Ann Lab Med.  2016 Jan;36(1):55-59. 10.3343/alm.2016.36.1.55.

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

• Schuring A
• Kelsch R
• Pierscinski G
• Nofer JR

• KMID: 2373498
• DOI: http://doi.org/10.3343/alm.2016.36.1.55

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.

Keyword

Reference intervals; Prolactin; Sex hormones; Immunoassays

MeSH Terms

Adult
Aged
Female
Follicular Phase
Gonadal Steroid Hormones/*blood
Humans
Immunoassay
Luteal Phase
Male
Middle Aged
Postmenopause
Reference Values
Sex Factors
Gonadal Steroid Hormones

Figure

• 

  Fig. 1 Distribution of prolactin in the examined population. Prolactin was determined in apparently healthy male (N=220) and female subjects (N=329; 139 in the follicular phase, 87 in the luteal phase, and 103 postmenopausal). Box-Whisker plots show the distribution of prolactin values as measured with the Advia Centaur (Siemens Healthcare) or Immulite 2000XP (Siemens Healthcare) platforms. Middle lines represent medians. The central box represents the values from the lower to upper quartile. Outliers were identified and disregarded as indicated in the text. Significances were calculated with the Mann-Whitney test.

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