Differential Reactivity of anti-hepatitis C Virus Screening Assays in Patients With Waning Antibodies

Abstract

Hepatitis C virus (HCV) leads to persistent infection. Viral clearance can be obtained through pharmacological treatment or spontaneously. After viral clearance, anti-HCV antibodies (Abs) slowly decline and finally disappear. Subjects with a resolved HCV infection are reactive to anti-HCV screening assays for a long time. These subjects pose a diagnostic challenge, and therefore, a more accurate interpretation of laboratory tests is needed for cases with resolved HCV infection. However, the performances of anti-HCV screening assays against declining anti-HCV Abs have not been assessed. Here we evaluated 1509 samples with different screening assays. Screening assays provided discrepant results in patients with waning Abs. The identification of signal-to-cut-off values indicative of waning Abs for each anti-HCV assay could avoid unnecessary confirmatory tests and reduce the impact of misdiagnosis.

Keywords:

• anti-HCV screening assay
• anti-HCV waning antibodies
• HCV confirmatory assay
• HCV infection

Financial & competing interests disclosure

This work was possible thanks to the financial support provided by Siemens Healthcare S.r.l., Italy. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.