糖化血红蛋白原装进口试剂和国产配套试剂的对比性研究

A Comparative Study of Imported Original Package Reagent and Domestic Matching Reagent on Hb1Ac Detection

目的探讨糖化血红蛋白进口原装试剂与国产配套试剂检测结果的一致性,为合理选择检测试剂提供依据。方法应用美国BIO- RAD D- 10、日本ARKRAY HA- 8180、日本ARKRAY HA- 8160和日本TOSOH HLC- 723 G8等机器的高压液相法进口原装检测试剂和北京爱瑞达生物科技有限公司的配套试剂检测患者糖化血红蛋白样本300例,其中正常样本100例,糖尿病患者样本200例,比较两种试剂检测结果的一致性。结果所有机型的国产配套试剂检测结果在批内、批间的高、低值变异系数均小于进口原装检测试剂,精密度良好。四种机型的进口原装试剂和国产配套试剂Hb1Ac检测值具有良好的相关性, R^2 分别为0.9943、0.9938、0.9975、0.9972。国产试剂线性良好,实测数值与理论数值契合度很高。国产配套试剂盒和进口原装试剂的携带污染率均小于3%,均在可允许范围内。结论国产配套检测试剂与进口原装试剂相比较差异无统计学意义,国产配套试剂完全可以满足临床需要。

Objective This study aimed to investigate the consistency of the detection results of imported original package of Hb1Ac reagent and domestic matching reagent,so to provide a knowledge refernce for the detection reagent selection. Methods The imported original package for detection reagents of BIO- RAD D- 10 ,Japan ARKRAY HA HA- 8180,8160 and Japan TOSOH HLC- 723 G8 machine and the detection reagent for Beijing Eredars Biotec Co.,Ltd were used in the study.The percentage of Hb1Ac in 300 blood samples,including 100 cases from healthy donor and 200 cases from diabetes patients,were detected by High Performance Liquid Chromatography method.The testing results of the two types of reagents were compared. Results The variation coefficients of high and low values of intra- assay and inter- assay of domestic matching reagents were less than those in original package reagents in all models,with a good precision.The Hb1Ac detection values of the original package reagent and the domestic matching reagent in the four models all had a good correlation,with R^2 of 0.9943,0.9938,0.9975 and 0.9972,respectively.The domestic reagent had a good linearity,and the measured value fit well with the theoretical value.The carrying contamination rates of domestic and imported reagent were both less than 3%,which were within the allowable range. Conclusion There is no significant difference between the domestic matching reagent and the imported original package reagent.The domestic matching reagent can fully meet the clinical requirements.