Performance evaluation and comparison of the newly developed Elecsys anti-HCV II assay with other widely used assays

• Published in: Clinica chimica acta 2013-11, Vol.426, p.95-101
• Main Authors: Yang, Ruifeng, Guan, Wenli, Wang, Qian, Liu, Yan, Wei, Lai
• Format: Article
• Language: English
• Subjects: Anti-HCV; Architect anti-HCV; Clinical Laboratory Techniques - methods; Elecsys anti-HCV II; Genotype; Hepacivirus - immunology; Hepatitis C - blood; Hepatitis C - diagnosis; Hepatitis C - virology; Hepatitis C Antibodies - blood; Hepatitis C Antibodies - immunology; Hepatitis C virus; Humans; Sensitivity and Specificity; Vitros anti-HCV
• ISSN: 0009-8981; 1873-3492
• DOI: 10.1016/j.cca.2013.09.010

Anti-HCV assays remain the first choice for screening HCV infection in most clinical laboratories. The Elecsys anti-HCV II assay has been recently launched and we aimed to evaluate its performance compared with other widely used methods. Four seroconversion panels, 861 consecutive sera under routine clinical conditions, 100 preselected sera with low positive anti-HCV results and 178 samples from patients infected with HIV were tested using Elecsys anti-HCV II, Architect anti-HCV and Vitros anti-HCV assays. Confirmatory testing was performed using RIBA and HCV RNA tests. Moreover, 203 samples with different HCV genotypes were assessed using Elecsys anti-HCV II. Elecsys anti-HCV II detected seroconversion 7–14days earlier than the Architect and Vitros assays. Furthermore, it had 100% sensitivity and superior specificity in screening routine clinical samples, including those with low positive anti-HCV, and detected 97.6% (122/125) anti-HCV-positive samples from HIV-infected patients with HCV viremia. However, the anti-HCV levels in the genotype 3b samples were slightly underestimated. Elecsys anti-HCV II shortens the seroconversion window. It is suitable for screening HCV infection in clinical samples, including those from immunocompromised patients, due to the excellent sensitivity and specificity. Further investigation of the subtype inclusivity in a larger sample number might be warranted. •We compared the performance of three commercially available anti-HCV immunoassays.•Elecsys anti-HCV II was sensitive in detecting seroconversion and clinical samples.•Elecsys showed good specificity in distinguishing samples with weak anti-HCV.•Elecsys detected HCV infection in 97.6% of samples co-infected with HIV.•Elecsys slightly underestimated anti-HCV titers in genotype 3b samples.