【摘要】 目的对我国2007～2008年度用于血液筛查的HIV试剂进行质量分析。方法采用HIV抗体和HIVP24抗原国家参考品,对我国2007～2008年度用于血液筛查的第三代(218批)和第四代(27批)试剂进行敏感性、特异性及精密性分析。结果2007～2008年度检测的245批试剂全部符合质量要求。在敏感度指标中,约36%(88/245)试剂的抗体检测水平和74%(20/27)的抗原检测水平优于最低检出限的标准;在特异性指标中,95%以上的试剂优于合格标准;试剂的批内变异系数均在11%以内,但大部分试剂的批间变异系数在30%以上。结论我国2007～2008年度用于血液筛查的HIV试剂质量均达到国家现行标准,但试剂的批间差异有待进一步缩小。更多还原

【Abstract】 Objective To analyze the quality of reagents for screening of HIV in blood samples during 2007 ～ 2008 in China. Methods The sensitivities and specificities of 218 batches of reagents of passage 3 and 27 of reagents of passage 4 used for screening of HIV in blood samples during 2007 ～ 2008 in China were analyzed by using national reference HIV antibody and HIV P24 antigen. Results All the quality indexes of the 245 batches of reagents met the relevant requirements. The detection levels of antibody with 36%(88 / 245)and antigen with 74%(20 / 27)of the reagents were lower than the minimum detection limit in relevant requirements. The specificities of more than 95% of the reagents were higher than relevant requirements. The intra-variation coefficients of the reagents were not more than 11%, while the inter-variation coefficients of most of the reagents were more than 30%. Conclusion The quality of reagents for screening of HIV in blood samples during 2007 ～ 2008 in China met the current national requirements. However, the inter-variation coefficient was to be further decreased.更多还原