ELISA室内质控品在冷藏条件下的时间稳定性分析

Time stability analysis of ELISA internal quality control products under refrigeration condition

目的:对血站ELISA室内质控品在冷藏条件下的时间稳定性进行分析,并建立稳定性评价方法。方法:留样得到在冷藏冰箱保存0、5、10、15、20、25、30 d共7次的商品化的ELISA质控品,将所有转移至冷藏冰箱的质控品与常规献血者标本一起加样检测。共筛查4个项目(HBsAg、抗HCV、HIV-Ag/Ab、抗TP),每个项目采用2种厂家的试剂,由于每种试剂的最低检出限不同,对应使用的质控品也不同(共6种),因此实验室1 d内共采用8种试剂在FAME上检测6种质控品,最终得到8块板的检测结果。采用单因素方差分析和t检验方法并结合质控图来评价不同时间段质控品的均一性和稳定性。结果:除抗-HCV质控品(质控品批号:201601001)的F略高于临界值F0.05(6,14)(F=3.93,0.010.05,差异无统计学意义;当t检验α=0.01时实验室冷藏保存30 d内的质控品表现总体稳定,仅抗TP质控品(质控品批号:201611033)在第10天差异有统计学意义,第15、20、25、30天均表现正常。当t检验α=0.05时,部分质控品结果呈现差异有统计学意义,集中出现在冷藏第10天及以后的质控品中,结合质控图发现抗-HCV质控品(质控品批号:201601001)和抗HIV质控品(质控品批号:201611033)可能有衰减趋势,质控图框架本身可能发生偏移。结论:实验室的ELISA第三方弱阳性质控品在2~8℃冷藏保存后30 d内基本能够保证均一和稳定,少数质控品可能存在衰减趋势,需要进一步观察,必要时及时更换质控品和缩短质控品冷藏保存的时限。实验室有必要建立自己的质控品稳定性的评价方法,以补充常规质控图的监控作用。

Objective:To analyze the time stability of ELISA internal quality control products in blood stations under cold storage conditions and establish a stability evaluation method.Method:Commercial ELISA quality control samples stored in refrigerator for 7groups in 0,5,10,15,20,25and 30days were obtained.All quality control samples transferred to refrigerator were tested together with routine blood donor samples.Four items(HBsAg,anti-HCV,HIV-Ag/Ab,anti-TP)were screened in the laboratory and two kinds of commercial reagents were used in each item.As the minimum detection limit of each reagent was different and the corresponding quality control products were also different(a total of 6kinds),a total of 8kinds of reagents were used to test 6kinds of quality control products in the laboratory within one day,and the test results of 8plates detected by FAME were finally obtained.One-way ANOVA and t test together with quality control chart were used to evaluate the homogeneity and stability of quality control products at different times.Result:Except that the Fvalue of the anti-HCV control(control lot number:201601001)was slightly higher than the critical value of F0.05(6,14)(F=3.93,0.01<P<0.05),the F values of the other controls were all around 1,P values were all greater than 0.05,and there was no statistical difference.When t testα=0.01,the quality control products stored in the laboratory during the 30days of cold storage showed overall stability.Only the anti-TP quality control products(control lot number:201611033)showed significant statistical differences on the 10th day,and showed normalSL?Eperformance on the 15th,20th,25th and 30th days.However,when t testα=0.05,some quality control results showed statistical differences,which were concentrated in the quality control products after 10days of cold storage.Combining with the quality control chart,it was found that the anti-HCV quality control products(quality control product lot number:201601001)and anti-HIV quality control products(quality control product lot number:201611033)might have an attenuation trend,and the quality control chart framework itself might have offset.Conclusion:The ELISA third-party weak positive quality control products in the central laboratory can basically ensure homogeneity and stability within 30days after being refrigerated at 2-8℃.A few quality control products may have an attenuation trend,which requires further observation.If necessary,the quality control products should be replaced in time and the time limit for the refrigerated storage of the quality control products should be shortened.It is necessary for the laboratory to establish its own evaluation method for the stability of quality control products to supplement the monitoring function of routine quality control charts.