U型微板法的性能确认  

Performance validation of U type micro plate method

作　　者：曾付芳 刘冬[1] 李立亮[1] 项渊[1] 田鹏 ZENG Fufang;LIU Dong;LI Liliang;XIANG Yuan;TIAN Peng(Shiyan Blood Center, Shiyan , 442000, Chin)

机构地区：[1]十堰市中心血站,湖北十堰442000

出　　处：《临床血液学杂志（输血与检验）》2018年第2期305-309,共5页Journal of Clinical Hematology(Blood Transfusion & Laboratory Medicine)

摘　　要：目的:使用新的U型微板法检测血型,使用前对其进行性能验证,确保血型检测结果的稳定性和准确性。方法:通过不同参数的试验结果对比,确定U型微板法凝集强度最佳的试验参数;用确证的最佳试验参数,分别使用2套正定型试剂、RhD试剂对血型质控品进行ABO、RhD血型鉴定质控试验,可接受标准:质控品的检测结果反定型试验凝集强度≥2+,正定型和RhD试验凝集强度≥3+;用确证的最佳实验参数,连续7d做平行试验,比较U型微板法和现用的UV型微板法的质控品试验结果、已知血型的献血者标本试验结果的一致性。结果:ABO、RhD血型鉴定质控试验质控品的试验结果满足质控品试验结果接受标准要求;U型微板法和UV型微板法的质控品试验结果和已知血型的献血者标本试验结果的一致性为优,用确证的最佳试验参数检测血型结果的正确率为100%。结论:新的U型微板法性能验证结果满足实验室质控结果的接受标准要求,不仅达到100%的检出结果正确率,还可对室内质控数据进行定期分析和评价,从而实现血型的室内质量控制。Objective：To use the new U type micro plate method to detect blood type,and carry out the performance verificationbefore using it,in order to ensure the stability and accuracy of blood group test results.Method：Compared with experimental results of different parameters,optimal experimental parameters of U type micro plate agglutination strength was determined.With the confirmed optimal experimental parameters,quality control testswere doneusing two sets of positive type reagent and Rh（D）reagent of blood quality control of the ABO and Rh（D）blood group identification,respectively.The acceptance criteria as follow：Quality control test results reverse typing agglutination strength was more than or equal to 2＋,positive type and Rh（D）agglutination strength was more than or equal to 3＋.With the confirmed optimal experimental parameters,parallel tests were done for 7 days and quality control in the experimental resultsusing U type micro plate method and current type UV micro plate methodand the consistencyof known blood group blood sampleswere compared.Result：The experimental results using ABO and Rh（D）blood group identification quality controlmet the quality control experimental results accepted standards.The consistencyof quality control experimental resultsand known blood group blood sampleresultsusing U type micro plate method and UV type micro plate was excellent.The correct rateusing the confirmed optimal parameters of blood test results was 100%.Conclusion：New U type micro plate method performance verification results could meet the accepted standardsof laboratory quality control results,not only achieving 100% detection accuracy,but also carrying out regular analysis and evaluation of internal quality control data,so as to realize the internal quality control of the blood group.

关 键 词：U型微板法 平行试验 室内质量控制 

分 类 号：R457.1[医药卫生—治疗学]