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
Wise, Stephen A.
Camara, Johanna E.
Burdette, Carolyn Q.
Kuszak, Adam J.
Durazo-Arvizu, Ramón A.
Williams, Emma L.
Van Slooten, Glen
Cidade Batista, Marcelo
Ahmed Khan, Dilshad
Twomey, Patrick J.
Sempos, Christopher T.
AffiliationUniversity 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 LLC
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AbstractAn 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.
CitationWise, 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/s00216-021-03577-0
DescriptionThe final publication is available at Springer via http://dx.doi.org/10.1007/s00216-021-03577-0
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Interaction between Dietary Fat Intake and Metabolic Genetic Risk Score on 25-Hydroxyvitamin D Concentrations in a Turkish Adult PopulationIsgin-Atici, Kubra; Alathari, Buthaina E.; Turan-Demirci, Busra; Sendur, Suleyman Nahit; Incilay, Lay; Ellahi, Basma; Alikasifoglu, Mehmet; Erbas, Tomris; Buyuktuncer, Zehra; Santhanakrishnan, Vimaleswaran Karani; et al. (MDPI, 2022-01-17)Previous studies have pointed out a link between vitamin D status and metabolic traits, however, consistent evidence has not been provided yet. This cross-sectional study has used a nutrigenetic approach to investigate the interaction between metabolic-genetic risk score (GRS) and dietary intake on serum 25-hydroxyvitamin D [25(OH)D] concentrations in 396 unrelated Turkish adults, aged 24-50 years. Serum 25(OH)D concentration was significantly lower in those with a metabolic-GRS ≥ 1 risk allele than those with a metabolic-GRS < 1 risk allele (p = 0.020). A significant interaction between metabolic-GRS and dietary fat intake (energy%) on serum 25(OH)D levels was identified (Pinteraction = 0.040). Participants carrying a metabolic-GRS ≥ 1 risk allele and consuming a high fat diet (≥38% of energy = 122.3 ± 52.51 g/day) had significantly lower serum 25(OH)D concentration (p = 0.006) in comparison to those consuming a low-fat diet (<38% of energy = 82.5 ± 37.36 g/d). In conclusion, our study suggests a novel interaction between metabolic-GRS and dietary fat intake on serum 25(OH)D level, which emphasises that following the current dietary fat intake recommendation (<35% total fat) could be important in reducing the prevalence of vitamin D deficiency in this Turkish population. Nevertheless, further larger studies are needed to verify this interaction, before implementing personalized dietary recommendations for the maintenance of optimal vitamin D status.
Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditionsSempos, Christopher T.; Williams, Emma L.; Carter, Graham D.; Jones, Julia; Camara, Johanna E.; Burdette, Carolyn Q.; Hahm, Grace; Nalin, Federica; Duewer, David L.; Kuszak, Adam J.; et al. (Springer, 2021-11-09)The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at −40 °C prior to distribution and the participants are instructed to store the samples frozen at −20 °C or lower after receipt; however, the samples are shipped to participants at ambient conditions (i.e., no temperature control). To address the question of whether shipment at ambient conditions is sufficient for reliable performance of various 25(OH)D assays, the equivalence of DEQAS human serum samples shipped under frozen and ambient conditions was assessed. As part of a Vitamin D Standardization Program (VDSP) commutability study, two sets of the same nine DEQAS samples were shipped to participants at ambient temperature and frozen on dry ice. Twenty-eight laboratories participated in this study and provided 34 sets of results for the measurement of 25(OH)D using 20 ligand binding assays and 14 liquid chromatography–tandem mass spectrometry (LC–MS/MS) methods. Equivalence of the assay response for the frozen versus ambient DEQAS samples for each assay was evaluated using multi-level modeling, paired t-tests including a false discovery rate (FDR) approach, and ordinary least squares linear regression analysis of frozen versus ambient results. Using the paired t-test and confirmed by FDR testing, differences in the results for the ambient and frozen samples were found to be statistically significant at p < 0.05 for four assays (DiaSorin, DIAsource, Siemens, and SNIBE prototype). For all 14 LC–MS/MS assays, the differences in the results for the ambient- and frozen-shipped samples were not found to be significant at p < 0.05 indicating that these analytes were stable during shipment at ambient conditions. Even though assay results have been shown to vary considerably among different 25(OH)D assays in other studies, the results of this study also indicate that sample handling/transport conditions may influence 25(OH)D assay response for several assays.
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