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目的由国家艾滋病参比实验室组织,对6种HIV抗体诊断试剂进行临床评估。方法对6种试剂均按试剂盒说明书要求,对100份已知结果的血清样本和100份未知结果的血清样本进行HIV抗体检测。结果阿克苏和Determine试剂的粗一致性最高,均为99.5%,漏检率为0;另外4种试剂灵敏度和特异度均不及上述2种试剂。对HIV抗体弱阳性样本检出率,阿克苏试剂最高,其它5种试剂有待提高。结论阿克苏和Determine试剂符合HIV抗体诊断的初筛试验要求,另外4种试剂在灵敏度和特异度方面仍有待提高。
Objective To evaluate the clinical efficacy of 6 HIV antibody diagnostic reagents by National AIDS Reference Laboratory. Methods According to the instructions of the kit, 100 serum samples of known result and 100 unknown serum samples were tested for HIV antibody. Results The highest consistencies of Aksu and Determine were 99.5% and the rate of missed detection was 0. The sensitivity and specificity of the other four reagents were lower than those of the above two reagents. Weak positive HIV antibody sample detection rate, the highest Aksu reagent, the other five reagents to be improved. Conclusion Akesu and Determine reagents meet the requirements of HIV antibody screening tests, and the other four reagents still need to be improved in terms of sensitivity and specificity.