Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Query Trace: de Castro VL[original query] |
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An automated immunoblot method for detection of IgG antibodies to hepatitis C virus: A potential supplemental antibody confirmatory assay
Kodani M , Martin M , de Castro VL , Drobeniuc J , Kamili S . J Clin Microbiol 2019 57 (3) An estimated 41,200 people were newly infected with hepatitis C virus (HCV) in 2016 in the United States. Screening tests for antibodies to HCV may generate up to 32% false positivity in low-risk populations. Current Centers for Disease Control and Prevention (CDC) screening recommendations do not require confirmatory testing of a screening anti-HCV positive test, however confirmation is valuable for surveillance in the absence of HCV RNA testing. Recombinant Immunoblot Assay (RIBA) was used as a confirmatory assay for anti-HCV reactive samples but was discontinued in 2013. Another anti-HCV confirmatory assay, INNO-LIA, is commercially available in Europe but not approved by the Food and Drug Administration (FDA) in the United States. We report the development of an anti-HCV assay performed on an automated immunoblot platform using a fourth generation HCV recombinant fusion protein. Based on testing of 70 well characterized samples of which 40 were HCV RNA and anti-HCV positive, 15 HCV RNA positive/anti-HCV negative and 15 HCV RNA and anti-HCV negative, the specificity and sensitivity of the HCV-WES assay was 100% and 95%, respectively. Concordance between INNO-LIA and HCV WES, was determined by testing 205 HCV RNA negative/anti-HCV positive samples, of which 149 (72.7%) were positive by HCV-WES, while 146 (71.2%) were positive by INNO-LIA. We have shown proof of concept for the use of this test for confirmation of screening anti-HCV results. The HCV-WES assay is advantageous over manual western blot assays and INNO-LIA including ease of use, low cost and reduced hands-on time. |
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