HIV初筛实验不同策略的选择及其在临床应用中的评价

Selection and evaluation of HIV screening strategies

目的回顾分析南京医科大学第一附属医院近5年332例初筛阳性标本使用的多种血清学方法的检测结果,为临床实验室推荐人类免疫缺陷病毒(HIV)初筛实验的优选方案。方法对2010年1月至2014年4月在南京医科大学第一附属医院就诊者的331 968份样本进行HIV抗体初筛,332例初筛阳性样本用第四代酶联免疫吸附试验(ELISA)试剂复检,以蛋白印迹试验(WB)结果为金标准,比较分析第三代ELISA试剂、第四代ELISA试剂以及分别与胶体金组合检测的结果。结果 332例HIV抗体筛查阳性样本,经WB试验确证阳性189例。第三代ELISA试剂检测确证阳性符合率为57.27%,第四代ELISA试剂检测确证阳性符合率为89.15%,两者比较,差异有统计学意义(P=0.00)。第三代ELISA试剂检测漏检1例确证阳性标本和1例确证不确定标本;第四代ELISA试剂检测未发现漏检阳性标本,并检出1例窗口期标本。第四代ELISA与胶体金组合后,确证阳性符合率较第三代ELISA与胶体金组合提高了3.91%。结论第四代ELISA试剂用于HIV抗体筛查优于第三代ELISA试剂,尤其是与胶体金的组合,明显提高了HIV检测的确证阳性符合率,并有利于HIV感染窗口期的检测,推荐作为临床实验室HIV优选筛查方案。

Objective To investigate suitable detection strategy for HIV antibody screening. Methods A total of 331 968 specimens of HIV antibody test were collected from clinical patients in the First Affiliated Hospital of Nanjing Medical University from Jan. 2010 to Apr. 2014. The 332 specimens, positive for the third generation enzyme linked immunosorbent assay （ELISA）, were re‐examined by using the fourth generation ELISA. Western blot （WB） was used as gold standard for confirming the reactivity of the specimens. Performance of the third and fourth genera‐tion ELISA and combined detection of ELISA and colloidal gold assay were comparatively analyzed. Results Among the 332 specimens, positive for the third generation ELISA, 189 cases were confirmed positive by WB, and the positive coincidence rate between the third generation ELISA and WB was 57. 27%. The positive coincidence rate between the fourth generation ELISA and WB was 89. 15%, which was higher than the 57. 27% between the third generation ELISA and WB （P=0. 00）. There were one false negative specimen and one indeterminate specimen, detected by the third generation ELISA. However, there was no false negative specimen, detected by the fourth generation ELISA, which even identified one specimen of window periods. The positive coincidence rate of combined detection of the fourth generation ELISA and colloidal gold assay was increased by 3. 91%, compared with combined detection of the third generation ELISA and colloidal gold assay. Conclusion The fourth generation ELISA could be better than the third generation ELISA for the HIV screening tests, especially when being combined with colloidal gold assay, could obviously increase the confirmed positive coincidence rate and be more feasible for the detection of window period of early HIV infection, which could be more suitable detection strategy for HIV screening test.