摘要
目的分析不同检测方法组合检测献血者HIV感染标志物的筛查阳性率、筛查阳性标本的确证阳性率,探讨血液HIV感染标志物的检测模式,为血液检测策略的选择提供参考依据。方法收集本中心2018年9月—2019年3月采集的标本,按2遍ELISA+1遍NAT的检测模式进行HIV筛查。将筛查阳性的血浆标本,送本地CDC艾滋病确证实验室确证;同时留取核酸检测标本,送国家卫生健康委员会临床检验中心进行复检。以CDC HIV抗体确证结果和临床检中心HIV RNA定量检测结果作为确证判定结果。根据不同的检测方法组合,将HIV检测模式分为:A组(ELISA双试剂+NAT)、B组(ELISA单试剂(3代)+NAT)、C组(ELISA单试剂(4代)+NAT),分析比较各组间筛查阳性率、筛查阳性标本的确证阳性率结果的差异,探讨检测灵敏度与特异性较高的组合模式。结果筛查51 283人份献血者血液标本,HIV筛查阳性标本57人份,确证阳性标本19人份。3种检测模式的筛查阳性率分别为0.11%、0.05%和0.09%,B组的筛查阳性率(0.05%)与A组(0.11%)和C组(0.09%)相比有差异(P<0.05);但检测灵敏度(即抗体的确证阳性率、HIV RNA确证阳性率)均为0.033%和0.037%,无差异。结论目前的血液检测策略中增加了NAT,可以将ELISA检测漏检早期感染的窗口期标本有效检出,对于确保血液的安全性有很重要意义。血清学检测中应用ELISA HIV第4代试剂可缩短HIV感染窗口期。
Objective To compare the reactive rates implicated in screening tests and discriminatory tests for HIV screening in blood donors as an approach to estimate the effect of different modes of HIV infection detection.Methods Donations collected from September 2018 to March 2019 in our center were routinely tested twice by ELISA and once by NAT screening. The reactive samples were send to local CDC HIV confirmation laboratory for confirmation. Meanwhile, NAT-reactive samples were retained and sent to National Center for Clinical Laboratories for re-test. The prevalence of HIV infection in blood donors were calculated according to the positive results confirmed by CDC. According to the combination pattern, HIV screening modes were grouped as: group A(duplicate ELISA assays+ NAT), group B(third generation ELISA assay+NAT), and group C(fourth generation ELISA assay+NAT). The reactive rates collected in screening tests and discriminatory tests for HIV infection among the three groups were compared to estimate the optimal combination with high sensitivity and specificity.Results Of all 51 283 donations, 57 were reactive in HIV screening, and 19 were confirmed positive for HIV RNA. The screening yield rate of three groups was 0.11%, 0.05% and 0.09%, respectively, among which group B(0.05%) was significantly lower than that of.group A(0.11%) and group C(0.09%)(P<0.05);however, the detection sensitivity, in terms of the positive rates of antibody and HIV RNA confirmed, of three groups were all 0.033% and 0.037%, with no significant difference.Conclusion The implementation of HIV NAT has an effective impact on the interdiction of window period donations missed by ELISA screening, which demonstrates significance in preventing transfusion-transmitted HIV. Window period can be shortened in serological screening of blood donors using the fourth generation HBsAg assays.
作者
周仲民
刘峭梅
王荔
ZHOU Zhongmin;LIU Qiaomei;WANG Li(Guangxi Blood Center,Liuzhou 545005,China)
出处
《中国输血杂志》
CAS
2020年第6期607-610,共4页
Chinese Journal of Blood Transfusion
