国产第3代与进口第4代HIV检测试剂的比较

Comparison of Third Generation of Domestic and The Fourth Generation of Imported Detection Kits for HIV

目的比较国产第3代与进口第4代HIV试剂检测结果的差异,为试剂的选择及设定血液报废标准提供参考。方法按试剂使用说明书的要求操作,用国产第3代(A和B)和进口第4代(C)HIV检测试剂对35 487份常规血液样本进行检测,试剂使用前用中国药品生物制品检定所血清盘进行质量评价。结果 3种试剂均符合质量要求;2个国产试剂和1个进口试剂s/co≥1.0的检测结果差异无统计学意义(P>0.05),s/co≥0.8的检测结果差异有统计学意义(P<0.05)。结论从血液安全考虑,建议国产第3代HIV检测试剂将s/co≥0.5作为血液报废标准,进口第4代试剂将s/co≥0.8作为血液报废标准。

Objective To compare the difference in detection results by the third generation of domestic and the fourth generation of imported kits for HIV,and provide a reference for selection of reagents and establish the standard for discard of blood.Methods A total of 35 487 blood samples were tested by the third generation of domestic（A and B） and the fourth generation of imported（C） kits separately for HIV following the instructions.The kits before use were evaluated for qualities by National Institute for the Control of Pharmaceutical and Biological Products（NICPBP）.Results All the three kits met the relevant requirements for quality.The detection results of s/co values of not less than 1.0 by kits A and B showed no significant difference,while those with s/co values of not less than 0.8 showed significant difference,with those by kit C.Conclusion Taking account for the safety of blood products,the standard for discard of blood is suggested as a s/co value of not less than 0.5 by the third generation of detection kit for HIV,or not less than 0.8 by the fourth generation of imported kit.