Clinical evaluation of the signal-to-cutoff ratios of hepatitis C virus antibody screening tests used in China

✍ Scribed by Shiji Wu; Yanling Liu; Liming Cheng; Botao Yin; Jing Peng; Ziyong Sun

• Publisher: John Wiley and Sons
• Year: 2011
• Tongue: English
• Weight: 305 KB
• Volume: 83
• Category: Article
• ISSN: 0146-6615
• DOI: 10.1002/jmv.22168

✦ Synopsis

Abstract

The clinical diagnosis of hepatitis C virus (HCV) infection is important to direct an accurate course of therapy. Previous studies have reported a correlation between the signal‐to‐cutoff (S/CO) ratios of the anti‐HCV screening test and confirm HCV infections for American anti‐HCV screening kits as well as for those in China. It is currently unknown whether clinical laboratories use the same threshold S/CO ratios under routine conditions and if these values are acceptable for the analysis of Chinese samples. A total of 336 anti‐HCV screening‐test‐positive serum samples were tested in duplicate using different lots of three most commonly used enzyme immunoassay (EIA) kits available in China. Samples were also tested using the Architect Anti‐HCV chemiluminescent microparticle immunoassay (CMIA) kit and measured for HCV RNA. Recombinant immunoblot assays (RIBA) were additionally performed on samples with HCV RNA‐negative results with RIBA HCV 3.0. The relationship between S/CO ratios and confirmed HCV infection rates were analyzed. The threshold S/CO ratio for each screening kit correlated with the ≥95% positive predictive value was InTec 12.0, KHB 4.0, Wantai 5.0, and Abbott Architect 5.0. Therefore, the same threshold S/CO ratios for manufactured domestically EIA kits was difficult to attain. A multi‐center study with a large sample size is required to identify a uniform threshold S/CO ratio for use in different diagnostic laboratories. Alternatively, individual laboratories may be required to establish threshold S/CO ratios in their own laboratories to obtain consistent diagnostic results. J. Med. Virol. 83:1930–1937, 2011. © 2011 Wiley‐Liss, Inc.