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 (C) 2013, Editrice Kurtis

A multicenter evaluation of immunoassays for follicle-stimulating hormone, luteinizing hormone and testosterone: Concordance, imprecision and reference values / Radicioni, Antonio; Lenzi, Andrea; Spaziani, M.; Anzuini, Antonella; Ruga, Gilda; Papi, G.; Raimondo, M.; Foresta, C.. - In: JOURNAL OF ENDOCRINOLOGICAL INVESTIGATION. - ISSN 0391-4097. - STAMPA. - 36:9(2013), pp. 739-744. [10.1007/bf03347112]

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

RADICIONI, Antonio;LENZI, Andrea;M. Spaziani;ANZUINI, Antonella;RUGA, GILDA;
2013

Abstract

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 (C) 2013, Editrice Kurtis
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/535291
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