 assembly was a 15 X 15 design with an initial enrichment of 4.013 wt% 235U, and the measured samples achieved burnups between 45.5 and 54.5 gigawatt days per metric ton of initial uranium (GWd/t). Measurements were performed mainly using inductively coupled plasma mass spectrometry after elemental separation via highmore » performance liquid chromatography. High precision measurements were achieved using isotope dilution techniques for many of the lanthanides, uranium, and plutonium isotopes. Measurements are reported for more than 50 different isotopes and 16 elements. One of the two TMI-1 fuel rods measured in this work had been measured previously by Argonne National Laboratory (ANL), and these data have been widely used to support code and nuclear data validation. Recently, ORNL provided an important opportunity to independently cross check results against previous measurements performed at ANL. The measured nuclide concentrations are used to validate burnup calculations using the SCALE nuclear systems modeling and simulation code suite. These results show that the new measurements provide reliable benchmark data for computer code validation.« less

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

Halbgewachs, Ronald D.; Chavez, Adrian R.

Process Control System (PCS) and Industrial Control System (ICS) security is critical to our national security. But there are a number of technological, economic, and educational impediments to PCS owners implementing effective security on their systems. Sandia National Laboratories has performed the research and development of the OPSAID (Open PCS Security Architecture for Interoperable Design), a project sponsored by the US Department of Energy Office of Electricity Delivery and Energy Reliability (DOE/OE), to address this issue. OPSAID is an open-source architecture for PCS/ICS security that provides a design basis for vendors to build add-on security devices for legacy systems, whilemore » providing a path forward for the development of inherently-secure PCS elements in the future. Using standardized hardware, a proof-of-concept prototype system was also developed. This report describes the improvements and capabilities that have been added to OPSAID since an initial report was released. Testing and validation of this architecture has been conducted in another project, Lemnos Interoperable Security Project, sponsored by DOE/OE and managed by the National Energy Technology Laboratory (NETL).« less

Development and applicability of a ready-to-use PCR system for GMO screening.

PubMed

Rosa, Sabrina F; Gatto, Francesco; Angers-Loustau, Alexandre; Petrillo, Mauro; Kreysa, Joachim; Querci, Maddalena

2016-06-15

With the growing number of GMOs introduced to the market, testing laboratories have seen their workload increase significantly. Ready-to-use multi-target PCR-based detection systems, such as pre-spotted plates (PSP), reduce analysis time while increasing capacity. This paper describes the development and applicability to GMO testing of a screening strategy involving a PSP and its associated web-based Decision Support System. The screening PSP was developed to detect all GMOs authorized in the EU in one single PCR experiment, through the combination of 16 validated assays. The screening strategy was successfully challenged in a wide inter-laboratory study on real-life food/feed samples. The positive outcome of this study could result in the adoption of a PSP screening strategy across the EU; a step that would increase harmonization and quality of GMO testing in the EU. Furthermore, this system could represent a model for other official control areas where high-throughput DNA-based detection systems are needed. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part I - rationale and aims.

PubMed

Davis, Bruce H; Wood, Brent; Oldaker, Teri; Barnett, David

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part I - Rationale and aims. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

Distinguishing infected from noninfected abdominal fluid collections after surgery: an imaging, clinical, and laboratory-based scoring system.

PubMed

Gnannt, Ralph; Fischer, Michael A; Baechler, Thomas; Clavien, Pierre-Alain; Karlo, Christoph; Seifert, Burkhardt; Lesurtel, Mickael; Alkadhi, Hatem

2015-01-01

Mortality from abdominal abscesses ranges from 30% in treated cases up to 80% to 100% in patients with undrained or nonoperated abscesses. Various computed tomographic (CT) imaging features have been suggested to indicate infection of postoperative abdominal fluid collections; however, features are nonspecific and substantial overlap between infected and noninfected collections exists. The purpose of this study was to develop and validate a scoring system on the basis of CT imaging findings as well as laboratory and clinical parameters for distinguishing infected from noninfected abdominal fluid collections after surgery. The score developmental cohort included 100 consecutive patients (69 men, 31 women; mean age, 58 ± 17 years) who underwent portal-venous phase CT within 24 hours before CT-guided intervention of postoperative abdominal fluid collections. Imaging features included attenuation (Hounsfield unit [HU]), volume, wall enhancement and thickness, fat stranding, as well as entrapped gas of fluid collections. Laboratory and clinical parameters included diabetes, intake of immunosuppressive drugs, body temperature, C-reactive protein, and leukocyte blood cell count. The score was validated in a separate cohort of 30 consecutive patients (17 men, 13 women; mean age, 51 ± 15 years) with postoperative abdominal fluid collections. Microbiologic analysis from fluid samples served as the standard of reference. Diabetes, body temperature, C-reactive protein, attenuation of the fluid collection (in HUs), wall enhancement and thickness of the wall, adjacent fat stranding, as well as entrapped gas within the fluid collection were significantly different between infected and noninfected collections (P < 0.001). Multiple logistic regression analysis revealed diabetes, C-reactive protein, attenuation of the fluid collection (in HUs), as well as entrapped gas as significant independent predictors of infection (P < 0.001) and thus was selected for constructing a scoring system from 0 to 10 (diabetes: 2 points; C-reactive protein, ≥ 100 mg/L: 1 point; attenuation of fluid collection, ≥ 20 HU: 4 points; entrapped gas: 3 points). The model was well calibrated (Hosmer-Lemeshow test, P = 0.36). In the validation cohort, scores of 2 or lower had a 90% (95% confidence interval [CI], 56%-100%) negative predictive value, scores of 3 or higher had an 80% (95% CI, 56%-94%) positive predictive value, and scores of 6 or higher a 100% (95% CI, 74%-100%) positive predictive value for diagnosing infected fluid collections. Receiver operating characteristic analysis revealed an area under the curve of 0.96 (95% CI, 0.88-1.00) for the score. We introduce an accurate scoring system including quantitative radiologic, laboratory, and clinical parameters for distinguishing infected from noninfected fluid collections after abdominal surgery.

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 comparable in terms of assay repeatability, precision and reproducibility. In all laboratories, both methods discriminated between the low, medium and high potency samples. Analysis of the data collected in this study showed a good correlation between EIA and TIA potency estimates as well as a close agreement between values obtained by in vitro and in vivo methods. The study demonstrated that EIA and TIA are suitable quality control methods for polyclonal human tetanus immunoglobulin, which can be standardised in a quality control laboratory using a quality assurance system. Consequently, the Ph. Eur. Group of Experts 6B on Human Blood and Blood products decided in April 2009 to include both methods as examples in the Ph. Eur. monograph 0398 on Human Tetanus immunoglobulin.

In-house validation study of the DuPont Qualicon BAX system Q7 instrument with the BAX system PCR Assay for Salmonella (modification of AOAC Official Method 2003.09 and AOAC Research Institute Performance-Tested Method 100201).

PubMed

Tice, George; Andaloro, Bridget; White, H Kirk; Bolton, Lance; Wang, Siqun; Davis, Eugene; Wallace, Morgan

2009-01-01

In 2006, DuPont Qualicon introduced the BAX system Q7 instrument for use with its assays. To demonstrate the equivalence of the new and old instruments, a validation study was conducted using the BAX system PCR Assay for Salmonella, AOAC Official Method 2003.09, on three food types. The foods were simultaneously analyzed with the BAX system Q7 instrument and either the U.S. Food and Drug Administration Bacteriological Analytical Manual or the U.S. Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method for detecting Salmonella. Comparable performance between the BAX system and the reference methods was observed. Of the 75 paired samples analyzed, 39 samples were positive by both the BAX system and reference methods, and 36 samples were negative by both the BAX system and reference methods, demonstrating 100% correlation. Inclusivity and exclusivity for the BAX system Q7 instrument were also established by testing 50 Salmonella strains and 20 non-Salmonella isolates. All Salmonella strains returned positive results, and all non-Salmonella isolates returned a negative response.

Prototype Development of a Responsive Emotive Sensing System (DRESS) to aid older persons with dementia to dress independently

PubMed Central

Mahoney, Diane Feeney; Burleson, Winslow; Lozano, Cecil; Ravishankar, Vijay; Mahoney, Edward Leo

2015-01-01

Background Prior research has critiqued the lack of attention to the stressors associated with dementia related dressing issues, stigmatizing patient clothing, and wearable technology challenges. This paper describes the conceptual development and feasibility testing of an innovative ‘smart dresser’ context aware affective system (DRESS) to enable dressing by people with moderate memory loss through individualized audio and visual task prompting in real time. Methods Mixed method feasibility study involving qualitative focus groups with 25 Alzheimer’s family caregivers experiencing dressing difficulties to iteratively inform system design and a quantitative usability trial with 10 healthy subjects in a controlled laboratory setting to assess validity of technical operations. Results Caregivers voiced the need for tangible dressing assistance to reduce their frustration from time spent in repetitive cueing and power struggles over dressing. They contributed 6 changes that influenced the prototype development, most notably adding a dresser top iPad to mimic a familiar ‘TV screen’ for the audio and visual cueing. DRESS demonstrated promising overall functionality, however the validity of identification of dressing status ranged from 0% for the correct pants dressing to 100% for all shirts dressing scenarios. Adjustments were made to the detection components of the system raising the accuracy of detection of all acted dressing scenarios for pants from 50% to 82%. Conclusions Findings demonstrate family caregiver acceptability of the proposed system, the successful interoperability of the built system’s components, and the system’s ability to interpret correct and incorrect dressing actions in controlled laboratory simulations. Future research will advance the system to the alpha stage and subsequent testing with end users in real world settings. PMID:26321895

Validation of Contact-Free Sleep Monitoring Device with Comparison to Polysomnography.

PubMed

Tal, Asher; Shinar, Zvika; Shaki, David; Codish, Shlomi; Goldbart, Aviv

2017-03-15

To validate a contact-free system designed to achieve maximal comfort during long-term sleep monitoring, together with high monitoring accuracy. We used a contact-free monitoring system (EarlySense, Ltd., Israel), comprising an under-the-mattress piezoelectric sensor and a smartphone application, to collect vital signs and analyze sleep. Heart rate (HR), respiratory rate (RR), body movement, and calculated sleep-related parameters from the EarlySense (ES) sensor were compared to data simultaneously generated by the gold standard, polysomnography (PSG). Subjects in the sleep laboratory underwent overnight technician-attended full PSG, whereas subjects at home were recorded for 1 to 3 nights with portable partial PSG devices. Data were compared epoch by epoch. A total of 63 subjects (85 nights) were recorded under a variety of sleep conditions. Compared to PSG, the contact-free system showed similar values for average total sleep time (TST), % wake, % rapid eye movement, and % non-rapid eye movement sleep, with 96.1% and 93.3% accuracy of continuous measurement of HR and RR, respectively. We found a linear correlation between TST measured by the sensor and TST determined by PSG, with a coefficient of 0.98 (R = 0.87). Epoch-by-epoch comparison with PSG in the sleep laboratory setting revealed that the system showed sleep detection sensitivity, specificity, and accuracy of 92.5%, 80.4%, and 90.5%, respectively. TST estimates with the contact-free sleep monitoring system were closely correlated with the gold-standard reference. This system shows good sleep staging capability with improved performance over accelerometer-based apps, and collects additional physiological information on heart rate and respiratory rate. © 2017 American Academy of Sleep Medicine

Integration of the CLS doctorate into the healthcare organization.

PubMed

Montoya, Isaac; Kimball, Olive

2009-01-01

A review of how the doctorally prepared CLS fits into the healthcare organization. Literature review. Numerous national studies have called for a reshaping of the health care delivery system and the need to improve patient outcomes. Because of unprecedented advances in laboratory related technology as well as the need for economic retrenchment strategies in health care, with its significant influence on patient care, the laboratory has become the subject of intensive study. It has been concluded that the traditional organizational structure of the laboratory information process and the required personnel skills both need rethinking. In order to foster change in the laboratory, an advanced degreed CLS laboratory professional is needed, one already equipped with a broad scientific base developed via a baccalaureate/masters level of education. With the addition of advanced technical expertise, basic medical skills, data interpretation skills and patient interaction abilities, and medical research experience, this laboratory professional can enhance the effective and efficient use of laboratory information and ultimately improve patient care. The clinical doctorates in CLS are educationally and experientially prepared to recommend support and enhance appropriate testing. They translate and transform complex laboratory data into an understandable product necessary for clinicians to be able to assess the validity of current and new assays to ensure better patient care. In addition, they assist in reducing questionable test usage, thereby reducing costs for both the patient and the laboratory.

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

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.

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.

Development and validation of a set of six adaptable prognosis prediction (SAP) models based on time-series real-world big data analysis for patients with cancer receiving chemotherapy: A multicenter case crossover study

PubMed Central

Kanai, Masashi; Okamoto, Kazuya; Yamamoto, Yosuke; Yoshioka, Akira; Hiramoto, Shuji; Nozaki, Akira; Nishikawa, Yoshitaka; Yamaguchi, Daisuke; Tomono, Teruko; Nakatsui, Masahiko; Baba, Mika; Morita, Tatsuya; Matsumoto, Shigemi; Kuroda, Tomohiro; Okuno, Yasushi; Muto, Manabu

2017-01-01

Background We aimed to develop an adaptable prognosis prediction model that could be applied at any time point during the treatment course for patients with cancer receiving chemotherapy, by applying time-series real-world big data. Methods Between April 2004 and September 2014, 4,997 patients with cancer who had received systemic chemotherapy were registered in a prospective cohort database at the Kyoto University Hospital. Of these, 2,693 patients with a death record were eligible for inclusion and divided into training (n = 1,341) and test (n = 1,352) cohorts. In total, 3,471,521 laboratory data at 115,738 time points, representing 40 laboratory items [e.g., white blood cell counts and albumin (Alb) levels] that were monitored for 1 year before the death event were applied for constructing prognosis prediction models. All possible prediction models comprising three different items from 40 laboratory items (40C3 = 9,880) were generated in the training cohort, and the model selection was performed in the test cohort. The fitness of the selected models was externally validated in the validation cohort from three independent settings. Results A prognosis prediction model utilizing Alb, lactate dehydrogenase, and neutrophils was selected based on a strong ability to predict death events within 1–6 months and a set of six prediction models corresponding to 1,2, 3, 4, 5, and 6 months was developed. The area under the curve (AUC) ranged from 0.852 for the 1 month model to 0.713 for the 6 month model. External validation supported the performance of these models. Conclusion By applying time-series real-world big data, we successfully developed a set of six adaptable prognosis prediction models for patients with cancer receiving chemotherapy. PMID:28837592

Measurement Sets and Sites Commonly Used for High Spatial Resolution Image Product Characterization

NASA Technical Reports Server (NTRS)

Pagnutti, Mary

2006-01-01

Scientists within NASA's Applied Sciences Directorate have developed a well-characterized remote sensing Verification & Validation (V&V) site at the John C. Stennis Space Center (SSC). This site has enabled the in-flight characterization of satellite high spatial resolution remote sensing system products form Space Imaging IKONOS, Digital Globe QuickBird, and ORBIMAGE OrbView, as well as advanced multispectral airborne digital camera products. SSC utilizes engineered geodetic targets, edge targets, radiometric tarps, atmospheric monitoring equipment and their Instrument Validation Laboratory to characterize high spatial resolution remote sensing data products. This presentation describes the SSC characterization capabilities and techniques in the visible through near infrared spectrum and examples of calibration results.

A validation test for Adagio through replication of Big Hill and Bayou Choctaw JAS3D models.

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

Park, Byoung Yoon

2013-06-01

JAS3D, a three dimensional iterative solid mechanics code, has been used for structural analyses for the Strategic Petroleum Reserve system since the 1990s. JAS3D is no longer supported by Sandia National Laboratories, and has been replaced by Adagio. To validate the transition from JAS3D to Adagio, the existing JAS3D input decks and user subroutines for Bayou Choctaw and Big Hill models were converted for use with Adagio. The calculation results from the Adagio runs are compared to the JAS3D. Since the Adagio results are very similar to the JAS3D results, Adagio is judged to be performing satisfactorily.

Clinical validation of the 50 gene AmpliSeq Cancer Panel V2 for use on a next generation sequencing platform using formalin fixed, paraffin embedded and fine needle aspiration tumour specimens.

PubMed

Rathi, Vivek; Wright, Gavin; Constantin, Diana; Chang, Siok; Pham, Huong; Jones, Kerryn; Palios, Atha; Mclachlan, Sue-Anne; Conron, Matthew; McKelvie, Penny; Williams, Richard

2017-01-01

The advent of massively parallel sequencing has caused a paradigm shift in the ways cancer is treated, as personalised therapy becomes a reality. More and more laboratories are looking to introduce next generation sequencing (NGS) as a tool for mutational analysis, as this technology has many advantages compared to conventional platforms like Sanger sequencing. In Australia all massively parallel sequencing platforms are still considered in-house in vitro diagnostic tools by the National Association of Testing Authorities (NATA) and a comprehensive analytical validation of all assays, and not just mere verification, is a strict requirement before accreditation can be granted for clinical testing on these platforms. Analytical validation of assays on NGS platforms can prove to be extremely challenging for pathology laboratories. Although there are many affordable and easily accessible NGS instruments available, there are no standardised guidelines as yet for clinical validation of NGS assays. We present an accreditation development procedure that was both comprehensive and applicable in a setting of hospital laboratory for NGS services. This approach may also be applied to other NGS applications in service laboratories. Copyright © 2016 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.

21 CFR 58.202 - Grounds for disqualification.

Code of Federal Regulations, 2011 CFR

2011-04-01

....202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.202... adversely affected the validity of the nonclinical laboratory studies; and (c) Other lesser regulatory...

21 CFR 58.202 - Grounds for disqualification.

Code of Federal Regulations, 2010 CFR

2010-04-01

....202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.202... adversely affected the validity of the nonclinical laboratory studies; and (c) Other lesser regulatory...

Modeling Acceleration of a System of Two Objects Using the Concept of Limits

NASA Astrophysics Data System (ADS)

Sokolowski, Andrzej

2018-01-01

Traditional school laboratory exercises on a system of moving objects connected by strings involve deriving expressions for the system acceleration, a = (∑F )/m, and sketching a graph of acceleration vs. force. While being in the form of rational functions, these expressions present great opportunities for broadening the scope of the analysis by using a more sophisticated math apparatus—the concept of limits. Using the idea of limits allows for extending both predictions and explanations of this type of motion that are—according to Redish—essential goals of teaching physics. This type of analysis, known in physics as limiting case analysis, allows for generalizing inferences by evaluating or estimating values of algebraic functions based on its extreme inputs. In practice, such transition provides opportunities for deriving valid conclusions for cases when direct laboratory measurements are not possible. While using limits is common for scientists, the idea of applying limits in school practice is not visible, and testing students' ability in this area is also rare.

Output-only modal parameter estimator of linear time-varying structural systems based on vector TAR model and least squares support vector machine

NASA Astrophysics Data System (ADS)

Zhou, Si-Da; Ma, Yuan-Chen; Liu, Li; Kang, Jie; Ma, Zhi-Sai; Yu, Lei

2018-01-01

Identification of time-varying modal parameters contributes to the structural health monitoring, fault detection, vibration control, etc. of the operational time-varying structural systems. However, it is a challenging task because there is not more information for the identification of the time-varying systems than that of the time-invariant systems. This paper presents a vector time-dependent autoregressive model and least squares support vector machine based modal parameter estimator for linear time-varying structural systems in case of output-only measurements. To reduce the computational cost, a Wendland's compactly supported radial basis function is used to achieve the sparsity of the Gram matrix. A Gamma-test-based non-parametric approach of selecting the regularization factor is adapted for the proposed estimator to replace the time-consuming n-fold cross validation. A series of numerical examples have illustrated the advantages of the proposed modal parameter estimator on the suppression of the overestimate and the short data. A laboratory experiment has further validated the proposed estimator.

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

PubMed

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse effects (p=0.008) in renal transplant recipients receiving tacrolimus and mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated construct validity. Intra-class correlation was 0.81 (95% confidence interval: 0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and verified substantial inter-rater reliability. This immunosuppressive adverse effects scoring system in stable renal transplant recipients was evaluated and substantiated face, content and construct validity with inter-rater reliability. The scoring system may facilitate prospective, standardized clinical monitoring of immunosuppressive adverse drug effects in stable renal transplant recipients and improve medication adherence.

Sandia National Laboratories analysis code data base

NASA Astrophysics Data System (ADS)

Peterson, C. W.

1994-11-01

Sandia National Laboratories' mission is to solve important problems in the areas of national defense, energy security, environmental integrity, and industrial technology. The laboratories' strategy for accomplishing this mission is to conduct research to provide an understanding of the important physical phenomena underlying any problem, and then to construct validated computational models of the phenomena which can be used as tools to solve the problem. In the course of implementing this strategy, Sandia's technical staff has produced a wide variety of numerical problem-solving tools which they use regularly in the design, analysis, performance prediction, and optimization of Sandia components, systems, and manufacturing processes. This report provides the relevant technical and accessibility data on the numerical codes used at Sandia, including information on the technical competency or capability area that each code addresses, code 'ownership' and release status, and references describing the physical models and numerical implementation.

Hyper-X Engine Design and Ground Test Program

NASA Technical Reports Server (NTRS)

Voland, R. T.; Rock, K. E.; Huebner, L. D.; Witte, D. W.; Fischer, K. E.; McClinton, C. R.

1998-01-01

The Hyper-X Program, NASA's focused hypersonic technology program jointly run by NASA Langley and Dryden, is designed to move hypersonic, air-breathing vehicle technology from the laboratory environment to the flight environment, the last stage preceding prototype development. The Hyper-X research vehicle will provide the first ever opportunity to obtain data on an airframe integrated supersonic combustion ramjet propulsion system in flight, providing the first flight validation of wind tunnel, numerical and analytical methods used for design of these vehicles. A substantial portion of the integrated vehicle/engine flowpath development, engine systems verification and validation and flight test risk reduction efforts are experimentally based, including vehicle aeropropulsive force and moment database generation for flight control law development, and integrated vehicle/engine performance validation. The Mach 7 engine flowpath development tests have been completed, and effort is now shifting to engine controls, systems and performance verification and validation tests, as well as, additional flight test risk reduction tests. The engine wind tunnel tests required for these efforts range from tests of partial width engines in both small and large scramjet test facilities, to tests of the full flight engine on a vehicle simulator and tests of a complete flight vehicle in the Langley 8-Ft. High Temperature Tunnel. These tests will begin in the summer of 1998 and continue through 1999. The first flight test is planned for early 2000.

Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values.

PubMed

Rigo-Bonnin, Raül; Blanco-Font, Aurora; Canalias, Francesca

2018-05-08

Values of mass concentration of tacrolimus in whole blood are commonly used by the clinicians for monitoring the status of a transplant patient and for checking whether the administered dose of tacrolimus is effective. So, clinical laboratories must provide results as accurately as possible. Measurement uncertainty can allow ensuring reliability of these results. The aim of this study was to estimate measurement uncertainty of whole blood mass concentration tacrolimus values obtained by UHPLC-MS/MS using two top-down approaches: the single laboratory validation approach and the proficiency testing approach. For the single laboratory validation approach, we estimated the uncertainties associated to the intermediate imprecision (using long-term internal quality control data) and the bias (utilizing a certified reference material). Next, we combined them together with the uncertainties related to the calibrators-assigned values to obtain a combined uncertainty for, finally, to calculate the expanded uncertainty. For the proficiency testing approach, the uncertainty was estimated in a similar way that the single laboratory validation approach but considering data from internal and external quality control schemes to estimate the uncertainty related to the bias. The estimated expanded uncertainty for single laboratory validation, proficiency testing using internal and external quality control schemes were 11.8%, 13.2%, and 13.0%, respectively. After performing the two top-down approaches, we observed that their uncertainty results were quite similar. This fact would confirm that either two approaches could be used to estimate the measurement uncertainty of whole blood mass concentration tacrolimus values in clinical laboratories. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Novel Directional Protection Scheme for the FREEDM Smart Grid System

NASA Astrophysics Data System (ADS)

Sharma, Nitish

This research primarily deals with the design and validation of the protection system for a large scale meshed distribution system. The large scale system simulation (LSSS) is a system level PSCAD model which is used to validate component models for different time-scale platforms, to provide a virtual testing platform for the Future Renewable Electric Energy Delivery and Management (FREEDM) system. It is also used to validate the cases of power system protection, renewable energy integration and storage, and load profiles. The protection of the FREEDM system against any abnormal condition is one of the important tasks. The addition of distributed generation and power electronic based solid state transformer adds to the complexity of the protection. The FREEDM loop system has a fault current limiter and in addition, the Solid State Transformer (SST) limits the fault current at 2.0 per unit. Former students at ASU have developed the protection scheme using fiber-optic cable. However, during the NSF-FREEDM site visit, the National Science Foundation (NSF) team regarded the system incompatible for the long distances. Hence, a new protection scheme with a wireless scheme is presented in this thesis. The use of wireless communication is extended to protect the large scale meshed distributed generation from any fault. The trip signal generated by the pilot protection system is used to trigger the FID (fault isolation device) which is an electronic circuit breaker operation (switched off/opening the FIDs). The trip signal must be received and accepted by the SST, and it must block the SST operation immediately. A comprehensive protection system for the large scale meshed distribution system has been developed in PSCAD with the ability to quickly detect the faults. The validation of the protection system is performed by building a hardware model using commercial relays at the ASU power laboratory.

Posturography using the Wii Balance Board™: A feasibility study with healthy adults and adults post-stroke.

PubMed

Llorens, Roberto; Latorre, Jorge; Noé, Enrique; Keshner, Emily A

2016-01-01

Posturography systems that incorporate force platforms are considered to assess balance and postural control with greater sensitivity and objectivity than conventional clinical tests. The Wii Balance Board (WBB) system has been shown to have similar performance characteristics as other force platforms, but with lower cost and size. To determine the validity and reliability of a freely available WBB-based posturography system that combined the WBB with several traditional balance assessments, and to assess the performance of a cohort of stroke individuals with respect to healthy individuals. Healthy subjects and individuals with stroke were recruited. Both groups were assessed using the WBB-based posturography system. Individuals with stroke were also assessed using a laboratory grade posturography system and a battery of clinical tests to determine the concurrent validity of the system. A group of subjects were assessed twice with the WBB-based system to determine its reliability. A total of 144 healthy individuals and 53 individuals with stroke participated in the study. Concurrent validity with another posturography system was moderate to high. Correlations with clinical scales were consistent with previous research. The reliability of the system was excellent in almost all measures. In addition, the system successfully characterized individuals with stroke with respect to the healthy population. The WBB-based posturography system exhibited excellent psychometric properties and sensitivity for identifying balance performance of individuals with stroke in comparison with healthy subjects, which supports feasibility of the system as a clinical tool. Copyright © 2015 Elsevier B.V. All rights reserved.

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 resulted in 75.9% in the low level of contamination samples and 96.4% in samples spiked with high level of E. coli O157 and specificity was calculated as 99.1%. Copyright © 2018 Elsevier B.V. All rights reserved.

Inter-laboratory analysis of selected genetically modified plant reference materials with digital PCR.

PubMed

Dobnik, David; Demšar, Tina; Huber, Ingrid; Gerdes, Lars; Broeders, Sylvia; Roosens, Nancy; Debode, Frederic; Berben, Gilbert; Žel, Jana

2018-01-01

Digital PCR (dPCR), as a new technology in the field of genetically modified (GM) organism (GMO) testing, enables determination of absolute target copy numbers. The purpose of our study was to test the transferability of methods designed for quantitative PCR (qPCR) to dPCR and to carry out an inter-laboratory comparison of the performance of two different dPCR platforms when determining the absolute GM copy numbers and GM copy number ratio in reference materials certified for GM content in mass fraction. Overall results in terms of measured GM% were within acceptable variation limits for both tested dPCR systems. However, the determined absolute copy numbers for individual genes or events showed higher variability between laboratories in one third of the cases, most possibly due to variability in the technical work, droplet size variability, and analysis of the raw data. GMO quantification with dPCR and qPCR was comparable. As methods originally designed for qPCR performed well in dPCR systems, already validated qPCR assays can most generally be used for dPCR technology with the purpose of GMO detection. Graphical abstract The output of three different PCR-based platforms was assessed in an inter-laboratory comparison.

Challenges and opportunities in the manufacture and expansion of cells for therapy.

PubMed

Maartens, Joachim H; De-Juan-Pardo, Elena; Wunner, Felix M; Simula, Antonio; Voelcker, Nicolas H; Barry, Simon C; Hutmacher, Dietmar W

2017-10-01

Laboratory-based ex vivo cell culture methods are largely manual in their manufacturing processes. This makes it extremely difficult to meet regulatory requirements for process validation, quality control and reproducibility. Cell culture concepts with a translational focus need to embrace a more automated approach where cell yields are able to meet the quantitative production demands, the correct cell lineage and phenotype is readily confirmed and reagent usage has been optimized. Areas covered: This article discusses the obstacles inherent in classical laboratory-based methods, their concomitant impact on cost-of-goods and that a technology step change is required to facilitate translation from bed-to-bedside. Expert opinion: While traditional bioreactors have demonstrated limited success where adherent cells are used in combination with microcarriers, further process optimization will be required to find solutions for commercial-scale therapies. New cell culture technologies based on 3D-printed cell culture lattices with favourable surface to volume ratios have the potential to change the paradigm in industry. An integrated Quality-by-Design /System engineering approach will be essential to facilitate the scaled-up translation from proof-of-principle to clinical validation.

Ethane-xenon mixtures under shock conditions

NASA Astrophysics Data System (ADS)

Flicker, Dawn; Magyar, Rudolph; Root, Seth; Cochrane, Kyle; Mattsson, Thomas

2015-06-01

Mixtures of light and heavy elements arise in inertial confinement fusion and planetary science. We present results on the physics of molecular scale mixing through a validation study of equation of state (EOS) properties. Density functional theory molecular dynamics (DFT/QMD) at elevated-temperature and pressure is used to obtain the properties of pure xenon, ethane, and various compressed mixture compositions along their principal Hugoniots. To validate the QMD simulations, we performed high-precision shock compression experiments using Sandia's Z-Machine. A bond tracking analysis of the simulations correlates the sharp rise in the Hugoniot curve with completion of dissociation in ethane. DFT-based simulation results compare well with experimental data and are used to provide insight into the dissociation as a function of mixture composition. Interestingly, we find that the compression ratio for complete dissociation is similar for ethane, Xe-ethane, polymethyl-pentene, and polystyrene, suggesting that a limiting compression exists for C-C bonded systems. Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Company, Security Administration under contract DE-AC04-94AL85000.

International Energy Agency Ocean Energy Systems Task 10 Wave Energy Converter Modeling Verification and Validation: Preprint

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

Wendt, Fabian F; Yu, Yi-Hsiang; Nielsen, Kim

This is the first joint reference paper for the Ocean Energy Systems (OES) Task 10 Wave Energy Converter modeling verification and validation group. The group is established under the OES Energy Technology Network program under the International Energy Agency. OES was founded in 2001 and Task 10 was proposed by Bob Thresher (National Renewable Energy Laboratory) in 2015 and approved by the OES Executive Committee EXCO in 2016. The kickoff workshop took place in September 2016, wherein the initial baseline task was defined. Experience from similar offshore wind validation/verification projects (OC3-OC5 conducted within the International Energy Agency Wind Task 30)more » [1], [2] showed that a simple test case would help the initial cooperation to present results in a comparable way. A heaving sphere was chosen as the first test case. The team of project participants simulated different numerical experiments, such as heave decay tests and regular and irregular wave cases. The simulation results are presented and discussed in this paper.« less

A Comprehensive Validation Approach Using The RAVEN Code

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

Alfonsi, Andrea; Rabiti, Cristian; Cogliati, Joshua J

2015-06-01

The RAVEN computer code , developed at the Idaho National Laboratory, is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. RAVEN is a multi-purpose probabilistic and uncertainty quantification platform, capable to communicate with any system code. A natural extension of the RAVEN capabilities is the imple- mentation of an integrated validation methodology, involving several different metrics, that represent an evolution of the methods currently used in the field. The state-of-art vali- dation approaches use neither exploration of the input space through sampling strategies, nor a comprehensive variety of metrics neededmore » to interpret the code responses, with respect experimental data. The RAVEN code allows to address both these lacks. In the following sections, the employed methodology, and its application to the newer developed thermal-hydraulic code RELAP-7, is reported.The validation approach has been applied on an integral effect experiment, representing natu- ral circulation, based on the activities performed by EG&G Idaho. Four different experiment configurations have been considered and nodalized.« less

Multi-Evaporator Miniature Loop Heat Pipe for Small Spacecraft Thermal Control

NASA Technical Reports Server (NTRS)

Ku, Jentung; Ottenstein, Laura; Douglas, Donya

2008-01-01

This paper presents the development of the Thermal Loop experiment under NASA's New Millennium Program Space Technology 8 (ST8) Project. The Thermal Loop experiment was originally planned for validating in space an advanced heat transport system consisting of a miniature loop heat pipe (MLHP) with multiple evaporators and multiple condensers. Details of the thermal loop concept, technical advances and benefits, Level 1 requirements and the technology validation approach are described. An MLHP breadboard has been built and tested in the laboratory and thermal vacuum environments, and has demonstrated excellent performance that met or exceeded the design requirements. The MLHP retains all features of state-of-the-art loop heat pipes and offers additional advantages to enhance the functionality, performance, versatility, and reliability of the system. In addition, an analytical model has been developed to simulate the steady state and transient operation of the MHLP, and the model predictions agreed very well with experimental results. A protoflight MLHP has been built and is being tested in a thermal vacuum chamber to validate its performance and technical readiness for a flight experiment.

IMPLEMENTATION AND VALIDATION OF A FULLY IMPLICIT ACCUMULATOR MODEL IN RELAP-7

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

Zhao, Haihua; Zou, Ling; Zhang, Hongbin

2016-01-01

This paper presents the implementation and validation of an accumulator model in RELAP-7 under the framework of preconditioned Jacobian free Newton Krylov (JFNK) method, based on the similar model used in RELAP5. RELAP-7 is a new nuclear reactor system safety analysis code being developed at the Idaho National Laboratory (INL). RELAP-7 is a fully implicit system code. The JFNK and preconditioning methods used in RELAP-7 is briefly discussed. The slightly modified accumulator model is summarized for completeness. The implemented model was validated with LOFT L3-1 test and benchmarked with RELAP5 results. RELAP-7 and RELAP5 had almost identical results for themore » accumulator gas pressure and water level, although there were some minor difference in other parameters such as accumulator gas temperature and tank wall temperature. One advantage of the JFNK method is its easiness to maintain and modify models due to fully separation of numerical methods from physical models. It would be straightforward to extend the current RELAP-7 accumulator model to simulate the advanced accumulator design.« less

Dynamic Operator Overload Estimation during Supervisory Control of Multiple UAVs

DTIC Science & Technology

2014-01-01

Olsen, and C. W. Nielsen, "Validating human-robot interaction schemes in multitasking environments," IEEE Systems, Man, and Cybernetics, vol. 35...Breslow is a cognitive scientist at the Naval Research Laboratory, Code 5515, Washington DC 20375; phone: 301-602-3585; email : len.breslow...nrl.navy.mil Daniel Gartenberg is a Ph.D. student at George Mason University, Fairfax VA; email : dgartenb@masonlive.gmu.edu J. Malcolm McCurry is a research

Uncertainty-based Estimation of the Secure Range for ISO New England Dynamic Interchange Adjustment

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

Etingov, Pavel V.; Makarov, Yuri V.; Wu, Di

2014-04-14

The paper proposes an approach to estimate the secure range for dynamic interchange adjustment, which assists system operators in scheduling the interchange with neighboring control areas. Uncertainties associated with various sources are incorporated. The proposed method is implemented in the dynamic interchange adjustment (DINA) tool developed by Pacific Northwest National Laboratory (PNNL) for ISO New England. Simulation results are used to validate the effectiveness of the proposed method.

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.

The Development of Point Doppler Velocimeter Data Acquisition and Processing Software

NASA Technical Reports Server (NTRS)

Cavone, Angelo A.

2008-01-01

In order to develop efficient and quiet aircraft and validate Computational Fluid Dynamic predications, aerodynamic researchers require flow parameter measurements to characterize flow fields about wind tunnel models and jet flows. A one-component Point Doppler Velocimeter (pDv), a non-intrusive, laser-based instrument, was constructed using a design/develop/test/validate/deploy approach. A primary component of the instrument is software required for system control/management and data collection/reduction. This software along with evaluation algorithms, advanced pDv from a laboratory curiosity to a production level instrument. Simultaneous pDv and pitot probe velocity measurements obtained at the centerline of a flow exiting a two-inch jet, matched within 0.4%. Flow turbulence spectra obtained with pDv and a hot-wire detected the primary and secondary harmonics with equal dynamic range produced by the fan driving the flow. Novel,hardware and software methods were developed, tested and incorporated into the system to eliminate and/or minimize error sources and improve system reliability.

Evolution of the INMARSAT aeronautical system: Service, system, and business considerations

NASA Technical Reports Server (NTRS)

Sengupta, Jay R.

1995-01-01

A market-driven approach was adopted to develop enhancements to the Inmarsat-Aeronautical system, to address the requirements of potential new market segments. An evolutionary approach and well differentiated product/service portfolio was required, to minimize system upgrade costs and market penetration, respectively. The evolved system definition serves to minimize equipment cost/size/mass for short/medium range aircraft, by reducing the antenna gain requirement and relaxing the performance requirements for non safety-related communications. A validation program involving simulation, laboratory tests, over-satellite tests and flight trials is being conducted to confirm the system definition. Extensive market research has been conducted to determine user requirements and to quantify market demand for future Inmarsat Aero-1 AES, using sophisticated computer assisted survey techniques.

Identification of Dyslipidemic Patients Attending Primary Care Clinics Using Electronic Medical Record (EMR) Data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) Database.

PubMed

Aref-Eshghi, Erfan; Oake, Justin; Godwin, Marshall; Aubrey-Bassler, Kris; Duke, Pauline; Mahdavian, Masoud; Asghari, Shabnam

2017-03-01

The objective of this study was to define the optimal algorithm to identify patients with dyslipidemia using electronic medical records (EMRs). EMRs of patients attending primary care clinics in St. John's, Newfoundland and Labrador (NL), Canada during 2009-2010, were studied to determine the best algorithm for identification of dyslipidemia. Six algorithms containing three components, dyslipidemia ICD coding, lipid lowering medication use, and abnormal laboratory lipid levels, were tested against a gold standard, defined as the existence of any of the three criteria. Linear discriminate analysis, and bootstrapping were performed following sensitivity/specificity testing and receiver's operating curve analysis. Two validating datasets, NL records of 2011-2014, and Canada-wide records of 2010-2012, were used to replicate the results. Relative to the gold standard, combining laboratory data together with lipid lowering medication consumption yielded the highest sensitivity (99.6%), NPV (98.1%), Kappa agreement (0.98), and area under the curve (AUC, 0.998). The linear discriminant analysis for this combination resulted in an error rate of 0.15 and an Eigenvalue of 1.99, and the bootstrapping led to AUC: 0.998, 95% confidence interval: 0.997-0.999, Kappa: 0.99. This algorithm in the first validating dataset yielded a sensitivity of 97%, Negative Predictive Value (NPV) = 83%, Kappa = 0.88, and AUC = 0.98. These figures for the second validating data set were 98%, 93%, 0.95, and 0.99, respectively. Combining laboratory data with lipid lowering medication consumption within the EMR is the best algorithm for detecting dyslipidemia. These results can generate standardized information systems for dyslipidemia and other chronic disease investigations using EMRs.

Utility of NIST Whole-Genome Reference Materials for the Technical Validation of a Multigene Next-Generation Sequencing Test.

PubMed

Shum, Bennett O V; Henner, Ilya; Belluoccio, Daniele; Hinchcliffe, Marcus J

2017-07-01

The sensitivity and specificity of next-generation sequencing laboratory developed tests (LDTs) are typically determined by an analyte-specific approach. Analyte-specific validations use disease-specific controls to assess an LDT's ability to detect known pathogenic variants. Alternatively, a methods-based approach can be used for LDT technical validations. Methods-focused validations do not use disease-specific controls but use benchmark reference DNA that contains known variants (benign, variants of unknown significance, and pathogenic) to assess variant calling accuracy of a next-generation sequencing workflow. Recently, four whole-genome reference materials (RMs) from the National Institute of Standards and Technology (NIST) were released to standardize methods-based validations of next-generation sequencing panels across laboratories. We provide a practical method for using NIST RMs to validate multigene panels. We analyzed the utility of RMs in validating a novel newborn screening test that targets 70 genes, called NEO1. Despite the NIST RM variant truth set originating from multiple sequencing platforms, replicates, and library types, we discovered a 5.2% false-negative variant detection rate in the RM truth set genes that were assessed in our validation. We developed a strategy using complementary non-RM controls to demonstrate 99.6% sensitivity of the NEO1 test in detecting variants. Our findings have implications for laboratories or proficiency testing organizations using whole-genome NIST RMs for testing. Copyright © 2017 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Demonstration/Validation of Low Volatile Organic Compound (VOC) Chemical Agent Resistant Coating (CARC)

DTIC Science & Technology

2003-11-25

alkyd resin enamel was 14 Figure 1 -- Test Panels Before Application of WD CARC at MCB Figure 2 -- Test Panels with WD CARC Applied at MCB...WD) Chemical Agent Resistant Coating (CARC) patented (#5,691,410) by the Army Research Laboratory (ARL) has undergone technology Demonstration...Resistant Coating (CARC) patented (#5,691,410) by the Army Research Laboratory (ARL) has undergone technology Demonstration/Validation (Dem/Val) testing

The impact of repeat-testing of common chemistry analytes at critical concentrations.

PubMed

Onyenekwu, Chinelo P; Hudson, Careen L; Zemlin, Annalise E; Erasmus, Rajiv T

2014-12-01

Early notification of critical values by the clinical laboratory to the treating physician is a requirement for accreditation and is essential for effective patient management. Many laboratories automatically repeat a critical value before reporting it to prevent possible misdiagnosis. Given today's advanced instrumentation and quality assurance practices, we questioned the validity of this approach. We performed an audit of repeat-testing in our laboratory to assess for significant differences between initial and repeated test results, estimate the delay caused by repeat-testing and to quantify the cost of repeating these assays. A retrospective audit of repeat-tests for sodium, potassium, calcium and magnesium in the first quarter of 2013 at Tygerberg Academic Laboratory was conducted. Data on the initial and repeat-test values and the time that they were performed was extracted from our laboratory information system. The Clinical Laboratory Improvement Amendment criteria for allowable error were employed to assess for significant difference between results. A total of 2308 repeated tests were studied. There was no significant difference in 2291 (99.3%) of the samples. The average delay ranged from 35 min for magnesium to 42 min for sodium and calcium. At least 2.9% of laboratory running costs for the analytes was spent on repeating them. The practice of repeating a critical test result appears unnecessary as it yields similar results, delays notification to the treating clinician and increases laboratory running costs.

Verification and Validation: High Charge and Energy (HZE) Transport Codes and Future Development

NASA Technical Reports Server (NTRS)

Wilson, John W.; Tripathi, Ram K.; Mertens, Christopher J.; Blattnig, Steve R.; Clowdsley, Martha S.; Cucinotta, Francis A.; Tweed, John; Heinbockel, John H.; Walker, Steven A.; Nealy, John E.

2005-01-01

In the present paper, we give the formalism for further developing a fully three-dimensional HZETRN code using marching procedures but also development of a new Green's function code is discussed. The final Green's function code is capable of not only validation in the space environment but also in ground based laboratories with directed beams of ions of specific energy and characterized with detailed diagnostic particle spectrometer devices. Special emphasis is given to verification of the computational procedures and validation of the resultant computational model using laboratory and spaceflight measurements. Due to historical requirements, two parallel development paths for computational model implementation using marching procedures and Green s function techniques are followed. A new version of the HZETRN code capable of simulating HZE ions with either laboratory or space boundary conditions is under development. Validation of computational models at this time is particularly important for President Bush s Initiative to develop infrastructure for human exploration with first target demonstration of the Crew Exploration Vehicle (CEV) in low Earth orbit in 2008.

[Validation of measurement methods and estimation of uncertainty of measurement of chemical agents in the air at workstations].

PubMed

Dobecki, Marek

2012-01-01

This paper reviews the requirements for measurement methods of chemical agents in the air at workstations. European standards, which have a status of Polish standards, comprise some requirements and information on sampling strategy, measuring techniques, type of samplers, sampling pumps and methods of occupational exposure evaluation at a given technological process. Measurement methods, including air sampling and analytical procedure in a laboratory, should be appropriately validated before intended use. In the validation process, selected methods are tested and budget of uncertainty is set up. The validation procedure that should be implemented in the laboratory together with suitable statistical tools and major components of uncertainity to be taken into consideration, were presented in this paper. Methods of quality control, including sampling and laboratory analyses were discussed. Relative expanded uncertainty for each measurement expressed as a percentage, should not exceed the limit of values set depending on the type of occupational exposure (short-term or long-term) and the magnitude of exposure to chemical agents in the work environment.

The Synthetic Experiment: E. B. Titchener's Cornell Psychological Laboratory and the Test of Introspective Analysis.

PubMed

Evans, Rand B

2017-01-01

Beginning in 1 9a0, a major thread of research was added to E. B. Titchener's Cornell laboratory: the synthetic experiment. Titchener and his graduate students used introspective analysis to reduce a perception, a complex experience, into its simple sensory constituents. To test the validity of that analysis, stimulus patterns were selected to reprodiuce the patterns of sensations found in the introspective analyses. If the original perception can be reconstructed in this way, then the analysis was considered validated. This article reviews development of the synthetic method in E. B. Titchener's laboratory at Cornell University and examines its impact on psychological research.

Concurrent validation of an inertial measurement system to quantify kicking biomechanics in four football codes.

PubMed

Blair, Stephanie; Duthie, Grant; Robertson, Sam; Hopkins, William; Ball, Kevin

2018-05-17

Wearable inertial measurement systems (IMS) allow for three-dimensional analysis of human movements in a sport-specific setting. This study examined the concurrent validity of a IMS (Xsens MVN system) for measuring lower extremity and pelvis kinematics in comparison to a Vicon motion analysis system (MAS) during kicking. Thirty footballers from Australian football (n = 10), soccer (n = 10), rugby league and rugby union (n = 10) clubs completed 20 kicks across four conditions. Concurrent validity was assessed using a linear mixed-modelling approach, which allowed the partition of between and within-subject variance from the device measurement error. Results were expressed in raw and standardised units for assessments of differences in means and measurement error, and interpreted via non-clinical magnitude-based inferences. Trivial to small differences were found in linear velocities (foot and pelvis), angular velocities (knee, shank and thigh), sagittal joint (knee and hip) and segment angle (shank and pelvis) means (mean difference: 0.2-5.8%) between the IMS and MAS in Australian football, soccer and the rugby codes. Trivial to small measurement errors (from 0.1 to 5.8%) were found between the IMS and MAS in all kinematic parameters. The IMS demonstrated acceptable levels of concurrent validity compared to a MAS when measuring kicking biomechanics across the four football codes. Wearable IMS offers various benefits over MAS, such as, out-of-laboratory testing, larger measurement range and quick data output, to help improve the ecological validity of biomechanical testing and the timing of feedback. The results advocate the use of IMS to quantify biomechanics of high-velocity movements in sport-specific settings. Copyright © 2018 Elsevier Ltd. All rights reserved.

Structural Health Monitoring of Nuclear Spent Fuel Storage Facilities

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

Yu, Lingyu

Interim storage of spent nuclear fuel from reactor sites has gained additional importance and urgency for resolving waste-management-related technical issues. To ensure that nuclear power remains clean energy, monitoring has been identified by DOE as a high priority cross-cutting need, necessary to determine and predict the degradation state of the systems, structures, and components (SSCs) important to safety (ITS). Therefore, nondestructive structural condition monitoring becomes a need to be installed on existing or to be integrated into future storage system to quantify the state of health or to guarantee the safe operation of nuclear power plants (NPPs) during their extendedmore » life span. In this project, the lead university and the collaborating national laboratory teamed to develop a nuclear structural health monitoring (n-SHM) system based on in-situ piezoelectric sensing technologies that can monitor structural degradation and aging for nuclear spent fuel DCSS and similar structures. We also aimed to identify and quantify possible influences of nuclear spent fuel environment (temperature and radiation) to the piezoelectric sensor system and come up with adequate solutions and guidelines therefore. We have therefore developed analytical model for piezoelectric based n-SHM methods, with considerations of temperature and irradiation influence on the model of sensing and algorithms in acoustic emission (AE), guided ultrasonic waves (GUW), and electromechanical impedance spectroscopy (EMIS). On the other side, experimentally the temperature and irradiation influence on the piezoelectric sensors and sensing capabilities were investigated. Both short-term and long-term irradiation investigation with our collaborating national laboratory were performed. Moreover, we developed multi-modal sensing, validated in laboratory setup, and conducted the testing on the We performed multi-modal sensing development, verification and validation tests on very complex structures including a medium-scale vacuum drying chamber and a small-scale mockup canister available for the desired testing. Our work developed the potential candidate for long term structural health monitoring of spent fuel canister through piezoelectric wafer sensors and provided the sensing methodologies based on AE and GUW methodologies. It overall provides an innovative system and methodology for enhancing the safe operation of nuclear power plant. All major accomplishments planned in the original proposal were successfully achieved.« less

Development of a Control Optimization System for Real Time Monitoring of Managed Aquifer Recharge and Recovery Systems Using Intelligent Sensors

NASA Astrophysics Data System (ADS)

Smits, K. M.; Drumheller, Z. W.; Lee, J. H.; Illangasekare, T. H.; Regnery, J.; Kitanidis, P. K.

2015-12-01

Aquifers around the world show troubling signs of irreversible depletion and seawater intrusion as climate change, population growth, and urbanization lead to reduced natural recharge rates and overuse. Scientists and engineers have begun to revisit the technology of managed aquifer recharge and recovery (MAR) as a means to increase the reliability of the diminishing and increasingly variable groundwater supply. Unfortunately, MAR systems remain wrought with operational challenges related to the quality and quantity of recharged and recovered water stemming from a lack of data-driven, real-time control. This research seeks to develop and validate a general simulation-based control optimization algorithm that relies on real-time data collected though embedded sensors that can be used to ease the operational challenges of MAR facilities. Experiments to validate the control algorithm were conducted at the laboratory scale in a two-dimensional synthetic aquifer under both homogeneous and heterogeneous packing configurations. The synthetic aquifer used well characterized technical sands and the electrical conductivity signal of an inorganic conservative tracer as a surrogate measure for water quality. The synthetic aquifer was outfitted with an array of sensors and an autonomous pumping system. Experimental results verified the feasibility of the approach and suggested that the system can improve the operation of MAR facilities. The dynamic parameter inversion reduced the average error between the simulated and observed pressures between 12.5 and 71.4%. The control optimization algorithm ran smoothly and generated optimal control decisions. Overall, results suggest that with some improvements to the inversion and interpolation algorithms, which can be further advanced through testing with laboratory experiments using sensors, the concept can successfully improve the operation of MAR facilities.

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.

Using Pulsed Power for Hydrodynamic Code Validation

DTIC Science & Technology

2001-06-01

Air Force Research Laboratory ( AFRL ). A...bank at the Air Force Research Laboratory ( AFRL ). A cylindrical aluminum liner that is magnetically imploded onto a central target by self-induced...James Degnan, George Kiuttu Air Force Research Laboratory Albuquerque, NM 87117 Abstract As part of ongoing hydrodynamic code

Monitoring and reporting of preanalytical errors in laboratory medicine: the UK situation.

PubMed

Cornes, Michael P; Atherton, Jennifer; Pourmahram, Ghazaleh; Borthwick, Hazel; Kyle, Betty; West, Jamie; Costelloe, Seán J

2016-03-01

Most errors in the clinical laboratory occur in the preanalytical phase. This study aimed to comprehensively describe the prevalence and nature of preanalytical quality monitoring practices in UK clinical laboratories. A survey was sent on behalf of the Association for Clinical Biochemistry and Laboratory Medicine Preanalytical Working Group (ACB-WG-PA) to all heads of department of clinical laboratories in the UK. The survey captured data on the analytical platform and Laboratory Information Management System in use; which preanalytical errors were recorded and how they were classified and gauged interest in an external quality assurance scheme for preanalytical errors. Of the 157 laboratories asked to participate, responses were received from 104 (66.2%). Laboratory error rates were recorded per number of specimens, rather than per number of requests in 51% of respondents. Aside from serum indices for haemolysis, icterus and lipaemia, which were measured in 80% of laboratories, the most common errors recorded were booking-in errors (70.1%) and sample mislabelling (56.9%) in laboratories who record preanalytical errors. Of the laboratories surveyed, 95.9% expressed an interest in guidance on recording preanalytical error and 91.8% expressed interest in an external quality assurance scheme. This survey observes a wide variation in the definition, repertoire and collection methods for preanalytical errors in the UK. Data indicate there is a lot of interest in improving preanalytical data collection. The ACB-WG-PA aims to produce guidance and support for laboratories to standardize preanalytical data collection and to help establish and validate an external quality assurance scheme for interlaboratory comparison. © The Author(s) 2015.

Validation techniques of agent based modelling for geospatial simulations

NASA Astrophysics Data System (ADS)

Darvishi, M.; Ahmadi, G.

2014-10-01

One of the most interesting aspects of modelling and simulation study is to describe the real world phenomena that have specific properties; especially those that are in large scales and have dynamic and complex behaviours. Studying these phenomena in the laboratory is costly and in most cases it is impossible. Therefore, Miniaturization of world phenomena in the framework of a model in order to simulate the real phenomena is a reasonable and scientific approach to understand the world. Agent-based modelling and simulation (ABMS) is a new modelling method comprising of multiple interacting agent. They have been used in the different areas; for instance, geographic information system (GIS), biology, economics, social science and computer science. The emergence of ABM toolkits in GIS software libraries (e.g. ESRI's ArcGIS, OpenMap, GeoTools, etc) for geospatial modelling is an indication of the growing interest of users to use of special capabilities of ABMS. Since ABMS is inherently similar to human cognition, therefore it could be built easily and applicable to wide range applications than a traditional simulation. But a key challenge about ABMS is difficulty in their validation and verification. Because of frequent emergence patterns, strong dynamics in the system and the complex nature of ABMS, it is hard to validate and verify ABMS by conventional validation methods. Therefore, attempt to find appropriate validation techniques for ABM seems to be necessary. In this paper, after reviewing on Principles and Concepts of ABM for and its applications, the validation techniques and challenges of ABM validation are discussed.

A Virtual Laboratory for Aviation and Airspace Prognostics Research

NASA Technical Reports Server (NTRS)

Kulkarni, Chetan; Gorospe, George; Teubert, Christ; Quach, Cuong C.; Hogge, Edward; Darafsheh, Kaveh

2017-01-01

Integration of Unmanned Aerial Vehicles (UAVs), autonomy, spacecraft, and other aviation technologies, in the airspace is becoming more and more complicated, and will continue to do so in the future. Inclusion of new technology and complexity into the airspace increases the importance and difficulty of safety assurance. Additionally, testing new technologies on complex aviation systems and systems of systems can be challenging, expensive, and at times unsafe when implementing real life scenarios. The application of prognostics to aviation and airspace management may produce new tools and insight into these problems. Prognostic methodology provides an estimate of the health and risks of a component, vehicle, or airspace and knowledge of how that will change over time. That measure is especially useful in safety determination, mission planning, and maintenance scheduling. In our research, we develop a live, distributed, hardware- in-the-loop Prognostics Virtual Laboratory testbed for aviation and airspace prognostics. The developed testbed will be used to validate prediction algorithms for the real-time safety monitoring of the National Airspace System (NAS) and the prediction of unsafe events. In our earlier work1 we discussed the initial Prognostics Virtual Laboratory testbed development work and related results for milestones 1 & 2. This paper describes the design, development, and testing of the integrated tested which are part of milestone 3, along with our next steps for validation of this work. Through a framework consisting of software/hardware modules and associated interface clients, the distributed testbed enables safe, accurate, and inexpensive experimentation and research into airspace and vehicle prognosis that would not have been possible otherwise. The testbed modules can be used cohesively to construct complex and relevant airspace scenarios for research. Four modules are key to this research: the virtual aircraft module which uses the X-Plane simulator and X-PlaneConnect toolbox, the live aircraft module which connects fielded aircraft using onboard cellular communications devices, the hardware in the loop (HITL) module which connects laboratory based bench-top hardware testbeds and the research module which contains diagnostics and prognostics tools for analysis of live air traffic situations and vehicle health conditions. The testbed also features other modules for data recording and playback, information visualization, and air traffic generation. Software reliability, safety, and latency are some of the critical design considerations in development of the testbed.

Ensuring the validity of calculated subcritical limits

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

Clark, H.K.

1977-01-01

The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less

Validation of a single-platform method for hematopoietic CD34+ stem cells enumeration according to accreditation procedure.

PubMed

Massin, Frédéric; Huili, Cai; Decot, Véronique; Stoltz, Jean-François; Bensoussan, Danièle; Latger-Cannard, Véronique

2015-01-01

Stem cells for autologous and allogenic transplantation are obtained from several sources including bone marrow, peripheral blood or cord blood. Accurate enumeration of viable CD34+ hematopoietic stem cells (HSC) is routinely used in clinical settings, especially to monitor progenitor cell mobilization and apheresis. The number of viable CD34+ HSC has also been shown to be the most critical factor in haematopoietic engraftment. The International Society for Cellular Therapy actually recommends the use of single-platform flow cytometry system using 7-AAD as a viability dye. In a way to move routine analysis from a BD FACSCaliburTM instrument to a BD FACSCantoTM II, according to ISO 15189 standard guidelines, we define laboratory performance data of the BDTM Stem Cell Enumeration (SCE) kit on a CE-IVD system including a BD FACSCanto II flow cytometer and the BD FACSCantoTM Clinical Software. InterQCTM software, a real time internet laboratory QC management system developed by VitroTM and distributed by Becton DickinsonTM, was also tested to monitor daily QC data, to define the internal laboratory statistics and to compare them to external laboratories. Precision was evaluated with BDTM Stem Cell Control (high and low) results and the InterQC software, an internet laboratory QC management system by Vitro. This last one drew Levey-Jennings curves and generated numeral statistical parameters allowing detection of potential changes in the system performances as well as interlaboratory comparisons. Repeatability, linearity and lower limits of detection were obtained with routine samples from different origins. Agreement evaluation between BD FACSCanto II system versus BD FACSCalibur system was tested on fresh peripheral blood, freeze-thawed apheresis, fresh bone marrow and fresh cord blood samples. Instrument's measure and staining repeatability clearly evidenced acceptable variability on the different samples tested. Intra- and inter-laboratory CV in CD34+ cell absolute count are consistent and reproducible. Linearity analysis, established between 2 and 329 cells/μl showed a linear relation between expected counts and measured counts (R2=0.97). Linear regression and Bland-Altman representations showed an excellent correlation on samples from different sources between the two systems and allowed the transfer of routine analysis from BD FACSCalibur to BD FACSCanto II. The BD SCE kit provides an accurate measure of the CD34 HSC, and can be used in daily routine to optimize the enumeration of hematopoietic CD34+ stem cells by flow cytometry. Moreover, the InterQC system seems to be a very useful tool for laboratory daily quality monitoring and thus for accreditation.

Interlaboratory Reproducibility of Droplet Digital Polymerase Chain Reaction Using a New DNA Reference Material Format.

PubMed

Pinheiro, Leonardo B; O'Brien, Helen; Druce, Julian; Do, Hongdo; Kay, Pippa; Daniels, Marissa; You, Jingjing; Burke, Daniel; Griffiths, Kate; Emslie, Kerry R

2017-11-07

Use of droplet digital PCR technology (ddPCR) is expanding rapidly in the diversity of applications and number of users around the world. Access to relatively simple and affordable commercial ddPCR technology has attracted wide interest in use of this technology as a molecular diagnostic tool. For ddPCR to effectively transition to a molecular diagnostic setting requires processes for method validation and verification and demonstration of reproducible instrument performance. In this study, we describe the development and characterization of a DNA reference material (NMI NA008 High GC reference material) comprising a challenging methylated GC-rich DNA template under a novel 96-well microplate format. A scalable process using high precision acoustic dispensing technology was validated to produce the DNA reference material with a certified reference value expressed in amount of DNA molecules per well. An interlaboratory study, conducted using blinded NA008 High GC reference material to assess reproducibility among seven independent laboratories demonstrated less than 4.5% reproducibility relative standard deviation. With the exclusion of one laboratory, laboratories had appropriate technical competency, fully functional instrumentation, and suitable reagents to perform accurate ddPCR based DNA quantification measurements at the time of the study. The study results confirmed that NA008 High GC reference material is fit for the purpose of being used for quality control of ddPCR systems, consumables, instrumentation, and workflow.

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…

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)

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation--the case of validation of the biochemistry analyzer Dimension Vista.

PubMed

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients' samples in both devices. 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.

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.

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

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...

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

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

Application and validation of the TTI based chill chain management system SMAS (Safety Monitoring and Assurance System) on shelf life optimization of vacuum packed chilled tuna.

PubMed

Tsironi, Theofania; Gogou, Eleni; Velliou, Eirini; Taoukis, Petros S

2008-11-30

The objective of the study was to establish a validated kinetic model for growth of spoilage bacteria on vacuum packed tuna slices in the temperature range of 0 to 15 degrees C and to evaluate the applicability of the TTI (Time Temperature Integrators) based SMAS (Safety Monitoring and Assurance System) system to improve tuna product quality at the time of consumption in comparison to the conventional First In First Out (FIFO) approach. The overall measurements of total flora and lactic acid bacteria (LAB) on the tuna samples used in a laboratory simulated field test were in close agreement with the predictions of the developed kinetic model. The spoilage profile of the TTI bearing products, handled with SMAS, was improved. Three out of the thirty products that were handled randomly, according to the FIFO approach, were already spoiled at the time of consumption (logN(LAB)>6.5) compared to no spoiled products when handled with the SMAS approach.

Predicting mortality in sick African children: the FEAST Paediatric Emergency Triage (PET) Score.

PubMed

George, Elizabeth C; Walker, A Sarah; Kiguli, Sarah; Olupot-Olupot, Peter; Opoka, Robert O; Engoru, Charles; Akech, Samuel O; Nyeko, Richard; Mtove, George; Reyburn, Hugh; Berkley, James A; Mpoya, Ayub; Levin, Michael; Crawley, Jane; Gibb, Diana M; Maitland, Kathryn; Babiker, Abdel G

2015-07-31

Mortality in paediatric emergency care units in Africa often occurs within the first 24 h of admission and remains high. Alongside effective triage systems, a practical clinical bedside risk score to identify those at greatest risk could contribute to reducing mortality. Data collected during the Fluid As Expansive Supportive Therapy (FEAST) trial, a multi-centre trial involving 3,170 severely ill African children, were analysed to identify clinical and laboratory prognostic factors for mortality. Multivariable Cox regression was used to build a model in this derivation dataset based on clinical parameters that could be quickly and easily assessed at the bedside. A score developed from the model coefficients was externally validated in two admissions datasets from Kilifi District Hospital, Kenya, and compared to published risk scores using Area Under the Receiver Operating Curve (AUROC) and Hosmer-Lemeshow tests. The Net Reclassification Index (NRI) was used to identify additional laboratory prognostic factors. A risk score using 8 clinical variables (temperature, heart rate, capillary refill time, conscious level, severe pallor, respiratory distress, lung crepitations, and weak pulse volume) was developed. The score ranged from 0-10 and had an AUROC of 0.82 (95 % CI, 0.77-0.87) in the FEAST trial derivation set. In the independent validation datasets, the score had an AUROC of 0.77 (95 % CI, 0.72-0.82) amongst admissions to a paediatric high dependency ward and 0.86 (95 % CI, 0.82-0.89) amongst general paediatric admissions. This discriminative ability was similar to, or better than other risk scores in the validation datasets. NRI identified lactate, blood urea nitrogen, and pH to be important prognostic laboratory variables that could add information to the clinical score. Eight clinical prognostic factors that could be rapidly assessed by healthcare staff for triage were combined to create the FEAST Paediatric Emergency Triage (PET) score and externally validated. The score discriminated those at highest risk of fatal outcome at the point of hospital admission and compared well to other published risk scores. Further laboratory tests were also identified as prognostic factors which could be added if resources were available or as indices of severity for comparison between centres in future research studies.

Validation of the Hexoskin wearable vest during lying, sitting, standing, and walking activities.

PubMed

Villar, Rodrigo; Beltrame, Thomas; Hughson, Richard L

2015-10-01

We tested the validity of the Hexoskin wearable vest to monitor heart rate (HR), breathing rate (BR), tidal volume (VT), minute ventilation, and hip motion intensity (HMI) in comparison with laboratory standard devices during lying, sitting, standing, and walking. Twenty healthy young volunteers participated in this study. First, participants walked 6 min on a treadmill at speeds of 1, 3, and 4.5 km/h followed by increasing treadmill grades until 80% of their predicted maximal heart rate. Second, lying, sitting, and standing tasks were performed (5 min each) followed by 6 min of treadmill walking at 80% of their ventilatory threshold. Analysis of each individual's mean values under each resting or exercise condition by the 2 measurement systems revealed low coefficient of variation and high intraclass correlation values for HR, BR, and HMI. The Bland-Altman results from HR, BR, and HMI indicated no deviation of the mean value from zero and relatively small variability about the mean. VT and minute ventilation were provided in arbitrary units by the Hexoskin device; however, relative magnitude of change from Hexoskin closely tracked the laboratory standard method. Hexoskin presented low variability, good agreement, and consistency. The Hexoskin wearable vest was a valid and consistent tool to monitor activities typical of daily living such as different body positions (lying, sitting, and standing) and various walking speeds.

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

Gauld, Ian C.; Giaquinto, J. M.; Delashmitt, J. S.

Destructive radiochemical assay measurements of spent nuclear fuel rod segments from an assembly irradiated in the Three Mile Island unit 1 (TMI-1) pressurized water reactor have been performed at Oak Ridge National Laboratory (ORNL). Assay data are reported for five samples from two fuel rods of the same assembly. The TMI-1 assembly was a 15 X 15 design with an initial enrichment of 4.013 wt% 235U, and the measured samples achieved burnups between 45.5 and 54.5 gigawatt days per metric ton of initial uranium (GWd/t). Measurements were performed mainly using inductively coupled plasma mass spectrometry after elemental separation via highmore » performance liquid chromatography. High precision measurements were achieved using isotope dilution techniques for many of the lanthanides, uranium, and plutonium isotopes. Measurements are reported for more than 50 different isotopes and 16 elements. One of the two TMI-1 fuel rods measured in this work had been measured previously by Argonne National Laboratory (ANL), and these data have been widely used to support code and nuclear data validation. Recently, ORNL provided an important opportunity to independently cross check results against previous measurements performed at ANL. The measured nuclide concentrations are used to validate burnup calculations using the SCALE nuclear systems modeling and simulation code suite. These results show that the new measurements provide reliable benchmark data for computer code validation.« less

Theoretical studies in isoelectric focusing. [mathematical modeling and computer simulation for biologicals purification process

NASA Technical Reports Server (NTRS)

Mosher, R. A.; Palusinski, O. A.; Bier, M.

1982-01-01

A mathematical model has been developed which describes the steady state in an isoelectric focusing (IEF) system with ampholytes or monovalent buffers. The model is based on the fundamental equations describing the component dissociation equilibria, mass transport due to diffusion and electromigration, electroneutrality, and the conservation of charge. The validity and usefulness of the model has been confirmed by using it to formulate buffer systems in actual laboratory experiments. The model has been recently extended to include the evolution of transient states not only in IEF but also in other modes of electrophoresis.

Structural Testing at the NWTC Helps Improve Blade Design and Increase System Reliability; NREL (National Renewable Energy Laboratory)

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

None

2015-08-01

Since 1990, the National Renewable Energy Laboratory’s (NREL's) National Wind Technology Center (NWTC) has tested more than 150 wind turbine blades. NWTC researchers can test full-scale and subcomponent articles, conduct data analyses, and provide engineering expertise on best design practices. Structural testing of wind turbine blades enables designers, manufacturers, and owners to validate designs and assess structural performance to specific load conditions. Rigorous structural testing can reveal design and manufacturing problems at an early stage of development that can lead to overall improvements in design and increase system reliability.

High Fidelity Measurement and Modeling of Interactions between Acoustics and Heat Release in Highly-Compact, High-Pressure Flames

DTIC Science & Technology

2016-05-24

experimental data. However, the time and length scales, and energy deposition rates in the canonical laboratory flames that have been studied over the...is to obtain high-fidelity experimental data critically needed to validate research codes at relevant conditions, and to develop systematic and...validated with experimental data. However, the time and length scales, and energy deposition rates in the canonical laboratory flames that have been

ISO/IEC 17025 Sysmex R-500 hematology reticulocyte analyzer validation.

PubMed

Dimopoulou, H A; Theodoridis, T; Galea, V; Christopoulou-Cokkinou, V; Spyridaki, M-H E; Georgakopoulos, C G

2007-01-01

The Sysmex R-500 (R-500) Hematology Analyzer is a bench-top system appropriate for the analysis of limited batches of blood samples. The R-500 provides percentage proportional (RET%), absolute reticulocyte (RET#), and absolute red blood cell (RBC#) counts. The system was validated at the Doping Control Laboratory of Athens, according to the International Committee for Standardization in Hematology, International Standards Organization (ISO/IEC) 17025, and World Antidoping Agency (WADA) specifications. The instrument calibration was performed according to the manufacturer and validation parameters comprised linearity, precision, uncertainty (intermediate and long-term precision), comparability, effect of drift, carryover, stability, and accuracy. The linearity and the comparability studies for RET#, RET%, and RBC# were expressed in regression factors (R2) and coefficients of correlation [r(x, y)], respectively. For the precision studies, the coefficients of variation for RET#, RET%, and RBC# were 9.49%, 9.83%, and <1.5%, respectively. For the intermediate precision studies, the coefficients of variation for RET#, RET%, and RBC# were 3.1%, 3.6%, and 0.6%, respectively. Carryover was found to be negligible. Sample stability was demonstrated at both room temperature and at 4 degrees C over a 24-hour period. Comparability studies for the R-500 were performed using a Sysmex SE-9500. The total evaluation led to the conclusion that the R-500 is an accurate and precise analyzer and because of to its relatively limited size, it can be considered a portable instrument, capable to be used in sports competition and training sites, where doping control and health tests are conducted. The analytical methodology of RET% measurement by the R-500 has been incorporated into the Doping Control Laboratory of Athens' Scope of Accreditation according to the ISO/IEC 17025 and WADA specifications.

Validation and transferability study of a method based on near-infrared hyperspectral imaging for the detection and quantification of ergot bodies in cereals.

PubMed

Vermeulen, Ph; Fernández Pierna, J A; van Egmond, H P; Zegers, J; Dardenne, P; Baeten, V

2013-09-01

In recent years, near-infrared (NIR) hyperspectral imaging has proved its suitability for quality and safety control in the cereal sector by allowing spectroscopic images to be collected at single-kernel level, which is of great interest to cereal control laboratories. Contaminants in cereals include, inter alia, impurities such as straw, grains from other crops, and insects, as well as undesirable substances such as ergot (sclerotium of Claviceps purpurea). For the cereal sector, the presence of ergot creates a high toxicity risk for animals and humans because of its alkaloid content. A study was undertaken, in which a complete procedure for detecting ergot bodies in cereals was developed, based on their NIR spectral characteristics. These were used to build relevant decision rules based on chemometric tools and on the morphological information obtained from the NIR images. The study sought to transfer this procedure from a pilot online NIR hyperspectral imaging system at laboratory level to a NIR hyperspectral imaging system at industrial level and to validate the latter. All the analyses performed showed that the results obtained using both NIR hyperspectral imaging cameras were quite stable and repeatable. In addition, a correlation higher than 0.94 was obtained between the predicted values obtained by NIR hyperspectral imaging and those supplied by the stereo-microscopic method which is the reference method. The validation of the transferred protocol on blind samples showed that the method could identify and quantify ergot contamination, demonstrating the transferability of the method. These results were obtained on samples with an ergot concentration of 0.02% which is less than the EC limit for cereals (intervention grains) destined for humans fixed at 0.05%.

Improving the Plasticity of LIMS Implementation: LIMS Extension through Microsoft Excel

NASA Technical Reports Server (NTRS)

Culver, Mark

2017-01-01

A Laboratory Information Management System (LIMS) is a databasing software with many built-in tools ideal for handling and documenting most laboratory processes in an accurate and consistent manner, making it an indispensable tool for the modern laboratory. However, a lot of LIMS end users will find that in the performance of analyses that have unique considerations such as standard curves, multiple stages incubations, or logical considerations, a base LIMS distribution may not ideally suit their needs. These considerations bring about the need for extension languages, which can extend the functionality of a LIMS. While these languages do provide the implementation team the functionality required to accommodate these special laboratory analyses, they are usually too complex for the end user to modify to compensate for natural changes in laboratory operations. The LIMS utilized by our laboratory offers a unique and easy-to-use choice for an extension language, one that is already heavily relied upon not only in science but also in most academic and business pursuits: Microsoft Excel. The validity of Microsoft Excel as a pseudo programming language and its usability and versatility as a LIMS extension language will be discussed. The NELAC implications and overall drawbacks of this LIMS configuration will also be discussed.

Validation of the Dynamic Direct Exposure Method for Toxicity Testing of Diesel Exhaust In Vitro

PubMed Central

Hayes, Amanda; Bakand, Shahnaz

2013-01-01

Diesel exhaust emission is a major health concern because of the complex nature of its gaseous content (e.g., NO2, NO, CO, and CO2) and high concentration of particulate matter (PM) less than 2.5 μm which allows for deeper penetration into the human pulmonary system upon inhalation. The aim of this research was to elucidate the potential toxic effects of diesel exhaust on a human pulmonary-based cellular system. Validation of a dynamic direct exposure method for both laboratory (230 hp Volvo truck engine) and field (Volkswagen Passat passenger car) diesel engines, at idle mode, was implemented. Human pulmonary type II epithelial cells (A549) grown on porous membranes were exposed to unmodified diesel exhaust at a low flow rate (37.5 mL/min). In parallel, diesel emission sampling was also conducted using real-time air monitoring techniques. Induced cellular effects were assessed using a range of in vitro cytotoxicity assays (MTS, ATP, and NRU). Reduction of cell viability was observed in a time-dependent manner following 30–60 mins of exposure with NRU as the most sensitive assay. The results suggest that the dynamic direct exposure method has the potential to be implemented for both laboratory- and field-based in vitro toxicity studies of diesel exhaust emissions. PMID:23986878

Validation of the Apnea Risk Evaluation System (ARES) device against laboratory polysomnography in pregnant women at risk for obstructive sleep apnea syndrome.

PubMed

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

2014-05-15

To assess the validity of using the Apnea Risk Evaluation System (ARES) Unicorder for detecting obstructive sleep apnea (OSA) in pregnant women. 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/m(2) 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. 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. The ARES Unicorder demonstrated reasonable consistency with PSG for diagnosing OSA in this small, heterogeneous sample of obese pregnant women.

Hydrogen Storage Engineering Center of Excellence Metal Hydride Final Report

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

Motyka, T.

2014-05-31

The Hydrogen Storage Engineering Center of Excellence (HSECoE) was established in 2009 by the U.S. Department of Energy (DOE) to advance the development of materials-based hydrogen storage systems for hydrogen-fueled light-duty vehicles. The overall objective of the HSECoE is to develop complete, integrated system concepts that utilize reversible metal hydrides, adsorbents, and chemical hydrogen storage materials through the use of advanced engineering concepts and designs that can simultaneously meet or exceed all the DOE targets. This report describes the activities and accomplishments during Phase 1 of the reversible metal hydride portion of the HSECoE, which lasted 30 months from Februarymore » 2009 to August 2011. A complete list of all the HSECoE partners can be found later in this report but for the reversible metal hydride portion of the HSECoE work the major contributing organizations to this effort were the United Technology Research Center (UTRC), General Motors (GM), Pacific Northwest National Laboratory (PNNL), the National Renewable Energy Laboratory (NREL) and the Savannah River National Laboratory (SRNL). Specific individuals from these and other institutions that supported this effort and the writing of this report are included in the list of contributors and in the acknowledgement sections of this report. The efforts of the HSECoE are organized into three phases each approximately 2 years in duration. In Phase I, comprehensive system engineering analyses and assessments were made of the three classes of storage media that included development of system level transport and thermal models of alternative conceptual storage configurations to permit detailed comparisons against the DOE performance targets for light-duty vehicles. Phase 1 tasks also included identification and technical justifications for candidate storage media and configurations that should be capable of reaching or exceeding the DOE targets. Phase 2 involved bench-level testing and evaluation of system configurations, including material packaging and balance-of-plant components, and conceptual design validation. Phase 3 includes fabrication and testing of the selected prototype storage system(s) for model validation and performance evaluation against the DOE targets. A DOE decision was needed for the HSECoE to advance to each phase and work on some classes of storage materials were recommended not to continue.« less

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)

TU-H-BRC-09: Validation of a Novel Therapeutic X-Ray Array Source and Collimation System

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

Trovati, S; King, GJ; Loo, BW

2016-06-15

Purpose: We have experimentally characterized and simulated the dosimetric properties and spatial fidelity of a novel X-ray array source and collimation system called SPHINX that has the potential to generate complex intensity modulated X-ray beams by varying the electron beam intensity only, and without any moving parts like in multi-leaf collimators. Methods: We investigated the spatial fidelity and the X-ray performances of a SPHINX prototype in tungsten, using a Cyber Knife and the experimental high-energy electron beam line at XTA at SLAC National Laboratory. Dose distributions were recorded with gafchromic films, placed at the distal end of SPHINX and atmore » several depths in a solid water phantom. The geometry of SPHINX and of the experimental set-ups was also modeled in Monte Carlo (MC) simulations with the FLUKA code, used to reproduce the experimental results and, after validation, to predict and optimize the performance and design of the SPHINX. Results: The results indicate significant particle leakage through the channels during a single-channel irradiation for high incident energies, followed by a rapid decrease for energies of clinical interest. When the collimator channels are used as target, the photon production increases, however at expense of the beam size that is also enlarged. The illumination of all channels simultaneously shows a fairly even transmission of the beam. Conclusion: With the measurements we have verified the MC models and the uniformity of beam transmission through SPHINX, and we have evaluated the importance of particle leakage through adjacent channels. These results can be used to optimize SPHINX design through the validated MC simulations. Funding: Weston Havens Foundation, Office of the Dean of Medical School and Office of the Provost (Stanford University). Loo, Maxim, Borchard, Tantawi are co-founders of TibaRay Inc. Loo and Tantawi are TibaRay Inc. board members. Loo and Maxim received grants from Varian Medical Systems and RaySearch Laboratory.« less

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.

Comparative analysis of four commercial on-farm culture methods to identify bacteria associated with clinical mastitis in dairy cattle.

PubMed

Ferreira, Jair C; Gomes, Marilia S; Bonsaglia, Erika C R; Canisso, Igor F; Garrett, Edgar F; Stewart, Jamie L; Zhou, Ziyao; Lima, Fabio S

2018-01-01

Several multiple-media culture systems have become commercially available for on-farm identification of mastitis-associated pathogens. However, the accuracy of these systems has not been thoroughly and independently validated against microbiological evaluations performed by referral laboratories. Therefore, the purpose of the present study was to evaluate the performance of commercially available culture plates (Accumast, Minnesota Easy System, SSGN and SSGNC Quad plates) to identify pathogens associated with clinical mastitis in dairy cows. Milk samples from the affected quarter with clinical mastitis were aerobically cultured with the on-farm culture systems and by two additional reference laboratories. Agreeing results from both standard laboratories were denoted as the reference standard (RS). Accuracy (Ac), sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and Cohen's kappa coefficient (k) of on-farm plates were determined based on the RS culture of 211 milk samples. All four plate-systems correctly identified ≥ 84.9% of milk samples with no bacterial growth. Accumast had greater values for all overall predictive factors (Ac, Se, Sp, PPV and NPV) and a substantial agreement (k = 0.79) with RS. The inter-rater agreements of Minnesota, SSGN, and SSGNC with RS were moderate (0.45 ≤ k ≤ 0.55). The effectiveness to categorize bacterial colonies at the genus and species was numerically different amongst the commercial plates. Our findings suggest that Accumast was the most accurate on-farm culture system for identification of mastitis-associated pathogens of the four systems included in the analysis.

Comparative analysis of four commercial on-farm culture methods to identify bacteria associated with clinical mastitis in dairy cattle

PubMed Central

Ferreira, Jair C.; Gomes, Marilia S.; Bonsaglia, Erika C. R.; Canisso, Igor F.; Garrett, Edgar F.; Stewart, Jamie L.; Zhou, Ziyao

2018-01-01

Several multiple-media culture systems have become commercially available for on-farm identification of mastitis-associated pathogens. However, the accuracy of these systems has not been thoroughly and independently validated against microbiological evaluations performed by referral laboratories. Therefore, the purpose of the present study was to evaluate the performance of commercially available culture plates (Accumast, Minnesota Easy System, SSGN and SSGNC Quad plates) to identify pathogens associated with clinical mastitis in dairy cows. Milk samples from the affected quarter with clinical mastitis were aerobically cultured with the on-farm culture systems and by two additional reference laboratories. Agreeing results from both standard laboratories were denoted as the reference standard (RS). Accuracy (Ac), sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and Cohen’s kappa coefficient (k) of on-farm plates were determined based on the RS culture of 211 milk samples. All four plate-systems correctly identified ≥ 84.9% of milk samples with no bacterial growth. Accumast had greater values for all overall predictive factors (Ac, Se, Sp, PPV and NPV) and a substantial agreement (k = 0.79) with RS. The inter-rater agreements of Minnesota, SSGN, and SSGNC with RS were moderate (0.45 ≤ k ≤ 0.55). The effectiveness to categorize bacterial colonies at the genus and species was numerically different amongst the commercial plates. Our findings suggest that Accumast was the most accurate on-farm culture system for identification of mastitis-associated pathogens of the four systems included in the analysis. PMID:29543852

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 qualitative research has uncovered several issues not explored by the quantitative research. It was concluded that incorporating the recommendations acquired from the qualitative research, especially elements of incorporating hardware experience to avoid lack of hands-on skills, into the laboratory pedagogy should help improve students' experience regardless of the environment in which the laboratory is conducted.

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.

Quantitative polymerase chain reaction (PCR) for detection of aquatic animal pathogens in a diagnostic laboratory setting

USGS Publications Warehouse

Purcell, Maureen K.; Getchell, Rodman G.; McClure, Carol A.; Weber, S.E.; Garver, Kyle A.

2011-01-01

Real-time, or quantitative, polymerase chain reaction (qPCR) is quickly supplanting other molecular methods for detecting the nucleic acids of human and other animal pathogens owing to the speed and robustness of the technology. As the aquatic animal health community moves toward implementing national diagnostic testing schemes, it will need to evaluate how qPCR technology should be employed. This review outlines the basic principles of qPCR technology, considerations for assay development, standards and controls, assay performance, diagnostic validation, implementation in the diagnostic laboratory, and quality assurance and control measures. These factors are fundamental for ensuring the validity of qPCR assay results obtained in the diagnostic laboratory setting.

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.

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)

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)

Validation of a FAST model of the Statoil-Hywind Demo floating wind turbine

DOE PAGES

Driscoll, Frederick; Jonkman, Jason; Robertson, Amy; ...

2016-10-13

To assess the accuracy of the National Renewable Energy Laboratory's (NREL's) FAST simulation tool for modeling the coupled response of floating offshore wind turbines under realistic open-ocean conditions, NREL developed a FAST model of the Statoil Hywind Demo floating offshore wind turbine, and validated simulation results against field measurements. Field data were provided by Statoil, which conducted a comprehensive test measurement campaign of its demonstration system, a 2.3-MW Siemens turbine mounted on a spar substructure deployed about 10 km off the island of Karmoy in Norway. A top-down approach was used to develop the FAST model, starting with modeling themore » blades and working down to the mooring system. Design data provided by Siemens and Statoil were used to specify the structural, aerodynamic, and dynamic properties. Measured wind speeds and wave spectra were used to develop the wind and wave conditions used in the model. The overall system performance and behavior were validated for eight sets of field measurements that span a wide range of operating conditions. The simulated controller response accurately reproduced the measured blade pitch and power. In conclusion, the structural and blade loads and spectra of platform motion agree well with the measured data.« less

Cold Climate Foundation Retrofit Experimental Hygrothermal Performance: Cloquet Residential Research Facility Laboratory Results

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

Goldberg, Louise F.; Harmon, Anna C.

2015-04-01

Thermal and moisture problems in existing basements create a unique challenge because the exterior face of the wall is not easily or inexpensively accessible. This approach addresses thermal and moisture management from the interior face of the wall without disturbing the exterior soil and landscaping. the interior and exterior environments. This approach has the potential for improving durability, comfort, and indoor air quality. This project was funded jointly by the National Renewable Energy Laboratory (NREL) and Oak Ridge National Laboratory (ORNL). ORNL focused on developing a full basement wall system experimental database to enable others to validate hygrothermal simulation codes.more » NREL focused on testing the moisture durability of practical basement wall interior insulation retrofit solutions for cold climates. The project has produced a physically credible and reliable long-term hygrothermal performance database for retrofit foundation wall insulation systems in zone 6 and 7 climates that are fully compliant with the performance criteria in the 2009 Minnesota Energy Code. The experimental data were configured into a standard format that can be published online and that is compatible with standard commercially available spreadsheet and database software.« less