【摘要】 [目的]了解目前艾滋病临床诊断试剂的质量情况,为我省艾滋病筛查实验室提供选择试剂的参考依据。[方法]选用7种酶联免疫吸附试验(ELISA)方法、5种金标法(快速法)对已知结果的189份血清样本分别进行检测。[结果]本次试剂评估共获得有效数据2 191个,其中酶联法1 246个,快速法549个。7种酶联试剂的特异性为73.53%~92.65%,功效率为91.04%~97.27%,5种快速试剂的特异性为93.17%~97.33%。功效率为95.94%~98.95%。所有试剂的假阴性均为0,敏感性均为100%。[结论]我国目前的HIV抗体诊断试剂质量已达到国外同类产品水平,但是部分试剂还存在一定差距。更多还原

【Abstract】 [Objective]To understand the quality of HIV antibody clinic diagnosis reagents used in Shandong province and to give the information on selecting and using reagents in HIV screening laboratories.[Methods]189 known blood serum samples were tested separately by seven ELISA methods and five gold standard methods(rapid test).[Results]There are 2 191 available numbers,which include 1 246 ELISA numbers and 549 rapid test numbers.The specialties and the efficacies of seven ELISA reagents separately ranged from 73.53% to 92.65% and 91.04% to 97.27%,and that of five rapid test reagents separately ranged from 93.17% to 97.33% and 95.94% to 98.95%.The false negativities and the sensitivities of all reagents were separately zero and 100.00%.[Conclusion]The quality of HIV antibody clinic diagnosis reagents were approaching the level of the same products abroad,but there were some difference in some reagents.更多还原