Vitamin D Standardization Program (VDSP) intralaboratory study for the assessment of 25-hydroxyvitamin D assay variability and bias

Wise, Stephen A.; Camara, Johanna E.; Sempos, Christopher T.; Lukas, Pierre; Goff, Caroline Le; Peeters, Stéphanie; Burdette, Carolyn Q.; Nalin, Federica; Hahm, Grace; Durazo‐Arvizu, Ramón; Kuszak, Adam; Merkel, Joyce; Cavalier, Étienne

doi:10.1016/j.jsbmb.2021.105917

Cited by 31 publications

(24 citation statements)

References 39 publications

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“…Analyses for the single-laboratory study within Intercomparison Study 2 were performed at the University of Liege (Belgium) following the same protocol as the participants in the commutability study with the exception that duplicate measurements were performed for each assay on two separate days (n = 4) for each of the 50 single-donor serum samples [34]. Whereas the intralaboratory study used all four replicates to assess assay variability and bias, the performance assessment reported in Intercomparison Study 2 used the mean of the four replicates.…”

Section: Results Used For Intercomparison Studymentioning

confidence: 99%

“…The 32 ligand binding assays used in 17 laboratories are summarized in Table 1. The calibrator and reagent information for the 20 assays from the commutability study are provided in Table S1 (see Supplementary Information, ESM); similar information for the 12 ligand binding assays from the singlelaboratory study are reported elsewhere [34]. For 7 of the 13 unique ligand binding assays, results were obtained from the assay manufacturer's laboratory, and the remaining results were from laboratories using the specified assay.…”

Section: Ligand Binding Assays Evaluated In Intercomparison Studymentioning

confidence: 99%

“…Diazyme Results for the Diazyme assay were from the intralaboratory study [34]. Diazyme met the ≤ |± 5%| criterion for mean % bias and had 20% of the individual samples within ± 5%.…”

Section: Performance Of Individual Ligand Binding Assaysmentioning

confidence: 99%

“…Fujirebio Inc. The Fujirebio Inc. assay was part of the intralaboratory study [34], and it met the ≤ |± 5%| mean bias criterion. The Fujirebio Inc. assay was not significantly biased by the high 25(OH)D 2 single-donor samples, and it had a slope near 1.00 from the regression analyses of both the 50-sample and 42sample sets (ESM Figs.…”

Section: Performance Of Individual Ligand Binding Assaysmentioning

confidence: 99%

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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

et al. 2021

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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 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 Published in the topical collection celebrating ABCs 20th Anniversary.

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Section: Results Used For Intercomparison Studymentioning

confidence: 99%

Section: Ligand Binding Assays Evaluated In Intercomparison Studymentioning

confidence: 99%

“…Diazyme Results for the Diazyme assay were from the intralaboratory study [34]. Diazyme met the ≤ |± 5%| criterion for mean % bias and had 20% of the individual samples within ± 5%.…”

Section: Performance Of Individual Ligand Binding Assaysmentioning

confidence: 99%

Section: Performance Of Individual Ligand Binding Assaysmentioning

confidence: 99%

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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

et al. 2021

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“…The results of this study to assess and compare the performance of 25(OH)D assays on samples distributed at ambient or frozen temperatures are reported in this paper. The complete results from the commutability study [10] and from a comprehensive interlaboratory assessment of assay performance, including variability, bias, and the impact of metabolite content, are reported elsewhere [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions

et al. 2021

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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. Keywords 25-Hydroxyvitamin D 3 • 25-Hydroxyvitamin D 2 • Total 25-hydroxyvitamin D • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) • Vitamin D External Quality Assessment Scheme (DEQAS) • Ligand binding assay * Stephen A. Wise

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A candidate reference method and multiple commutable control materials for serum 25‐hydroxyvitamin D measurement

Zhang

Long

Zhang

et al. 2022

Clinical Laboratory Analysis

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Objectives The aim of the current study was to establish a reliable candidate reference method for serum 25‐hydroxyvitamin D [25(OH)D] measurement and to assess the commutability of multiple control materials among liquid chromatography–tandem mass spectrometry (LC–MS/MS) methods. Methods Serum 25‐hydroxyvitamin D2 [25(OH)D2] and 25‐hydroxyvitamin D3 [25(OH)D3] together with spiked internal standards were extracted with a one‐step approach and then analyzed by LC–MS/MS. The commutability assessment for 25(OH)D was conducted according to the Clinical and Laboratory Standards Institute (CLSI) EP14‐A3 protocol. 25(OH)D concentrations in 5 levels of unprocessed serum pools, 7 levels of serum pools spiked with 25(OH)D3 or 25(OH)D2, 3 levels of commercial control materials, 2 levels of spiked bovine serum, and 4 levels of external quality assessment (EQA) materials were measured along with 30 single‐donor samples using the candidate reference method and two routine LC–MS/MS methods. Results The candidate reference method could separate 25(OH)D2 and 25(OH)D3 from 14 potential interfering compounds completely within a 9‐min analysis time. Good method precision was obtained, and measurement results on certified reference material NIST SRM 972a were within the uncertainty of the certified values. All candidate materials were assessed commutable for LC–MS/MS methods. Conclusions The candidate reference method for serum 25(OH)D measurement is precise, accurate, and robust against interferences and can provide an accuracy base for routine methods. The multiple alternative control materials with commutability among LC–MS/MS methods will facilitate the further standardization for serum 25(OH)D measurement.

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Vitamin D Standardization Program (VDSP) intralaboratory study for the assessment of 25-hydroxyvitamin D assay variability and bias

Cited by 31 publications

References 39 publications

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

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

Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions

A candidate reference method and multiple commutable control materials for serum 25‐hydroxyvitamin D measurement

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