Lack of correlation between sensitivity characteristics of the tests for hepatitis C virus antibodies estimated with serially diluted and natural low-reactive control specimens

Abstract

Sensitivity characteristics of seven commercial ELISA test systems for the detection of antibodies to hepatitis C virus were assessed using control panels consisting of: (i) serial dilutions of pooled sera highly reactive for anti-HCV; (ii) serial dilutions of RIBA 3.0 HCV SIA positive control; and (iii) natural (non-diluted, non-spiked) sera low-reactive for anti-HCV. "Dilutional sensitivity" values estimated with these two kinds of highly reactive samples did not coincide and were not found to correlate with the proportion of natural low-reactive specimens detected by each test. Thus, laboratories assessing sensitivity of anti-HCV ELISAs should take into consideration the nature and properties of the control material used. Natural low-reactive control specimens are preferable because they adequately reflect the real serological picture of early stage of HCV infection.