趋势分析方法在HIV血液筛查诊断试剂评价中的应用
发布时间：2018-08-01 21:15
【摘要】：目的评价趋势分析方法用于HIV血液筛查诊断试剂的质量稳定性。方法以国产3个厂家(A、B、C)的HIV血液筛查诊断试剂作为研究对象,采用各试剂连续批次检测灵敏度界值参考品S4、HIV-1型中等反应性样品(P18)、HIV-2型低反应性样品(P19)、阴性参考品的阴性符合比例,绘制Levey-Jennings趋势分析质控图,计算每个样品的检测平均值(mean)和标准差(SD),以mean±2 SD作为警戒限,mean±3 SD作为行动限,观察各厂家诊断试剂的检测指标变化趋势。结果试剂A质量稳定,S4、P18和P19样品的检测结果均未见超过行动限的批次;试剂B和C的阴性参考品阴性符合比例的变化均呈现在趋势分析中,试剂B检测P18样品出现2个批次检测结果超过行动限,试剂C连续8批S4、P18和P19样品的检测结果在均值同侧。在37℃加速稳定性试验中,32批试剂C分别检测P18、P19和S4样品的变化趋势一致;S4样品37℃加速稳定性及4℃稳定性检测结果差异有统计学意义(P0.01);企业和中检院S4、P18和P19样品37℃加速稳定性结果差异均有统计学意义(P均0.01)。结论我国血液筛查试剂质量稳定,趋势分析可发现试剂质量变化,可尝试用于HIV体外诊断试剂的稳定性评价。
[Abstract]:Objective to evaluate the quality stability of HIV blood screening diagnostic reagent by trend analysis. Methods the HIV blood screening and diagnosis reagents from three domestic manufacturers (Agna BU C) were used as the research object. The sensitivity limit of the reagents S4H4 HIV-1 medium reactive sample (P18) and HIV-2 low reactive sample (P19) were determined by successive batches of the reagents. The negative rate of the negative reference sample was consistent with that of the negative reference material. The Levey-Jennings trend analysis quality control chart was drawn, and the detection average (mean) and standard deviation (SD), of each sample were calculated. The warning limit of mean 卤2SD was taken as the warning limit and mean 卤3SD as the action limit. Results the quality stability of reagent A, S _ 4, P _ (18) and P _ (19) did not exceed the action limit, and the negative reference of reagent B and C showed the change of negative coincidence ratio in trend analysis. The results of two batches of reagent B for P18 samples exceeded the action limit, and the results of reagent C for 8 successive batches of S4, P18 and P19 samples were on the same side. In the 37 鈩，
本文编号：2158621
[Abstract]:Objective to evaluate the quality stability of HIV blood screening diagnostic reagent by trend analysis. Methods the HIV blood screening and diagnosis reagents from three domestic manufacturers (Agna BU C) were used as the research object. The sensitivity limit of the reagents S4H4 HIV-1 medium reactive sample (P18) and HIV-2 low reactive sample (P19) were determined by successive batches of the reagents. The negative rate of the negative reference sample was consistent with that of the negative reference material. The Levey-Jennings trend analysis quality control chart was drawn, and the detection average (mean) and standard deviation (SD), of each sample were calculated. The warning limit of mean 卤2SD was taken as the warning limit and mean 卤3SD as the action limit. Results the quality stability of reagent A, S _ 4, P _ (18) and P _ (19) did not exceed the action limit, and the negative reference of reagent B and C showed the change of negative coincidence ratio in trend analysis. The results of two batches of reagent B for P18 samples exceeded the action limit, and the results of reagent C for 8 successive batches of S4, P18 and P19 samples were on the same side. In the 37 鈩，
本文编号：2158621
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