HIV抗体筛查实验的检测策略评价

目的以蛋白印迹试验（WB）结果为金标准，对实验室的HIV抗体筛查，包括酶联免疫吸附试验（ELISA）和免疫层析快诊实验的检测策略进行回顾性分析与评价。方法参照2004年《全国艾滋病检测技术规范》的要求，对2007-2011年之间HIV抗体初筛呈阳性反应的标本，采用WB进行确证。结果727例HIV抗体复查标本中，确证试验阳性为540例，占筛查阳性总数的74.28％；其中两种ELISA及免疫层析快诊都呈阳性反应的为558例，确诊540例，不确定’18例，与确证试验的阳性符合率为96.77％；其余的ELISA呈阳性反应结果加上快诊结果与WB的阳性符合率为0，其中不确定72例，阴性97例。ELISA结果的1≤S／Co〈3，与确证试验阳性符合率为0.85％；S／Co值在3～6之间，与确证试验阳性符合率为11.11％；S／Co〉6，与确证试验阳性符合率为94.51％。阳性与不确定’、阳性与阴性的S／Co、不确定。的各组之间差异均有统计学意义（P均=0.00），不确定’与阴性之间差异有统计学意义（P=0.032）；而不确定。组之间差异均无统计学意义（均P〉0.05）。结论ELlSA检测试剂存在一定的假阳性，随着S／Co值的增高，与确证试验的阳性符合率也将升高，但是高S／Co值的样本并不代表感染HIV，HIV抗体阳性报告建议以确证试验结果为准；WB确证方法在不确定标本中存在一定的缺陷，快诊与ELISA的联合运用可以有效区分WB结果的感染一不确定与未感染一不确定，建议根据初筛结果，分类做好不确定人群的管理，尤其对两种ELISA及快诊均呈阳性反应的人群，应加大力度做好随访工作，确保无一例漏访。

Evaluation of the detection strategy for HIV antibody screening

Objective To retrospectively analyze and evaluate the detection strategy for HIV antibody screening tests including enzyme-linked immuno sorbent assay （ELISA） and immune chromatography rapid test by using the results of Western blot （WB） as the golden standard. Method Following the requirements of the ＂National AIDS Testing Technical Standards＂ （2004）, the HIV positive samples detected by ELISA from 2007 to 2011 were con- firmed with WB. Results Of the 727 positive samples detected by ELISA from 2007 to 2011, 540 were confirmed positive with WB. The WB positive coincidence rate was 74.28% ; of them 558 samples were positive with both ELISA and immune chromatography rapid test, and 18 samples were indeterminate1 , and the WB positive coinci- dence rate was 96.77 %; the positive coincidence rate between ELISA and rapid test reviewed with the confirmatory test was 0,of which, 72 samples were indeterminate^2 and 97 samples were negative. When the ELISA results of S/ Co was less than 3, the positive coincidence rate with the confirmatory test was 0.85 ~ ~ when S/Co was between 3 and 6, the coincidence rate with the confirmatory test was 11.11 ~/~0~ if S/Co was above 6, then the coincidence rate with the confirmatory test was 94.51~/00. The S/Co results between positive and indeterminate1 samples, between positive and negative samples, and between various indeterminatez samples, bad significant difference （all P= 0.00）. The difference between the negative and indeterminate samples had statistical significance （ P= 0. 032）, but the difference between the two indelerminate2 groups had no statistical significance （P〈0.05）. Conclusion ELISA displays certain false positivity. The coincidence rate with the confirmatory test increases along with the rise of S/Covalue, but the samples with higher S/Co value do not always indicate HIV infection. Therefore, any HIV positive report should be based on the results of con- firmatory tests. There are certain defects in indetermi- nate samples as detected by WB assay, and the combi- nation of ELIZA with the rapid test can effectively dis- tinguish infection-indetermination from the non-infec- tion indetermination as detected by WB assay. It is suggested that based on the results of screening, classi-fled management for the population whose WB results are indeterminate should be essential, especially for those whose HIV- antibody results with ELISA and rapid test are all positive. Follow-up to ensure that no case is missing should be strengthened.