Evaluation of a New Fully Automated Assay for Plasma Intact FGF23.

[en] Several FGF23 immunoassays are available. However, they are reserved for research purposes as none have been approved for clinical use. We evaluated the performances of a new automated assay for intact FGF23 on the DiaSorin Liaison platform which is approved for clinical use. We established reference values in 908 healthy French subjects aged 18-89 years, and measured iFGF23 in patients with disorders of phosphate metabolism and in patients with chronic kidney disease (CKD). Intra-assay CV was 1.04-2.86% and inter-assay CV was 4.01-6.3%. The limit of quantification was <10 ng/L. Serum iFGF23 concentrations were considerably lower than EDTA values highlighting the importance of using exclusively EDTA plasma. Liaison iFGF23 values were approximately 25% higher than Immutopics values. In the 908 healthy subjects, distribution of the Liaison iFGF23 values was Gaussian with a mean +/- 2SD interval of 22.7-93.1 ng/L. Men had a slightly higher level than women (60.3 +/- 17.6 and 55.2 +/- 17.2 ng/L, respectively). Plasma iFGF23 concentration in 11 patients with tumour-induced osteomalacia, 8 patients with X-linked hypophosphatemic rickets, 43 stage 3a, 43 stage 3b, 43 stage 4, 44 stage 5 CKD patients, and 44 dialysis patients were 217.2 +/- 144.0, 150.9 +/- 28.6, 98.5 +/- 42.0, 130.8 +/- 88.6, 130.8 +/- 88.6, 331.7 +/- 468.2, 788.8 +/- 1306.6 and 6103.9 +/- 11,178.8 ng/L, respectively. This new iFGF23 assay available on a platform that already allows the measurement of other important parameters of the mineral metabolism is a real improvement for the laboratories and clinicians/researchers involved in this field.

Disciplines :

Laboratory medicine & medical technology
Urology & nephrology

Author, co-author :

Souberbielle, Jean-Claude

Prie, Dominique

Piketty, Marie-Liesse

Rothenbuhler, Anya

DELANAYE, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Service de néphrologie

Chanson, Philippe

Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale

Language :

English

Title :

Evaluation of a New Fully Automated Assay for Plasma Intact FGF23.

Publication date :

2017

Journal title :

Calcified Tissue International

ISSN :

0171-967X

eISSN :

1432-0827

Publisher :

Springer, Germany

Volume :

101

Issue :

Pages :

510-518

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 23 January 2018

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