Multicenter analytical performance evaluation of a fully automated anti-Müllerian hormone assay and reference interval determination.
OBJECTIVE
Anti-Müllenria hormone (AMH) is an established biomarker for assessing ovarian reserve and predicting response to controlled ovarian stimulation. Its routine clinical use is hampered by the variability and low-throughput of available enzyme-linked immunosorbent assays (ELISA). The presented study examined if a fully automated AMH electrochemiluminescence assay (ECLIA; Elecsys® AMH assay, Roche Diagnostics) was suitable for measuring AMH levels in healthy women and in those diagnosed with polycystic ovary syndrome (PCOS).


METHODS
Five European laboratories evaluated the Elecsys® AMH assay independently under routine conditions over eight months. Within-run imprecision, repeatability, intermediate precision, linearity and functional sensitivity were assessed. The Elecsys® AMH assay was compared to a manual ELISA microtiter plate format test (AMH Gen II ELISA, modified version; Beckman Coulter Inc.) using 1729 routine serum samples. AMH reference intervals were determined in 887 healthy women with regular menstrual cycle aged 20–50 years, and 149 women diagnosed with PCOS.


RESULTS
The fully automated Elecsys® AMH assay showed excellent precision, linearity, and functional sensitivity. The coefficient of variation was 1.8% for repeatability and 4.4% for intermediate precision. Values measured with the Elecsys® AMH assay were highly correlated with the manual ELISA method (modified version) but 24–28% lower. Reference intervals showed the expected AMH decline with age in healthy women and increased AMH levels in women with PCOS.


CONCLUSIONS
The Elecsys® AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma.
Laboratory of Hormonology and Tumour Markers, Universitair Ziekenhuis Brussel, Free University of Brussels (VUB), Brussels, Belgium. Electronic address: ellen.anckaert@uzbrussel.be.
E
E
Anckaert
Duzen Laboratories Group, Tunus Cad. No. 95, Kavaklidere, Ankara, Turkey.
M
M
Öktem
MVZ wagnerstibbe für Laboratoriumsmedizin and Pathologie GmbH, Georgstraße 50, 30159 Hannover, Germany.
A
A
Thies
Laboratoire Eylau Saint Didier, 55, rue Saint Didier, 75116 Paris, France.
M
M
Cohen-Bacrie
Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
N M P
NM
Daan
Laboratory of Hormonology and Tumour Markers, Universitair Ziekenhuis Brussel, Free University of Brussels (VUB), Brussels, Belgium.
J
J
Schiettecatte
Limbach Laboratory, Medical Care Center, Im Breitspiel 15, 69126 Heidelberg, Germany.
C
C
Müller
Duzen Laboratories Group, Tunus Cad. No. 95, Kavaklidere, Ankara, Turkey.
D
D
Topcu
MVZ wagnerstibbe für Laboratoriumsmedizin and Pathologie GmbH, Georgstraße 50, 30159 Hannover, Germany.
A
A
Gröning
Laboratoire Eylau Saint Didier, 55, rue Saint Didier, 75116 Paris, France.
F
F
Ternaux
Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
C
C
Engel
Roche Diagnostics GmbH, Sandhofer Str. 116, 68305 Mannheim, Germany.
S
S
Engelmann
Limbach Laboratory, Medical Care Center, Im Breitspiel 15, 69126 Heidelberg, Germany.
C
C
Milczynski
D000293:Adolescent; D000328:Adult; D054304:Anti-Mullerian Hormone / Q000032:analysis* / Q000097:blood; D057205:Automation, Laboratory / Q000295:instrumentation / Q000379:methods; D015415:Biomarkers / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D007753:Laboratories; D008163:Luminescent Measurements / Q000379:methods* / Q000592:standards; D008597:Menstrual Cycle / Q000378:metabolism; D008875:Middle Aged; D011085:Polycystic Ovary Syndrome / Q000097:blood; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015415:Biomarkers; D054304:Anti-Mullerian Hormone
Anti-Müllerian hormone (AMH); Elecsys® AMH; Electrochemiluminescence immunoassay (ECLIA); Immunoassay; Polycystic ovary syndrome (PCOS)