国家冰冻人血清总蛋白标准物质在参考方法量值传递中的应用

Application of total protein standard reference material in frozen human serum in value transfer of reference method

目的评价以冰冻人血清总蛋白标准物质为校准品的参考方法测量结果的准确性。方法分别以SRM927e、SRM927f、GBW09186~188为校准品测量国际比对样本RELA 22A、22B,选出合适的校准品测量国际比对样本RELA 23A、23B、18A、18B、17A、17B和53份临床剩余单人份血清。参考美国临床实验室标准化协会(CLSI)EP09-A3文件对结果进行比对。结果以SRM927f为校准品,RELA 22A、22B的测量结果超出国际临床化学和检验医学联合会(IFCC)等效限,以SRM927e为校准品的测量结果在等效限范围内。以冰冻人血清总蛋白标准物质GBW09186~188为校准品的测量结果均在IFCC等效限范围内,其中以GBW09188的测量偏移最小;以GBW09188为校准品测量3年国际比对样本的测量偏移为-0.45%~0.45%,均在等效限范围内。以SRM927e、GBW09188为校准品的Bland-Altman一致性分析结果显示,所有数据均在95%可信区间(CI)内,2个校准品有较好的一致性;4种回归分析结果显示,各医学决定水平处的偏移均在临床可接受范围内。结论以冰冻人血清总蛋白标准物质GBW09188为校准品的血清总蛋白参考方法的测量结果准确可靠。

Objective To evaluate the accuracy of the measurement results in reference method using total protein standard reference material in frozen human serum as calibrator.Methods SRM927e,SRM927f and GBW09186-188 were used as calibrators to measure RELA 22A and 22B,appropriate calibrators were selected,and then RELA 23A,23B,18A,18B,17A,17B and 53 individual serum samples were measured,and the results were compared with the Clinical and Laboratory Standards Institute(CLSI)EP09-A3.Results The measurement results of RELA 22A and 22B using SRM927f as calibrator exceeded the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)equivalent limit,while the measurement results using SRM927e as calibrator were within the equivalent limit.The measurement results using GBW09186-188 as calibrators were all within the equivalent limit,and the bias of GBW09188 was the least.The bias range of the 3-year international comparison samples measured with GBW09188 as calibrator was-0.45%-0.45%,all of which were within the equivalent limit.The Bland-Altman results using SRM927e and GBW09188 as calibrators were all within 95%confidence interval(CI),indicating good consistency in the measurement results of the 2 calibrators.The bias at the medical decision level of the 4 regression analyses was within the clinically acceptable range.Conclusions The measurement results of serum total protein reference method with GBW09188 as calibrator are accurate and reliable.