Comparison of the two test procedures of ORTHO HCV 3.0 ELISA test system for blood donor screening

Objective To check if there was a difference between the two test procedures of ORTHO HCV 3.0 ELISA test system for the blood donor screening.Methods A total of 180 storage samples,which were screened out from the routine blood donors,underwent anti-HCV detection and the supplementary assays of HCV RNA.RIBA and other anti-HCV ELISA kit were implemented.The samples were tested repeatedly with two test procedures of ORTHO HCV 3.0 ELISA assay,and both of the trials were performed according to the operation instruction manually under the same experimental condition.Results The results of 16 out of 180 samples were inconsistent,and 5 samples were reactive with short incubation test procedure,and 11 samples were reactive with standard incubation test procedure.Two confirmed anti-HCV positive samples were missed by short incubation test procedure.The standard incubation test procedure of ORTHO HCV 3.0 ELISA was much more sensitivity.The S/CO value distribution between two test procedures showed no significant differences,but some of the S/CO values of RIBA indeterminate samples were within certain range of the gray zone.Conclusion For the blood donor population screening,both the choice of a much more sensitive anti-HCV test procedure and a reasonable establishment of gray zone are necessary for preventing the transfusion transmitted infected hepatitis C virus.