摘要
目的 为正确评估目前酶免抗体筛检方法的血液安全性,探讨在我国血液筛检中引进核酸扩增技术(NAT),防止酶免抗体筛检方法窗口期漏检的可行性。方法 使用Procleix^(TM)TMA HIV-1/HCV检测方法,分2个阶段,分别以8份样品和24份样品混合的形式,总共筛选了103539份上海市区的献血标本。结果 发现5份第2次酶免检测(EIA-2)HCV抗体和NAT同时阳性的标本,同时也发现275份(0.27％)EIA-2 HCV抗体阳性但NAT阴性标本和107份(0.10％)EIA-2 HIV抗体阳性但NAT阴性的标本,未发现血清抗体转换窗口期标本。结论 上海市的血液安全水平目前已接近发达国家水平,HCV和HIV的感染危险性已经小于1:100000,Procleix^(TM)TMAHIV-1/HCV检测技术具有较高的敏感性和特异性,适合在中国血液筛检中应用。
Objective To assess the blood safety under the current sero-screening program and gain experience on how to implement NAT as a routine assay for blood screening in China. Methods Sera from 103,539 non-remunerated donors of Shanghai blood center were tested by Chiron's Procleix(TMA HIV-1/HCV Assay in 2 study stages with 8 and 24 sample-pool respectively. Results 5 NAT positive samples were found to be Anti-HCV EIA-2 test positive at the same time. No window period cases of HIV-1/HCV were found in this donor group. But 275 (0.27% ) anti-HCV and 107 (0. 10%) anti-HIV false positive samples were identified by the second sero-screening. Conclusion The blood quality of Shanghai city was high to be close to the level of developed countries and the window period risk of HIV-1 and HCV was less than 1:100,000. With its high sensitivity and specificity,Procleix( TMA HIV-1/HCV Assay can be used in routine blood screening in China.
出处
《中国输血杂志》
CAS
CSCD
2003年第3期157-160,共4页
Chinese Journal of Blood Transfusion
