2000～2003年湖北省HIV抗体筛查试剂质量评估分析

Evaluation of the Quality of HIV Antibody Screening Reagents Used in Hubei Province from 2000 to 2003

目的 对 2 0 0 0～ 2 0 0 3年湖北省 HIV抗体筛查试剂质量评估结果进行分析 ,掌握全省内使用的各种试剂质量情况 ,为各检测单位选择试剂提供信息 ,为湖北省招标试剂提供依据。方法 用各参评试剂对已知样品与未知样品进行检测 ,统计各试剂敏感性、特异性和功效率 ,分析 4年评估结果。结果 通过比较 4年的评估结果看出 ,国产 HIV抗体筛查试剂质量有所提高 ,有些筛查试剂敏感性和特异性已经接近国外同类产品水平。试剂质量有波动。结论 试剂质量不稳定 ,证明每年开展试剂评估工作的重要性 ;为保证检测工作质量应选择质量好的国产试剂作为常规检测试剂 ;试剂敏感性达不到 10 0 % 。

Objective To understand the quality of HIV antibody screening reagents used in Hubei province.Methods Known and unknown samples were tested with the reagents used in Hubei province from 2000 to 2003 and their sensitivities, specialties and efficacies were compared.Results The sensitivities and specialties of some domestic reagents were approaching the level of the same products abroad, but the quality of reagents was not stable enough.Conclusion It is necessary to evaluate the quality of reagents every year and choose the reagents of high quality as the routine testing reagents. The screening laboratories should prepare at least two reagents to test samples which are difficult to judge.