机构:[1]Laboratory Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China[2]Department of Laboratory Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China大德路总院检验科大德路总院检验科广东省中医院
Background The aim of this study was to define the performance characteristics of the Mindray chemiluminescence assay for anti-Mullerian hormone (AMH) detection. Designs and methods Intra-assay and total imprecision, analytical sensitivity, linearity, and interference were compared between the Mindray and Roche assays using pools of human serum according to Clinical and Laboratory Standards Institute protocols. Additionally, male and female reference intervals were established using serum specimens collected from otherwise healthy groups and patients with polycystic ovary syndrome (PCOS). Results The intra-assay and total imprecision percent coefficients of variation for low and high AMH serum levels were 2.74%/ 3.01% and 5.41%/5.35% respectively. The limits of blank, detection, and quantitation were 0.007, 0.01, and 0.03 ng/ml, respectively. The assay displayed good linearity over the range of 0.01-23 ng/ml. The coefficient of determination (R-2) of the Mindray versus Roche assays was 0.9713 with 411 samples with AMH concentrations ranging from 0.014 to 22.1 ng/ml. The slope and intercept of the regression equation were 0.9687 and 0.3419, respectively. There was no significant interference from triglycerides (up to 3000 mg/dl), bilirubin (up to 50 mg/dl), hemoglobin (up to 500 mg/dl), or total protein (up to 10 g/dl). Reference intervals showed the expected decrease in serum AMH levels with age in healthy women and increased levels in women with PCOS. Conclusion The Mindray AMH assay demonstrated acceptable analytical performance under routine conditions and is suitable for determining AMH levels in serum samples.
基金:
Medical Scientific Research Foundation
of Guangdong Province of China,
Grant/Award Number: A2019282 and
A2020108; Natural Science Fund of
Guangdong, Grant/Award Number:
2019A1515010178; President Foundation
of Nanfang Hospital, Southern Medical
University, Grant/Award Number:
2017C044
第一作者机构:[1]Laboratory Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China
共同第一作者:
通讯作者:
通讯机构:[1]Laboratory Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China[*1]Laboratory Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China.
推荐引用方式(GB/T 7714):
Zhao Jing-Jing,Kang Chun-Min,Zhang Peng,et al.Performance characteristics of the Mindray chemiluminescence anti-Mullerian hormone assay[J].JOURNAL OF CLINICAL LABORATORY ANALYSIS.2021,35(4):doi:10.1002/jcla.23734.
APA:
Zhao, Jing-Jing,Kang, Chun-Min,Zhang, Peng&Zheng, Lei.(2021).Performance characteristics of the Mindray chemiluminescence anti-Mullerian hormone assay.JOURNAL OF CLINICAL LABORATORY ANALYSIS,35,(4)
MLA:
Zhao, Jing-Jing,et al."Performance characteristics of the Mindray chemiluminescence anti-Mullerian hormone assay".JOURNAL OF CLINICAL LABORATORY ANALYSIS 35..4(2021)