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目的对在我国上市的9个品种的ABO正定型和RhD定型检测卡(柱凝集法)进行实验室质量分析。方法使用性能良好的红细胞试剂对上述试剂盒的外观、特异性、灵敏度、重复性、批间重复性和稳定性进行检测。结果参与验证的ABO正定型和RhD定型检测卡(柱凝集法),外观、特异性、灵敏度、重复性、批间重复性和稳定性均能达到要求。结论通过对ABO正定型和RhD定型检测卡(柱凝集法)的实验室验证,形成了相关的性能条款,制定了相关的行业标准。
Objective To analyze the laboratory quality of nine varieties of ABO positive type and RhD stereotypes test card (column agglutination method) which are listed in our country. Methods The erythrocyte reagent with good performance was used to test the appearance, specificity, sensitivity, repeatability, inter-assay repeatability and stability of the kit. Results The ABO positive type and RhD type detection card (column agglutination method) involved in validation met the requirements of appearance, specificity, sensitivity, repeatability, batch-to-batch repeatability and stability. Conclusions Laboratory validation of the ABO positive and RhD stereotypes (column agglutination assay) resulted in relevant performance clauses and established relevant industry standards.