Development of low cost peptide-based anti-hepatitis C virus screening and confirmatory assays: comparison with commercially available tests.

Screening and confirmatory low cost reagent tests have been developed for detection of anti-hepatitis C virus (HCV). Assays are based on the use of specific synthetic peptides from several structural and non-structural viral proteins. The efficacy of the screening anti-HCV EIA-Spep assay was compared with both Abbott EIA 2.0 (Abbott Laboratories, North Chicago, IL) and Ortho EIA 2.0 (Ortho Diagnostic Systems, Raritan, NJ) anti-HCV detection kits and the confirmatory EIA-Cpep assay was compared with the Abbott Matrix anti-HCV confirmation test. In the EIA-Spep, a pool of 3 peptides was added to each well of a microtiter plate. In EIA-Cpep, each well was separately coated with 1 of 4 peptides and 1 recombinant protein. A total of 867 blood donor samples from Costa Rica tested simultaneously with the 3 screening assays yielded the same specificity and negative predictive values of > or =99.9% and 100%, respectively. A comparative study on voluntary blood donor samples from Honduras, Nicaragua, and El Salvador using the 2 anti-HCV confirmatory assays revealed different patterns that are 46% positive, 24% indeterminate, and 30% negative with the EIA-Cpep assay vs. 31% positive, 48% indeterminate, and 21% negative with the Matrix assay. A study of 71 patient samples from Costa Rica showed a higher correlation between initially reactive samples when analyzed by the Abbott and Ortho kits, than when the assay results were compared between the Abbott and EIA-Spep kits; the latter detected 7 and 15 non-reactive samples, respectively. These results could reflect the use of a similar antigen source for the 2 commercial assays. The presence of HCV RNA in a group of 29 samples analyzed was related to the simultaneous reactivity in all 3 screening assays. None of the discordant samples had detectable levels of HCV RNA. Economic difficulties for health care services in the developing countries of Central America have prevented implementation of routine anti-HCV blood donor screening tests. This is likely to be the primary reason for uncontrolled dissemination of HCV, and the lack of identification of potential high risk groups. Alternative low cost reagents developed locally as described in this article could be a useful tool in the control of HCV spread throughout the developing world.