我国5城市合格献血者血液HIV及HCV残余风险研究

目的研究我国献血者血液HIV及HCV残余风险;评估我国开展血液核酸检测(NAT)的可行性和必要性。方法采集乌鲁木齐、昆明、北京、广州、杭州5城市献血者血样,用Chiron Procleix HIV-1/HCV Assay血液核酸检测体系,对各项血清学筛查均合格的89 467份血液作16人份混合血样NAT检测,凡筛查不合格血样再作单人份检测;对于抗-HCV阴性而HCV RNA NAT阳性者,用备用管作抗-HCV、ALT、及HCV RNA NAT复检。结果共检出HCV RNA NAT阳性但抗-HCV EIA阴性标本3例,未检出HIV RNA NAT阳性但抗-HIV EIA阴性标本;在87 034份血清学筛查合格献血者中,检出HCV NAT阳性2例,其中1例复检ALT为254U/L,未检出HIVNAT阳性;在2 613份血清学筛查不合格者中,检出1例HCV NAT阳性但抗-HCV EIA阴性标本,该献血者抗-HIV阳性、ALT 372U/L;未检出HIV NAT阳性但抗-HIV EIA阴性的标本。结论血清学筛查使我国的血液安全性已有相当高的保障;而NAT技术可进一步提高血液的安全性,但在我国是否可应用于常规血液筛查,需考虑成本与效益比。此外,ALT筛查对排除抗-HCV漏检血液仍有一定的作用。

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.