COMPARISON OF THE RESULTS OF DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS REAGENTS FROM DIFFERENT MANUFACTURERS

Abstract

We conducted a comparative characteristic analysis of the four kits Anti-HCV Abbott (AbHCV), Anti-HCV II Roche (RoHCV), Vector-best Anti-HCV spectrum ELISA (VeHCVsp) and Vector-best screening ELISA (VeHCVsc) to select screening and confirming method measurement antibody to hepatitis C virus (anti-HCV) considering Se, Sp.We evaluated 321 samples in the three stages. At the first stage after examining 214 primary positive in screening samples we received conflicting results AbHCV, VbHCVsp and RocHCV with discrepancies in 12.6% of cases. In the second phase, we selected 67 samples with conventionally border values cut-off that is “weakly positive” or “doubtful negative” results. Differences for this group was 17.9%. In the third phase, we selected 40 conventionally border results samples (CBRS). We used for comparison immunoblotting method “Recomline HCV IgG”, Microgen diagnostic (MGHCV). We evaluated Se with positive and doubtful MGHCV results, Sp - with negative results. Se: AbbHCV = 75,0%, RocHCV = 60,0%, VbHCV = 50,0%. Sp: AbbHCV = 5,0%, RocHCV = 75,0%, VbHCV = 95,0%. To understand the causes of discrepancies of various kits, we conducted an analysis HCV antigens (Core 1, Core 2, Helicase, NS3, NS4, NS5). The uncertainty of the results for CBRS is determined by different design of recombinant molecules used each kit. Therefore, at the stage of screening samples for HCV antibodies will always be samples with conflicting results. The best decision for screening is a combination of primary screening and retesting of positive samples to use kits with the “opposite” benefits.