Evaluation of the Elecsys registered Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection

Background Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission. Objectives To evaluate the Elecsys registered Anti-HCV II assay as a routine screening assay in Asia using a large number of samples from different Asian Pacific populations and compare its performance with other HCV assays routinely used in the region. Study design The sensitivity and specificity of the Elecsys registered Anti-HCV II assay were determined using routine hospital samples and compared with at least one of the following comparator assays at nine independent centers: ARCHITECT(TM) Anti-HCV; Serodia registered -HCV Particle Agglutination; Vitros registered ECi Anti-HCV; Elecsys registered Anti-HCV; ADVIA Centaur registered HCV; InTec registered HCV EIA; or Livzon registered Anti-HCV. Commercially available seroconversion panels were used to assess sensitivity for early detection of infection. Results The Elecsys registered Anti-HCV II assay was more sensitive in recognizing early infection and detected acute HCV infection earlier on average than the comparator assays for all six panels tested. 7,726 routine samples were tested and 322 identified as HCV positive. Elecsys registered Anti-HCV II had a sensitivity of 100% and a specificity of 99.66%, both of which were comparable or superior to the results obtained for competitor assays, which ranged from 87.5-100% and 98.98-100%, respectively. Conclusions The Elecsys registered Anti-HCV II assay has the sensitivity and specificity to support its use as a routine screening method in the Asia Pacific region. Furthermore, this assay shortens the diagnostic window between infection and the detection of antibodies compared with established methods.