We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

MINDRAY In-Vitro Diagnostics

As a global leader in in-vitro diagnostics, Mindray provides a wide range of efficient, reliable IVD solutions for la... read more Featured Products: More products

Download Mobile App




Chemiluminescence Anti‐Müllerian Hormone Assay Performance Characterized

By LabMedica International staff writers
Posted on 18 Mar 2021
Print article
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


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
Reagent Reservoirs
Reagent Reservoirs

Print article

Channels

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.