趋势分析法评价我国用于血液筛查中丙型肝炎病毒抗体诊断试剂的质量

Evaluation on quality of hepatitis C virus antibody diagnostic reagents used for blood screening in China by trend analysis approach

目的趋势分析法评价我国用于血液筛查中丙型肝炎病毒（hepatitis C virus,HCV）抗体诊断试剂的质量。方法选取2014年1月-2015年12月期间,经同批国家参考品进行批批检定的国内3个厂家HCV抗体诊断试剂（编码A、B、C,分别为53、55和64个连续批次）作为研究对象,对3种试剂检测第5套HCV抗体诊断试剂国家参考品中的弱阳性参考品（P9、P27）和最低检出限L3（界值参考品）的结果进行趋势分析。同时将中检院和企业C自检的37℃加速稳定性试验结果进行比较。结果试剂A的趋势分析发现,L3样品出现了第4-14批检测数据在均值同侧的情况,被界定为偏离数据,第4-14批与15批以后的检测S/CO值差异有统计学意义（P〈0.001）;试剂B趋势分析发现,P27样品出现了第26-34批检测数据在均值同侧的情况,被界定为偏离数据,第26-34批与35批以后的检测S/CO值差异有统计学意义（P〈0.05）;试剂C的趋势分析发现,L3样品出现了第42-50、57-64批检测数据在均值同侧的情况,被界定为偏离数据,第57-64批与56批之前的检测S/CO值差异有统计学意义（P〈0.01）。中检院与企业C自检P9、P27和L3样品37℃加速稳定性结果差异均有统计学意义（P均〈0.01）。结论趋势分析可反映HCV抗体诊断试剂质量变化,该方法可用于试剂质量稳定性的评价。

Objective To evaluate the quality of hepatitis C virus（HCV） antibody diagnostic reagents used for blood screening in China by trend analysis approach. Methods A total of 53, 55 and 64 consecutive batches of HCV antibody diagnostic reagents A, B, C, from different domestic manufacturers were tested with the same batch of the 5th series of national reference for HCV antibody, in which the results of weak positive references（P9, P27） and minimum detection limit reference（L3, cut-off value reference） were analyzed by trend analysis approach. Meanwhile, the results of accelerated stability tests at 37 ℃ performed in National Institutes for Food and Drug Control（NIFDC） and in manufacturer C were compared. Results The trend analysis of reagent A showed that the test data of L3 for batches 4 to14 were in the same side of the mean, which were defined as deviation data, and the S / CO values of batches 4 to 14 showed significant difference with those of batches 15 to 53（P〈0. 001）. The trend analysis of reagent B showed that the data of P27 for batches 26 to 34 were in the same side of the mean, which were defined as deviation data, and the S / CO values of batches 26 to 34 showed significant difference with those of batches 35 to 55（P〈0. 05）. The trend analysis of reagent C showed that the data of L3 for batches 42 to 50 and batches 57 to 64 were in the same side of the mean, which were defined as deviation data, and the S / CO values of batches 57 to 64 showed significant difference with those of batches 1 to 56（P〈0. 01）. The accelerated stability test results of P9, P27 and L3 at 37 ℃ at both NIFDC and manufacturer C showed significant difference（each P〈0. 01）. Conclusion The trend analysis reflected the quality change of HCV antibody diagnostic reagent, which might be used for the evaluation on reagent quality stability.