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Sample records for conventional serological screening

  1. Posttherapeutic Cure Criteria in Chagas' Disease: Conventional Serology followed by Supplementary Serological, Parasitological, and Molecular Tests

    PubMed Central

    Silva, A. R.; Do Bem, V. A. L.; Bahia, M. T.; Martins-Filho, O. A.; Dias, J. C. P.; Albajar-Viñas, P.; Torres, R. M.; Lana, M.

    2012-01-01

    We performed a critical study of conventional serology, followed by supplementary serological, parasitological, and molecular tests, to assess the response to etiologic treatment of Chagas' disease. A group of 94 Chagas' disease patients treated with benznidazole at least 10 years earlier were evaluated from the laboratory and clinical points of view. When conventional serology (enzyme-linked immunosorbent assay [ELISA], indirect immunofluorescence [IIF], and indirect hemagglutination [IHA]) and classic criteria (consistent results with any two of the three tests) or more rigorous criteria (consistent results from the three tests) were used, 10.6% and 8.5% of patients were considered treated and cured (TC) by classic and rigorous criteria, respectively. Patients were then evaluated using supplementary (recombinant ELISA and Trypanosoma cruzi excreted-secreted antigen blotting [TESA-blot]), parasitological (hemoculture), and molecular (PCR) tests. The results of recombinant ELISA were similar to those with the rigorous criterion (three consistent test results). The TESA-blot group showed a higher percentage (21.3%) of negative results than the groups defined by either cure criterion. Hemoculture and PCR gave negative results for all treated and cured (TC) patients, regardless of the criterion used. Recombinant ELISA and TESA-blot tests showed negative results for 70% and 87.5% of the patients categorized as TC by the classic and three-test criteria, respectively. For patients with discordant conventional serology, the supplementary serological and molecular tests were the decisive factor in determining therapeutic failure. Clinical evaluation showed that 62.5% of TC patients presented with the indeterminate form of the disease. Additionally, treated patients with negative TESA-blot results should be reevaluated later with all methodologies used here to verify whether TESA-blot is a reliable way to determine early parasitological cure of Chagas' disease. PMID

  2. Facts and myths in serological screening of ART couples

    PubMed Central

    Mocanu, E.V.

    2012-01-01

    Serological screening of couples attending for ART therapy is now common practice. The frequency of such screening is a topic of debate as few publications have addressed this question. Emerging evidence shows that the ART population has similar prevalence of infectious diseases compared with the general EU population. The need to pursue repeat screening is mainly related to the risk of seroconversion in this highly selected population. The evidence presented here shows that seroconversion among cohabitating ART couples is negligible. Even if a theoretical risk of seroconversion during therapy exists, with correct laboratory practice the risk of cross-contamination is negligible as laboratory processing eliminates the infective risk. As such ART laboratory processing of contaminated samples becomes an indication rather than a risk. To strengthen the evidence it is recommended that data on prevalence and incidence should be prospectively collected by all ART units. PMID:24753908

  3. Serological responses to Cryptosporidium antigens among women using riverbank-filtered water, conventionally filtered surface water and groundwater in Hungary.

    PubMed

    Frost, Floyd; Craun, Gunther; Mihály, Kádár; György, Berencsi; Calderon, Rebecca; Muller, Tm

    2005-03-01

    We compared serological responses to Cryptosporidium parvum antigens using surplus sera from females undergoing routine screening for pregnancy from three counties in Hungary where bank-filtered surface water, conventionally filtered and disinfected surface water, and groundwater from either a karst or confined aquifer are commonly used for drinking water. The primary purpose was to determine whether the prevalence and intensity of serological responses, indicators of prior Cryptosporidium infection were similar for these populations. Women using groundwater from a confined aquifer had significantly lower mean serological responses for both the 15/17-kDa and 27-kDa (p < 0.0001) antigen groups than women using conventionally filtered and disinfected surface water or karst well water. This is suggestive of less frequent infections. Women using bank-filtered water also had lower mean responses for both antigen groups. Among women using bank-filtered water, the mean intensity of response for both antigen groups was almost one-third of the mean response observed for women using conventionally filtered and disinfected surface water. These findings suggest that riverbank filtration may be an effective alternative to conventional treatment for reducing Cryptosporidium exposures and infection from surface drinking water sources. PMID:15952455

  4. First TBEV serological screening in Flemish wild boar

    PubMed Central

    Roelandt, Sophie; Suin, Vanessa; Van der Stede, Yves; Lamoral, Sophie; Marche, Sylvie; Tignon, Marylène; Saiz, Juan Carlos; Escribano-Romero, Estela; Casaer, Jim; Brochier, Bernard; Van Gucht, Steven; Roels, Stefan; Vervaeke, Muriel

    2016-01-01

    In the frame of a Flemish wildlife surveillance in 2013, a serological screening was performed on sera from wild boar (Sus scrofa; n=238) in order to detect tick-borne encephalitis virus (TBEV)-specific antibodies. Neutralising antibodies were titrated with a seroneutralisation test (SNT), using two cut-off titres (1/10–1/15). Seven wild boars were found TBEV-seropositive and showed moderate (>1/15) to high (>1/125) SNT-titres; three individuals had borderline results (1/10–1/15). This study demonstrated the presence of TBEV-specific antibodies in wild boar and highlighted potential TBEV-foci in Flanders. Additional surveillance including direct virus testing is now recommended. PMID:27087689

  5. Serological Screening of the Schistosoma mansoni Adult Worm Proteome

    PubMed Central

    Ludolf, Fernanda; Patrocínio, Paola R.; Corrêa-Oliveira, Rodrigo; Gazzinelli, Andréa; Falcone, Franco H.; Teixeira-Ferreira, André; Perales, Jonas; Oliveira, Guilherme C.; Silva-Pereira, Rosiane A.

    2014-01-01

    Background New interventions tools are a priority for schistosomiasis control and elimination, as the disease is still highly prevalent. The identification of proteins associated with active infection and protective immune response may constitute the basis for the development of a successful vaccine and could also indicate new diagnostic candidates. In this context, post-genomic technologies have been progressing, resulting in a more rational discovery of new biomarkers of resistance and antigens for diagnosis. Methodology/Principal Findings Two-dimensional electrophoresed Schistosoma mansoni adult worm protein extracts were probed with pooled sera of infected and non-infected (naturally resistant) individuals from a S. mansoni endemic area. A total of 47 different immunoreactive proteins were identified by mass spectrometry. Although the different pooled sera shared most of the immunoreactive protein spots, nine protein spots reacted exclusively with the serum pool of infected individuals, which correspond to annexin, major egg antigen, troponin T, filamin, disulphide-isomerase ER-60 precursor, actin and reticulocalbin. One protein spot, corresponding to eukaryotic translation elongation factor, reacted exclusively with the pooled sera of non-infected individuals living in the endemic area. Western blotting of two selected recombinant proteins, major egg antigen and hemoglobinase, showed a similar recognition pattern of that of the native protein. Concluding/Significance Using a serological proteome analysis, a group of antigens related to the different infection status of the endemic area residents was identified and may be related to susceptibility or resistance to infection. PMID:24651847

  6. Barriers impeding serologic screening for celiac disease in clinically high-prevalence populations

    PubMed Central

    2014-01-01

    Background Celiac disease is present in ~1% of the general population in the United States and Europe. Despite the availability of inexpensive serologic screening tests, ~85% of individuals with celiac disease remain undiagnosed and there is an average delay in diagnosis of symptomatic individuals with celiac disease that ranges from ~5.8-11 years. This delay is often attributed to the use of a case-based approach for detection rather than general population screening for celiac disease, and deficiencies at the level of health care professionals. This study aimed to assess if patient-centered barriers have a role in impeding serologic screening for celiac disease in individuals from populations that are clinically at an increased risk for celiac disease. Methods 119 adults meeting study inclusion criteria for being at a higher risk for celiac disease were recruited from the general population. Participants completed a survey/questionnaire at the William K. Warren Medical Research Center for Celiac Disease that addressed demographic information, celiac disease related symptoms (gastrointestinal and extraintestinal), family history, co-morbid diseases and conditions associated with celiac disease, and patient-centered barriers to screening for celiac disease. All participants underwent serologic screening for celiac disease using the IgA tissue transglutaminase antibody (IgA tTG) and, if positive, testing for IgA anti-endomysial antibody (IgA EMA) as a confirmatory test. Results Two barriers to serologic testing were significant across the participant pool. These were participants not knowing they were at risk for celiac disease before learning of the study, and participants not knowing where to get tested for celiac disease. Among participants with incomes less than $25,000/year and those less than the median age, not having a doctor to order the test was a significant barrier, and this strongly correlated with not having health insurance. Symptoms and co

  7. Syphilis detection: evaluation of serological screening and pilot reverse confirmatory assay algorithm in blood donors.

    PubMed

    Sommese, Linda; Paolillo, Rossella; Sabia, Chiara; Costa, Dario; De Pascale, Maria Rosaria; Iannone, Carmela; Esposito, Antonella; Schiano, Concetta; Napoli, Claudio

    2016-07-01

    Serological assays are still considered the most useful tests in the diagnosis of syphilis. Since no single serological assay is able to provide a satisfactory result, in our laboratory we have evaluated the usefulness of a commercially-available immunoblot to diagnose syphilis infection among blood donors. From October 2012 to June 2013, 4572 blood donors were screened for syphilis with an automated chemiluminescent microparticle immunoassay (CMIA). To confirm the presence of treponemal antibodies, CMIA-reactive sera were tested by standard Treponema pallidum haemagglutination assay (TPHA). In addition, an alternative confirmatory test - the immunoblot INNO-LIA assay was introduced in our laboratory. Since two additional positives among CMIA-reactive-TPHA-negative samples were found, we concluded that the INNO-LIA immunoblot allowed a better detection of syphilis compared to TPHA. A confirmatory strategy based on the use of two treponemal assays could meet the screening requirements for blood donors as well as in our centre. PMID:26068964

  8. Screening for Celiac Disease in a North American Population: Sequential Serology and Gastrointestinal Symptoms

    PubMed Central

    Katz, Kent D.; Rashtak, Shahrooz; Lahr, Brian D.; Melton, L Joseph; Krause, Patricia K.; Maggi, Kristine; Talley, Nicholas J.; Murray, Joseph A.

    2011-01-01

    Background The prevalence of diagnosed celiac disease is less than 1 in 2,000 in the United States, but screening studies undertaken in European and other populations have revealed a much higher prevalence. Objectives To determine the prevalence of celiac disease and the utility of screening in the general adult population of a geographically isolated area. Methods Serum tissue transglutaminase antibodies (tTG-IgA) were measured in volunteer health care participants aged 18 years and over at Annual Casper, Wyoming Blue Envelope Health Fair Blood Draw. Subjects with positive tTG-IgA tests had their endomysial IgA antibodies checked. Double positives were offered endoscopy with small bowel biopsy. All subjects completed a short GI symptom questionnaire. Results 3850 residents of the Natrona County had serologic evaluation for celiac disease, 34 of whom tested positive for both tTG and EMA IgA. Excluding three individuals with previous diagnosis of celiac disease, the overall prevalence of celiac serology positive in this community sample was 0.8%. All 31 subjects were offered a small bowel biopsy. Seventeen of the 18 biopsied subjects (94%) had at least partial villous atrophy. Symptoms that were reported by the fair attendees did not predict positivity. Conclusions Screening for celiac disease was widely accepted in this preventative healthcare setting. Undiagnosed celiac disease affects 1 in 126 individuals in this Wyoming community. Most were asymptomatic or had atypical presentations. Serologic testing can readily detect this disease in a general population. PMID:21364545

  9. Maternal Serologic Screening to Prevent Congenital Toxoplasmosis: A Decision-Analytic Economic Model

    PubMed Central

    Stillwaggon, Eileen; Carrier, Christopher S.; Sautter, Mari; McLeod, Rima

    2011-01-01

    Objective To determine a cost-minimizing option for congenital toxoplasmosis in the United States. Methodology/Principal Findings A decision-analytic and cost-minimization model was constructed to compare monthly maternal serological screening, prenatal treatment, and post-natal follow-up and treatment according to the current French (Paris) protocol, versus no systematic screening or perinatal treatment. Costs are based on published estimates of lifetime societal costs of developmental disabilities and current diagnostic and treatment costs. Probabilities are based on published results and clinical practice in the United States and France. One- and two-way sensitivity analyses are used to evaluate robustness of results. Universal monthly maternal screening for congenital toxoplasmosis with follow-up and treatment, following the French protocol, is found to be cost-saving, with savings of $620 per child screened. Results are robust to changes in test costs, value of statistical life, seroprevalence in women of childbearing age, fetal loss due to amniocentesis, and to bivariate analysis of test costs and incidence of primary T. gondii infection in pregnancy. Given the parameters in this model and a maternal screening test cost of $12, screening is cost-saving for rates of congenital infection above 1 per 10,000 live births. If universal testing generates economies of scale in diagnostic tools—lowering test costs to about $2 per test—universal screening is cost-saving at rates of congenital infection well below the lowest reported rates in the United States of 1 per 10,000 live births. Conclusion/Significance Universal screening according to the French protocol is cost saving for the US population within broad parameters for costs and probabilities. PMID:21980546

  10. Cost effectiveness analysis of population-based serology screening and 13C-Urea breath test for Helicobacter pylori to prevent gastric cancer: A markov model

    PubMed Central

    Xie, Feng; Luo, Nan; Lee, Hin-Peng

    2008-01-01

    AIM: To compare the costs and effectiveness of no screening and no eradication therapy, the population-based Helicobacter pylori (H pylori) serology screening with eradication therapy and 13C-Urea breath test (UBT) with eradication therapy. METHODS: A Markov model simulation was carried out in all 237 900 Chinese males with age between 35 and 44 from the perspective of the public healthcare provider in Singapore. The main outcome measures were the costs, number of gastric cancer cases prevented, life years saved, and quality-adjusted life years (QALYs) gained from screening age to death. The uncertainty surrounding the cost-effectiveness ratio was addressed by one-way sensitivity analyses. RESULTS: Compared to no screening, the incremental cost-effectiveness ratio (ICER) was $16 166 per life year saved or $13 571 per QALY gained for the serology screening, and $38 792 per life year saved and $32 525 per QALY gained for the UBT. The ICER was $477 079 per life year saved or $390 337 per QALY gained for the UBT compared to the serology screening. The cost-effectiveness of serology screening over the UBT was robust to most parameters in the model. CONCLUSION: The population-based serology screening for H pylori was more cost-effective than the UBT in prevention of gastric cancer in Singapore Chinese males. PMID:18494053

  11. Serologic screening for 13 infectious agents in roe deer (Capreolus capreolus) in Flanders

    PubMed Central

    Tavernier, Paul; Sys, Stanislas U.; De Clercq, Kris; De Leeuw, Ilse; Caij, Anne Brigitte; De Baere, Miet; De Regge, Nick; Fretin, David; Roupie, Virginie; Govaerts, Marc; Heyman, Paul; Vanrompay, Daisy; Yin, Lizi; Kalmar, Isabelle; Suin, Vanessa; Brochier, Bernard; Dobly, Alexandre; De Craeye, Stéphane; Roelandt, Sophie; Goossens, Els; Roels, Stefan

    2015-01-01

    Introduction In order to investigate the role of roe deer in the maintenance and transmission of infectious animal and human diseases in Flanders, we conducted a serologic screening in 12 hunting areas. Materials and methods Roe deer sera collected between 2008 and 2013 (n=190) were examined for antibodies against 13 infectious agents, using indirect enzyme-linked immunosorbent assay, virus neutralisation, immunofluorescence, or microagglutination test, depending on the agent. Results and discussion High numbers of seropositives were found for Anaplasma phagocytophilum (45.8%), Toxoplasma gondii (43.2%) and Schmallenberg virus (27.9%), the latter with a distinct temporal distribution pattern following the outbreak in domestic ruminants. Lower antibody prevalence was found for Chlamydia abortus (6.7%), tick-borne encephalitis virus (5.1%), Neospora caninum (4.8%), and Mycobacterium avium subsp paratuberculosis (4.1%). The lowest prevalences were found for Leptospira (1.7%), bovine viral diarrhoea virus 1 (1.3%), and Coxiella burnetii (1.2%). No antibodies were found against Brucella sp., bovine herpesvirus 1, and bluetongue virus. A significant difference in seroprevalence between ages (higher in adults >1 year) was found for N. caninum. Four doubtful reacting sera accounted for a significant difference in seroprevalence between sexes for C. abortus (higher in females). Conclusions Despite the more intensive landscape use in Flanders, the results are consistent with other European studies. Apart from maintaining C. abortus and MAP, roe deer do not seem to play an important role in the epidemiology of the examined zoonotic and domestic animal pathogens. Nevertheless, their meaning as sentinels should not be neglected in the absence of other wild cervid species. PMID:26609692

  12. Serological Screening for Celiac Disease in Adult Chinese Patients With Diarrhea Predominant Irritable Bowel Syndrome.

    PubMed

    Wang, Hongling; Zhou, Guoying; Luo, Linjie; Crusius, J Bart A; Yuan, Anlong; Kou, Jiguang; Yang, Guifang; Wang, Min; Wu, Jing; von Blomberg, B Mary E; Morré, Servaas A; Peña, A Salvador; Xia, Bing

    2015-10-01

    Celiac disease (CD) is common in Caucasians, but thought to be rare in Asians. Our aim was to determine the prevalence of CD in Chinese patients with chronic diarrhea predominant irritable bowel syndrome (IBS-D).From July 2010 to August 2012, 395 adult patients with IBS-D and 363 age and sex-matched healthy controls were recruited in Zhongnan Hospital of Wuhan University and Xiaogan Central Hospital in Hubei province, central China. Patients with IBS-D were diagnosed according to the Rome III criteria. Serum Immunoglobulin (IgA/IgG) anti-human tissue transglutaminase (anti-htTG)-deamidated gliadin peptide (DGP) antibodies were measured in a single ELISA (QUANTA Lite h-tTG/DGP Screen). Upper endoscopy with duodenal biopsies and HLA-DQA1 and HLA-DQB1 genotyping were performed in seropositive subjects and a gluten-free diet was prescribed.Seven IBS-D patients (7/395, 1.77%) and 2 healthy controls (2/363, 0.55%), were positive for anti-htTG/DGP antibodies. Of these 9 cases, 1 was lost to follow-up, 3 were suspected to have CD and 5 were eventually diagnosed as CD with intestinal histological lesions classified as Marsh Type II in 2 and Type III in 3. Of these 5 diagnosed CD patients, 4 (4/395, 1.01%) were from the IBS-D group and 1 (1/363, 0.28%) from the healthy control had asymptomatic CD. Two Type III CD patients with relatively high titers in the serologic assay were homozygous and heterozygous for haplotype HLA-DQA1*03-DQB1*03:03 (HLA-DQ9.3), respectively.In the present study, CD was present in 1.01% of patients with IBS-D and in 0.28% of the control group. We like to suggest that the haplotype HLA-DQA1*03-DQB1*03:03 (HLA-DQ9.3), which is common in Chinese, is a new susceptibility factor for CD in China. Larger screening and genetic studies are needed in the Chinese population of different regions. PMID:26496305

  13. Serological Screening for Celiac Disease in Adult Chinese Patients With Diarrhea Predominant Irritable Bowel Syndrome

    PubMed Central

    Wang, Hongling; Zhou, Guoying; Luo, Linjie; Crusius, J. Bart A.; Yuan, Anlong; Kou, Jiguang; Yang, Guifang; Wang, Min; Wu, Jing; von Blomberg, B. Mary E.; Morré, Servaas A.; Peña, A. Salvador; Xia, Bing

    2015-01-01

    Abstract Celiac disease (CD) is common in Caucasians, but thought to be rare in Asians. Our aim was to determine the prevalence of CD in Chinese patients with chronic diarrhea predominant irritable bowel syndrome (IBS-D). From July 2010 to August 2012, 395 adult patients with IBS-D and 363 age and sex-matched healthy controls were recruited in Zhongnan Hospital of Wuhan University and Xiaogan Central Hospital in Hubei province, central China. Patients with IBS-D were diagnosed according to the Rome III criteria. Serum Immunoglobulin (IgA/IgG) anti-human tissue transglutaminase (anti-htTG)-deamidated gliadin peptide (DGP) antibodies were measured in a single ELISA (QUANTA Lite h-tTG/DGP Screen). Upper endoscopy with duodenal biopsies and HLA-DQA1 and HLA-DQB1 genotyping were performed in seropositive subjects and a gluten-free diet was prescribed. Seven IBS-D patients (7/395, 1.77%) and 2 healthy controls (2/363, 0.55%), were positive for anti-htTG/DGP antibodies. Of these 9 cases, 1 was lost to follow-up, 3 were suspected to have CD and 5 were eventually diagnosed as CD with intestinal histological lesions classified as Marsh Type II in 2 and Type III in 3. Of these 5 diagnosed CD patients, 4 (4/395, 1.01%) were from the IBS-D group and 1 (1/363, 0.28%) from the healthy control had asymptomatic CD. Two Type III CD patients with relatively high titers in the serologic assay were homozygous and heterozygous for haplotype HLA-DQA1∗03-DQB1∗03:03 (HLA-DQ9.3), respectively. In the present study, CD was present in 1.01% of patients with IBS-D and in 0.28% of the control group. We like to suggest that the haplotype HLA-DQA1∗03-DQB1∗03:03 (HLA-DQ9.3), which is common in Chinese, is a new susceptibility factor for CD in China. Larger screening and genetic studies are needed in the Chinese population of different regions. PMID:26496305

  14. Serologic Screening for Herpes Simplex Virus among University Students: A Pilot Study

    ERIC Educational Resources Information Center

    Mark, Hayley; Nanda, Joy P.; Joffe, Alain; Roberts, Jessica; Rompalo, Anne; Melendez, Johan; Zenilman, Jonathan

    2008-01-01

    Objective: The authors examined the feasibility of conducting serologic testing for the herpes simplex virus 2 (HSV-2) among university students and assessed the psychosocial impact of an HSV-2 diagnosis. Methods: The authors recruited a convenience sample of 100 students (aged 18-39 years) without a history of genital herpes from 1 university…

  15. Swine cysticercosis in the Karangasem district of Bali, Indonesia: An evaluation of serological screening methods.

    PubMed

    Swastika, Kadek; Dharmawan, Nyoman Sadra; Suardita, I Ketut; Kepeng, I Nengah; Wandra, Toni; Sako, Yasuhito; Okamoto, Munehiro; Yanagida, Tetsuya; Sasaki, Mizuki; Giraudoux, Patrick; Nakao, Minoru; Yoshida, Takahiko; Eka Diarthini, Luh Putu; Sudarmaja, I Made; Purba, Ivan Elisabeth; Budke, Christine M; Ito, Akira

    2016-11-01

    A serological assessment was undertaken on pigs from the Kubu and Abang sub-districts of Karangasem on the island of Bali, Indonesia, where earlier studies had detected patients with cysticercosis. Antigens purified from Taenia solium cyst fluid by cation-exchange chromatography were used to evaluate antibody responses in the pigs and the serological tests were also evaluated using sera from pigs experimentally infected with T. solium eggs. A total of 392 serum samples from naturally exposed pigs were tested using an ELISA that could be read based on both a colour change perceptible by the naked eye and an ELISA based on absorbance values. Twenty six (6.6%) pigs were found seropositive by the naked-eye ELISA and were categorized into three groups: strongly positive (absorbance values >0.8, n=6), moderately positive (absorbance values between 0.2 and 0.8, n=7), and weakly positive (absorbance values <0.2, n=13). Necropsies performed on 11 strongly and moderately positive pigs revealed that six strongly positive pigs were infected either solely with T. solium cysticerci (n=3), or co-infected with both T. solium and Taenia hydatigena (n=3). Four moderately positive pigs were infected solely with T. hydatigena. No cysticerci were found in one pig that was moderately positive by the naked-eye ELISA. Two experimentally infected pigs became antibody positive by 6 weeks post-infection, whereas eight control pigs remained negative. An additional 60 pigs slaughtered at authorized abattoirs on Bali were tested using the same ELISA. All 60 pigs were seronegative with no evidence of Taenia infection at necropsy. The results confirm the presence of porcine cysticercosis on Bali and, while the serological responses seen in T. solium infected animals were much stronger than those infected with T. hydatigena, the diagnostic antigens are clearly not species specific. Further studies are necessary to confirm if it is possible to draw a cut off line for differentiation of pig infected

  16. Serological screening of Tick-borne encephalitis (TBE) among Malaysian encephalitis patients.

    PubMed

    Thayan, Ravindran; Khairullah, Nor Shahidah; Tze Ming, Ho

    2004-12-01

    Tick-borne encephalitis (TBE) is a viral infection of the central nervous system and is caused by tick bites, usually after travel to rural or forested areas. The disease is prevalent in Scandinavia, Western Europe, Central Europe and the former Soviet Union and East Asia including Japan. In Malaysia, so far there are no reported cases of TBE. In the present time, many illnesses have been attributed to traveling to other parts of the world. Thus it is important to carry out TBE prevalence study to determine whether the virus is present among Malaysian population. Samples (sera and CSF) from patients admitted to major MOH hospitals in Peninsular Malaysia and Sabah with a clinical diagnosis of encephalitis but is IgM negative for JE, were tested for TBEV IgM ELISA and TBEV IgG ELISA (DRG, Germany). Out of the 600 samples screened for TBEV IgG, all were non-reactive. In addition, out of the 100 samples screened for TBEV IgM, all the samples were also non-reactive. Our results indicate that currently TBE is not present in the Malaysian population. Among the reasons for this could be lack of the infection agent, absence of the suitable vector or subjects selected for the study did not fit the criteria of possible exposure to TBE infections. Hence we recommend that for any future study, the selection of subjects should include those who returned from tick-infested forested areas. PMID:16493408

  17. Serological diagnosis of autoimmune bullous skin diseases: Prospective comparison of the BIOCHIP mosaic-based indirect immunofluorescence technique with the conventional multi-step single test strategy

    PubMed Central

    2012-01-01

    Background Various antigen-specific immunoassays are available for the serological diagnosis of autoimmune bullous diseases. However, a spectrum of different tissue-based and monovalent antigen-specific assays is required to establish the diagnosis. BIOCHIP mosaics consisting of different antigen substrates allow polyvalent immunofluorescence (IF) tests and provide antibody profiles in a single incubation. Methods Slides for indirect IF were prepared, containing BIOCHIPS with the following test substrates in each reaction field: monkey esophagus, primate salt-split skin, antigen dots of tetrameric BP180-NC16A as well as desmoglein 1-, desmoglein 3-, and BP230gC-expressing human HEK293 cells. This BIOCHIP mosaic was probed using a large panel of sera from patients with pemphigus vulgaris (PV, n = 65), pemphigus foliaceus (PF, n = 50), bullous pemphigoid (BP, n = 42), and non-inflammatory skin diseases (n = 97) as well as from healthy blood donors (n = 100). Furthermore, to evaluate the usability in routine diagnostics, 454 consecutive sera from patients with suspected immunobullous disorders were prospectively analyzed in parallel using a) the IF BIOCHIP mosaic and b) a panel of single antibody assays as commonly used by specialized centers. Results Using the BIOCHIP mosaic, sensitivities of the desmoglein 1-, desmoglein 3-, and NC16A-specific substrates were 90%, 98.5% and 100%, respectively. BP230 was recognized by 54% of the BP sera. Specificities ranged from 98.2% to 100% for all substrates. In the prospective study, a high agreement was found between the results obtained by the BIOCHIP mosaic and the single test panel for the diagnosis of BP, PV, PF, and sera without serum autoantibodies (Cohen’s κ between 0.88 and 0.97). Conclusions The BIOCHIP mosaic contains sensitive and specific substrates for the indirect IF diagnosis of BP, PF, and PV. Its diagnostic accuracy is comparable with the conventional multi-step approach. The highly

  18. Screening Donated Blood for Transfusion Transmitted Infections by Serology along with NAT and Response Rate to Notification of Reactive Results: An Indian Experience.

    PubMed

    Chaurasia, Rahul; Zaman, Shamsuz; Das, Bankim; Chatterjee, Kabita

    2014-01-01

    Background. Transfusion safety begins with healthy donors. A fundamental part of preventing transfusion transmitted infections (TTIs) is to notify and counsel reactive donors. Donor notification and counselling protect the health of the donor and prevent secondary transmission of infectious diseases. Methods. 113,014 donations were screened for TTIs, namely, HIV, HBV, HCV, and syphilis, by serology and nucleic acid testing. All reactive donors were retested (wherever possible) and notified of their status by telephone or letter. All initial reactive screens were followed over six months. Results. We evaluated 2,838 (2.51%) cases with reactive screening test results (1.38% HBV, 0.54% HCV, 0.27% HIV, and 0.32% syphilis). Only 23.3% of donors (662) responded to notification. The response among voluntary donors was better as compared to the replacement donors (43.6% versus 21.2%). Only 373 (56.3%) responsive donors followed their first attendance at referral specialties. Over six months, only 176 of 662 (26.6%) reactive donors received treatment. Conclusion. Our study shed light on the importance of proper donor counselling and notification of TTI status to all reactive donors who opt to receive this information. There is also an urgent need to formulate the nationally acceptable guidelines for notification and follow-up of reactive donors. PMID:25485163

  19. Proof of concept: A bioinformatic and serological screening method for identifying new peptide antigens for Chlamydia trachomatis related sequelae in women☆

    PubMed Central

    Stansfield, Scott H.; Patel, Pooja; Debattista, Joseph; Armitage, Charles W.; Cunningham, Kelly; Timms, Peter; Allan, John; Mittal, Aruna; Huston, Wilhelmina M.

    2013-01-01

    This study aimed to identify new peptide antigens from Chlamydia (C.) trachomatis in a proof of concept approach which could be used to develop an epitope-based serological diagnostic for C. trachomatis related infertility in women. A bioinformatics analysis was conducted examining several immunodominant proteins from C. trachomatis to identify predicted immunoglobulin epitopes unique to C. trachomatis. A peptide array of these epitopes was screened against participant sera. The participants (all female) were categorized into the following cohorts based on their infection and gynecological history; acute (single treated infection with C. trachomatis), multiple (more than one C. trachomatis infection, all treated), sequelae (PID or tubal infertility with a history of C. trachomatis infection), and infertile (no history of C. trachomatis infection and no detected tubal damage). The bioinformatics strategy identified several promising epitopes. Participants who reacted positively in the peptide 11 ELISA were found to have an increased likelihood of being in the sequelae cohort compared to the infertile cohort with an odds ratio of 16.3 (95% c.i. 1.65–160), with 95% specificity and 46% sensitivity (0.19–0.74). The peptide 11 ELISA has the potential to be further developed as a screening tool for use during the early IVF work up and provides proof of concept that there may be further peptide antigens which could be identified using bioinformatics and screening approaches. PMID:24600556

  20. Proof of concept: A bioinformatic and serological screening method for identifying new peptide antigens for Chlamydia trachomatis related sequelae in women.

    PubMed

    Stansfield, Scott H; Patel, Pooja; Debattista, Joseph; Armitage, Charles W; Cunningham, Kelly; Timms, Peter; Allan, John; Mittal, Aruna; Huston, Wilhelmina M

    2013-01-01

    This study aimed to identify new peptide antigens from Chlamydia (C.) trachomatis in a proof of concept approach which could be used to develop an epitope-based serological diagnostic for C. trachomatis related infertility in women. A bioinformatics analysis was conducted examining several immunodominant proteins from C. trachomatis to identify predicted immunoglobulin epitopes unique to C. trachomatis. A peptide array of these epitopes was screened against participant sera. The participants (all female) were categorized into the following cohorts based on their infection and gynecological history; acute (single treated infection with C. trachomatis), multiple (more than one C. trachomatis infection, all treated), sequelae (PID or tubal infertility with a history of C. trachomatis infection), and infertile (no history of C. trachomatis infection and no detected tubal damage). The bioinformatics strategy identified several promising epitopes. Participants who reacted positively in the peptide 11 ELISA were found to have an increased likelihood of being in the sequelae cohort compared to the infertile cohort with an odds ratio of 16.3 (95% c.i. 1.65-160), with 95% specificity and 46% sensitivity (0.19-0.74). The peptide 11 ELISA has the potential to be further developed as a screening tool for use during the early IVF work up and provides proof of concept that there may be further peptide antigens which could be identified using bioinformatics and screening approaches. PMID:24600556

  1. Serological diagnosis of canine leishmaniosis: comparison of three commercial ELISA tests (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT

    PubMed Central

    2014-01-01

    Background Speed Leish K® is used as a serological screening test for Leishmania infection prior to vaccination. Limited comparative serological studies with Speed Leish K® have been performed. The aim of this study was to evaluate the diagnostic performance of four commercially available serologic tests including ELISAs (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT for the detection of specific antibodies against Leishmania infantum antigen in dogs in different states of infection. Methods Sick infected dogs (n = 36), healthy infected dogs (n = 18), L. infantum seropositive dogs with low to high levels of antibodies (n = 53), dogs seropositive to other pathogens (to evaluate cross reaction) (n = 14) and uninfected dogs from a non-endemic area (n = 50) and from an endemic area (n = 32) were analysed by the serological methods mentioned above. Results The sensitivity was as follows: ID Screen® (0.953), Leiscan® and Leishmania 96® (0.925), IFAT (0.869) and Speed Leish K® (0.636). The maximum specificity (1.000) was attained for all diagnostic tests except the Leishmania 96® (0.896) and IFAT (0.917). The accuracy was as follows: ID Screen® (0.975), Leiscan® (0.961), Leishmania 96® (0.911), IFAT (0.892) and Speed Leish K® (0.808). In relation to the area under the ROC curve (AUC-ROC), the maximum value was attained with the ID Screen® (0.993) closely followed by Leiscan® (0.990), then, Leishmania 96® (0.962), IFAT (0.926) and Speed Leish K® (0.818). For the Kappa index, the best result was obtained by the ID Screen® (0.951) followed by Leiscan® (0.921), Leishmania 96® (0.822), IFAT (0.783) and Speed Leish K® (0.622). Statistically significant differences were found between the AUC-ROC of quantitative serological tests and the only qualitative rapid test evaluated. There were also statistically significant differences between AUC-ROC of the ELISAs (ID Screen® and Leiscan

  2. Sediment toxicity screening with cost-effective microbiotests and conventional assays: A comparative study

    SciTech Connect

    Vanciheluwe, M.L.; Janssen, C.R.; Persoone, G.

    1995-12-31

    A large monitoring study of freshwater sediments, using the TRIAD approach, was conducted in Flanders (Belgium). This paper reports on the results of the toxicity assessment of 80 sediment samples evaluated with a battery of microbiotests and conventional assays. Sediment pore waters, extracted by squeezing, were tested with the Microtox{reg_sign} (Vibrio fischerii) and Thamnotoxkit{trademark} F (Thamnocephalus platyurus) microbiotests and the conventional (acute) assays with algae (Selenastrum capricornutum) and daphnids (Daphnia magna). A newly developed 5 day ELS test with the catfish Clarias gariepinus was also applied to the pore waters. Solid-phase testing was performed with the Microtox Sp{reg_sign} assay and the 10 day tests with Chironomus riparius and Hyalella azteca. Uni- and multivariate statistical techniques were applied to the data matrix to select a minimal test battery from the water phase and solid phase assays and from all tests combined. The influence of sediment associated confounding factors on the validity of the test results obtained with the various assays will be discussed. Finally a comparison of the predictive power of the selected battery of signal tests and that of the complete battery will be made and the potential use of the minimal battery for the initial hazard assessment of contaminated sediments will be reviewed.

  3. The serologic screening for celiac disease in the general population (blood donors) and in some high-risk groups of adults (patients with autoimmune diseases, osteoporosis and infertility) in the Czech republic.

    PubMed

    Vanciková, Z; Chlumecký, V; Sokol, D; Horáková, D; Hamsíková, E; Fucíková, T; Janatková, I; Ulcová-Gallová, Z; Stĕpán, J; Límanová, Z; Dvorák, M; Kocna, P; Sánchez, D; Tucková, L; Tlaskalová-Hogenová, H

    2002-01-01

    The prevalence of celiac disease (CD) was determined in healthy blood donors and in high-risk groups of adults (a total of 1835 adults--randomly selected 1312 healthy blood donors, 102 patients with primary osteoporosis, 58 patients with autoimmune diseases and 365 infertile women). It was calculated on the basis of a two-step serologic screening method--in the first step IgA and IgG antigliadin antibodies (AGA) and IgA anti-gamma-glutamyltransferase ('transglutaminase') antibodies (ATG) were estimated, in the second step sera positive for IgA AGA and/or IgA ATG were examined for antiendomysial IgA (AEA) antibodies. Immunoenzymic assay (ELISA) was used for determining of AGA and ATG antibodies; immunofluorescence method, performed on human umbilical cord tissue, was used for assaying of AEA antibodies. Total serum IgA level in only IgG AGA positive subjects was measured by routine turbidimetric method. 0.45% of healthy blood donors, 0.98% of osteoporotic patients, 2.7% of patients suffering from autoimmune disease and 1.13% of women with infertility considered as immunologically mediated were found to be positive in both steps of serologic screening (AGA and/or ATG and antiendomysium positive). The presumed high prevalence of seropositivity for CD in apparently healthy Czech adult population was confirmed. In the high-risk groups, the prevalence of seropositivity for CD was approximately 2-4 times higher than in healthy blood donors. The real prevalence of CD in the tested groups, however, can be estimated after performing small intestinal biopsy in the seropositive patients. PMID:12630332

  4. European guidelines for quality assurance in cervical cancer screening: recommendations for collecting samples for conventional and liquid-based cytology.

    PubMed

    Arbyn, M; Herbert, A; Schenck, U; Nieminen, P; Jordan, J; Mcgoogan, E; Patnick, J; Bergeron, C; Baldauf, J-J; Klinkhamer, P; Bulten, J; Martin-Hirsch, P

    2007-06-01

    The current paper presents an annex in the second edition of the European Guidelines for Quality Assurance in Cervical Cancer Screening. It provides guidance on how to make a satisfactory conventional Pap smear or a liquid-based cytology (LBC) sample. Practitioners taking samples for cytology should first explain to the woman the purpose, the procedure and how the result will be communicated. Three sampling methods are considered as acceptable for preparing conventional Pap smears: (i) the cervical broom; (ii) the combination of a spatula and an endocervical brush; and (iii) the extended tip spatula. Smear takers should take care to sample the entire circumference of the transformation zone, to quickly spread the cellular material over a glass slide, and to fix the preparation within a few seconds to avoid drying artefacts. According to local guidelines, one of these three methods may be preferred. Sampling with a cotton tip applicator is inappropriate. Similar procedures should be followed for sampling cells for LBC, but only plastic devices may be used. The collected cells should be quickly transferred into a vial with fixative liquid according to the instructions of the manufacturer of the LBC system. Subsequently, the slide or vial and the completed request form are sent to the laboratory for cytological interpretation. PMID:17573762

  5. Histology Verification Demonstrates That Biospectroscopy Analysis of Cervical Cytology Identifies Underlying Disease More Accurately than Conventional Screening: Removing the Confounder of Discordance

    PubMed Central

    Gajjar, Ketan; Ahmadzai, Abdullah A.; Valasoulis, George; Trevisan, Júlio; Founta, Christina; Nasioutziki, Maria; Loufopoulos, Aristotelis; Kyrgiou, Maria; Stasinou, Sofia Melina; Karakitsos, Petros; Paraskevaidis, Evangelos; Da Gama-Rose, Bianca; Martin-Hirsch, Pierre L.; Martin, Francis L.

    2014-01-01

    Background Subjective visual assessment of cervical cytology is flawed, and this can manifest itself by inter- and intra-observer variability resulting ultimately in the degree of discordance in the grading categorisation of samples in screening vs. representative histology. Biospectroscopy methods have been suggested as sensor-based tools that can deliver objective assessments of cytology. However, studies to date have been apparently flawed by a corresponding lack of diagnostic efficiency when samples have previously been classed using cytology screening. This raises the question as to whether categorisation of cervical cytology based on imperfect conventional screening reduces the diagnostic accuracy of biospectroscopy approaches; are these latter methods more accurate and diagnose underlying disease? The purpose of this study was to compare the objective accuracy of infrared (IR) spectroscopy of cervical cytology samples using conventional cytology vs. histology-based categorisation. Methods Within a typical clinical setting, a total of n = 322 liquid-based cytology samples were collected immediately before biopsy. Of these, it was possible to acquire subsequent histology for n = 154. Cytology samples were categorised according to conventional screening methods and subsequently interrogated employing attenuated total reflection Fourier-transform IR (ATR-FTIR) spectroscopy. IR spectra were pre-processed and analysed using linear discriminant analysis. Dunn’s test was applied to identify the differences in spectra. Within the diagnostic categories, histology allowed us to determine the comparative efficiency of conventional screening vs. biospectroscopy to correctly identify either true atypia or underlying disease. Results Conventional cytology-based screening results in poor sensitivity and specificity. IR spectra derived from cervical cytology do not appear to discriminate in a diagnostic fashion when categories were based on conventional screening

  6. High-yield radiography of the maxillofacial complex using the free focus and conventional imaging concepts. The resolution performance of nonscreen and screen-film combinations.

    PubMed

    Jensen, T W; Goldberg, A J; Randall, G J

    1983-09-01

    Free focus radiography with miniaturized dental x-ray machines may be a valuable source of "high-yield" diagnostic information in dentistry. This study evaluated the resolution performance of conventional image receptors, including nonscreen and screen-film combinations which were available in sizes suitable for panoramic free focus radiography or conventional extraoral radiography. Results with nonscreen films produced resolution performances ranging from about 10 lp/mm. to about 20 lp/mm. For each film tested, the performances in conventional radiography as well as in free focus radiography with the film in the buccal fold approached the maximum measurable of 20 lp/mm. In a mode of free focus radiography with the film positioned extraorally, there were significant variations in performance according to film brand. A significant reduction in resolution performance occurred when screen-film combinations were tested; resolution ranged between 4.0 lp/mm. and 7.4 lp/mm., with the better performance obtained with free focus radiography. The performance of a rare earth system was similar to other screen-film combinations tested in conventional radiography. In free focus radiography the performance of the rare earth system was slightly below the mean resolution for conventional screen-film combinations at 4.0 lp/mm. and 4.3 lp/mm. An example of a small cassette adapted for intraoral use was given. PMID:6579466

  7. Serological thymidine kinase 1 is a biomarker for early detection of tumours--a health screening study on 35,365 people, using a sensitive chemiluminescent dot blot assay.

    PubMed

    Chen, Zhi Heng; Huang, Shou Qing; Wang, Yande; Yang, Ai Zhen; Wen, Jian; Xu, Xiao Hong; Chen, Yan; Chen, Qu Bo; Wang, Ying Hong; He, Ellen; Zhou, Ji; Skog, Sven

    2011-01-01

    Serological thymidine kinase 1 (STK1) is a reliable proliferation marker for prognosis, monitoring tumour therapy, and relapse. Here we investigated the use of STK1 in health screening for early detection of pre-malignant and malignant diseases. The investigation was based on 35,365 participants in four independent health screening studies in China between 2005-2011. All participants were clinically examined. The concentration of STK1 was determined by a sensitive chemiluminescent dot blot ECL assay. The ROCvalue of the STK1 assay was 0.96. At a cut-off STK1 value of 2.0 pM, the likelihood (+) value was 236.5, and the sensitivity and the specificity were 0.78 and 0.99, respectively. The relative number of city-dwelling people with elevated STK1 values (≥2.0 pM) was 0.8% (198/26,484), while the corresponding value for the group of oil-field workers was 5.8% (514/8,355). The latter group expressed significantly higher frequency of refractory anaemia, fatty liver, and obesity, compared to the city dwellers, but no cases of breast hyperplasia or prostate hyperplasia. Furthermore, people working in oil drilling/oil transportation showed higher STK1 values and higher frequency of pre-malignancies and benign diseases than people working in the oil-field administration. In the STK1 elevated group of the city-dwelling people, a statistically significantly higher number of people were found to have malignancies, pre-malignancies of all types, moderate/severe type of hyperplasia of breast or prostate, or refractory anaemia, or to be at high risk for hepatitis B, compared to people with normal STK1 values (<2.0 pM). No malignancies were found in the normal STK1 group. In the elevated STK1 group 85.4% showed diseases linked to a higher risk for pre-/early cancerous progression, compared to 52.4% of those with normal STK1 values. Among participants with elevated STK1 values, 8.8% developed new malignancies or progress in their pre-malignancies within 5 to 72 months, compared

  8. Evaluation of atypical squamous cells on conventional cytology smears: An experience from a screening program practiced in limited resource settings

    PubMed Central

    Rekhi, Bharat; Ajit, Dulhan; Joseph, Santhosh K; Gawas, Sonali; Deodhar, Kedar K

    2010-01-01

    Background: The Bethesda system (TBS) 2001 has subdivided the category of atypical squamous cells (ASC) into: ASC-US (undetermined significance) and ASC-H (cannot exclude high-grade squamous intraepithelial lesion (HSIL)). The present study is an analysis of ASC-US and ASC-H cases diagnosed in a screening program practiced in limited resource settings. Methods: During the period January 2005 to December 2008, a total of 9190 smears were received, of which 568 were unsatisfactory. Cases initially diagnosed as ASC-US (n=74) and ASC-H (n=29) on conventional cytology smears were reviewed. Biopsy and human papilloma virus (HPV) results were available in limited cases. Results: On review, diagnosis of ASC-US was retained in 49 (66.2%) of the 74 initially diagnosed ASC-US cases. Remaining 12 cases were re-labeled as negative for intraepithelial lesion or malignancy (NILM), nine as low-grade squamous intraepithelial lesion (LSIL), three as ASC-H and one case as squamous carcinoma (SCC). Similarly, on review, diagnosis of ASC-H cases was retained in 17 of the 29 initially diagnosed ASC-H cases. Seven cases were re-labeled as NILM, three as HSIL and one case each as ASC-US and SCC. Overall, 8622 cases (96.6%) were diagnosed as NILM, 72 (0.83%) as LSIL, 121 (1.40%) as HSIL, 23 (0.26%) as SCC, 50 (0.57%) as ASC-US cases, 20 (0.23%) as ASC-H, five (0.05%) as atypical glandular cells (AGC) and two cases as adenocarcinomas. Out of 50 ASC-US cases, biopsy in 23 cases showed presence of CIN 1 in 16 cases (69.5%) and CIN 2 in one case (4.34%), while the remaining six cases were negative for CIN/malignancy. The remaining 20 cases with unavailable biopsy results were HPV-positive. Out of 20 ASC-H cases, biopsy in 15 revealed CIN 2 and above in 11 cases (73.3%). Three cases (20%) revealed CIN 1. Conclusions: Critical review is helpful in further reducing the number of ASC cases. The percentage of cases with CIN 2 and above is higher with ASC-H cases. The reason for relative increase in

  9. Epstein - Barr virus Serology as a Potential Screening Marker for Nasopharyngeal Carcinoma among High-risk Individuals from Multiplex Families in Taiwan

    PubMed Central

    Coghill, Anna E.; Hsu, Wan-Lun; Pfeiffer, Ruth M.; Juwana, Hedy; Yu, Kelly J.; Lou, Pei-Jen; Wang, Cheng-Ping; Chen, Jen-Yang; Chen, Chien-Jen; Middeldorp, Jaap M.; Hildesheim, Allan

    2014-01-01

    Background Nasopharyngeal carcinoma (NPC) is an EBV associated cancer that is highly treatable when diagnosed early, with 5-year disease-free survival of ~90%. However, NPC is typically diagnosed at advanced stages, where disease-free survival is <50%. There is therefore a need for clinical tools to assist in early NPC detection, particularly in high-risk individuals. Methods We evaluated the ability of anti-EBV IgA antibodies to detect incident NPC among high-risk Taiwanese individuals. NPC cases (N=21) and age and sex-matched controls (N=84) were selected. Serum collected prior to NPC diagnosis was tested for ELISA-based IgA markers against the following EBV peptides: EBNA1, VCAp18, EAp138, Ead_p47, and VCAp18 + EBNA1 peptide mixture. The sensitivity, specificity, and screening program parameters were calculated. Results EBNA1 IgA had the best performance characteristics. At an optimized threshold value, EBNA1 IgA measured at baseline identified 80% of the high-risk individuals who developed NPC during follow-up (80% sensitivity). However, approximately 40% of high-risk individuals who did not develop NPC also tested positive (false positives). Application of EBNA1 IgA as a biomarker to detect incident NPC in a previously unscreened, high-risk population revealed that 164 individuals needed to be screened to detect 1 NPC and that 69 individuals tested positive per case detected. Conclusions EBNA1 IgA proved to be a sensitive biomarker for identifying incident NPC, but future work is warranted to develop more specific screening tools to decrease the number of false positives. Impact Results from this study could inform decisions regarding screening biomarkers and referral thresholds for future NPC early-detection program evaluations. PMID:24769890

  10. Accuracy of advanced versus strictly conventional 12-lead ECG for detection and screening of coronary artery disease, left ventricular hypertrophy and left ventricular systolic dysfunction

    PubMed Central

    2010-01-01

    Background Resting conventional 12-lead ECG has low sensitivity for detection of coronary artery disease (CAD) and left ventricular hypertrophy (LVH) and low positive predictive value (PPV) for prediction of left ventricular systolic dysfunction (LVSD). We hypothesized that a ~5-min resting 12-lead advanced ECG test ("A-ECG") that combined results from both the advanced and conventional ECG could more accurately screen for these conditions than strictly conventional ECG. Methods Results from nearly every conventional and advanced resting ECG parameter known from the literature to have diagnostic or predictive value were first retrospectively evaluated in 418 healthy controls and 290 patients with imaging-proven CAD, LVH and/or LVSD. Each ECG parameter was examined for potential inclusion within multi-parameter A-ECG scores derived from multivariate regression models that were designed to optimally screen for disease in general or LVSD in particular. The performance of the best retrospectively-validated A-ECG scores was then compared against that of optimized pooled criteria from the strictly conventional ECG in a test set of 315 additional individuals. Results Compared to optimized pooled criteria from the strictly conventional ECG, a 7-parameter A-ECG score validated in the training set increased the sensitivity of resting ECG for identifying disease in the test set from 78% (72-84%) to 92% (88-96%) (P < 0.0001) while also increasing specificity from 85% (77-91%) to 94% (88-98%) (P < 0.05). In diseased patients, another 5-parameter A-ECG score increased the PPV of ECG for LVSD from 53% (41-65%) to 92% (78-98%) (P < 0.0001) without compromising related negative predictive value. Conclusion Resting 12-lead A-ECG scoring is more accurate than strictly conventional ECG in screening for CAD, LVH and LVSD. PMID:20565702

  11. A new surface plasmon resonance immunosensor for triazine pesticide determination in bovine milk: a comparison with conventional amperometric and screen-printed immunodevices.

    PubMed

    Tomassetti, Mauro; Martini, Elisabetta; Campanella, Luigi; Favero, Gabriele; Sanzó, Gabriella; Mazzei, Franco

    2015-01-01

    A detailed comparison was made of the analytical features of a new Surface Plasmon Resonance (SPR) immunodevice for triazine pesticide determination with those of two other amperometric (conventional and screen-printed) immunosensors and the advantages and disadvantages of the SPR method were thoroughly investigated. For conventional amperometric and screen-printed devices, "competitive" assays were used; conversely, the SPR transduction technique allowed a "direct" measurement format to be used. As far as the main analytical data are concerned, the SPR method does not seem to offer substantial advantages. Nevertheless the measurement time is much shorter and the measurement itself much easier to perform. Lastly several applications and recovery tests were carried out on bovine milk samples, before and after spiking, to check for triazine pesticides in the samples, obtaining satisfactory results. PMID:25942643

  12. A comparative study between conventional and liquid-based cytology in screening for anal intraepithelial lesions in HIV-positive patients.

    PubMed

    Maia, Livia Bravo; Marinho, Larissa Cardoso; Wanderley Paes Barbosa, Tania; Batalha Filho, Eronides Salustiano; Ribeiro Velasco, Lara Franciele; Garcia Costa, Patrícia Godoy; Carneiro, Fabiana Pirani; de Oliveira, Paulo Gonçalves

    2014-10-01

    Anal intraepithelial neoplasia (AIN) is associated with HPV infection and can be detected by cytological screening. While conventional exfoliative cytology (CC) is a low-cost and nonaggressive method, liquid-based cytology (LBC) tends to give clearer readings. Although studies of the efficacy of anal cancer screening methods would be of great importance for groups at high risk for AIN, few such studies have been conducted. The aim of the present study was to assess the concordance of CC and LBC in diagnosing anal pre-neoplastic lesions, and to compare cytological results with anoscopy, histopathological, and molecular biology findings. Comparative study involving 33 HIV-positive patients, who underwent anoscopy and biopsy of suspected lesions. Concordance between the two cytology methods was calculated, as were the associations between cytology results and findings from other screening methods. A total of 54.5% of cases were considered AIN-negative by CC and LBC, and concordance between the two methods was statistically significant (P < 0.05). Anoscopy was negative in 15 of the 18 CC- and LBC-negative cases. CC identified 75% of patients with positive biopsy, while LBC identified 85.71% of these patients. Molecular biology results showed that patients with LSIL tested positive for the highest number of HPV subtypes. The associations between positive biopsy and high grade HPV, HPV 16, and multiple HPV infections were not statistically significant. Conventional and liquid-based cytology are equally effective in screening for anal preneoplastic lesions. PMID:24591207

  13. Two Kdo-Heptose Regions Identified in Hafnia alvei 32 Lipopolysaccharide: the Complete Core Structure and Serological Screening of Different Hafnia O Serotypes▿ †

    PubMed Central

    Lukasiewicz, Jolanta; Niedziela, Tomasz; Jachymek, Wojciech; Kenne, Lennart; Lugowski, Czeslaw

    2009-01-01

    Hafnia alvei, a gram-negative bacterium, is an opportunistic pathogen associated with mixed hospital infections, bacteremia, septicemia, and respiratory diseases. Various 3-deoxy-d-manno-oct-2-ulosonic acid (Kdo)-containing fragments different from known structures of core oligosaccharides were previously found among fractions obtained by mild acid hydrolysis of some H. alvei lipopolysaccharides (LPSs). However, the positions of these segments in the LPS structure were not known. Analysis of de-N,O-acylated LPS by nuclear magnetic resonance spectroscopy and mass spectrometry allowed the determination of the location of a Kdo-containing trisaccharide in the structure of H. alvei PCM 32 LPS. It was established that the trisaccharide {l-α-d-Hepp-(1→4)-[α-d-Galp6OAc-(1→7)]-α-Kdop-(2→} is an integral part of the outer-core oligosaccharide of H. alvei 32 LPS. The very labile ketosidic linkage between →4,7)-α-Kdop and →2)-Glcp in the core oligosaccharide was identified. Screening for this Kdo-containing trisaccharide was performed on the group of 37 O serotypes of H. alvei LPSs using monospecific antibodies recognizing the structure. It was established that this trisaccharide is a characteristic component of the outer-core oligosaccharides of H. alvei 2, 32, 600, 1192, 1206, and 1211 LPSs. The weaker cross-reactions with LPSs of strains 974, 1188, 1198, 1204, and 1214 suggest the presence of similar structures in these LPSs, as well. Thus, we have identified new examples of endotoxins among those elucidated so far. This type of core oligosaccharide deviates from the classical scheme by the presence of the structural Kdo-containing motif in the outer-core region. PMID:19011031

  14. Serology in leprosy

    PubMed Central

    de Almeida, J. Oliveira

    1970-01-01

    A critical survey of the literature on serology in leprosy has shown that sera taken from lepromatous patients display some striking differences in comparison with sera from tuberculoid patients. The tests most frequently employed were complement-fixation, haemagglutination, electrophoresis, precipitation and immunofluorescence, together with a variety of antigens not only from lepromas but also from Mycobacterium tuberculosis and other actinomycetales. With the exception of the Rubino test, all these serological tests are lacking in specificity for leprosy since leprous sera have a broad range of reactivity with different antigens, including those employed in the serological diagnosis of syphilis. Some features of the leprous sera could be related to a hypersensitivity state involving circulating immune complexes, low levels of complement and the presence of antibodies similar to those found in sera from patients with autoimmune diseases. PMID:20604357

  15. Spatial awareness comparisons between large-screen, integrated pictorial displays and conventional EFIS displays during simulated landing approaches

    NASA Technical Reports Server (NTRS)

    Parrish, Russell V.; Busquets, Anthony M.; Williams, Steven P.; Nold, Dean E.

    1994-01-01

    An extensive simulation study was performed to determine and compare the spatial awareness of commercial airline pilots on simulated landing approaches using conventional flight displays with their awareness using advanced pictorial 'pathway in the sky' displays. Sixteen commercial airline pilots repeatedly made simulated complex microwave landing system approaches to closely spaced parallel runways with an extremely short final segment. Scenarios involving conflicting traffic situation assessments and recoveries from flight path offset conditions were used to assess spatial awareness (own ship position relative the the desired flight route, the runway, and other traffic) with the various display formats. The situation assessment tools are presented, as well as the experimental designs and the results. The results demonstrate that the integrated pictorial displays substantially increase spatial awareness over conventional electronic flight information systems display formats.

  16. Serology of coccidioidomycosis.

    PubMed Central

    Pappagianis, D; Zimmer, B L

    1990-01-01

    Serologic tests have assisted in the diagnosis and prognosis of coccidioidomycosis for a half-century. The causative agent, Coccidioides immitis, is a dimorphic fungus existing in a hyphal form with arthroconidia in nature and in the usual culture. The arthroconidia represent the inhaled infective forms which in vivo and under special laboratory conditions form spherules which endosporulate. The culture filtrate/autolysate (coccidioidin) from the hyphal phase has provided antigens of suitable reliability for currently used serologic tests. These tests are primarily to determine the two major antibody responses: the early immunoglobulin M (IgM) response is useful in the diagnosis of acute primary coccidioidomycosis. Later, IgG is produced and usually outlasts the IgM, persisting in chronic coccidioidomycosis. The IgM is detectable by tube precipitin, a corresponding immunodiffusion, or latex particle agglutination tests. The pertinent antigen(s) is heat stable and pronase resistant and appears to be largely carbohydrate, mainly mannose with some 3-O-methyl mannose. The IgG detectable in the serum and other body fluids by complement fixation and a corresponding immuno-diffusion is useful in diagnosis, and its quantitation provides an indicator of progression of disease (increasing titer) or regression (decreasing titer). The pertinent antigen appears to be a heat-labile, pronase-sensitive protein which in an unreduced form has a molecular weight of 110,000. A third very useful serologic procedure is the exoantigen test for identification of putative cultures of C. immitis. Images PMID:2200605

  17. Trypanosoma cruzi in Persons without Serologic Evidence of Disease, Argentina

    PubMed Central

    Basquiera, Ana L.; Sembaj, Adela; Aguerri, Ana M.; Reyes, María E.; Omelianuk, Mirtha; Fernández, Ruth A.; Enders, Julio; Palma, Atilio; Barral, José Moreno; Madoery, Roberto J.

    2003-01-01

    Current diagnosis of chronic Chagas disease relies on serologic detection of specific immunoglobulin G against Trypanosoma cruzi. However, the presence of parasites detected by polymerase chain reaction (PCR) in patients without positive conventional serologic testing has been observed. We determined the prevalence and clinical characteristics of persons with seronegative results for T. cruzi DNA detected by PCR in a population at high risk for chronic American trypanosomiasis. We studied a total of 194 persons from two different populations: 110 patients were recruited from an urban cardiology clinic, and 84 persons were nonselected citizens from a highly disease-endemic area. Eighty (41%) of persons had negative serologic findings; 12 (15%) had a positive PCR. Three patients with negative serologic findings and positive PCR results had clinical signs and symptoms that suggested Chagas cardiomyopathy. This finding challenges the current recommendations for Chagas disease diagnosis, therapy, and blood transfusion policies. PMID:14720396

  18. Serological testing in malaria*

    PubMed Central

    1974-01-01

    The main purpose of this paper is to evaluate, in a critical manner, various serological tests with general emphasis on their value in the epidemiological assessment of malaria. Several tests have been employed in the past. However, the present memorandum will deal only with the methods that have been widely used recently—i.e., indirect immunofluorescence (IFA), passive haemagglutination (IHA), and gel-diffusion. The three immunoglobulins most commonly involved in these tests are IgG, IgM, and—to a lesser extent—IgA. PMID:4218506

  19. From the application of antibiotics to antibiotic residues in liquid manures and digestates: A screening study in one European center of conventional pig husbandry.

    PubMed

    Widyasari-Mehta, Arum; Hartung, Susen; Kreuzig, Robert

    2016-07-15

    In conventional pig husbandry, antibiotics are frequently applied. Together with excreta, antibiotic residues enter liquid manures finally used as organic soil fertilizers or input materials for biogas plants. Therefore, this first screening study was performed to survey the application patterns of antibiotics from fall 2011 until spring 2013. Manures and digestates were then analyzed for selected antibiotic residues from spring 2012 to 2013. The data analysis of veterinary drug application documents revealed the use of 34 different antibiotics belonging to 11 substance classes at 21 farms under study. Antibiotics, particularly tetracyclines, frequently administered to larger pig groups were detected in manure samples up to higher mg kg(-1) dry weight (DW) concentrations. Antibiotic residues in digestates, furthermore, show that a full removal capacity cannot be guaranteed through the anaerobic digestion process in biogas plants. PMID:27088209

  20. Canine hip dysplasia radiographic screening. Prevalence of rotation of the pelvis along its length axis in 7,012 conventional hip extended radiographs.

    PubMed

    Genevois, J-P; Cachon, T; Fau, D; Carozzo, C; Viguier, E; Collard, F; Remy, D

    2007-01-01

    The prevalence of rotation of the pelvis along its length axis was noted, as was the number of rotations towards the right or left hand side of the dog, on 7,012 conventional hip extended radiographs, which were sent for official screening. 29.8% of the radiographs showed a rotation the pelvis. The rotation was statistically more frequent towards the left hand side of the dog. The number of rejected radiographs for too important pelvis rotation was only 5.2%. The consequences of the pelvis rotation on the Norberg-Olsson angle, on the dorsal femoral head coverage, and in the aspect of cranial acetabular edge have to be taken into account when scoring the dog for hip dysplasia. PMID:18038007

  1. Investigation of a hepatotoxicity screening system in primary cell cultures --"what biomarkers would need to be addressed to estimate toxicity in conventional and new approaches?".

    PubMed

    Kikkawa, Rie; Yamamoto, Toshinori; Fukushima, Tamio; Yamada, Hiroshi; Horii, Ikuo

    2005-02-01

    High throughput toxicological estimation is required for safety evaluation in the early stage of drug discovery. In this context, establishment of an in vitro screening system reflecting in vivo toxicity is demanded for earlier safety assessment. We investigated LDH release and mitochondrial respiration (WST-1 reduction assay; WST-1) to detect cytotoxicity, morphological evaluation, and proteomics for estimating the reliable and sensitive biomarkers by using rat primary hepatocytes exposed to the compounds (acetaminophen, amiodarone, tetracycline and carbon tetrachloride) that are known to induce hepatotoxicity. In LDH release, no significant difference was detected between the control and compound exposed cells after exposure for 3 or 6 hr, but a dose-dependent increase was observed after exposure for 24 hr. Regarding the WST-1 assay, a dose-dependent reduction was detected after exposure for 6 and 24 hr to all of the compounds evaluated. In the proteomics analysis, 31 candidate proteins were identified from among the 103 demonstrating altered expression spots after exposure to acetaminophen. It was concluded that the cytotoxicity was detected earlier by measuring WST-1 than by measuring LDH release because the reduction of mitochondrial respiration is an expressions of earlier toxicity for cellular function, while the measured increase in the LDH release occurs after the failure of the cell membrane. Mitochondrial respiration ability was a useful parameter for cytotoxicity in in vitro hepato-toxicity screening, as cytotoxicity can be detected during the early stage of exposure. In addition to the conventional biomarkers, several protein biomarkers which relate to oxidative stress and metabolism-regulation were detected. Further comprehensive analysis of defined proteins would be necessary to estimate the more sensitive toxicology biomarker. PMID:15800402

  2. Imaging performance of a thin Lu2O3:Eu nanophosphor scintillating screen coupled to a high resolution CMOS sensor under X-ray radiographic conditions: comparison with Gd2O2S:Eu conventional phosphor screen

    NASA Astrophysics Data System (ADS)

    Seferis, I.; Michail, C.; Valais, I.; Zeler, J.; Liaparinos, P.; Kalyvas, N.; Fountos, G.; Zych, E.; Kandarakis, I.; Panayiotakis, G.

    2014-03-01

    The purpose of the present study was to experimentally evaluate the imaging characteristics of the Lu2O3:Eu nanophosphor thin screen coupled to a high resolution CMOS sensor under radiographic conditions. Parameters such as the Modulation Transfer Function (MTF), the Normalized Noise Power Spectrum (NNPS) and the Detective Quantum Efficiency (DQE) were investigated at 70 kVp under three exposure levels (20 mAs, 63 mAs and 90 mAs). Since Lu2O3:Eu emits light in the red wavelength range, the imaging characteristics of a 33.3 mg/cm2 Gd2O2S:Eu conventional phosphor screen were also evaluated for comparison purposes. The Lu2O3:Eu nanophosphor powder was produced by the combustion synthesis, using urea as fuel. A scintillating screen of 30.2 mg/cm2 was prepared by sedimentation of the nanophosphor powder on a fused silica substrate. The CMOS/Lu2O3:Eu detector`s imaging characteristics were evaluated using an experimental method proposed by the International Electrotechnical Commission (IEC) guidelines. It was found that the CMOS/Lu2O3:Eu nanophosphor system has higher MTF values compared to the CMOS/Gd2O2S:Eu sensor/screen combination in the whole frequency range examined. For low frequencies (0 to 2 cycles/mm) NNPS values of the CMOS/Gd2O2S:Eu system were found 90% higher compared to the NNPS values of the CMOS/Lu2O3:Eu nanophosphor system, whereas from medium to high frequencies (2 to 13 cycles/mm) were found 40% higher. In contrast with the CMOS/ Gd2O2S:Eu system, CMOS/Lu2O3:Eu nanophosphor system appears to retain high DQE values in the whole frequency range examined. Our results indicate that Lu2O3:Eu nanophosphor is a promising scintillator for further research in digital X-ray radiography.

  3. Equine influenza serological methods.

    PubMed

    Chambers, Thomas M; Reedy, Stephanie E

    2014-01-01

    Serologic tests for equine influenza virus (EIV) antibodies are used for many purposes, including retrospective diagnosis, subtyping of virus isolates, antigenic comparison of different virus strains, and measurement of immune responses to EIV vaccines. The hemagglutination-inhibition (HI), single radial hemolysis (SRH), and serum micro-neutralization tests are the most widely used for these purposes and are described here. The presence of inhibitors of hemagglutination in equine serum complicates interpretation of HI assay results, and there are alternative protocols (receptor-destroying enzyme, periodate, trypsin-periodate) for their removal. With the EIV H3N8 strains in particular, equine antibody titers may be magnified by pretreating the HI test antigen with Tween-80 and ether. The SRH assay offers stronger correlations between serum antibody titers and protection from disease. Other tests are sometimes used for specialized purposes such as the neuraminidase-inhibition assay for subtyping, or ELISA for measuring different specific antibody isotypes, and are not described here. PMID:24899450

  4. Serological prevalence of tularemia in cottontail rabbits of southern Illinois.

    PubMed

    Lepitzki, D A; Woolf, A; Cooper, M

    1990-04-01

    Sera of cottontail rabbits (Sylvilagus floridanus) collected in southern Illinois in 1983 and 1984 were screened for the presence of antibodies against Francisella tularensis by rapid slide agglutination and enzyme linked immunosorbent assay techniques; 6% of 118 and 16% of 119 samples were positive by these methods, respectively. Rabbits gained, lost and maintained titers over at least an 8 mo period. Francisella tularensis tularensis was isolated from one serologically negative, clinically healthy rabbit. PMID:2338733

  5. Toxicology screen

    MedlinePlus

    Barbiturates - screen; Benzodiazepines - screen; Amphetamines - screen; Analgesics - screen; Antidepressants - screen; Narcotics - screen; Phenothiazines - screen; Drug abuse screen; Blood alcohol test

  6. 42 CFR 493.923 - Syphilis serology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Syphilis serology. 493.923 Section 493.923 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.923 Syphilis serology. (a) Program content and frequency of challenge. To be approved for proficiency testing in syphilis serology, a...

  7. 42 CFR 493.923 - Syphilis serology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Syphilis serology. 493.923 Section 493.923 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.923 Syphilis serology. (a) Program content and frequency of challenge. To be approved for proficiency testing in syphilis serology, a...

  8. 42 CFR 493.923 - Syphilis serology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Syphilis serology. 493.923 Section 493.923 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.923 Syphilis serology. (a) Program content and frequency of challenge. To be approved for proficiency testing in syphilis serology, a...

  9. 42 CFR 493.923 - Syphilis serology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Syphilis serology. 493.923 Section 493.923 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.923 Syphilis serology. (a) Program content and frequency of challenge. To be approved for proficiency testing in syphilis serology, a...

  10. 42 CFR 493.923 - Syphilis serology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Syphilis serology. 493.923 Section 493.923 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.923 Syphilis serology. (a) Program content and frequency of challenge. To be approved for proficiency testing in syphilis serology, a...

  11. New Platform Technology for Comprehensive Serological Diagnostics of Autoimmune Diseases

    PubMed Central

    Willitzki, Annika; Hiemann, Rico; Peters, Vanessa; Sack, Ulrich; Schierack, Peter; Rödiger, Stefan; Anderer, Ursula; Conrad, Karsten; Bogdanos, Dimitrios P.; Reinhold, Dirk; Roggenbuck, Dirk

    2012-01-01

    Antibody assessment is an essential part in the serological diagnosis of autoimmune diseases. However, different diagnostic strategies have been proposed for the work up of sera in particular from patients with systemic autoimmune rheumatic disease (SARD). In general, screening for SARD-associated antibodies by indirect immunofluorescence (IIF) is followed by confirmatory testing covering different assay techniques. Due to lacking automation, standardization, modern data management, and human bias in IIF screening, this two-stage approach has recently been challenged by multiplex techniques particularly in laboratories with high workload. However, detection of antinuclear antibodies by IIF is still recommended to be the gold standard method for antibody screening in sera from patients with suspected SARD. To address the limitations of IIF and to meet the demand for cost-efficient autoantibody screening, automated IIF methods employing novel pattern recognition algorithms for image analysis have been introduced recently. In this respect, the AKLIDES technology has been the first commercially available platform for automated interpretation of cell-based IIF testing and provides multiplexing by addressable microbead immunoassays for confirmatory testing. This paper gives an overview of recently published studies demonstrating the advantages of this new technology for SARD serology. PMID:23316252

  12. Effect-Based Screening Methods for Water Quality Characterization Will Augment Conventional Analyte-by-Analyte Chemical Methods in Research As Well As Regulatory Monitoring

    EPA Science Inventory

    Conventional approaches to water quality characterization can provide data on individual chemical components of each water sample. This analyte-by-analyte approach currently serves many useful research and compliance monitoring needs. However these approaches, which require a ...

  13. A new survey of the serology of human Trypanosoma cruzi infection in the Rio Negro microregion, Brazilian Amazon: a critical analysis

    PubMed Central

    Coura, José Rodrigues; Marquez, Maurício Humberto Peña; Guerra, Jorge Augusto de Oliveira; Zauza, Patricia Lago; Miguel, Julio Cesar; Pereira, José Borges

    2013-01-01

    The serology of human Trypanosoma cruzi infection in the Rio Negro microregion is very complex because of the large numbers of false-positive cases that result from low antibody titres and cross-reactions with other infections. In the present study, we collected 4,880 blood samples on filter paper; of these, indirect immunofluorescence (IIF) was strongly reactive in 221 (4.5%), which were considered to be positive (IIF strongly reactive; high intensity of fluorescence) and weakly reactive in 302 (6.2%), which were considered to be doubtful (IIF weakly reactive; low intensity of fluorescence). The confirmatory test on the serum using at least two of three techniques (IIF, conventional ELISA and recombinant ELISA) on 137 samples that were positive in the screening test only confirmed 33 cases (24.1%). Of the 178 samples that were considered doubtful in the screening test, only 10 (5.6%) were considered to be positive in the confirmatory test. Finally, we recommend that the serological diagnosis of T. cruzi infection in the Amazon region be made using at least two different techniques, for example immunofluorescence and ELISA and confirmed by Western blot analysis when possible. PMID:24141967

  14. Serological tests for syphilis in Saudi Arabia.

    PubMed Central

    Hossain, A

    1986-01-01

    A total of 6684 sera were initially screened for syphilis by the Venereal Disease Research Laboratory (VDRL) test and the Treponema pallidum haemagglutination assay (TPHA). Reactive sera from either or both these tests were tested for confirmation by the fluorescent treponemal antibody-absorbed (FTA-ABS) test. VDRL biological false positive reactors were detected in 0.5% of the total sera examined, with 0.4% and 0.8%, respectively, obtained in pregnant women and blood donors. Eight sera (0.1%) were found to be positive in the TPHA test alone. An overall positivity of 2.7% for syphilis was detected, with a 0.85% positivity in antenatal patients. Infection with T pallidum seemed to be more common in men than in women (1.6:1) and predominated in the age group 20-39 years. Serological testing of sera from 26 mother and infant pairs allowed one case of congenital syphilis to be detected by FTA-ABS (IgM) and identified VDRL biological false positivity in seven infants. PMID:3770753

  15. Small-Angle X-ray Scattering Screening Complements Conventional Biophysical Analysis: Comparative Structural and Biophysical Analysis of Monoclonal Antibodies IgG1, IgG2, and IgG4

    PubMed Central

    Tian, Xinsheng; Langkilde, Annette E; Thorolfsson, Matthias; Rasmussen, Hanne B; Vestergaard, Bente

    2014-01-01

    A crucial step in the development of therapeutic monoclonal antibodies is the selection of robust pharmaceutical candidates and screening of efficacious protein formulations to increase the resistance toward physicochemical degradation and aggregation during processing and storage. Here, we introduce small-angle X-ray scattering (SAXS) to characterize antibody solution behavior, which strongly complements conventional biophysical analysis. First, we apply a variety of conventional biophysical techniques for the evaluation of structural, conformational, and colloidal stability and report a systematic comparison between designed humanized IgG1, IgG2, and IgG4 with identical variable regions. Then, the high information content of SAXS data enables sensitive detection of structural differences between three IgG subclasses at neutral pH and rapid formation of dimers of IgG2 and IgG4 at low pH. We reveal subclass-specific variation in intermolecular repulsion already at low and medium protein concentrations, which explains the observed improved stability of IgG1 with respect to aggregation. We show how excipients dramatically influence such repulsive effects, hence demonstrating the potential application of extensive SAXS screening in antibody selection, eventual engineering, and formulation development. PMID:24700358

  16. Celiac disease in Tunisian children: a second screening study using a "new generation" rapid test.

    PubMed

    Hariz, Mongi Ben; Laadhar, Lilia; Kallel-Sellami, Maryam; Siala, Nadia; Bouraoui, Saadia; Bouziri, Sonia; Borgi, Abdelhafidh; Karouia, Faouzia; Maherzi, Ahmed; Makni, Sondès

    2013-01-01

    This work aims to estimate celiac disease prevalence in school-children in the island of Djerba and assess rapid method feasibility for screening. We screened 2064 schoolchildren by a rapid method to detect IgA anti-tissue transglutaminase and IgA deficiency. Children with positive results were tested for IgA anti-transglutaminase and anti-endomysium by conventional tests. In positive children, intestinal biopsy was performed. IgA deficiency suspected by rapid method was confirmed by nephelometry. In these cases IgG anti-endomysium was performed. Rapid test was positive in 7 children; conventional serology was positive in all and 6 of them accepted the biopsy. Total villous atrophy was observed in 5 while intestinal mucosa was normal in one. Among children with positive serology, 3 had silent form, 1 chronic diarrhea, one growth failure and 2 had borderline growth. IgA deficiency was suspected in 13 cases and was confirmed in 11 children tested. Prevalence of celiac disease was 0.24-0.34% and that of IgA deficiency 0.5-0.6%. This screening study confirms that celiac disease is relatively common in schoolchildren in Tunisia. It confirms also that even those with symptoms typical for celiac disease escape diagnosis. Rapid test is better accepted by parents and children than test requiring a venous blood sample. PMID:23883201

  17. Serologic celiac disease in patients with inflammatory bowel disease

    PubMed Central

    Tavakkoli, Hamid; Haghdani, Saeid; Adilipour, Haiedeh; Daghaghzadeh, Hamed; Minakari, Mohammad; Adibi, Peyman; Ahmadi, Khalil; Emami, Mohammah Hasan

    2012-01-01

    Background: There is an association of celiac disease (CD) with several gastrointestinal illnesses. We aimed to determine the prevalence of CD in patients with inflammatory bowel disease (IBD) to evaluate the value of the routine serological tests for CD in these patients. Materials and Methods: patients with IBD underwent screening test for CD. The screening test was based on IgA anti-tTG antibody evaluated by ELISA method and IgA EMA (endomysial antibody) measured by the indirect immunofluorescence method. Fisher exact and chi-square and t tests were used for data analysis. Results: the study was conducted on 100 patients, with a mean age of 34.74 ± 12.03 (SD) years. The mean simplified Crohn's disease activity index was 90 ± 17 (SE) and the mean colitis activity index was 3.46± 0.96 (SE). Seventeen patients (17%) had IgA anti-tTG antibody levels above the cutoff point (> 20). Thirty-two patients were positive for IgA EMA. IgA EMA was positive in nine IgA anti-tTG positive patients (three patients with Crohn's Disease and six ones with ulcerative colitis). Then, the prevalence of serologic CD was 9% that was higher than that of general population. A significant correlation was found between the results of IgA EMA and those of IgA anti-tTG (P=0.001) whereas Fisher exact test revealed significant difference between frequency distribution of positive and negative results of IgA EMA and IgA anti-tTG in patients with ulcerative colitis and Crohn's disease (P=0). Conclusion: the prevalence of serologic CD in general population in Iran has been reported to be 0.6–0.96%. Then, its prevalence in our sample size was about ten times more than that in general population. PMID:23264789

  18. Rapid polyvalent screening for largescale environmental Spiroplasma surveys

    PubMed Central

    French, Frank E.; Whitcomb, Robert F.; Williamson, David L.; Regassa, Laura B.

    2009-01-01

    Surface serology is an important determinant in Spiroplasma systematics. Reciprocal antigen/antibody reactions between spiroplasmas and individual antisera delineate the 38 described groups and species. However, reciprocal serology is impractical for large-scale studies. This report describes a successful, streamlined polyvalent screening approach used to examine isolates from an environmental survey. PMID:24031412

  19. Serological diagnosis of toxoplasmosis and standardization.

    PubMed

    Zhang, Kuo; Lin, Guigao; Han, Yanxi; Li, Jinming

    2016-10-01

    Humans can be infected by the intracellular parasite Toxoplasma gondii, which causes toxoplasmosis, a common parasitic disease. Although the infection is generally asymptomatic for most adults, severe complications may occur in some individuals, especially women in early pregnancy. Serologic diagnosis is used as a routine practice to determine the immune status for infection by T. gondii. In this review, we attempt to provide an overview of the serological diagnosis of toxoplasmosis, including diagnostic strategy, current problems in detection with specific antibodies, and the standardization of T. gondii serological detection. PMID:27470936

  20. Course of Chronic Trypanosoma cruzi Infection after Treatment Based on Parasitological and Serological Tests: A Systematic Review of Follow-Up Studies

    PubMed Central

    Sguassero, Yanina; Cuesta, Cristina B.; Roberts, Karen N.; Hicks, Elizabeth; Comandé, Daniel; Ciapponi, Agustín; Sosa-Estani, Sergio

    2015-01-01

    screened, 54 studies (six RCTs and 48 cohort studies) were included. The smoothed curves for positive xenodiagnosis and positive polymerase chain reaction (PCR) were characterized by a sharp decrease at twelve month posttreatment. Afterwards, they reached 10–20% and 40% for xenodiagnosis and PCR, respectively. The smoothed curves for negative conventional serological tests increased up to 10% after 48 months of treatment. In the long-term, the rate of negativization was between 20% and 45%. The main sources of bias identified across cohort studies were the lack of control for confounding and attrition bias. In general, RCTs were judged as low risk of bias in all domains. The level of heterogeneity across included studies was moderate to high. Additional analysis were incomplete because of the limited availability of data. In this regard, the country of origin of study participants might affect the results of parasitological and molecular tests, while the level of risk of bias might affect serological outcomes. Subgroup analysis suggested that seronegativization occurs earlier in children compared to adults. Conclusions We acknowledge that there is a dynamic pattern of response based on parasitological, molecular and serological tests in subjects chronically infected with T. cruzi after treatment. Our findings suggest a trypanocidal effect in the long-term follow-up. Further research is needed to explore potential sources of heterogeneity and to conduct reliable subgroup analysis. PMID:26436678

  1. Results of serological tests for syphilis among Gurkhas and other high risk groups.

    PubMed

    Thin, R N; O'Rorke, C M

    1985-02-01

    Serological tests for syphilis gave more positive results in serving Gurkha (Nepali) soldiers from west Nepal than in those from east Nepal or in Gurkha recruits. The soldiers had served from four to 11 years. The source of their infection was not clear. Positive results were rather less common in black patients born in the tropics attending a genitourinary medicine in London and were similar to findings in blood donors in the West Indies. British born male patients attending a genitourinary medicine department in London had a much lower prevalence. Malay and Nepali women attending an antenatal clinic in Singapore had a higher prevalence of positive serological results than women attending an antenatal clinic in London. Nepalis, Malays, and black people born in the tropics continue to require serological screening. PMID:3910540

  2. FIV, FeLV, and FIPV: interpretation and misinterpretation of serological test results.

    PubMed

    Barr, M C

    1996-08-01

    Serological testing is a common method of diagnosis of felina viral infections, including feline immunodeficiency virus (FIV), feline leukemia virus (FeLV), and feline infectious peritonitis virus (FIPV). Infections with these viruses can be difficult to diagnose by clinical signs alone and are sometimes clinically inapparent for months after initial exposure. Serological testing to confirm a tentative diagnosis or as a screening tool for infection can be invaluable. However, serological tests must be used only with a thorough understanding of the mechanisms and abilities of the tests, and with recognition of their potential inadequacies and misinterpretations. This report summarizes the assays available for FIV, FeLV, and FIPV, and discusses merits and pitfalls associated with each test. PMID:8942210

  3. 21 CFR 866.3510 - Rubella virus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Rubella virus serological reagents. 866.3510... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3510 Rubella virus serological reagents. (a) Identification. Rubella virus serological reagents are devices that consist...

  4. High-throughput screening of a large collection of non-conventional yeasts reveals their potential for aroma formation in food fermentation.

    PubMed

    Gamero, Amparo; Quintilla, Raquel; Groenewald, Marizeth; Alkema, Wynand; Boekhout, Teun; Hazelwood, Lucie

    2016-12-01

    Saccharomyces yeast species are currently the most important yeasts involved in industrial-scale food fermentations. However, there are hundreds of other yeast species poorly studied that are highly promising for flavour development, some of which have also been identified in traditional food fermentations. This work explores natural yeast biodiversity in terms of aroma formation, with a particular focus on aromas relevant for industrial fermentations such as wine and beer. Several non-Saccharomyces species produce important aroma compounds such as fusel alcohols derived from the Ehrlich pathway, acetate esters and ethyl esters in significantly higher quantities than the well-known Saccharomyces species. These species are Starmera caribaea, Hanseniaspora guilliermondii, Galactomyces geotrichum, Saccharomycopsis vini and Ambrosiozyma monospora. Certain species revealed a strain-dependent flavour profile while other species were very homogenous in their flavour profiles. Finally, characterization of a selected number of yeast species using valine or leucine as sole nitrogen sources indicates that the mechanisms of regulation of the expression of the Ehrlich pathway exist amongst non-conventional yeast species. PMID:27554157

  5. Intramodality and Intermodality Comparisons of Storage Phosphor Computed Radiography and Conventional Film-Screen Radiography in the Recognition of Small Pneumoconiotic Opacities

    PubMed Central

    Petsonk, Edward L.; Attfield, Michael D.

    2011-01-01

    Background: Digital radiography systems are replacing traditional film for chest radiographic monitoring in the recognition of pneumoconiosis. Methods: To further investigate previous findings regarding the equivalence of film-screen radiographs (FSRs) and storage phosphor computed radiographs (CRs), FSRs and CRs from 172 underground coal miners were classified independently by seven National Institute for Occupational Safety and Health-approved B readers, using the International Labor Office (ILO) classification of radiographs of pneumoconiosis. Results: More CRs were classified as “good” quality compared with FSRs (prevalence ratio [PR], 1.5; 95% CI, 1.4-1.6; P , .001). B readers showed good overall agreement on scoring small opacity profusion using CRs vs FSRs (weighted κ, 0.58; 95% CI, 0.54-0.62). Significantly more irregular opacities (compared with rounded) were classified using CR images compared with FSR (PR, 1.3; 95% CI, 1.1-1.6; P = .01). Similarly, the smallest sized opacities (width < 1.5 mm, p and s type) were reported more frequently using CR vs FSR images (PR, 1.3; 95% CI, 1.1-1.5; P < .001). Interreader and intrareader agreement was lower with respect to the classification of shape and size than for small opacity profusion. Overall, interreader and intrareader variability did not differ significantly using CR vs FSR. Conclusions: Under optimal conditions, using standardized methods and equipment, reader visualization of small pneumoconiotic opacities does not appear to differ meaningfully, whether using CR or FSR. Variability in ILO classifications between imaging modalities appears to be considerably lower than variability among readers. The well-documented challenge of reader variability does not appear to be resolved through the use of digital imaging alone, and additional approaches must be evaluated. PMID:21622551

  6. [Serological diagnosis of congenital infections and algorithms to improve diagnostic efficacy].

    PubMed

    García-Bermejo, Isabel; de Ory-Manchón, Fernando

    2015-07-01

    Congenital infection is those transmitted by the mother to the fetus before delivery. It can occur transplacentally or by direct contact with the pathogen during birth or in the immediate postnatal period. Congenital infection can be due to viruses (rubella, cytomegalovirus, herpes simplex, varicella-zoster, hepatitis B and C virus, human inunodeficiencia, erythrovirus B19) as bacteria (Treponema pallidum) and parasites (Toxoplasma gondii and Trypanosoma cruzi). Serological diagnosis of congenital infection is based on both the knowledge of infectious serology in the mother, including the systematic serological screening and diagnostic aspects of the determination of IgM and confirmatory methods, IgG avidity tests, establishment of antibody profiles, and in the diagnosis the neonate. Serological diagnosis of congenital infection in the newborn is mainly based on the detection of specific IgM usually by immunoenzymatic assays or immunochemiluminescence techniques. In some instances it is important to perform the serological follow up of the newborn to confirm the congenital infection. PMID:26320992

  7. Screening Brucella spp. in bovine raw milk by real-time quantitative PCR and conventional methods in a pilot region of vaccination, Edirne, Turkey.

    PubMed

    Kaynak-Onurdag, F; Okten, S; Sen, B

    2016-05-01

    samples were Brucella positive, by both bacteriological method and the novel qPCR method. We concluded that, to obtain true-positive results in Brucella spp. screening studies for milk, differentiating the virulent and vaccine strain should not be disregarded. PMID:26971148

  8. Diagnosis of Pneumocystis pneumonia: evaluation of four serologic biomarkers.

    PubMed

    Esteves, F; Calé, S S; Badura, R; de Boer, M G; Maltez, F; Calderón, E J; van der Reijden, T J; Márquez-Martín, E; Antunes, F; Matos, O

    2015-04-01

    The diagnosis of Pneumocystis pneumonia (PCP) relies on microscopic visualization of Pneumocystis jirovecii organisms or DNA detection in pulmonary specimens. This study aimed to assess the usefulness of (1-3)-β-d-glucan (BG), Krebs von den Lungen-6 antigen (KL-6), lactate dehydrogenase (LDH) and S-adenosyl methionine (SAM) as serologic biomarkers in the diagnosis of PCP. Serum levels of BG, KL-6, LDH and SAM were investigated in 145 Portuguese patients, 50 patients from the Netherlands, 25 Spanish patients and 40 Portuguese blood donors. Data on clinical presentation, chest imaging and gasometry tests were available. PCP cases were confirmed by microscopy and PCR techniques. A cost-effectiveness analysis was performed. BG was found to be the most reliable serologic biomarker for PCP diagnosis, followed by KL-6, LDH and SAM. The BG/KL-6 combination test was the most accurate serologic approach for PCP diagnosis, with 94.3% sensitivity and 89.6% specificity. Although less sensitive/specific than the reference standard classic methods based on bronchoalveolar lavage followed by microscopic or molecular detection of P. jirovecii organisms, the BG/KL-6 test may provide a less onerous procedure for PCP diagnosis, as it uses a minimally invasive and inexpensive specimen (blood), which may be also a major benefit for the patient's care. The BG/KL-6 combination test should be interpreted within the clinical context, and it may be used as a preliminary screening test in patients with primary suspicion of PCP, or as an alternative diagnostic procedure in patients with respiratory failure or in children, avoiding the associated risk of complications by the use of bronchoscopy. PMID:25630458

  9. Utility of Serological Tests in the Era of Molecular Testing for Diagnosis of Human Brucellosis in Endemic Area with Limited Resources

    PubMed Central

    Metgud, Sharada C.; Mutnal, Manohar B; Nagamoti, Mahantesh B; Patil, Chidanand S.

    2016-01-01

    Background The culture has always been the gold standard test for diagnosis of human brucellosis but the conventional Brucella diagnostic tests viz. serology and culture are often beset with poor specificity & sensitivity respectively. The culture positivity rates for Brucella vary from 92% for bone marrow to 10% for non-blood samples and also dependent on the type of sample. The primary immune-determinant for Brucella species is the cell wall surface lipopolysaccharide, which is antigenically similar to other gram-negative rods. Hence, Brucella serological tests cross react with Escherichia coli 0116 and 0157, Salmonella urbana, Yersinia enterocolitica 0:9, Vibrio cholerae, Xanthomonas maltophilia and Afipia clevellandensis infections, which are common in developing countries also having higher incidence of brucellosis. Aim The aim of the study was evaluation of conventional serological techniques and PCR for diagnosis of human brucellosis in and around north Karnataka which is endemic for brucellosis and patients often present with elevated base line antibody titers and confounding clinical manifestations. Materials and Methods Blood/serum samples of 400 patients suffering from acute undifferentiated fever (AUF) were subjected to culture, Brucella slide agglutination test (SAT), standard tube agglutination test (STAT coupled with 2 ME) and PCR. Results Of the 400 AUF patients, anti-Brucella antibodies were detected by SAT and STAT in serum of 35 and 34 patients respectively. IS711 gene for Brucella was identified in 32 patients by PCR. Twenty samples yielded Brucella in culture on biphasic medium with average incubation period of 9 days. All patients having titer of ≥ 160IU / ml in STAT were found positive by PCR also. Conclusion Brucella STAT corroborated well with PCR results in all those cases where antibodies were present at least one dilution above cut-off value of 80 IU/ml. We probably need to raise cut-off titers to ≥160 IU/ml because of endemic region

  10. Basic problems of serological laboratory diagnosis.

    PubMed

    Fierz, W

    1999-12-01

    Serological laboratory diagnosis is inflicted with at least two kinds of basic problems. One type relates to the fact that the serological diagnosis of infectious diseases is double indirect: First, to diagnose an infectious disease, the identification of the microbial agent is sought that caused the disease. Second, to identify this infectious agent, the patient's immune response to potential agents is measured. So, the serological test is neither measuring directly disease nor the cause of the disease, but the patient's immune system. Another type of problem is based on the fact that each person's immune system is very individual. The exact physicochemical properties of antibodies are unique for each clone of antibodies. The way an individual's immune system sees an infectious agent depends not only on the genetic makeup of the person but also on the personal experience from former encounters with infectious agents. Both types of problems lead to complexities in selecting the appropriate test, in interpreting the results, and in standardizing serological tests. Therefore, a close collaboration of the laboratory with the clinic is mandatory to avoid erroneous conclusions from serological test results, which might lead to wrong decisions in patient care. PMID:10934525

  11. Invasive candidiasis serological diagnosis in solid organ transplant recipients

    PubMed Central

    Sikora, Magdalena; Gołaś, Marlena; Dąbkowska, Maria; Pączek, Leszek; Swoboda-Kopeć, Ewa

    2014-01-01

    Solid organ transplant recipients are at high risk of fungal infections, because of ongoing immunosuppressive treatment. There are three post organ transplant phases: early, intermediate, and late, all of them at risk of Candida infections. Since conventional tests are insufficient, specific secondary diagnostic tests are still being explored. Serological tests are currently the most common choice. The present study was to determine the usefulness of mannan antigen and anti-mannan antibody detection in diagnosing invasive candidiasis in liver or kidney transplant recipients. The levels of mannan and anti-mannan antibodies were assessed with Platelia Candida Ag Plus, and Platelia Candida Ab Plus (Biorad, Marne-la-Coquette, France) commercial tests, according to manufacturer's guidelines. Sixty six serum samples were obtained from 25 patients (9 liver transplant recipients, 7 kidney transplant recipients, and 9 patients prepared for a kidney transplant), 29 serum samples from 15 patients tested positive for mannan antigen. Serum samples were obtained from 14 patients tested positive for anti- mannan antibodies. Fungal antigen detection in blood serum in patients under immunosuppression, especially with neutropenia, suggests that antifungal treatment should be administered. Serological tests, especially mannan and anti-mannan ones, are very useful for confirmation or exclusion of invasive candidiasis in high-risk patients. PMID:26155122

  12. Diagnostic performance of serological tests for swine brucellosis in the presence of false positive serological reactions.

    PubMed

    Dieste-Pérez, L; Blasco, J M; de Miguel, M J; Moriyón, I; Muñoz, P M

    2015-04-01

    Swine brucellosis caused by Brucella suis biovar 2 is an emerging disease in Europe. Currently used diagnostic tests for swine brucellosis detect antibodies to the O-polysaccharide (O-PS) of Brucella smooth lipopolysaccharide (S-LPS) but their specificity is compromised by false-positive serological reactions (FPSRs) when bacteria carrying cross-reacting O-PS infect pigs. FPSRs occur throughout Europe, and the only tool available for a specific B. suis diagnosis is the intradermal test with Brucella protein extracts free of O-PS or S-LPS. Using sera of 162 sows naturally infected by B. suis biovar 2, 406 brucellosis-free sows, and 218 pigs of brucellosis-free farms affected by FPSR, we assessed the diagnostic performance of an indirect ELISA with rough LPS (thus devoid of O-PS) and of gel immunodiffusion, counterimmunoelectrophoresis, latex agglutination and indirect ELISA with O-PS free proteins in comparison with several S-LPS tests (Rose Bengal, complement fixation, gel immunodiffusion and indirect ELISA). When adjusted to 100% specificity, the sensitivity of the rough LPS ELISA was very low (30%), and adoption of other cut-offs resulted in poor specificity/sensitivity ratios. Although their specificity was 100%, the sensitivity of protein tests (ELISA, latex agglutination, counterimmunoelectrophoresis, and gel immunodiffusion) was only moderate (45, 58, 61 and 63%, respectively). Among S-LPS tests, gel immunodiffusion was the only test showing acceptable sensitivity/specificity (68 and 100%, respectively). Despite these shortcomings, and when the purpose is to screen out FPSR at herd level, gel immunodiffusion tests may offer a technically simple and practical alternative to intradermal testing. PMID:25661496

  13. 21 CFR 866.3700 - Staphylococcus aureus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Staphylococcus aureus serological reagents. 866... Staphylococcus aureus serological reagents. (a) Identification. Staphylococcus aureus serological reagents are... epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an...

  14. 21 CFR 866.3700 - Staphylococcus aureus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Staphylococcus aureus serological reagents. 866... Staphylococcus aureus serological reagents. (a) Identification. Staphylococcus aureus serological reagents are... epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an...

  15. 21 CFR 866.3700 - Staphylococcus aureus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Staphylococcus aureus serological reagents. 866... Staphylococcus aureus serological reagents. (a) Identification. Staphylococcus aureus serological reagents are... epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an...

  16. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Rubeola (measles) virus serological reagents. 866... Rubeola (measles) virus serological reagents. (a) Identification. Rubeola (measles) virus serological... to rubeola virus in serum. The identification aids in the diagnosis of measles and...

  17. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rubeola (measles) virus serological reagents. 866... Rubeola (measles) virus serological reagents. (a) Identification. Rubeola (measles) virus serological... to rubeola virus in serum. The identification aids in the diagnosis of measles and...

  18. 21 CFR 866.3940 - West Nile virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false West Nile virus serological reagents. 866.3940... virus serological reagents. (a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human...

  19. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Rubeola (measles) virus serological reagents. 866... Rubeola (measles) virus serological reagents. (a) Identification. Rubeola (measles) virus serological... to rubeola virus in serum. The identification aids in the diagnosis of measles and...

  20. 21 CFR 866.3940 - West Nile virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false West Nile virus serological reagents. 866.3940... virus serological reagents. (a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human...

  1. 21 CFR 866.3940 - West Nile virus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false West Nile virus serological reagents. 866.3940... virus serological reagents. (a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human...

  2. 21 CFR 866.3940 - West Nile virus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false West Nile virus serological reagents. 866.3940... virus serological reagents. (a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human...

  3. 21 CFR 866.3940 - West Nile virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false West Nile virus serological reagents. 866.3940... virus serological reagents. (a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human...

  4. [Diagnosis of whooping cough by serology and real-time PCR].

    PubMed

    Mikešová, Romana; Stiborová, Ivana; Richter, Josef; Rajnohová Dobiášová, Lucie; Král, Vlastimil

    2013-09-01

    The goal of this study is to summarize the results of the detection of Bordetella pertussis (BP) and Bordetella parapertussis (BPP) by a real-time polymerase chain reaction (RT-PCR) assay and serological methods. In 2008-2010, 73 patients of the Department of Clinical Immunology and Allergology of the Centre for Immunology and Microbiology, Public Health Institute in Ústí nad Labem were screened for pertussis. They were selected according to the WHO and ECDC criteria, i. e. they presented with a persistent cough lasting more than two weeks. Direct detection of BP and BPP DNA from nasopharyngeal wash specimens was performed using a RT PCR assay. The serological responses were evaluated by a direct agglutination test for the detection of total antibodies and by enzyme-linked immunosobent assay (ELISA) for the detection of IgG, IgA, and IgM antibodies against pertussis toxin. Forty-two patients were positive for BP and/or BPP, 19 of them by RT-PCR (group A) and 23 by serology (group B). Ten group A patients (52.6%) were also positive by serology. Our results show that pertussis needs to be a consideration in persistent cough. We believe that increased awareness of the medical community, along with improved laboratory tests will result in increased detection of pertussis that is still considered by many physicians as a childhood infection. PMID:24116698

  5. A Computationally Designed Serological Assay for Porcine Epidemic Diarrhea Virus.

    PubMed

    Song, Yunfeng; Singh, Pankaj; Nelson, Eric; Ramamoorthy, Sheela

    2016-08-01

    The periodic emergence of new infectious agents and the genetic and antigenic evolution of existing agents necessitate the improvement of technology for the rapid development of diagnostic assays. The porcine epidemic diarrhea virus (PEDV) emerged in the United States in 2013, causing severe economic damage to the pork industry. The primary goal of this study was to develop methods to reduce the lead time for serological assay development. An approach involving the computational prediction of diagnostic targets, followed by a rapid synthesis of antigens, was adopted to achieve this objective. To avoid cross-reactivity with other closely related swine coronaviruses, the N protein sequences of PEDV were analyzed to identify sequences unique to PEDV. The potential antigenicity of the identified sequence was predicted computationally using the Jameson-Wolf method. A sequence with a high antigenic index was rapidly synthesized using an in vitro transcription and translation system to yield the diagnostic antigen. The computationally designed enzyme-linked immunosorbent assay (ELISA) was validated using 169 field sera, whose statuses were determined by a PEDV-specific immunofluorescence assay. Comparison of the computationally designed ELISA to a conventionally developed ELISA, using bacterially expressed N protein, and to the immunofluorescence assay showed a high degree of agreement among the three tests (mean kappa statistic, 0.842). The sensitivity and specificity, compared to the conventionally developed assay, were 90.62 and 95.18, respectively. Therefore, the described approach is useful in reducing the development time for serological assays in the face of an infectious disease outbreak. PMID:27225413

  6. Serological and bacteriological study of swine brucellosis.

    PubMed Central

    Lord, V R; Cherwonogrodzky, J W; Marcano, M J; Melendez, G

    1997-01-01

    A serological and bacteriological study was performed with sera taken from 2,228 swine from six states in Venezuela. None of the animals were vaccinated against brucellosis, and the prevalence of the disease varied from 5 to 89% on farms located in these states. Our studies indicated that the animals could be categorized into four groups depending on the degree of reactivity in serological tests. Brucella suis biovar 1 was isolated from the lymph nodes, spleens, and semen samples of seropositive animals and identified by oxidative metabolic techniques. B. suis could not be isolated from tissues of seronegative swine even from farms with cases of the disease (detected by serology). Results suggest that, although the immunodiffusion assay using Brucella melitensis B115 polysaccharide B or B. abortus 1119-3 O-polysaccharide could be useful in the detection of active infections, it is perhaps not as sensitive as some of the other standard serological tests used in this study for the detection of swine brucellosis. PMID:8968931

  7. Basic problems of serological laboratory diagnosis.

    PubMed

    Fierz, Walter

    2004-01-01

    Serological laboratory diagnosis of infectious diseases is inflicted with several kinds of basic problems. One difficulty relates to the fact that the serological diagnosis of infectious diseases is double indirect: The first indirect aim in diagnosing an infectious disease is to identify the microbial agent that caused the disease. The second indirect aim is to identify this infectious agent by measuring the patient's immune response to the potential agent. Thus, the serological test is neither measuring directly disease nor the cause of the disease, but the patient's immune system. The latter poses another type of problem, because each person's immune system is unique. The immune response to an infectious agent is usually of polyclonal nature, and the exact physicochemical properties of antibodies are unique for each clone of antibody. The clonal makeup and composition and, therefore, the way an individual's immune system sees an infectious agent, depends not only on the genetic background of the person but also on the individual experience from former encounters with various infectious agents. In consequence, the reaction of a patient's serum in an analytical system is not precisely predictable. Also, the antigenic makeup of an infectious agent is not always foreseeable. Antigenic variations leading to different serotypes is a quite common phenomenon. Altogether, these biological problems lead to complexities in selecting the appropriate tests and strategies for testing, in interpreting the results, and in standardizing serological test systems. For that reason, a close collaboration of the laboratory with the clinic is mandatory to avoid erroneous conclusions from serological test results, which might lead to wrong decisions in patient care. PMID:14959841

  8. Should adults be screened for celiac disease? What are the benefits and harms of screening?

    PubMed

    Collin, Pekka

    2005-04-01

    The symptoms of celiac disease are diverse, and the disease is often asymptomatic. Without active serologic screening, most cases probably remain undiagnosed. Recent serologic screening assays allow mass screening for the disease. However, there is no evidence as yet to suggest that symptom-free celiac disease patients run an increased risk of small intestinal lymphoma or other complications. The prevention of osteoporosis seems to be the strongest indicator for widespread screening today. Screening asymptomatic individuals for celiac disease may be even harmful. A lifelong gluten-free diet is not easy to maintain, and the subject's quality of life may deteriorate. It is also debatable whether patients found by active screening adhere to a gluten-free diet similarly to symptomatic ones. The cost-effectiveness of population screening is dubious. Serologic screening should be applied in individuals with even subtle symptoms indicative of celiac disease, such as subclinical-isolated iron deficiency. In various autoimmune conditions, the risk of celiac disease is approximately 5% and, in individuals with affected first-degree relatives, 15%. Infertility, neurologic symptoms such as polyneuropathy, ataxia, epilepsy with posterior cerebral calcification, and osteoporosis are conditions in which celiac disease should be kept in mind. Elevated aminotransferases and liver failure can lead to a diagnosis of celiac disease. Evidence today does not support mass screening of celiac disease. Instead, increased alertness should be observed in patients at risk of the condition. PMID:15825117

  9. Core Oligosaccharide of Plesiomonas shigelloides PCM 2231 (Serotype O17) Lipopolysaccharide—Structural and Serological Analysis

    PubMed Central

    Maciejewska, Anna; Lukasiewicz, Jolanta; Kaszowska, Marta; Man-Kupisinska, Aleksandra; Jachymek, Wojciech; Lugowski, Czeslaw

    2013-01-01

    The herein presented complete structure of the core oligosaccharide of lipopolysaccharide (LPS) P. shigelloides Polish Collection of Microorganisms (PCM) 2231 (serotype O17) was investigated by 1H, 13C NMR spectroscopy, mass spectrometry, chemical analyses and serological methods. The core oligosaccharide is composed of an undecasaccharide, which represents the second core type identified for P. shigelloides serotype O17 LPS. This structure is similar to that of the core oligosaccharide of P. shigelloides strains 302-73 (serotype O1) and 7-63 (serotype O17) and differs from these only by one sugar residue. Serological screening of 55 strains of P. shigelloides with the use of serum against identified core oligosaccharide conjugated with bovine serum albumin (BSA) indicated the presence of similar structures in the LPS core region of 28 O-serotypes. This observation suggests that the core oligosaccharide structure present in strain PCM 2231 could be the most common type among P. shigelloides lipopolysaccharides. PMID:23389090

  10. Serological Measures of Trachoma Transmission Intensity

    PubMed Central

    Martin, Diana L.; Wiegand, Ryan; Goodhew, Brook; Lammie, Patrick; Black, Carolyn M.; West, Sheila; Gaydos, Charlotte A.; Dize, Laura; Mkocha, Harran; Kasubi, Mabula; Gambhir, Manoj

    2015-01-01

    Ocular infection with Chlamydia trachomatis can lead to trachoma, a leading infectious cause of blindness. Trachoma is targeted for elimination by 2020. Clinical grading for ocular disease is currently used for evaluating trachoma elimination programs, but serological surveillance can be a sensitive measure of disease transmission and provide a more objective testing strategy than clinical grading. We calculated the basic reproduction number from serological data in settings with high, medium, and low disease transmission based on clinical disease. The data showed a striking relationship between age seroprevalence and clinical data, demonstrating the proof-of-principle that age seroprevalence predicts transmission rates and therefore could be used as an indicator of decreased transmission of ocular trachoma. PMID:26687891

  11. Serological Measures of Trachoma Transmission Intensity.

    PubMed

    Martin, Diana L; Wiegand, Ryan; Goodhew, Brook; Lammie, Patrick; Black, Carolyn M; West, Sheila; Gaydos, Charlotte A; Dize, Laura; Mkocha, Harran; Kasubi, Mabula; Gambhir, Manoj

    2015-01-01

    Ocular infection with Chlamydia trachomatis can lead to trachoma, a leading infectious cause of blindness. Trachoma is targeted for elimination by 2020. Clinical grading for ocular disease is currently used for evaluating trachoma elimination programs, but serological surveillance can be a sensitive measure of disease transmission and provide a more objective testing strategy than clinical grading. We calculated the basic reproduction number from serological data in settings with high, medium, and low disease transmission based on clinical disease. The data showed a striking relationship between age seroprevalence and clinical data, demonstrating the proof-of-principle that age seroprevalence predicts transmission rates and therefore could be used as an indicator of decreased transmission of ocular trachoma. PMID:26687891

  12. Serological Evidence of Influenza A Viruses in Frugivorous Bats from Africa

    PubMed Central

    Müller, Marcel Alexander; de Bruin, Erwin; van Beek, Janko; Corman, Victor Max; Rasche, Andrea; Drexler, Jan Felix; Sylverken, Augustina; Oppong, Samuel K.; Adu-Sarkodie, Yaw; Tschapka, Marco; Cottontail, Veronika M.; Drosten, Christian; Koopmans, Marion

    2015-01-01

    Bats are likely natural hosts for a range of zoonotic viruses such as Marburg, Ebola, Rabies, as well as for various Corona- and Paramyxoviruses. In 2009/10, researchers discovered RNA of two novel influenza virus subtypes – H17N10 and H18N11 – in Central and South American fruit bats. The identification of bats as possible additional reservoir for influenza A viruses raises questions about the role of this mammalian taxon in influenza A virus ecology and possible public health relevance. As molecular testing can be limited by a short time window in which the virus is present, serological testing provides information about past infections and virus spread in populations after the virus has been cleared. This study aimed at screening available sera from 100 free-ranging, frugivorous bats (Eidolon helvum) sampled in 2009/10 in Ghana, for the presence of antibodies against the complete panel of influenza A haemagglutinin (HA) types ranging from H1 to H18 by means of a protein microarray platform. This technique enables simultaneous serological testing against multiple recombinant HA-types in 5μl of serum. Preliminary results indicate serological evidence against avian influenza subtype H9 in about 30% of the animals screened, with low-level cross-reactivity to phylogenetically closely related subtypes H8 and H12. To our knowledge, this is the first report of serological evidence of influenza A viruses other than H17 and H18 in bats. As avian influenza subtype H9 is associated with human infections, the implications of our findings from a public health context remain to be investigated. PMID:25965069

  13. Serological evidence of influenza A viruses in frugivorous bats from Africa.

    PubMed

    Freidl, Gudrun Stephanie; Binger, Tabea; Müller, Marcel Alexander; de Bruin, Erwin; van Beek, Janko; Corman, Victor Max; Rasche, Andrea; Drexler, Jan Felix; Sylverken, Augustina; Oppong, Samuel K; Adu-Sarkodie, Yaw; Tschapka, Marco; Cottontail, Veronika M; Drosten, Christian; Koopmans, Marion

    2015-01-01

    Bats are likely natural hosts for a range of zoonotic viruses such as Marburg, Ebola, Rabies, as well as for various Corona- and Paramyxoviruses. In 2009/10, researchers discovered RNA of two novel influenza virus subtypes--H17N10 and H18N11--in Central and South American fruit bats. The identification of bats as possible additional reservoir for influenza A viruses raises questions about the role of this mammalian taxon in influenza A virus ecology and possible public health relevance. As molecular testing can be limited by a short time window in which the virus is present, serological testing provides information about past infections and virus spread in populations after the virus has been cleared. This study aimed at screening available sera from 100 free-ranging, frugivorous bats (Eidolon helvum) sampled in 2009/10 in Ghana, for the presence of antibodies against the complete panel of influenza A haemagglutinin (HA) types ranging from H1 to H18 by means of a protein microarray platform. This technique enables simultaneous serological testing against multiple recombinant HA-types in 5 μl of serum. Preliminary results indicate serological evidence against avian influenza subtype H9 in about 30% of the animals screened, with low-level cross-reactivity to phylogenetically closely related subtypes H8 and H12. To our knowledge, this is the first report of serological evidence of influenza A viruses other than H17 and H18 in bats. As avian influenza subtype H9 is associated with human infections, the implications of our findings from a public health context remain to be investigated. PMID:25965069

  14. A multipurpose serological survey in Kenya

    PubMed Central

    Geser, Anton; Christensen, Svend; Thorup, Ib

    1970-01-01

    The need to develop methods for serological sample surveys has increased during recent years. The article describes the methods of sampling and blood collecting employed in a serological survey which was conducted in three different areas of Kenya. The purpose of the survey was primarily to gather information about the age-specific prevalence of various infections which were thought to pose public health problems in the country. An attempt was also made to identify environmental factors which might be associated with variation in the prevalence of the different infections. This was done by collecting data about such factors at the same time as the serological specimens were obtained in the selected survey groups. The experience gained during the field work showed that it is possible to achieve a high coverage of bleeding (80%) in randomly selected population groups living in rural Kenya when proper incentives are given to the examines. Venous blood could be obtained from subjects under field conditions down to the age of 2 years; from the babies only capillary blood could be obtained. PMID:5313065

  15. Display screen and method of manufacture therefor

    NASA Technical Reports Server (NTRS)

    Dubin, Matthew B. (Inventor); Larson, Brent D. (Inventor)

    2002-01-01

    A screen assembly that combines an angle re-distributing prescreen with a conventional diffusion screen. The prescreen minimizes or eliminates the sensitivity of the screen assembly to projector location. The diffusion screen provides other desirable screen characteristics. Compatible screen structures, along with methods for fabricating high resolution prescreens and methods and devices for maintaining the desired relationship between the prescreen and the diffusion screen are contemplated.

  16. Seroprevalence and comparison of different serological tests for brucellosis detection in small ruminants

    PubMed Central

    Sadhu, Dashrath B.; Panchasara, H. H.; Chauhan, H. C.; Sutariya, D. R.; Parmar, V. L.; Prajapati, H. B.

    2015-01-01

    Aim: The aim was to study the seroprevalence and efficacy of the different serological tests used for detection of antibody against Brucella species in small ruminants of Banaskantha district of North-Gujarat. Materials and Methods: Total 1000 serum samples comprising of 485 from sheep and 515 from goat tested for detection of antibodies against the Brucella species by three different serological tests viz., Rose bengal plate test (RBPT), Standard tube agglutination test (STAT), and Indirect Enzyme-linked immunosorbent assay (I-ELISA). Results: The seroprevalence of brucellosis in small ruminants was 11.30%, 11.10%, and 8.80% by RBPT, STAT, and I-ELISA, respectively. The seroprevalence of brucellosis was found to be higher in sheep than goats. The sensitivity of RBPT was found slight more than STAT, but the specificity of both tests was same. In this study, the overall agreement of RBPT and STAT with I-ELISA was found 92.50% and 92.30% in small ruminants, respectively. Conclusion: I-ELISA was a better serological test as compared to RBPT and STAT in the sense of sensitivity, specificity, and rapidity and it could be advocated for screening of brucellosis in sheep and goats. PMID:27047135

  17. [Experience with simple ELISA test systems for Brucella serology in cattle, sheep and goats].

    PubMed

    Sting, R; Ortmann, G

    2000-01-01

    The objective of this work was to use the ELISA technique for the serological surveillance for freedom of brucellosis of cattle, sheep and goats. By comparing 28 cattle sera taken after a brucellosis outbreak, 15 bovine sera supplied by the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) and 497 serum slow agglutination test (SSAT) and complement fixation test (CFT) negative bovine sera from herds officially declared free of brucellosis, the ELISA technique not only shows higher sensitivity as compared to SSAT and CFT but also distinguishes clearly between positive and negative reactions. The serological comparison by SSAT, CFT and ELISA of 615 cattle, 624 sheep and 630 goat sera from herds acknowledged as brucellosis free showed equivalent specificities for both CFT and ELISA. The specificity of the SSAT was much lower, 81.1% in cattle and 96.2% in goat sera. The examination of 5796 cattle, 1337 calf, 5031 sheep and 1796 goat sera demonstrates the advantage of the ELISA technique as routine method. The possible application of the ELISA technique as a screening method for serological brucellosis tests in sheep, goats and possibly also in pigs is discussed. PMID:10684180

  18. GlpQ: an antigen for serological discrimination between relapsing fever and Lyme borreliosis.

    PubMed Central

    Schwan, T G; Schrumpf, M E; Hinnebusch, B J; Anderson, D E; Konkel, M E

    1996-01-01

    Tick-borne relapsing fever is caused by numerous Borrelia species maintained in nature by Ornithodoros tick-mammal cycles. Serological confirmation is based on either an immunofluorescence assay or an enzyme-linked immunosorbent assay using whole cells or sonicated Borrelia hermsii as the antigen. However, antigenic variability of this bacterium's outer surface proteins and antigens shared with the Lyme disease spirochete (B. burgdorferi), may cause both false-negative and false-positive results when testing sera of patients suspected to have either relapsing fever or Lyme disease. To develop a specific serological test for relapsing fever, we created a genomic DNA library of B. hermsii, screened transformed Escherichia coli cells for immunoreactivity with high-titered (> or = 1:2,048) human anti-B. hermsii antiserum, and selected an immunoreactive clone (pSPR75) expressing a 39-kDa protein. DNA sequencing, subcloning, and serum adsorption experiments identified the immunoreactive protein as a homolog of GlpQ, a glycerophosphodiester phosphodiesterase identified previously in E. coli, Haemophilus influenzae, and Bacillus subtilis. Serum samples from humans and mice infected with B. hermsii or other species of relapsing fever spirochetes contained antibodies recognizing GlpQ, whereas serum samples from Lyme disease and syphilis patients were nonreactive. Serologic tests based on this antigen will identify people exposed previously to relapsing fever spirochetes and help clarify the distribution of relapsing fever and Lyme disease in situations in which the occurrence of their causative agents is uncertain. PMID:8880505

  19. Delayed Serological Transfusion Reaction After Platelet Transfusion Due to Anti-e.

    PubMed

    Sachan, Deepti; Kumar, Aswin; Jothimani, Dinesh; Rela, Mohamed

    2016-06-01

    Delayed serological transfusion reaction (DSTR) is defined as absence of clinical signs of hemolysis and demonstration of new, clinically-significant antibodies against red blood cells after a transfusion, by either positive direct antiglobulin test or positive antibody screen with newly identified RBC alloantibody. Various delayed hemolytic transfusion reaction cases are reported after red cell transfusions. However, the incidence of DSTR after platelet transfusion due to non-Rh(D) antibodies is not much documented. We report here a case of DSTR due to anti-e Rh antibody in a multiply red cell alloimmunized female patient after single donor platelets transfusion. PMID:27408414

  20. Serological examination of fattening pigs reveals associations between Ascaris suum, lung pathogens and technical performance parameters.

    PubMed

    Vlaminck, Johnny; Düsseldorf, Simon; Heres, Lourens; Geldhof, Peter

    2015-06-15

    Diagnosing the presence of the highly prevalent and economically important pig parasite Ascaris suum on fattening farms has so far been challenging. Currently, only the number of livers affected at slaughter is routinely used to measure parasite exposure. However, recently, a new serological test was developed based on the detection of antibodies to the A. suum haemoglobin molecule. The test showed to be highly sensitive for the detection of exposure to A. suum in fattening pigs. In this study we first compared the performance of A. suum serology versus the percentage of affected livers at slaughter, subsequently we investigated potential associations between A. suum infection levels and exposure to important lung pathogens and finally we identified correlations between serological data and technical performance parameters (TPIs) from 20 Belgian and 20 German pig fattening farms. In both Belgian and German farms, a significant relationship was detected between elevated average Ascaris serology and percentages of affected livers (ρ=0.63 and ρ=0.75, respectively). On the Belgian farms, both Ascaris serology and the percentage of affected livers were negatively correlated with average daily gain (ADG) (ρ=-0.69 and ρ=-0.56, respectively). Using the German dataset, only a borderline negative association was detected between the percentage of affected livers and the ADG (ρ=-0.44, P=0.053). In contrast, only in the German farms, correlations between the percentage of affected lungs at slaughter and elevated presence of A. suum and several other airway pathogens were detected. To conclude, this study indicates that serological screening for A. suum on fattening farms is an attractive new diagnostic tool that can be used to indicate the presence of roundworm infection by measuring infection intensity. Furthermore the results of this study also add weight to the evidence that both roundworm infections as well as herd exposure to airway pathogens have a significant

  1. Accuracy of Five Serologic Tests for the Follow up of Strongyloides stercoralis Infection

    PubMed Central

    Buonfrate, Dora; Sequi, Marco; Mejia, Rojelio; Cimino, Ruben O.; Krolewiecki, Alejandro J.; Albonico, Marco; Degani, Monica; Tais, Stefano; Angheben, Andrea; Requena-Mendez, Ana; Muñoz, José; Nutman, Thomas B.; Bisoffi, Zeno

    2015-01-01

    Background Traditional faecal-based methods have poor sensitivity for the detection of S. stercoralis, therefore are inadequate for post-treatment evaluation of infected patients who should be carefully monitored to exclude the persistence of the infection. In a previous study, we demonstrated high accuracy of five serology tests for the screening and diagnosis of strongyloidiasis. Aim of this study is to evaluate the performance of the same five tests for the follow up of patients infected with S. stercoralis. Methods Retrospective study on anonymized, cryo-preserved samples available at the Centre for Tropical Diseases (Negrar, Verona, Italy). Samples were collected before and from 3 to 12 months after treatment. The samples were tested with two commercially-available ELISA tests (IVD, Bordier), two techniques based on a recombinant antigen (NIE-ELISA and NIE-LIPS) and one in-house IFAT. The results of each test were evaluated both in relation to the results of fecal examination and to those of a composite reference standard (classifying as positive a sample with positive stools and/or at least three positive serology tests). The associations between the independent variables age and time and the dependent variable value of serological test (for all five tests), were analyzed by linear mixed-effects regression model. Results A high proportion of samples demonstrated for each test a seroreversion or a relevant decline (optical density/relative light units halved or decrease of at least two titers for IFAT) at follow up, results confirmed by the linear mixed effects model that showed a trend to seroreversion over time for all tests. In particular, IVD-ELISA (almost 90% samples demonstrated relevant decline) and IFAT (almost 87%) had the best performance. Considering only samples with a complete negativization, NIE-ELISA showed the best performance (72.5% seroreversion). Conclusions Serology is useful for the follow up of patients infected with S. stercoralis and

  2. Multiyear Serological Surveillance of Notifiable Influenza A Viruses in Belgian Poultry: A Retrospective Analysis.

    PubMed

    Marché, Sylvie; Houdart, Philippe; van den Berg, Thierry; Lambrecht, Bénédicte

    2016-05-01

    Surveillance of notifiable avian influenza (NAI) virus is mandatory in European member states, and each year a serological survey is performed to detect H5 and H7 circulation in poultry holdings. In Belgium, this serological monitoring is a combination of a stratified and a risk-based approach and is applied to commercial holdings with more than 200 birds. Moreover, a competitive nucleoprotein (NP) ELISA has been used as first screening method since 2010. A retrospective analysis of the serological monitoring performed from 2007 through 2013 showed sporadic circulation of notifiable low-pathogenicity avian influenza (LPAI) viruses in Belgian holdings with a fluctuating apparent flock seroprevalence according to years and species. Overall, the highest apparent flock seroprevalence was detected for the H5 subtype in domestic Anatidae, with 20%-50% for breeding geese and 4%-9% for fattening ducks. Positive serology against non-H5/H7 viruses was also observed in the same species with the use of the IDScreen influenza A antibody competition ELISA kit (ID-vet NP ELISA), and confirmed by isolation of H2, H3, H6, and H9 LPAI viruses. Among Galliformes, the apparent flock seroprevalence was lower, ranging between 0.3% and 1.3%. Circulation of notifiable LPAI viruses was only observed in laying hens with a similar seroprevalence for H5 and H7. Based on ID-vet NP ELISA results, no circulation of LPAI viruses, regardless the subtype, was observed in breeding chickens and fattening turkeys. Retrospectively, the use of an ELISA as first-line test not only reduced the number of hemagglutination inhibition tests to be performed, but also gave a broader evaluation of the prevalence of LPAI viruses in general, and might help to identify the most at-risk farms. PMID:27309088

  3. Multiyear Serological Surveillance of Notifiable Influenza A Viruses in Belgian Poultry: A Retrospective Analysis.

    PubMed

    Marché, Sylvie; Houdart, Philippe; van den Berg, Thierry; Lambrecht, Bénédicte

    2015-12-01

    Surveillance of notifiable avian influenza (NAI) virus is mandatory in European member states, and each year a serological survey is performed to detect H5 and H7 circulation in poultry holdings. In Belgium, this serological monitoring is a combination of a stratified and a risk-based approach and is applied to commercial holdings with more than 200 birds. Moreover, a competitive nucleoprotein (NP) ELISA has been used as first screening method since 2010. A retrospective analysis of the serological monitoring performed from 2007 through 2013 showed sporadic circulation of notifiable low-pathogenicity avian influenza (LPAI) viruses in Belgian holdings with a fluctuating apparent flock seroprevalence according to years and species. Overall, the highest apparent flock seroprevalence was detected for the H5 subtype in domestic Anatidae, with 20%-50% for breeding geese and 4%-9% for fattening ducks. Positive serology against non-H5/H7 viruses was also observed in the same species with the use of the IDScreen influenza A antibody competition ELISA kit (ID-vet NP ELISA), and confirmed by isolation of H2, H3, H6, and H9 LPAI viruses. Among Galliformes, the apparent flock seroprevalence was lower, ranging between 0.3% and 1.3%. Circulation of notifiable LPAI viruses was only observed in laying hens with a similar seroprevalence for H5 and H7. Based on ID-vet NP ELISA results, no circulation of LPAI viruses, regardless the subtype, was observed in breeding chickens and fattening turkeys. Retrospectively, the use of an ELISA as first-line test not only reduced the number of hemagglutination inhibition tests to be performed, but also gave a broader evaluation of the prevalence of LPAI viruses in general, and might help to identify the most at-risk farms. PMID:26629630

  4. 42 CFR 493.1207 - Condition: Syphilis serology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: Syphilis serology. 493.1207 Section 493.1207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1207 Condition: Syphilis serology. If the laboratory provides services in the subspecialty of...

  5. 42 CFR 493.835 - Standard; Syphilis serology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Standard; Syphilis serology. 493.835 Section 493.835 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.835 Standard; Syphilis serology. (a) Failure to attain an overall testing event...

  6. 42 CFR 493.835 - Standard; Syphilis serology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Standard; Syphilis serology. 493.835 Section 493.835 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.835 Standard; Syphilis serology. (a) Failure to attain an overall testing event...

  7. 42 CFR 493.835 - Standard; Syphilis serology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Syphilis serology. 493.835 Section 493.835 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.835 Standard; Syphilis serology. (a) Failure to attain an overall testing event...

  8. 42 CFR 493.1207 - Condition: Syphilis serology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Syphilis serology. 493.1207 Section 493.1207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1207 Condition: Syphilis serology. If the laboratory provides services in the subspecialty of...

  9. 42 CFR 493.1207 - Condition: Syphilis serology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Syphilis serology. 493.1207 Section 493.1207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1207 Condition: Syphilis serology. If the laboratory provides services in the subspecialty of...

  10. 42 CFR 493.1207 - Condition: Syphilis serology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: Syphilis serology. 493.1207 Section 493.1207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1207 Condition: Syphilis serology. If the laboratory provides services in the subspecialty of...

  11. 42 CFR 493.1207 - Condition: Syphilis serology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition: Syphilis serology. 493.1207 Section 493.1207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1207 Condition: Syphilis serology. If the laboratory provides services in the subspecialty of...

  12. 42 CFR 493.835 - Standard; Syphilis serology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Syphilis serology. 493.835 Section 493.835 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.835 Standard; Syphilis serology. (a) Failure to attain an overall testing event...

  13. 42 CFR 493.835 - Standard; Syphilis serology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard; Syphilis serology. 493.835 Section 493.835 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.835 Standard; Syphilis serology. (a) Failure to attain an overall testing event...

  14. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  15. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  16. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  17. 21 CFR 866.3740 - Streptococcus spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Streptococcus spp. serological reagents. 866.3740 Section 866.3740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3740...

  18. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  19. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  20. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  1. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  2. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  3. 21 CFR 866.3740 - Streptococcus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Streptococcus spp. serological reagents. 866.3740 Section 866.3740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3740...

  4. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  5. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  6. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  7. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  8. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  9. 21 CFR 866.3700 - Staphylococcus aureus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Staphylococcus aureus serological reagents. 866.3700 Section 866.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  10. 21 CFR 866.3550 - Salmonella spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Salmonella spp. serological reagents. 866.3550 Section 866.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3550...

  11. 21 CFR 866.3550 - Salmonella spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Salmonella spp. serological reagents. 866.3550 Section 866.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3550...

  12. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  13. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  14. 21 CFR 866.3740 - Streptococcus spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Streptococcus spp. serological reagents. 866.3740 Section 866.3740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3740...

  15. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  16. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  17. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  18. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  19. 21 CFR 866.3740 - Streptococcus spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Streptococcus spp. serological reagents. 866.3740 Section 866.3740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3740...

  20. 21 CFR 866.3700 - Staphylococcus aureus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Staphylococcus aureus serological reagents. 866.3700 Section 866.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  1. Systematic Review of Measles and Rubella Serology Studies.

    PubMed

    Thompson, Kimberly M; Odahowski, Cassie L

    2016-07-01

    Serological tests provide information about individual immunity from historical infection or immunization. Cross-sectional serological studies provide data about the age- and sex-specific immunity levels for individuals in the studied population, and these data can provide a point of comparison for the results of transmission models. In the context of developing an integrated model for measles and rubella transmission, we reviewed the existing measles and rubella literature to identify the results of national serological studies that provided cross-sectional estimates of population immunity at the time of data collection. We systematically searched PubMed, the Science Citation Index, and references we identified from relevant articles published in English. We extracted serological data for comparison to transmission model outputs. For rubella, serological studies of women of child-bearing age provide information about the potential risks of infants born with congenital rubella syndrome. Serological studies also document the loss of maternal antibodies, which occurs at different rates for the different viruses and according to the nature of the induced immunity (i.e., infection or vaccine). The serological evidence remains limited for some areas, with studies from developed countries representing a disproportionate part of the evidence. The collection and review of serological evidence can help program managers identify immunity gaps in the population, which may help them better understand the characteristics of individuals within their populations who may participate in transmission and manage risks. PMID:26077609

  2. 21 CFR 866.3270 - Flavobacterium spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Flavobacterium spp. serological reagents. 866.3270 Section 866.3270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  3. 21 CFR 866.3280 - Francisella tularensis serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Francisella tularensis serological reagents. 866.3280 Section 866.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 866.3415 - Pseudomonas spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pseudomonas spp. serological reagents. 866.3415 Section 866.3415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3415...

  5. 21 CFR 866.3010 - Acinetobacter calcoaceticus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Acinetobacter calcoaceticus serological reagents. 866.3010 Section 866.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  6. 21 CFR 866.3140 - Corynebacterium spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Corynebacterium spp. serological reagents. 866.3140 Section 866.3140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  7. 21 CFR 866.3065 - Bordetella spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bordetella spp. serological reagents. 866.3065 Section 866.3065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3065...

  8. 21 CFR 866.3300 - Haemophilus spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Haemophilus spp. serological reagents. 866.3300 Section 866.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3300...

  9. 21 CFR 866.3350 - Leptospira spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Leptospira spp. serological reagents. 866.3350 Section 866.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3350...

  10. 21 CFR 866.3360 - Lymphocytic choriomeningitis virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Lymphocytic choriomeningitis virus serological reagents. 866.3360 Section 866.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  11. 21 CFR 866.3360 - Lymphocytic choriomeningitis virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lymphocytic choriomeningitis virus serological reagents. 866.3360 Section 866.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  12. 21 CFR 866.3340 - Klebsiella spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Klebsiella spp. serological reagents. 866.3340 Section 866.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3340...

  13. 21 CFR 866.3175 - Cytomegalovirus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cytomegalovirus serological reagents. 866.3175 Section 866.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  14. 21 CFR 866.3395 - Norovirus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Norovirus serological reagents. 866.3395 Section 866.3395 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3395...

  15. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rubeola (measles) virus serological reagents. 866.3520 Section 866.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  16. 21 CFR 866.3320 - Histoplasma capsulatum serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Histoplasma capsulatum serological reagents. 866.3320 Section 866.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  17. 21 CFR 866.3255 - Escherichia coli serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Escherichia coli serological reagents. 866.3255 Section 866.3255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3255...

  18. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  19. 21 CFR 866.3020 - Adenovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Adenovirus serological reagents. 866.3020 Section 866.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3020...

  20. 21 CFR 866.3400 - Parainfluenza virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Parainfluenza virus serological reagents. 866.3400 Section 866.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3400...

  1. 21 CFR 866.3500 - Rickettsia serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rickettsia serological reagents. 866.3500 Section 866.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3500...

  2. 21 CFR 866.3340 - Klebsiella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Klebsiella spp. serological reagents. 866.3340 Section 866.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3340...

  3. 21 CFR 866.3360 - Lymphocytic choriomeningitis virus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Lymphocytic choriomeningitis virus serological reagents. 866.3360 Section 866.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  4. 21 CFR 866.3405 - Poliovirus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Poliovirus serological reagents. 866.3405 Section 866.3405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3405...

  5. 21 CFR 866.3300 - Haemophilus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Haemophilus spp. serological reagents. 866.3300 Section 866.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3300...

  6. 21 CFR 866.3085 - Brucella spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Brucella spp. serological reagents. 866.3085 Section 866.3085 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3085 Brucella...

  7. 21 CFR 866.3200 - Echinococcus spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Echinococcus spp. serological reagents. 866.3200 Section 866.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3200...

  8. 21 CFR 866.3250 - Erysipelothrix rhusiopathiae serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Erysipelothrix rhusiopathiae serological reagents. 866.3250 Section 866.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  9. 21 CFR 866.3255 - Escherichia coli serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Escherichia coli serological reagents. 866.3255 Section 866.3255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3255...

  10. 21 CFR 866.3040 - Aspergillus spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Aspergillus spp. serological reagents. 866.3040 Section 866.3040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3040...

  11. 21 CFR 866.3320 - Histoplasma capsulatum serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Histoplasma capsulatum serological reagents. 866.3320 Section 866.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  12. 21 CFR 866.3135 - Coccidioides immitis serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Coccidioides immitis serological reagents. 866.3135 Section 866.3135 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  13. 21 CFR 866.3255 - Escherichia coli serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Escherichia coli serological reagents. 866.3255 Section 866.3255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3255...

  14. 21 CFR 866.3065 - Bordetella spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bordetella spp. serological reagents. 866.3065 Section 866.3065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3065...

  15. 21 CFR 866.3380 - Mumps virus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mumps virus serological reagents. 866.3380 Section 866.3380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3380 Mumps...

  16. 21 CFR 866.3035 - Arizona spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Arizona spp. serological reagents. 866.3035 Section 866.3035 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3035 Arizona...

  17. 21 CFR 866.3205 - Echovirus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Echovirus serological reagents. 866.3205 Section 866.3205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3205...

  18. 21 CFR 866.3165 - Cryptococcus neoformans serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cryptococcus neoformans serological reagents. 866.3165 Section 866.3165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  19. 21 CFR 866.3145 - Coxsackievirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Coxsackievirus serological reagents. 866.3145 Section 866.3145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  20. 21 CFR 866.3050 - Beta-glucan serological assays.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Beta-glucan serological assays. 866.3050 Section 866.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3050...

  1. 21 CFR 866.3035 - Arizona spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arizona spp. serological reagents. 866.3035 Section 866.3035 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3035 Arizona...

  2. 21 CFR 866.3375 - Mycoplasma spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mycoplasma spp. serological reagents. 866.3375 Section 866.3375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3375...

  3. 21 CFR 866.3330 - Influenza virus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Influenza virus serological reagents. 866.3330 Section 866.3330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3330...

  4. 21 CFR 866.3200 - Echinococcus spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Echinococcus spp. serological reagents. 866.3200 Section 866.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3200...

  5. 21 CFR 866.3240 - Equine encephalomyelitis virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Equine encephalomyelitis virus serological reagents. 866.3240 Section 866.3240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  6. 21 CFR 866.3500 - Rickettsia serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Rickettsia serological reagents. 866.3500 Section 866.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3500...

  7. 21 CFR 866.3165 - Cryptococcus neoformans serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cryptococcus neoformans serological reagents. 866.3165 Section 866.3165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  8. 21 CFR 866.3125 - Citrobacter spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Citrobacter spp. serological reagents. 866.3125 Section 866.3125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3125...

  9. 21 CFR 866.3020 - Adenovirus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Adenovirus serological reagents. 866.3020 Section 866.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3020...

  10. 21 CFR 866.3205 - Echovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Echovirus serological reagents. 866.3205 Section 866.3205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3205...

  11. 21 CFR 866.3510 - Rubella virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rubella virus serological reagents. 866.3510 Section 866.3510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3510 Rubella...

  12. 21 CFR 866.3395 - Norovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Norovirus serological reagents. 866.3395 Section 866.3395 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3395...

  13. 21 CFR 866.3355 - Listeria spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Listeria spp. serological reagents. 866.3355 Section 866.3355 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3355 Listeria...

  14. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  15. 21 CFR 866.3085 - Brucella spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Brucella spp. serological reagents. 866.3085 Section 866.3085 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3085 Brucella...

  16. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  17. 21 CFR 866.3120 - Chlamydia serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chlamydia serological reagents. 866.3120 Section 866.3120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3120...

  18. 21 CFR 866.3300 - Haemophilus spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Haemophilus spp. serological reagents. 866.3300 Section 866.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3300...

  19. 21 CFR 866.3120 - Chlamydia serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chlamydia serological reagents. 866.3120 Section 866.3120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3120...

  20. 21 CFR 866.3240 - Equine encephalomyelitis virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Equine encephalomyelitis virus serological reagents. 866.3240 Section 866.3240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  1. 21 CFR 866.3240 - Equine encephalomyelitis virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Equine encephalomyelitis virus serological reagents. 866.3240 Section 866.3240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  2. 21 CFR 866.3490 - Rhinovirus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Rhinovirus serological reagents. 866.3490 Section 866.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3490...

  3. 21 CFR 866.3480 - Respiratory syncytial virus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Respiratory syncytial virus serological reagents. 866.3480 Section 866.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 866.3200 - Echinococcus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Echinococcus spp. serological reagents. 866.3200 Section 866.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3200...

  5. 21 CFR 866.3065 - Bordetella spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bordetella spp. serological reagents. 866.3065 Section 866.3065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3065...

  6. 21 CFR 866.3375 - Mycoplasma spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mycoplasma spp. serological reagents. 866.3375 Section 866.3375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3375...

  7. 21 CFR 866.3085 - Brucella spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Brucella spp. serological reagents. 866.3085 Section 866.3085 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3085 Brucella...

  8. 21 CFR 866.3135 - Coccidioides immitis serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Coccidioides immitis serological reagents. 866.3135 Section 866.3135 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  9. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  10. 21 CFR 866.3205 - Echovirus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Echovirus serological reagents. 866.3205 Section 866.3205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3205...

  11. 21 CFR 866.3050 - Beta-glucan serological assays.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Beta-glucan serological assays. 866.3050 Section 866.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3050...

  12. 21 CFR 866.3140 - Corynebacterium spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Corynebacterium spp. serological reagents. 866.3140 Section 866.3140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  13. 21 CFR 866.3405 - Poliovirus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Poliovirus serological reagents. 866.3405 Section 866.3405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3405...

  14. 21 CFR 866.3145 - Coxsackievirus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Coxsackievirus serological reagents. 866.3145 Section 866.3145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  15. 21 CFR 866.3355 - Listeria spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Listeria spp. serological reagents. 866.3355 Section 866.3355 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3355 Listeria...

  16. 21 CFR 866.3510 - Rubella virus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Rubella virus serological reagents. 866.3510 Section 866.3510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3510 Rubella...

  17. 21 CFR 866.3280 - Francisella tularensis serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Francisella tularensis serological reagents. 866.3280 Section 866.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  18. 21 CFR 866.3490 - Rhinovirus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Rhinovirus serological reagents. 866.3490 Section 866.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3490...

  19. 21 CFR 866.3500 - Rickettsia serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Rickettsia serological reagents. 866.3500 Section 866.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3500...

  20. 21 CFR 866.3050 - Beta-glucan serological assays.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Beta-glucan serological assays. 866.3050 Section 866.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3050...

  1. 21 CFR 866.3020 - Adenovirus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Adenovirus serological reagents. 866.3020 Section 866.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3020...

  2. 21 CFR 866.3020 - Adenovirus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Adenovirus serological reagents. 866.3020 Section 866.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3020...

  3. 21 CFR 866.3250 - Erysipelothrix rhusiopathiae serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Erysipelothrix rhusiopathiae serological reagents. 866.3250 Section 866.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Rubeola (measles) virus serological reagents. 866.3520 Section 866.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  5. 21 CFR 866.3145 - Coxsackievirus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Coxsackievirus serological reagents. 866.3145 Section 866.3145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  6. 21 CFR 866.3125 - Citrobacter spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Citrobacter spp. serological reagents. 866.3125 Section 866.3125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3125...

  7. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  8. 21 CFR 866.3125 - Citrobacter spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Citrobacter spp. serological reagents. 866.3125 Section 866.3125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3125...

  9. 21 CFR 866.3280 - Francisella tularensis serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Francisella tularensis serological reagents. 866.3280 Section 866.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  10. 21 CFR 866.3330 - Influenza virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Influenza virus serological reagents. 866.3330 Section 866.3330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3330...

  11. 21 CFR 866.3340 - Klebsiella spp. serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Klebsiella spp. serological reagents. 866.3340 Section 866.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3340...

  12. 21 CFR 866.3305 - Herpes simplex virus serological assays.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Herpes simplex virus serological assays. 866.3305 Section 866.3305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3305...

  13. 21 CFR 866.3205 - Echovirus serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Echovirus serological reagents. 866.3205 Section 866.3205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3205...

  14. 21 CFR 866.3415 - Pseudomonas spp. serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pseudomonas spp. serological reagents. 866.3415 Section 866.3415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3415...

  15. 21 CFR 866.3040 - Aspergillus spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Aspergillus spp. serological reagents. 866.3040 Section 866.3040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3040...

  16. 21 CFR 866.3035 - Arizona spp. serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Arizona spp. serological reagents. 866.3035 Section 866.3035 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3035 Arizona...

  17. 21 CFR 866.3145 - Coxsackievirus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Coxsackievirus serological reagents. 866.3145 Section 866.3145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  18. 21 CFR 866.3320 - Histoplasma capsulatum serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Histoplasma capsulatum serological reagents. 866.3320 Section 866.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  19. 21 CFR 866.3510 - Rubella virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rubella virus serological reagents. 866.3510 Section 866.3510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3510 Rubella...

  20. 21 CFR 866.3010 - Acinetobacter calcoaceticus serological reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Acinetobacter calcoaceticus serological reagents. 866.3010 Section 866.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  1. 21 CFR 866.3470 - Reovirus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Reovirus serological reagents. 866.3470 Section 866.3470 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3470...

  2. 21 CFR 866.3405 - Poliovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Poliovirus serological reagents. 866.3405 Section 866.3405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3405...

  3. 21 CFR 866.3480 - Respiratory syncytial virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Respiratory syncytial virus serological reagents. 866.3480 Section 866.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 866.3120 - Chlamydia serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chlamydia serological reagents. 866.3120 Section 866.3120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3120...

  5. 21 CFR 866.3360 - Lymphocytic choriomeningitis virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lymphocytic choriomeningitis virus serological reagents. 866.3360 Section 866.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  6. 21 CFR 866.3350 - Leptospira spp. serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Leptospira spp. serological reagents. 866.3350 Section 866.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3350...

  7. 21 CFR 866.3010 - Acinetobacter calcoaceticus serological reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Acinetobacter calcoaceticus serological reagents. 866.3010 Section 866.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  8. 21 CFR 866.3270 - Flavobacterium spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Flavobacterium spp. serological reagents. 866.3270 Section 866.3270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  9. 21 CFR 866.3380 - Mumps virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mumps virus serological reagents. 866.3380 Section 866.3380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3380 Mumps...

  10. 21 CFR 866.3400 - Parainfluenza virus serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Parainfluenza virus serological reagents. 866.3400 Section 866.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3400...