Nucleic acid testing of human immunodeficiency virus and hepatitis C virus among blood donors from five cities of China: estimation of residual transfusion risk

Objective We conducted a multi blood center study in China to evaluate the NAT donor screening technology and to study the current residual transfusion risks for HIV and HCV among Chinese blood donors.Methods From November 2003 to May 2005,blood samples from donors in five cities(Urumchi,Kunming,Beijing,Guangzhou and Hangzhou)were collected randomly.PROCLEIX HIV-1/HCV Duplex Assay(Chiron,Inc) was used to detect HIV RNA and HCV RNA.NAT was performed using pools of 16 serologically negative samples.Any pools positive in NAT would undergo NAT again individually.For HCV EIA(-),but HCV RNA NAT(+) samples,confirmatory tests were performed to detect anti-HCV(Ortho HCV 3.0 EIA),ALT,and HCV RNA NAT(Roche Cobas Amplicor HCV Test).Results NAT was done on 89647 samples,and 3 samples were found HCV RNA(+),but HCV EIA(-),and none were HIV RNA(+),but HIV EIA(-).Of all the 87034 serologically negative samples,two were positive for HCV RNA NAT(2/87034),and one of them had elevated ALT(254U/L).No HIV RNA NAT(+) sample was detected among the 87034 samples.Among the 2,613 serologically positive samples,one HCV RNA(+),but HCV EIA(-) sample was detected,and further detection found this sample to be also anti-HCV(+) with elevated ALT(372U/L).Conclusion Of all the serologically negative samples,no one missed the HIV test,and only 2 sample missed the HCV test(2/87034).The results above indicate that NAT can further enhance the blood safety in China,although the cost-effectiveness should also be taken into account.Among 3 samples that were HCV NAT(+),but anti-HCV(-),two had elevated ALT,which suggests that ALT testing is still useful in decreasing the risk of HCV transmission with the current donor screening system.