Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO ‐ LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?

BACKGROUND: The objective of this study is to evaluate whether the rapid lateral flow immunochromatography Geenius HCV Supplemental Assay (ICH) can serve as an alternative to INNO-LIA HCV Score Confirmatory western blot (WB) assay in a population of blood donors. METHODS: Sera of 60 blood donors, anti-HCV antibodies repeatedly reactive after first line screening with Architect anti-HCV chemiluminescent immunoassay, (ABBOTT, Wiesbaden, Germany) (ICL) were evaluated for anti-HCV antibodies with Geenius HCV Supplemental assay (Bio-Rad. Marnes-la-Coquette-France) (ICH) and Inno-LIA HCV Score (Inogenetics NV. Gent. Belgium) (Inno-LIA WB). The level of agreement between ICH and WB results was determined by kappa statistics. RESULTS: Out of 60 samples identified as anti-HCV antibodies repeatedly reactive by ICL, ICH identified 32% samples as reactive and 2% as indeterminate. WB identified 35% samples as positive and 20% as indeterminate. Kappa analysis detected moderate agreement between ICH and WB in detecting anti-HCV antibodies (kappa = 0.60). Moderate to almost very good agreement is acknowledged between ICH and WB in reactivity with individual HCV antigens. CONCLUSION: Given the limited number of samples analyzed in this study we can summarize that Geenius HCV Supplemental and Inno-LIA WB assays are comparable pertaining to anti-HCV positive samples, but with discrepancy in results occurring in the area of samples classified with WB assay as indeterminate. However, there is very good agreement between Inno-LIA WB and Geenius ICH positivity/reactivity with individual HCV antigens. Our findings indicate that Geenius ICH Supplemental test cannot replace anti-HCV Inno-LIA WB in confirming anti-HCV antibodies.