Brief Communication

Ann Lab Med 2016; 36(1): 55-59

Published online January 1, 2016

Copyright © Korean Society for Laboratory Medicine.

Establishing Reference Intervals for Sex Hormones on the Analytical Platforms Advia Centaur and Immulite 2000XP

Andreas N. Schüring, M.D.1, Reinhard Kelsch, M.D.2, Grzegorz Pierściński, M.D.3, and Jerzy-Roch Nofer, M.D.3

UKM Kinderwunschzentrum1, Department of Gynecology and Obstetrics; Institute for Transfusion Medicine and Transplantation Immunology2; Center for Laboratory Medicine3, University Hospital Münster, Münster, Germany

Correspondence to: Jerzy-Roch Nofer
Centrum für Laboratoriumsmedizin, Universitätsklinikum Münster, Albert Schweizer Campus 1, Gebäude A1 48149 Münster, Germany
Tel: +49-2518347228
Fax: +49-2518347225

Received: April 28, 2015; Revised: August 7, 2015; Accepted: October 12, 2015


Reliable reference intervals for sex hormones are indispensable in evaluations of the hypothalamo-pituitary-gonadal axis. This study established reference intervals for estradiol, progesterone, luteinizing hormone, follicle-stimulating hormone, and prolactin with the immunoassay platforms Advia Centaur and Immulite 2000XP (Siemens Healthcare, Germany). We recruited healthy men (n=220), women in the follicular (n=139) or luteal (n=87) phases of the menstrual cycle, and postmenopausal women (n=103). Data was analyzed according to CLSI EP28-A3c guidelines. Although reference intervals established with both platforms showed good agreement with ranges quoted by the assay manufacturer, two discrepancies were noted. First, intervals for prolactin in women were influenced by hormonal status, and the partition analysis supported their separation into subgroups based on menstrual cycle. Second, the upper limit for estradiol in the follicular phase was nearly a half of that provided by the manufacturer. This discrepancy was attributed to the stringent definition of the follicular phase (consistently set at days 3-5 after menstruation onset). Our findings suggest that reference values for prolactin should both be gender specific and account for menstrual cycle phase. The results also emphasize that clear-cut selection criteria are required when assembling populations for establishing endocrine reference intervals.

Keywords: Reference intervals, Prolactin, Sex hormones, Immunoassays