绵阳市无偿献血者HIV筛查及确证结果分析

HIV screening and confirmatory analysis of voluntary blood donors in Mianyang

目的探究无偿献血者HIV检测策略,保障临床用血安全。方法使用2种(国产、进口各一) ELISA试剂对2013—2017年绵阳市238 605人份无偿献血者血液标本做抗-HIV筛查,筛查阳性者送检做WB确证试验,根据确证结果对筛查检测情况做分析。结果本组无偿献血者抗-HIV筛查阳性率72. 50/10万(173/238 605),确证阳性率0. 289‰或28. 92/10万(69/238 605)(P<0. 05);确证阴性68份、不确定36份。ELISA双试剂筛查阳性者的确证阳性率93. 24%(69/74),确证阴性率5. 41%(4/74),不确定率1. 35(1/74);单试剂筛查阳性者的确证阳性率0(0/99),不确定35份、确证阴性64份,S/CO值分布为<6和≥0. 8;另有灰区(S/CO值0. 8—1)标本20份,确证均为阴性。国产与进口试剂灵敏度均为100%,阳性预测值为73. 40%,45. 10%。结论 ELISA双试剂筛查阳性与确证阳性呈现明显正相关,灰区设置意义不大,核酸检测实施批签发之后,减少1次酶免检测时,需要合理评估选择检测试剂和方法,科学制定新的献血者检测策略。

Objectives To explore the HIV screening strategy in voluntary blood donors to ensure the safety of clinical blood use. Methods Two types of ELISA reagents(domestic and imported) were used to screen 238 605 blood samples in the voluntary blood donors in Mianyang City during 2013 to 2017. Reactive results were followed up by the WB confirmatory test to evaluate the performance of screening tests. Results The positive rate of anti-HIV screening among voluntary blood donors in Mianyang City was 72. 50/100 000(173/238,605). The positive rate was 0. 289,28. 92/100 000/(69/238,605)(P < 0. 05) with 68 negative cases and 36 unidentified cases. The positive rate of ELISA dual-reagent screening was93. 24%(69/74),the negative rate was 5. 41%(4/74),and the uncertainty rate was 1. 35(1/74). The positive rate of the single-reagent screening was 0(0/99),35 uncertainties and 64 negative confirmations. The distribution of S/CO value was < 6 and ≥ 0. 8. In addition,there were 20 samples in the grey area(S/CO value 0. 8-1),all of which were negative.Both domestic and imported reagents yielded 100% sensitivity,and positive predicting values of 73. 4% and 45. 1%.Conclusion The positive rate of HIV screening and confirmed positive rate of voluntary blood donors has fluctuated obviously in each statistical year. The positive rate of ELISA dual-reagent screening has been positively correlated with confirmed positive rate,and the setting of the grey area was not significant. After the implementation of mass-batch nucleic acid testing,it is necessary to rationally evaluate the selection of detection reagents and methods,scientifically formulating new detection strategies for blood donors with reduced enzyme immunoassays.