趋势分析方法在HIV血液筛查诊断试剂评价中的应用

Application of trend analysis in evaluation of blood screening diagnostic kit for HIV

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(P<0.01);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。

Objective To investigate the stability of trend analysis used for the evaluation of blood screening diagnostic kit for HIV. Methods The coincidence rates of negative results of reference S4 for cutoff value of sensitivity, HIV-1 sample with moderate reactivity （P18）, HIV-2 sample with low reactivity （P19） and negative reference were determined by consecutive batches of blood screening diagnostic kits from manufacturers A, B and C, based on which Levey-Jennings trend analysis curve was plotted, and the mean and standard deviation （SD） of each sample were calculated. The change trend of test indexes of diagnostic kits from various manufacturers were observed serving mean ± 2 SD as a warning limit and mean ±3 SD as an action limit. Results The quality of kit A was stable, with any batch of which the determination results of samples S4, P18 and P19 were not beyond the action limit. The coincidence rates of negative results of negative reference with kits B and C were shown in the trend analysis. However, the determination results of sample P18 with kit B of two batches were beyond the action limits, while those of samples S4, P18 and P19 by kit C of eight consecutive batches were on the same sides of mean. In accelerated stability test at 37 %, the change trends of determination results of samples P18, P19 and S4 determined by 32 batches of kit C were in agreement. The results of accelerated stability test at 37 ℃ and stability test at 4 ℃ of sample S4 showed significant difference （P 〈 0. 01 ）.. The results of accelerated stability tests of samples S4, P18 and P19 from various manufacturers showed significant difference with those from Na- tional Institutes for Food and Drug Control （NIFDC） （each P 〈 0. 01 ）. Conclusion The qualities of domestic blood screeningdiagnostic kits for HIV were stable, of which the change could by found by trend analysis. Trend analysis may be used for the evaluation on stability of in vitro diagnostic kits for HIV.