摘要
目的对天津地区无偿献血者HIV筛查和确证结果比较分析,为制定更为合理的检测策略提供数据支持。方法对2019年1—9月本实验室检测的102 538份无偿献血者标本HIV筛查结果、确证结果进行数据分析。结果 HIV筛查阳性率为18.6/万(191/102 538),确证阳性率为3.70/万(38/102 538),确证阴性143例,不确定10例(0.98/万)。ELISA(酶联免疫法)双试剂阳性率92.5%(37/40,含1例HIV完美控制者),确证阴性率5%(2/40),不确定2.5%(1/40)。单试剂阳性150例无确证阳性,不确定9例,阴性141例。核酸反应性39例,确证阳性率94.9%(37/39)确证阴性1例,不确定1例。试剂1、试剂2灵敏度均为97.4%、阳性预期值分别为47.4%、24.3%。最大约登指数对应的最适临界值分别为22.385、6.435。结论 ELISA双试剂反应性、核酸反应性和确证结果符合率较高;S/CO值越大确证阳性的机率就越高,当S/CO值大于最适临界值时阳性预期值达最高;ELISA与NAT联合检测,成功的阻断了HIV完美控制者和窗口期标本的血液传播;如果要减少1遍酶免检测,需要对试剂进行合理评估,制定科学的献血者检测策略。
Objective To compare and analyze the screening and confirmation of anti-HIV results in voluntary blood donors in Tianjin area in 2019,so as to provide data support for formulating more reasonable testing strategies.Methods The screening and confirmation of anti-HIV results in 102 538 donations tested in our laboratory from January to September 2019 were analyzed. Results Out of 102 538 donations screened,191(18.6/10 000)were initially anti-HIVpositive, among which 38(3.70/10 000)were confirmed positive,143 confirmed negative,and 10(0.98/10 000)donations can′t be determined. The confirmed positive rate of ELISA was 92.5%(37/40), including one case of perfect HIV control;confirmed negative rate was 5%(2/40), and uncertain 2.5%(1/40). For 150 cases in presence of single reagent reactivity, none was confirmed positive,uncertain in 9 cases, and negative in 141 cases. Nucleic acid reactivity was confirmed in 39 cases, with positive rate of 94.9%(37/39), confirmed negative in 1 case, and uncertain in 1 case. The sensitivities of reagents 1 and 2 were both 97.4% and the expected positive values was 47.4% and 24.3%, respectively.The optimal critical values corresponding to the Youden index were 22.385 and 6.435. Conclusion ELISA double reagent reactivity, nucleic acid reactivity and validation results are highly consistent. The higher S/CO value is, the higher the probability of positive confirmation could be. When S/CO value is larger than the optimal critical value, the positive expected value reaches the highest. ELISA and NAT combined detection successfully blocked the blood transmission of HIV perfect control and window specimens. In order to reduce one enzyme assay, it is necessary to evaluate the reagent reasonably and develop a scientific detection strategy for blood donors.
作者
王全慧
刘晗
潘彤
刘军
WANG Quanhui;LIU Han;PAN Tong;LIU Jun(Tianjin Blood Center,Tianjin 300110,China)
出处
《中国输血杂志》
CAS
2020年第6期603-606,共4页
Chinese Journal of Blood Transfusion
关键词
HIV
筛查
确证
窗口期
最适临界值
screening results
confirmation results
window period
optimal critical value
