Performance of the ELITe InGenius system for hepatitis B virus DNA quantification

Abstract

Measurement of hepatitis B virus (HBV) DNA levels is the standard of care for diagnosis active HBV infection, assessing disease severity and prognosis, and guiding treatment decisions and monitoring response to therapy. In the study, the analytical and clinical performance of the ELITe InGenius System for quantifying HBV DNA was evaluated. A total of 377 of archived EDTA plasma or serum specimens were tested. The HBV ELITe MGB Kit demonstrated linear quantification of HBV DNA with high precision. The specificity was 100 %. There was a satisfactory correlation with the cobas HBV Test, including patients on antiviral treatment with nucleos(t)ide analogues. The HBV ELITe MGB Kit using the ELITe InGenius System is suitable to detect and quantify HBV DNA in HBsAg-positive patients across the entire quantification dynamic range.