两家化学发光系统用于血液筛查HIV的性能评价

Evaluation of two CLIA reagents for blood screening HIV

目的对2家化学发光检测系统用于血液筛查HIV项目进行评估。方法使用1种化学发光试剂（CLIA试剂）、1种电化学发光试剂（ECLIA试剂）和2种酶联免疫吸附试剂（国产第3代HIV ELISA试剂、进口第4代HIV ELISA试剂）同时检测卫生部临检中心提供的HIV血清盘,分别将2种化学发光试剂和ELISA试剂的检测性能进行比较。结果 1） 4种试剂的灵敏度由高到低依次为ECLIA（100%）=进口ELISA（100%）〉 CLIA（96. 64%）=国产ELISA（96. 64%）。2） 4种试剂的特异性由高到低依次为CLIA （98. 72%）〉国产ELISA （97. 44%）〉进口ELISA（92. 30%）〉ECLIA（87. 18%）。3） 4种试剂检测结果的一致性很好,准确率均较高（AUC为0. 989 2—0. 999 9）。4）稀释灵敏度：ECLIA试剂能检出稀释比例为1：800的HIV抗体稀释样本,其余3种试剂能检出的最高稀释比例为1：400。5） ECLIA试剂可以检出浓度为1 IU/mL的HIV p24抗原,检出5份窗口期核酸阳性样本（5/7）,与进口第4代ELISA试剂的结果一致。第3代试剂均未能检出。6） ECLIA试剂的批内精密度CV为3. 03%—6. 34%,批间精密度为7. 52%和15. 76%,精密性总体优于2种ELISA试剂; CLIA试剂的批内精密度CV为3. 39%—7. 12%,批间精密度为10. 28%和11. 41%,精密性总体优于2种ELISA试剂。结论 4种评估试剂的检测性能相似,化学发光试剂的准确性与ELISA试剂相近,检测结果一致性好。ECLIA试剂具有较高的检测灵敏度,提高早期感染样本的检出能力,能缩短HIV检测的窗口期,降低输血感染风险。

Objective To evaluate the performances of the two Chemiluminescence Immune Assay （CLIA） reagents in blood HIV screening. Methods The sero-panel samples from NCCL were tested with two CLIA reagents （Roche and AN- TU） and two ELISA reagents （domestic 3rd generation and imported 4th generation reagents）. The performances of these 4 reagents were compared. Results 1 ） The sensitivity of these 4 reagents from high to low were ECLIA （ 100% ） and imported ELISA （ 100% ） 〉 CLIA （96. 64% ） and domestic ELISA （ 96. 64% ）. 2） The specificity of CLIA, domestic ELISA, imported ELISA and ECLIA is 98. 72%, 97.44%, 92. 30% and 87. 18% respectively. 3） The accuracy of these 4 reagents were good with AUC between 0. 989 2 to 0. 999 9. And the results of reagents were of good concordance. 4） ECLIA reagent can detect the samples with the dilution rate up to 1：800, while the other 3 reagents can only detect the samples with 1：400 dilution rate. 5） As for HIV p24 antigen, ECLIA can detect samples at 1 IU/mL, and can detect 5 of 7 early infection stage samples, which was the same result with imported 4tb generation ELISA reagent. While 3rd generation assays missed all these window period samples. 6） The within-run precision of ECLIA was 3.03%--6. 34% （CV）, and the between-run precision was 7.52% and 15.76% （CV） ; the CVs for CLIA were 3.39%--7. 12%, 10. 28% and 11.41% respectively. Conclusion The performances of 4 evaluated reagents were similar. The detection accuracy of CLIA reagents was similar to ELISA reagents. And the results between them were of good concordance. Because of high detection sensitivity and superior screening capacity in early infection stage, 4tb generation ECLIA reagent can shorten window period in detection and thus reduce blood transfu- sion infection risk.