How to Interpret Borderline HCV Antibody Test Results: A Comparative Study Investigating Four Different Anti-HCV Assays
| العنوان: | How to Interpret Borderline HCV Antibody Test Results: A Comparative Study Investigating Four Different Anti-HCV Assays |
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| المؤلفون: | Markus Cornberg, Heiner Wedemeyer, R. Raupach, Benjamin Maasoumy, P. Lehmann, Birgit Bremer, Michael P. Manns |
| المصدر: | Viral Immunology. 27:7-13 |
| بيانات النشر: | Mary Ann Liebert Inc, 2014. |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Concordance, Immunoblotting, Immunology, Hepacivirus, Sensitivity and Specificity, Gastroenterology, Virology, Internal medicine, Humans, Medicine, Hematologic Tests, Plasma samples, business.industry, Anti hiv, virus diseases, Hepatitis C Antibodies, Hepatitis C, Chronic, Middle Aged, HCV Antibody, Management implications, Molecular Medicine, Female, Reagent Kits, Diagnostic, business |
| الوصف: | Anti-HCV testing is the first step to diagnose hepatitis C. Although anti-HCV assay performance improved during the last 2 decades, very high sensitivity required for screening may lead to limitations in specificity. Thus, there remains an uncertainty how to interpret anti-HCV test results with a borderline signal-to-cut-off ratio. Comparison was made of concordance and performance of four licensed anti-HCV assays in samples with borderline signal-to-cut-off ratios. Out of 12,090 consecutive samples tested for anti-HCV with the Abbott Architect Anti-HCV assay over a period of 29 months, 95 plasma samples with a signal-to-cut-off ratio between 0.5 and 2 were selected for this study. All samples were re-tested with the Enzygnost Anti-HCV version 4.0, the Ortho anti-HCV version 3.0, and the Monolisa anti-HCV-Plus version 2 assays. Discordant samples were classified by additional immunoblot testing. Overall, only 52% of the Architect borderline samples gave similar results in all four assays. Inter-assay concordance ranged between 58% and 80%. The highest discordance was observed between the Architect and the Monolisa assay (42%). In contrast, a high level of concordance was found between the Enzygnost and Ortho assays (80%). The Monolisa was best to identify negative samples (100%), while the Enzygnost correctly classified most of the positive samples (96%). Anti-HCV antibody assays show significant variation in classifying samples with low signal-to-cut-off ratios. Different performances may have cost and management implications, as false-positive results are not infrequent. However, sensitivities were good for all assays if indeterminate results are not considered as negative. |
| تدمد: | 1557-8976 0882-8245 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5a53b1f8793ac3bf015970e65abc641Test https://doi.org/10.1089/vim.2013.0064Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....e5a53b1f8793ac3bf015970e65abc641 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15578976 08828245 |
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