临床医学实验室非配套试剂使用性能验证  

Performance verification of new reagents in clinical laboratory

作　　者：周锡铧[1] 邸玉玮[1] 戴耀宗[1] 董晖[1] 黎艳湘[1] 马建宏[1] 

机构地区：[1]广东省医学科学院,广东省人民医院病理医学部检验科,广州市510080

出　　处：《实用医学杂志》2012年第22期3824-3826,共3页The Journal of Practical Medicine

摘　　要：目的:以AU产淀粉酶试剂(AMYX)为例,探讨临床医学实验室在使用非配套试剂前,进行多项要素性能验证的方法。方法:取低、高值两份临床新鲜血清样本,重复检测10次,计算均值、SD、CV%,评估使用AMYX试剂检测的批内重复性。检测高、低两个水平液态人基质血清质控物,1次/d共20d,计算均值、SD、CV%,评估批间检测变异。收集在34～1233U/L范围内的20份新鲜血清样本,使用配套试剂、AMYX分别双份检测,参照美国临床实验室标准化委员会(NCCLS)EP9-A2提供的方法进行比对,验证准确度。用高、低值临床血清样本配制6个浓度混合样本,双份检测,参照美国临床实验室标准化委员会(NCCLS)EP6-A进行AMYX线性范围的评价。使用AMYX试剂检测20份来自健康人的新鲜血清样本,验证正常参考范围是否适用。结果:AU产淀粉酶试剂(AMYX)的批内检测低值样本CV为2.87%,高值样本CV为1.49%。批间检测低水平质控物CV为1.80%,高水平质控物CV为2.00%。与配套试剂比较,y=0.98x-0.62,R2=0.998,以1/4CLIA’88TEa(30%)=7.5%为可接受标准,估计误差SE=9.4U/L<37.5U/L。在31.5～1233U/L范围内,AMYX检测结果符合一次方程,呈线性。20份来自健康人的新鲜血清样本检测结果均在正常参考值范围内。结论:AU产淀粉酶试剂(AMYX)与仪器配套试剂(AMY)检测结果可比,其批内、批间变异符合实验室要求,线性范围与厂家提供的一致,正常值参考范围适用,AMYX可用于临床实验室日常检测。Objective Make AMYX as an example and explore the performance verification of new reagent in clinical laboratory. Methods The reproducibility was evaluated based on clinical sample measurement （it = 10）. The interassay coefficient of variation was got from twenty-day measurement of two level IQC human serum. Accuracy verification was performed through detecting 20 clinical serum samples based on the method of EP9-A2. According to EP6-A,linearity range verification was handled. Normal reference range was confirmed using twenty samples from health peple. Results The CV% of repeat clinical measurement is 2.87% and 1.49%, and the interassay CV% is 1.80% and 2.00% ,all less than 1/4 CLIA＇88 TEa （7.5%）.Compared with origin reagent AMY, the regression equation is y = 0.98x-0.62,R2 = 0.998, SE = 9.4 U/L 〈 37.5 U/L （1/4CLIA＇88TEa = 7.5%） at the medicine decision level of 500 U/L. In the range of 31.5 - 1 233 U/L, AMYX measure appear linearity. The data from all samples of twenty health people were all in the medical reference range of 16-108 U/L. Conclusion The performance parameters of new reagent AMYX meet the standards of clinical laboratory, and AMYX ean be used for clinical detection.

关 键 词：临床实验室 性能验证 淀粉酶 NCCLS EP9-A2 NCCLS EP6-A 

分 类 号：R446[医药卫生—诊断学]