Abstract
BackgroundAll commercial Hepatitis C virus antibody (anti-HCV) assays use a combination of recombinant antigens to detect antibody response. Antibody responses to individual antigenic regions (core, NS3/4 and NS5) used in assays have not been investigated.MethodsIn this study, we quantified HCV viral load, tested anti-HCV with four commercial assays (Ortho-ELISA, Murex-ELISA, Architect-CMIA and Elecsys-ECLIA) in 682 plasma specimens. In antigenic region ELISA platform, microwells were coated with three antigens: core (c22-3), NS3/4 (c200) and NS5 individually. The signal-to-cutoff (S/Co) values of different assays, and antibody responses to individual antigens were compared. The specimens were divided into HCV RNA positive group, anti-HCV consistent group, and anti-HCV discrepant group.ResultsAnti-core and anti-NS3/4 were simultaneously detected in 99.2% of HCV RNA positive specimens and showed great consistency with total anti-HCV signals. Responses to the core region were more robust than those to the NS3/4 region in anti-HCV consistent group (p < 0.001). Anti-NS5 only occurred in companying with responses to the core and NS3/4 antigens, and failed to affect the final anti-HCV positive signals. In anti-HCV discrepant group, 39.0% of positive signals could not be traced back to any single antigenic region.ConclusionAntibody responses to the core and NS3/4 antigens were stronger, whereas responses to the NS5 antigen were the weakest, indicating that individual antigenic regions played different roles in total anti-HCV signals. This study provides an impetus for optimizing commercial anti-HCV assays.
Highlights
Chronic hepatitis C virus (HCV) infection is a public health problem worldwide
These specimens were primary screened with Enzyme immunoassay (EIA) assays mentioned previously [20] and transported on dry ice to National Center for Clinical Laboratories (NCCL) in Beijing
The recombinant core protein was named c22-3, the recombinant NS3 (c33c) and NS4 (c100-3) proteins were fused into a new protein c200. c22-3, c200 and NS5 recombinant antigens were coated on microplates to form the anti-HCV detection platform [22]
Summary
Chronic hepatitis C virus (HCV) infection is a public health problem worldwide. In 2015, the World Health Organization (WHO) estimated that 1% (71 million) ofJiang et al Virol J (2021) 18:137WHO set the goals for HCV elimination with an 80% reduction in new infections and 65% reduction in liverrelated mortality by 2030 [4]. The seroconversion period from the incident infection to the detection of anti-HCV was 4–6 months and the falsepositive rate was up to 70% in blood donors from low endemic areas [10]. To overcome these drawbacks, second-generation assays contained recombinant antigen from the NS3 (c33c) and NS4 (5-1-1p) regions together with an antigen (c22-3) from the core region, shortening the average seroconversion period to 10 weeks [11]. Regardless of the format used, the CIA or the EIA screening tests have generated notable discrepant results, in low-prevalence populations, with supplemental assays for anti-HCV confirmation always required. Antibody responses to individual antigenic regions (core, NS3/4 and NS5) used in assays have not been investigated
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