2004年至2007年上海市HIV抗体筛查试剂临床质量评估分析

Evaluation of the quality of screening reagents human immunodeficiency virus antibody Shanghai from 2004 to 2007

目的对2004年至2007年上海市人类免疫缺陷病毒（HIV）抗体筛查试剂临床质量评估结果进行分析，了解全市使用的筛查试剂质量情况。方法用各参评试剂对已知样本与未知样本进行检测，统计各试剂敏感性、特异性和功效率，分析4年评估结果。结果酶联免疫吸附试验（ELISA）试剂的敏感性除1家试剂在2006年的评估中为98．53％以外，其余酶标试剂均为100．00％；特异性为95．89％～100．00％；年平均特异性从2004年的98．14％提高到2007年99．06％。快速试剂的敏感性为96．23％～100．00％，2004年试剂平均敏感性为100．00％；2005年回落至97．86％，随后又逐年提高；特异性为97．86％～100．00％，各年波动不定。结论国产HIV抗体筛查试剂质量的整体水平有所提高，ELISA试剂敏感性和特异性已与国外同类产品一致。快速试剂的质量有待提高。应加强试剂的质量评估，并合理选择筛查试剂。

Objective To evaluate the quality of antibody screening reagents for anti-human immunodeficiency virus（HIV） used in Shanghai. Methods The known and unknown samples were tested with the screening reagents and their sensitivity, specificity and efficacity were compared from 2004 to 2007. Results The sensitivities of enzyme-linked immunosorbent assay（ELISA） reagents were 100.00% , but one reagent of 2006 was 98.53%. The specificities of ELISA were from 95.89% to 100.00%. The sensitivities of the rapid reagents were from 96.23% to 100.00% and the specificities were from 97.86 to 100.00%. Conclusions The sensitivities and specificities of some domestic ELISA reagents were in the same level as imported products and the quality of the rapid reagents should be improved. It is important to evaluate the quality of reagents and choose the screening reagents properly.