2005年山东省HIV抗体诊断试剂质量评估

Evaluation of HIV Antibody Diagnosis Reagents Used in Shandong Province in 2005

[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.

[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 effieaeies 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.