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Keywords:

Enzyme immunoassay, Hepatitis C, Hepatitis C antibodies, Laboratory diagnosis, Science & Technology, Life Sciences & Biomedicine, Virology, hepatitis C, hepatitis C antibodies, enzyme immunoassay, laboratory diagnosis, HEPATITIS-C VIRUS, DETECTION ASSAYS, BLOOD-DONORS, INFECTION, DIAGNOSIS, INDETERMINATE, SEROREVERSION, MANAGEMENT, RNA, Hepacivirus, Hepatitis C Antibodies, Humans, Immunoblotting, Immunoenzyme Techniques, Polymerase Chain Reaction, RNA, Viral, Sensitivity and Specificity, United Kingdom, 0605 Microbiology, 1103 Clinical Sciences, 1108 Medical Microbiology, 3202 Clinical sciences, 3207 Medical microbiology

Abstract:

Background: Centers for Disease Control (CDC) guidelines require confirmation of hepatitis C virus (HCV) screening-test-positive sera with a low signal/cut-off (S/CO) ratio by recombinant immunoblot or PCR. The UK Health Protection Agency has suggested that a second enzyme immunoassay (EIA) could be used as an alternative for confirmation in non-immunocompromised patients. Objective: To evaluate the UK HPA approach in 17,936 consecutive in-house sera submitted for HCV testing. Study design: AxSYM-positive sera (S/CO≥1.0) were tested with Monolisa Plus. AxSYM-positive sera of patients that were confirmed PCR-positive were considered HCV+. All other AxSYM-positive sera were confirmed with immunoblot according to CDC guidelines. Results: 17,299 sera were negative with AxSYM. Of the 637 AxSYM-positive sera, 384 were from patients confirmed as PCR-positive. Of other 250 sera, 120 were negative with immunoblot, 103 were positive and 30 were indeterminate. All 30 immunoblot-indeterminate sera were PCR-negative. Two patients were Monolisa Plus+ and immunoblot− and PCR−. One patient was known as immunoblot−, while the other patientwas diagnosed with non-A non-B hepatitis in 1980s. Nine sera from HCV-positive patients were Monolisa Plus−. Two PCR−sera were from immunocompetent patients who were PCR− for ≥8 years and six PCR− sera and one PCR+ serum were from immunocompromised patients. Sensitivity and specificity of confirmation with Monolisa Plus were 98.15% and 98.33% and the positive and negative predictive values were 99.58% and 92.91% in AxSYM-positive sera (excluding immunoblot-indeterminate/PCR-negative sera). If immunocompromised patients that were false-negative were excluded, sensitivity was 99.58%. Conclusion: Monolisa Plus can be used as an alternative to immunoblot for the confirmation of AxSYM-positive sera.