A multicenter evaluation of immunoassays for follicle-stimulating hormone, luteinizing hormone and testosterone: Concordance, imprecision and reference values

Background: Numerous laboratories in Italy use radioimmunoassay to determine concentrations of sex hormones (FSH, LH, testosterone). A comparison of assay methods is thus an important starting point for the achievement of universally accepted reference values. Aim: To carry out an external quality a...

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Bibliographic Details
Published in:Journal of endocrinological investigation 2013-10, Vol.36 (9), p.739-744
Main Authors: Radicioni, A., Lenzi, A., Spaziani, M., Anzuini, A., Ruga, G., Papi, G., Raimondo, M., Foresta, C.
Format: Article
Language:English
Subjects:
Endocrinology
Female
Follicle Stimulating Hormone - blood
Humans
Immunoassay
Italy
Luteinizing Hormone - blood
Male
Medicine
Medicine & Public Health
Metabolic Diseases
Original Article
Radioimmunoassay
Reference Values
Reproducibility of Results
Testosterone - blood
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Summary:Background: Numerous laboratories in Italy use radioimmunoassay to determine concentrations of sex hormones (FSH, LH, testosterone). A comparison of assay methods is thus an important starting point for the achievement of universally accepted reference values. Aim: To carry out an external quality assessment for FSH, LH, and testosterone. Materials and methods: Fifteen aliquots from 5 serum pools were assayed in multiple replicates by 16 Italian laboratories with 5 automated immunoassays (Abbott Architect, DiaSorin Liaison, Perkin-Elmer AutoDelfia, Roche Elecsys, Siemens Immulite 2000), and 1 radioimmunoassay (Adaltis). Results: The variance was below 12% for FSH, between 11.61 % and 14.76% for LH, and between 9.57% and 12.48% for testosterone. Assay precision was good, except for Elecsys at low concentrations of FSH and for Immulite at low concentrations of LH and testosterone. ARCHITECT showed a negative bias for FSH and LH and a positive bias for testosterone; Liaison a positive bias for LH; Elecsys a positive bias for FSH and a negative bias for testosterone; Immulite a positive bias for FSH; AutoDelfia a negative bias for FSH and a positive bias for testosterone. Reference ranges at the low end varied widely, even among laboratories using the same assay. Conclusions: The analytical performances of widely used immunoassays for FSH, LH, and testosterone show a fair to strong degree of consistency. A careful evaluation of reference ranges by clinical and laboratory experts needs to be carried out, in order to reach a consensus.
ISSN:0391-4097
1720-8386
DOI:10.1007/BF03347112