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目的评价Sebia Minicap Flex Piercing全自动毛细管电泳仪检测糖化血红蛋白(HbA1c)的检测性能。方法根据美国临床和实验室标准化协会(CLSI)的相关文件及其他相关标准对该检测系统检测HbA1c的精密度、准确度、携带污染率和参考区间指标进行评价,同时与Premier Hb 9210糖化血红蛋白仪检测结果进行一致性验证。结果该检测系统检测高低两个浓度的HbA1c的批内精密度分别为1.2%和0.74%;准确度验证其与Premier Hb 9210糖化血红蛋白仪相关性较好,r2为0.990 26,相对偏倚<5%;携带污染率为0.99%。结论 Sebia Minicap Flex Piercing全自动毛细管电泳仪检测HbA1c主要仪器性能达到CLSI指南和厂家说明书的要求,可满足临床检测需求。
Objective To evaluate the detection performance of glycosylated hemoglobin (HbA1c) by Sebia Minicap Flex Piercing automated capillary electrophoresis system. Methods According to the relevant documents of CLSI and other related standards, the accuracy, accuracy, carrying rate and reference interval of HbA1c in this detection system were evaluated. Meanwhile, the accuracy of HbA1c was compared with that of the Premier Hb 9210 HbA1c Test results for consistency verification. Results The intra-assay precision of HbA1c was 1.2% and 0.74%, respectively. The accuracy of HbA1c was close to that of the Premier Hb 9210 HbA1c, r2 was 0.990 26 and the relative bias was less than 5% ; Carrying pollution rate of 0.99%. Conclusion The Sebia Minicap Flex Piercing Automated Capillary Electrophoresis System can meet the requirements of CLSI guidelines and manufacturer’s instructions for testing the performance of HbA1c main instruments to meet clinical testing needs.