Analysis on the performance of aldosterone testing and the results of EQA in China
10.3760/cma.j.issn.1009-9158.2020.03.014
- VernacularTitle:我国醛固酮检测方法性能和不同类型室间质量评价结果分析
- Author:
Weiyan ZHOU
1
;
Wenbo LUO
;
Qingxiang LIU
;
Jiangtao ZHANG
;
Rong MA
;
Cuihua HU
;
Haijian ZHAO
;
Chuanbao ZHANG
Author Information
1. 北京医院 国家老年医学中心 国家卫生健康委临床检验中心 北京市临床检验工程技术研究中心 中国医学科学院老年医学研究院，北京 100730
- From:
Chinese Journal of Laboratory Medicine
2020;43(3):267-273
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the performance of aldosterone testing in China through the External Quality Assessment (EQA) and improve the testing quality of aldosterone.Methods:Two kinds of EQA program for aldosterone were carried out in China, one of which is Routine EQA and the other is Trueness verification scheme. Lyophilized sera with 5 concentration levels were used as quality control of Routine EQA. The results were grouped according to the instrument. Target values and the coefficient of variation ( CV) were calculated in each group. Trueness verification scheme was verified by using frozen human sera of 3 concentration levels determined by the reference method, and the bias of each instrument group from the target value was calculated. Results:272 laboratories submitted the testing results, and 91.6% of laboratories used chemiluminescence method. The maximum CV was obtained by radioimmunoassay and liquid chromatography mass spectrometry, and the robust CVs were 14.6%-33.4% and 43.5%-53.9%, respectively. For chemiluminescence methods, the robust group CV was less than 10%. The results of the Trueness verification scheme showed that liquid chromatography mass spectrometry method was the most accurate method, with biases of -7.9%, 8.9% and -0.7% for the three quality controls. Diasorin system had the more accurate results deviated from the target by 58.7%, 7.9% and -2.1%, respectively. The results of other chemiluminescence methods were negatively correlated with the sample concentration, and one of them with a bias of 479%. Conclusions:The accuracy and comparability of aldosterone among laboratories in China are not satisfactory. Reagent manufacturers and laboratories should pay more attention to EQA, with the aldosterone results traceable to SI unit, and improve the test quality of aldosterone.
