Background: Recent data on the evaluation of screening serological assays on anti-HCV among a large sample of blood donors is lacking. The present study aimed to perform a multicenter evaluation of EIAs and CLIAs for detection of anti-HCV among blood donors in 16 different Chinese blood establishments.Methods: A total of 1,309 samples containing 582 anti-HCV screening negatives and 727 positives collected from 15 blood establishments all over China. A total of 10 different anti-HCV assays (8 EIAs and 2 CLIAs) were evaluated in 16 different blood centers/banks. Confirmatory testing was performed using recombinant immunoblot assay and HCV RNA tests.Results: There were 963 true negatives, 261 positives, and 85 indeterminate samples. False positive rate of screening testing was 39.67% (382/963) and the positive prediction value was only 35.76% (260/727). Roche and InTec had the highest sensitivity (98.47%) and KHB and Wantai (indirect EIA) had the highest specificity (99.23%). Ortho/Abbott together with InTec could detect all the true positives. Among samples with discrepant results by different assays, indeterminate samples showed quite different S/CO ratios detected by Roche compared with confirmed positives (4.84 vs 19.36, P<0.0001), and higher signal to cutoff (S/CO) ratios than confirmed negatives (4.84 vs 2.94, P=0.020). However, there was no difference among the three groups when detected by Abbott. When S/CO ratio went to 8.2 on Roche and 4.2 on Abbott, the PPV could achieve more than 95%.Conclusion: False reactive problem of anti-HCV screening should be solved urgently. RIBA indeterminate donations may be a special group, should be further studied.
Background: Recent data on anti-HCV screening assays among large population of blood donors is limited. The present study aimed to perform a multicenter evaluation of EIAs and CLIAs for detection of anti-HCV among blood donors in 16 different Chinese blood establishments.Methods: A total of 1,309 samples including 582 anti-HCV screening negatives and 727 positives collected from 15 blood establishments all over China. Ten different anti-HCV assays (eight EIAs and two CLIAs) were evaluated in 16 different blood centers/banks. Confirmatory testing was performed using recombinant immunoblot assay and HCV RNA tests.Results: The plasma panel contained 963 negative samples, 261 positives, and 85 indeterminate samples, based on the results of confirmatory test. False positive rate of screening tests was 39.67% (382/963) and the positive prediction value was only 35.76% (260/727). Among ten anti-HCV assays, Roche and InTec had the highest sensitivity (98.47%), while KHB and Wantai (indirect) had the highest specificity (99.23%). Then we analyzed the combined performance of these assays with two assays’ strategy widely used in China: Ortho or Abbott together with InTec could find all the true positives and Wantai (indirect) with Livzon (sandwich) got a highest specificity of 97.80%. Indeterminate samples showed quite different signal to cutoff (S/CO) ratios tested by Roche compared with confirmed positives (4.84 vs 19.36, p<0.0001), and higher S/CO ratios than confirmed negatives (4.84 vs 2.94, p=0.020). Conclusion: False reactivity in anti-HCV screening should be treated as urgent issue. RIBA indeterminate donations may be a special group, while it still worth to be further studied.
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