Interlaboratory Comparison of 25-Hydroxyvitamin D Assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 – Part 2 Ligand Binding Assays – Impact of 25 Hydroxyvitamin D2 and 24R,25- Dihydroxyvitamin D3 on Assay Performance
Affiliation
University of Chester; National Institutes of Health; National Institute of Standards and Technology; University of Southern California; Imperial Healthcare NHS Trust; Abbott Laboratories; Awareness Technology; bioMérieux; Bio-Rad Laboratories; Hospital Israelita Albert Einstein; Immunodiagnostic Systems; National Institute of Public Health and the Environment; National University of Medical Sciences; St. Vincent’s University Hospital; Siemens-Healthineers; Yale University; University of Liège; Vitamin D Standardization Program LLCPublication Date
2021-08-25Metadata
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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 D2 [25(OH)D2], 25-hydroxyvitamin D3 [25(OH)D3], 3-epi-25-hydroxyvitamin D3 [3-epi-25(OH)D3], and 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3] 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)D2 and several assays (Abbott, bioMérieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH)2D3. 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)2D3 content using results from a reference measurement procedure.Citation
Wise, S. A., Camara, J. E., Burdette, C. Q., Hahm, G., Nalin, F., Kuszak, A.J., Merkel, J., Durazo-Arvizu, R. A., Williams, E. L., Popp, C., Beckert, C., Schultess, J., Van Slooten, G., Tourneur, C., Pease, C., Kaul, R., Villarreal, A., Batista, M. C., Pham, H., Bennett, A., Jansen, E., Khan, D. A., Kilbane, M., Twomey, P. J., Freeman, J., Parker, N., Mushtaq, S., Simpson, C., Lukas, P., Cavalier É, & Sempos, C. T. (2021). Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) intercomparison study 2 - part 2 ligand binding assays - impact of 25-hydroxyvitamin D2 and 24R,25-dihydroxyvitamin D3 on assay performance. Analytical and Bioanalytical Chemistry, 414, 351–366. https://doi.org/10.1007/s00216-021-03577-0Publisher
SpringerAdditional Links
https://link.springer.com/article/10.1007/s00216-021-03577-0Type
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The final publication is available at Springer via http://dx.doi.org/10.1007/s00216-021-03577-0ISSN
1618-2642EISSN
1618-2650Scopus Count
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