Commutability assessment of 16 processed materials for 17-hydroxyprogesterone based on two approaches in China
10.3760/cma.j.issn.1009-8158.2020.01.004
- VernacularTitle: 16种17-羟孕酮制备物基于两种评价方案的互通性研究
- Author:
Qichen LONG
1
;
Tianjiao ZHANG
2
;
Ying YAN
2
;
Weiyan ZHOU
2
;
Xin LI
3
;
Shuijun LI
4
;
Haijian ZHAO
2
;
Wenxiang CHEN
2
;
Chuanbao ZHANG
2
Author Information
1. Peking Union Medical College, National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
2. National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
3. Nuclear Medicine Department, Beijing Hospital, National Center of Gerontology, Beijing 100730, China
4. Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China
- Publication Type:Journal Article
- Keywords:
17-α
-Hydroxyprogesterone;
Quality control;
Chromatography, liquid;
Ttandem mass spectrometry
- From:
Chinese Journal of Laboratory Medicine
2020;43(1):44-50
- CountryChina
- Language:Chinese
-
Abstract:
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.
