Format

Send to

Choose Destination
Ann Lab Med. 2016 Jan;36(1):55-9. doi: 10.3343/alm.2016.36.1.55.

Establishing reference intervals for sex hormones on the analytical platforms Advia Centaur and Immulite 2000XP.

Author information

1
UKM Kinderwunschzentrum, Department of Gynecology and Obstetrics, University Hospital Münster, Münster, Germany.
2
Institute for Transfusion Medicine and Transplantation Immunology, University Hospital Münster, Münster, Germany.
3
Center for Laboratory Medicine, University Hospital Münster, Münster, Germany.
4
Center for Laboratory Medicine, University Hospital Münster, Münster, Germany. nofer@uni-muenster.de.

Abstract

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:

Immunoassays; Prolactin; Reference intervals; Sex hormones

PMID:
26522760
PMCID:
PMC4697344
DOI:
10.3343/alm.2016.36.1.55
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for The Korean Society for Laboratory Medicine Icon for PubMed Central
Loading ...
Support Center