16种17-羟孕酮制备物基于两种评价方案的互通性研究

Commutability assessment of 16 processed materials for 17-hydroxyprogesterone based on two approaches in China

目的应用两种互通性评价方案评价16种17-羟孕酮制备物的互通性。方法互通性研究,收集2018年2月至2019年6月之间北京医院检验科的新鲜人血清共52份。根据美国临床和实验室间标准化研究所文件(CLSI)EP14-A3和国际临床化学和检验医学联合会(IFCC)互通性评价工作组报告,以血清17-羟孕酮同位素稀释液相色谱串联质谱法(ID-LC/MS/MS)为比对方法,3种临床常规分析系统(1种放射免疫法,2种LC/MS分析法)为待评方法,一同测定52个人血清样本和16种制备物的17-羟孕酮浓度,评价制备物质的互通性。结果综合两种互通性评价结果,所有正确度验证材料和国家甾体激素标准物质在LC/MS分析系统中都显示出良好的互通性,6/9的EQA材料在三种常规分析系统中都显示出互通性。其中所有材料在偏倚差值法中所有材料的LC/MS分析系统中都显示出良好的互通性。结论两种互通性评价结果有所差异,使用新鲜冰冻人血清作为血清17-羟孕酮的质评材料均能满足互通性要求。

Objective The aim of this study is to evaluate the commutability of 16 processed materials for 17-hydroxyprogesterone by using 2 commutability assessment approaches.Methods 52 serum specimens were collected in Clinical Laboratory Department of Beijing Hospital from February 2018 to June 2019.According to the report of the Clinical and Laboratory Standards Institute(EP14-A3)document and the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)working group on commutabilityassessment,serum 17-hydroxyprogesterone isotope diluent chromatogram tandem mass spectrometry(ID-LC/MS/MS)was used for comparison.Three clinical routine analysis systems(1 radioimmunoassay,2 LC/MS analysis methods)were used to determine the concentration of 17-hydroxyprogesterone in 52 human serum samples and 16 processed materialsfor commutabilityassessment.Results Combined with the results of the two commutability assessment,all accuracy verification materials and national steroid hormone standards showed good commutability in the LC/MS analysis system,and 6/9 EQA materials showed commutability in the three routine analysis systems.All materials showed good commutability in the LC/MS analysis system of bias difference method.Conclusions The two kinds of commutability assessment results are different.Bias difference method has more clinical value,but it has certain application limitations.The use of fresh frozen human serum as a quality assessment materialfor serum 17-hydroxyprogesterone is meets the commutability requirement.