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Chemiluminescence Anti‐Müllerian Hormone Assay Performance Characterized

By LabMedica International staff writers
Posted on 18 Mar 2021
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Image: The Mindray CL-2000i Chemiluminescence Immunoassay System (Photo courtesy of Mindray Bio‐Medical Electronics).
Image: The Mindray CL-2000i Chemiluminescence Immunoassay System (Photo courtesy of Mindray Bio‐Medical Electronics).
Müllerian hormone (AMH), a dimeric glycoprotein hormone, is a member of the transforming growth factor‐β superfamily that plays a predominant role in male and female sexual differentiation.

In males, AMH, which is expressed by sustentacular cells in the testis, promotes regression of the Müllerian ducts and maintains normal development of the reproductive system. In females, AMH is specifically expressed by granulosa cells of the developing pre‐antral and antral follicles and can be measured in the serum.

Medical Laboratory Scientists at the Southern Medical University (Guangzhou, China) collected residual serum samples after routine analysis from 1,055 blood donors (150 healthy males, 779 healthy females, and 126 women with polycystic ovary syndrome [PCOS]) presenting to a local hospital from August 2015 to October 2016.

Serum levels of AMH were detected with the Mindray AMH chemiluminescence immunoassay (CLIA) kit (Mindray Bio‐Medical Electronics Co., Ltd., Shenzhen, China) and determined with a Mindray CL‐2000i analyzer and the Roche AMH electrochemiluminescence immunoassay (ECLIA) kit (Roche Diagnostics International AG, Rotkreuz, Switzerland) and determined with the Roche Cobas E602 analyzer. Intra‐assay and total imprecision, analytical sensitivity, linearity, and interference were compared between the Mindray and Roche assays using pools of human serum. Additionally, male and female reference intervals were established using serum specimens collected from otherwise healthy groups and patients with PCOS.

The scientists reported that 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 (R2) 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 3,000 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.

The authors concluded that the Mindray chemiluminescence assay for AMH demonstrated good performance for all evaluated parameters, including precision, detection capability, and linearity. This assay can applied in the laboratory for rapid assessment of ovarian reserve assessment and PCOS diagnosis. The study was published on March 4, 2021 in the Journal of Clinical Laboratory Analysis.

Related Links:
Southern Medical University
Mindray Bio‐Medical Electronics Co., Ltd
Roche Diagnostics International

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