艾滋病诊断试剂的临床评估

CLINICAL EVALUATION ON SEVERAL ANTI - HIV DIAGNOSTIC REAGENTS

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 We joined clinical evaluation on 6 anti - HIV diagnostic reagents which was organized by National Reference Laboratory of National Center for AIDS Prevention and Control. Method 100 sera of known result and 100 sera of unknown result were detected with 6 reagents according to test procedure of the reagents. Result The crude agreement(99.5% )of Organon Teknika and Determine reagents were higher than that of the other reagents. No anti - HIV positive serum was detected negative with Organon Teknika and Determine reagents. The sensitivity and specificity of Organon Teknika and Determine reagents were higher than those of the other reagents. The capacity of Organon Teknika reagent to detect the mild positive serum was greater than that of the other reagent. Conclusion Organon Teknika and Determine anti - HIV diagnostic reagents were qualified for anti - HIV screening test while the other 4 reagents should be improved on sensitivity and specificity.