Analysis of difference of result of anti-HCV detected by ELISA kit from different manufacturer

Objective To explore the difference in the results of anti-hepatitis C virus(HCV) detected by enzyme-linked immunosorbent assay(ELISA) kit from different manufacturer. Methods Using the third-generation anti-HCV ELISA kit of four different manufacturers to test 62 anti-HCV positive serum samples tested by Shanghai Kehua ELISA kit,those samples with inconsistent positive and negative results were further confirmed by MP HCV BLOT3.0 test. Results Number of positive reaction by A,B,C,D four reagents was 59,50,43 and 53 respectively.Statistically,reagent B and C,B and D had no significant difference(P0.05);the difference between reagent C and D was significant(P0.05).37 samples were positive by four ELISA kits,25 samples with inconsistent positive or negative results were tested by MP HCV BLOT 3.0, 9 samples were confirmed as positive. Conclusions There are considerable differences of anti-HCV tested by different ELISA kits,which indicates that the reagents for screening should be highly sensitive,and should select a highly sensitive and specific detection reagent for re-test.It can be concluded anti-HCV positive when the results in two detection reagents are both positive and sample absorbency/cut off(S/CO) value is ≥3.8.While the test result is positive but its S/CO value ≤(3.8) or the outcome is negative by one ELISA kit,we propose to use recombinant immunoblot assay(RIBA) for confirmation.