First fully automated immunoassay for anti-Müllerian hormone
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Dieter Gassner
und
Rebecca Jung
Abstract
Background: The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.
Methods: Development of a high sensitive, fast and fully automated AMH assay on the Elecsys®/cobas e electrochemiluminescence immunoassay platform.
Results: Elecsys® AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys® AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20–25 °C or 2–8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at −20 °C and −80 °C for up to 9 months was without any effect on measured AMH.
Conclusions: Availability of an automated Elecsys® AMH assay offers an attractive alternative to the current manual AMH assays.
Acknowledgments
Our thanks go to Werner Kraus for preparation of antibody conjugates and Klaus Hirzel providing support in gel filtration chromatography. The technical assistance of Frigga Heister is acknowledged.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Employment played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision tosubmit the report for publication.
Research funding: None declared.
Employment or leadership: D.G. and R.J. are employed by Roche Diagnostics GmbH, which is a manufacturer of in vitro diagnostic products, including the current assay for the measurement of AMH.
Honorarium: None declared.
Elecsys, cobas e and PreciControl are trademarks of Roche.
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©2014 by Walter de Gruyter Berlin/Boston
Artikel in diesem Heft
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- Reticulated platelets: analytical aspects and clinical utility
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Colorectal cancer and screening programs: not only analytical issues
- Reviews
- Laboratory diagnostics of inherited platelet disorders
- Reticulated platelets: analytical aspects and clinical utility
- Genetics and Molecular Diagnostics
- Advanced tools for BRCA1/2 mutational screening: comparison between two methods for large genomic rearrangements (LGRs) detection
- General Clinical Chemistry and Laboratory Medicine
- Establishing, harmonizing and analyzing critical values in a large academic health center
- Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations
- First fully automated immunoassay for anti-Müllerian hormone
- A multicenter evaluation of dysthyroxinemia in a defined patient cohort
- New biomarkers in diagnosis of early onset preeclampsia and imminent delivery prognosis
- Soluble Fms-like tyrosine kinase-1 to placental growth factor ratio in mid-pregnancy as a predictor of preterm preeclampsia in asymptomatic pregnant women
- Development of a new immunoassay for the detection of ethyl glucuronide (EtG) in meconium: validation with authentic specimens analyzed using LC-MS/MS. Preliminary results
- Optimizing centrifugation of coagulation samples in laboratory automation
- Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories
- A new sampling device for faecal immunochemical testing: haemoglobin stability is still an open issue
- Reference Values
- Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening
- Cancer Diagnostics
- Enhanced miR-182 transcription is a predictor of poor overall survival in colorectal adenocarcinoma patients
- Importance of promoter methylation of GATA4 and TP53 genes in endometrioid carcinoma of endometrium
- Frequent methylation of HOXA9 gene in tumor tissues and plasma samples from human hepatocellular carcinomas
- Letters to the Editor
- Further comments on “Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation”
- A questionnaire study among nurses: awareness of blood and urine sample collection procedures
- Measurement uncertainty and clinical interpretation of measurement results
- Laboratory automation: how will you select the boarding assays?
- Improvement and evaluation of a 1,2-dioleoylglycerol method for measuring pancreatic lipase catalytic activity in serum
- The novel variant p.Ser465Leu in the PCSK9 gene does not account for the decreased LDLR activity in members of a FH family
- 1,5 Anhydroglucitol serum concentration as a biomarker for screening gestational diabetes in early pregnancy
- A rare condition: IgE type monoclonal gammopathy of undetermined significance
- Laboratory analysis of intraosseous blood: bad to the bone?
