论文部分内容阅读
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 analyze the quality of diagnostic reagents for hepatitis C virus (HCV) antibody used in blood screening in China. Methods The diagnostic reagents of three domestic manufacturers of HCV antibodies (code A, B and C, respectively, 53, 55 and 64 continuous batch) were tested during the period from January 2014 to December 2015 through the same batch of national reference materials. Times) as the research object. The trend of the weak positive reference (P9, P27) and the lowest detection limit (L3) in the national reference of the fifth HCV antibody diagnostic reagent was detected. At the same time the CIC and C self-test 37 ℃ accelerated stability test results were compared. Results The trend analysis of Reagent A showed that there was a case where the fourth to fourteenth batch of test data were on the same side of the mean for the L3 samples, which was defined as the deviation data. There was statistics on the difference between the S / CO values after the 4th to 14th and the 15th batch (P <0.001). According to the trend analysis of reagent B, there was a case that the detection data of the 26th to 34th batch in the P27 sample were on the same side of the mean value, which was defined as deviation data. After the 26th to 34th batch and the 35th batch to detect S / CO values were statistically significant (P <0.05). Reagent C trend analysis showed that L3 samples appeared the same as the 42 ~ 50,57 ~ 64 batch test data in the same situation, is defined as deviation data, the first The difference of S / CO values before 57 ~ 64 batches and 56 batches was statistically significant (P <0.01). The results of accelerated stability at 37 ℃ of P9, P27 and L3 samples from both CPS and C were all statistically significant (all P <0.01). Conclusion The trend analysis can reflect the quality change of diagnostic reagents for HCV antibodies. This method can be used to evaluate the stability of reagents.