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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。
OBJECTIVE To confirm the applicability of the fully automatic blood analysis system by taking the Beckman PK7300 automatic blood analysis system as an example. Method 1) According to the manufacturer’s recommendation and other laboratory experience, six parameters such as incubation temperature, red blood cell concentration, standard erythrocyte concentration, reagent addition amount, dilution amount and determination method were selected, and incubation time, standard antisera dilution and specimen Plasma dilution and other 3 parameters to be confirmed, at the same time through the matching test to confirm. 2) Confirm the specificity and sensitivity by using specimens of known blood type and special specimens of Rh D (-). 3) Confirmation of consistency and suspicious rate by parallel testing with current microplate method. Results 1) The best parameters of our laboratory were determined: the standard anti-serum dilution was 1:40, the sample plasma dilution was 1: 2.5 and the incubation time was 60 min. 2) After confirming the parameters, 3 930 samples with known ABO blood type were tested and the accuracy of interpretation was> 95%. The accuracy of interpretation of 70 Rh D (-) and 4 positive and negative samples were all 100% . 3) Compared with the microplate method, the consistency of the test results is> 95%, and the overall suspicious rate of the system test is <2%. Conclusion The specificity, sensitivity, consistency and suspiciousness of the three main parameters to be confirmed and the other parameters meet the requirements of clinical trials.