Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 - Part 2 ligand binding assays - impact of 25-hydroxyvitamin D(2) and 24R,25-dihydroxyvitamin D(3) on assay performance.
Wise, Stephen A.; Camara, Johanna E.; Burdette, Carolyn Q.et al.
24R,25-Dihydroxyvitamin D3 [24R,25(OH)2D3]; 25-Hydroxyvitamin D2 [25(OH)D2]; 25-Hydroxyvitamin D3 [25(OH)D3]; Ligand binding assay; Liquid chromatography–tandem mass spectrometry (LC-MS/MS); Total 25-hydroxyvitamin D [25(OH)D]
Abstract :
[en] An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of ligand binding assays (Part 2) for the determination of serum total 25-hydroxyvitamin D [25(OH)D]. Fifty single-donor samples were assigned target values for concentrations of 25-hydroxyvitamin D(2) [25(OH)D(2)], 25-hydroxyvitamin D(3) [25(OH)D(3)], 3-epi-25-hydroxyvitamin D(3) [3-epi-25(OH)D(3)], and 24R,25-dihydroxyvitamin D(3) [24R,25(OH)(2)D(3)] using isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 2 includes results from 17 laboratories using 32 ligand binding assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 50% of the ligand binding assays achieved the VDSP criterion of mean % bias ≤ |± 5%|. For the 13 unique ligand binding assays evaluated in this study, only 4 assays were consistently within ± 5% mean bias and 4 assays were consistently outside ± 5% mean bias regardless of the laboratory performing the assay. Based on multivariable regression analysis using the concentrations of individual vitamin D metabolites in the 50 single-donor samples, most assays underestimate 25(OH)D(2) and several assays (Abbott, bioMérieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH)(2)D(3). The results of this interlaboratory study represent the most comprehensive comparison of 25(OH)D ligand binding assays published to date and is the only study to assess the impact of 24R,25(OH)(2)D(3) content using results from a reference measurement procedure.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Wise, Stephen A.
Camara, Johanna E.
Burdette, Carolyn Q.
Hahm, Grace
Nalin, Federica
Kuszak, Adam J.
Merkel, Joyce
Durazo-Arvizu, Ramón A.
Williams, Emma L.
Popp, Christian
Beckert, Christian
Schultess, Jan
Van Slooten, Glen
Tourneur, Carole
Pease, Camille
Kaul, Ravi
Villarreal, Alfredo
Batista, Marcelo Cidade
Pham, Heather
Bennett, Alex
Jansen, Eugene
Khan, Dilshad Ahmed
Kilbane, Mark
Twomey, Patrick J.
Freeman, James
Parker, Neil
Mushtaq, Sohail
Simpson, Christine
LUKAS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Bone and cartilage markers laboratory
Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 - Part 2 ligand binding assays - impact of 25-hydroxyvitamin D(2) and 24R,25-dihydroxyvitamin D(3) on assay performance.
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