Abstract
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 centers/banks.
Methods
A total of 1,309 samples containing 582 anti-HCV screening negatives and 727 positives collected from 15 blood centers/banks 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 RIBA and HCV RNA tests.
Results
There were 963 true negatives, 261 positives, and 85 indeterminate samples. False positive rate of screening testing was 52.54% (382/727). 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. RIBA indeterminate samples showed quite different S/CO ratios detected by Roche compared with RIBA positives (4.84 vs 19.36, P < 0.0001), and higher S/CO ratios than RIBA negatives (4.84 vs 2.94, P = 0.020). However, there was no difference among the three groups when detected by Abbott. Also, the antigen distribution and band intensity were different between indeterminate and RIBA positive. 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.
Hepatitis C virus antibody positive blood donors.