Validation of an LC-MS/MS Method Using Solid-Phase Extraction for the Quantification of 1-84 Parathyroid Hormone: Toward a Candidate Reference Measurement Procedure.
LC-MS/MS; intact parathormone; liquid chromatography; mass spectrometry; reference measurement procedure; Parathyroid Hormone; Humans; Chromatography, Liquid/methods; Solid Phase Extraction; Reference Standards; Reproducibility of Results; Tandem Mass Spectrometry/methods; Biochemistry (medical); Clinical Biochemistry
Abstract :
[en] ("[en] BACKGROUND: Parathyroid hormone (PTH) measurement is important for patients with disorders of calcium metabolism, including those needing bone-turnover monitoring due to chronic kidney disease-mineral bone disorder. There are currently 2 generations of PTH immunoassays on the market, both having cross-reactivity issues and lacking standardization. Therefore, we developed an LC-MS/MS higher-order method for PTH analysis.
METHODS: The method was calibrated against the international standard for 1-84 PTH (WHO 95/646). Antibody-free sample preparation with the addition of an isotope-labeled internal standard was performed by solid-phase extraction. Extracts were analyzed by LC-MS/MS. EDTA-K2 plasma was used throughout the development and validation. Bias and uncertainty sources were tested according to ISO 15193. Clinical Laboratory Standards Institute guidelines and reference measurement procedures were consulted for the design of the validation. Patient samples and external quality controls were compared between LC-MS/MS and 2 third-generation immunoassays.
RESULTS: The method was validated for 1-84 PTH from 5.7 to 872.6 pg/mL. The interassay imprecision was between 1.2% and 3.9%, and the accuracy ranged from 96.2% to 103.2%. The measurement uncertainty was <5.6%. The comparison between LC-MS/MS and the immunoassays showed a proportional bias but moderate to substantial correlation between methods.
CONCLUSIONS: This LC-MS/MS method, which is independent of antibodies, is suitable for a wide range of PTH concentrations. The obtained analytical performance specifications demonstrate that development of a reference measurement procedure will be possible once a higher order reference standard is available.","[en] ","")
Disciplines :
Biochemistry, biophysics & molecular biology Laboratory medicine & medical technology Endocrinology, metabolism & nutrition
Author, co-author :
Farre Segura, Jordi ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
Le Goff, Caroline ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
LUKAS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
Cobraiville, Gaël ; Centre Hospitalier Universitaire de Liège - CHU > > Service de rhumatologie
Fillet, Marianne ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Servais, Anne-Catherine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Delanaye, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > > Service de néphrologie ; Department of Nephrology-Dialysis-Apheresis, Hôpital Universitaire Carémeau, Nîmes, France
Cavalier, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
Language :
English
Title :
Validation of an LC-MS/MS Method Using Solid-Phase Extraction for the Quantification of 1-84 Parathyroid Hormone: Toward a Candidate Reference Measurement Procedure.
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