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Performance characteristics of the Mindray chemiluminescence anti-Mullerian hormone assay

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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
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关键词: analytical performance anti‐ Mü llerian hormone Mindray chemiluminescence assay Roche assay

摘要:
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.

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出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 医学实验技术
最新[2025]版:
大类 | 4 区 医学
小类 | 3 区 医学实验技术
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出版当年[2019]版:
Q3 MEDICAL LABORATORY TECHNOLOGY
最新[2023]版:
Q2 MEDICAL LABORATORY TECHNOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

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第一作者机构: [1]Laboratory Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China
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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.
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