PK7300全自动血型分析系统性能使用前确认

发布时间：2018-01-05 08:52

本文关键词：PK7300全自动血型分析系统性能使用前确认　出处：《中国输血杂志》2017年09期 　论文类型：期刊论文

【摘要】：目的以Beckman PK7300全自动血型分析系统为例,对全自动血型分析系统的性能的适用性进行确认。方法 1)依据厂家推荐和其他实验室经验选取孵育温度、标本红细胞浓度、标准红细胞浓度、试剂加入量、稀释标本加入量及判定方法等6项参数,与孵育时间、标准抗血清稀释度及标本血浆稀释度等3项待确认参数,同时通过匹配试验进行确认。2)使用血型已知的标本和正反不符及Rh D(-)的特殊标本进行特异性、灵敏度的确认。3)通过与现用微板法进行平行检测进行一致性及可疑率的确认。结果 1)确定本实验室的最佳参数:标准抗血清稀释度为1∶40、标本血浆稀释度为1∶2.5及孵育时间为60 min。2)使用确认后的参数对3 930份ABO血型已知的标本进行检测,判读正确率均95%,70份Rh D(-)及4份正反不符标本的判读正确率均为100%。3)与微板法的比对,检测结果的一致性95%,系统检测的总体可疑率2%。结论待确认的3项主参数与其它参数所构成的检测系统的特异性、灵敏度、一致性及可疑率满足到临床试验要求。
[Abstract]:With the purpose of Beckman PK7300 automatic blood analysis system as an example, the applicability of automatic blood analysis system performance are confirmed. Methods 1) on the basis of experience recommended by the manufacturer and other selected laboratory incubation temperature, sample concentration of red blood cells, red blood cell standard concentration, reagent adding amount, adding amount of 6 parameters of samples and dilution the estimation method, with incubation times, standard serum dilution and plasma dilution of 3 samples to be confirmed at the same time parameters by matching test to confirm.2) using blood specimens and the known discrepancy of Rh and D (-) special specimens confirm the specificity, the sensitivity of.3) and by now parallel testing to confirm the consistency and suspicious rate by micro plate method. Results 1) to determine the optimal parameters of the laboratory standard dilution of antiserum was 1: 40, 1 samples of plasma dilution and incubation time: 2.5 to 60 min.2). To detect 3930 ABO blood specimens with known parameters after confirmation, the interpretation accuracy were 95%, 70 Rh D (-) the correct rate of interpretation and 4 discrepancy samples were 100%.3) compared with the micro plate method, the consistency of 95% test results, the overall rate of detection of suspicious system 2%. The specificity of detection system consists of 3 main parameters of conclusion to be confirmed with other parameters of sensitivity, consistency and suspicious rate meet to clinical testing requirements.

【作者单位】：天津市血液中心;
【分类号】：R446.1
【正文快照】： ABO和Rh D血型是献血者血液检测项目之一[1],批量检测方法包括微板法及各种全自动血型分析系统。目前多数全自动血型分析系统为开放式,设备厂家仅向用户推荐设备的试验参数,并未提供与分析系统匹配的血型试剂的相关参数,那么如何对包括检测试剂在内的整个检测系统进行使用前的

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