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

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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
Analytical and Bioanalytical Chemistry ( IF 3.8 ) Pub Date : 2021-08-25 , DOI: 10.1007/s00216-021-03577-0
Stephen A Wise _{1,

2} , Johanna E Camara ₃ , Carolyn Q Burdette ₃ , Grace Hahm ₃ , Federica Nalin ₃ , Adam J Kuszak ₁ , Joyce Merkel ₁ , Ramón A Durazo-Arvizu ₄ , Emma L Williams ₅ , Christian Popp ₆ , Christian Beckert ₆ , Jan Schultess ₆ , Glen Van Slooten ₇ , Carole Tourneur ₈ , Camille Pease ₈ , Ravi Kaul ₉ , Alfredo Villarreal ₉ , Marcelo Cidade Batista ₁₀ , Heather Pham ₁₁ , Alex Bennett ₁₁ , Eugene Jansen ₁₂ , Dilshad Ahmed Khan ₁₃ , Mark Kilbane ₁₄ , Patrick J Twomey ₁₄ , James Freeman ₁₅ , Neil Parker ₁₅ , Sohail Mushtaq ₁₆ , Christine Simpson ₁₇ , Pierre Lukas ₁₈ , Étienne Cavalier ₁₈ , Christopher T Sempos _{1,

19}

Affiliation

Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA.
Scientist Emeritus, National Institute of Standards and Technology (NIST), MD, 20899, Gaithersburg, USA.
Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA.
Biostatistics Core, The Sabin Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90027, USA.
Imperial Healthcare NHS Trust, London, W6 8RF, UK.
Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany.
Awareness Technology, Inc., Palm City, FL, 34990, USA.
bioMérieux, 69280, Marcy-l'Étoile, France.
Clinical Diagnostics, Bio-Rad Laboratories, Hercules, CA, 94547, USA.
Clinical Lab, Hospital Israelita Albert Einstein, São Paulo, 05652-900, Brazil.
Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK.
National Institute of Public Health and the Environment (RIVM), 3720, Bilthoven, BA, Netherlands.
National University of Medical Sciences (NUMS), Rawalpindi, 46000, Pakistan.
Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland.
Siemens-Healthineers, Tarrytown, NY, 10591, USA.
University of Chester, Chester, CH1 4BJ, UK.
School of Medicine, Yale University, New Haven, CT, USA.
Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium.
Vitamin D Standardization Program LLC, Havre de Grace, MD, 21078, USA.

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.

Graphical abstract

中文翻译：

25-羟基维生素 D 测定的实验室间比较：维生素 D 标准化计划 (VDSP) 相互比较研究 2 - 第 2 部分配体结合测定 - 25-羟基维生素 D2 和 24R,25-二羟基维生素 D3 对测定性能的影响

维生素 D 标准化计划 (VDSP) 进行了一项实验室间比较研究，以评估配体结合试验（第 2 部分）测定血清总 25-羟基维生素 D [25(OH)D] 的性能。50 个单一供体样本被指定为 25-羟基维生素 D ₂ [25(OH)D ₂ ]、25-羟基维生素 D ₃ [25(OH)D ₃ ]、3-epi-25-羟基维生素 D ₃ [ 3-epi-25(OH)D ₃ ]和24R,25-二羟基维生素D ₃ [24R,25(OH) ₂ D ₃] 使用同位素稀释液相色谱-串联质谱法 (ID LC-MS/MS)。VDSP 比对研究 2 第 2 部分包括来自 17 个实验室使用 32 种配体结合分析的结果。使用与指定目标值相比的平均偏差百分比并使用测试测定平均结果和目标值的线性回归分析来评估测定性能。只有 50% 的配体结合测定达到了 VDSP 标准的平均偏差百分比 ≤ |± 5%|。对于本研究中评估的 13 种独特的配体结合测定，只有 4 种测定始终在 ± 5% 的平均偏差范围内，而 4 种测定始终在 ± 5% 的平均偏差范围内，而与执行测定的实验室无关。基于使用 50 个单一供体样本中单个维生素 D 代谢物浓度的多变量回归分析，大多数检测低估了 25(OH)D_{2和几种检测方法（Abbott、bioMérieux、DiaSorin、IDS-EIA 和 IDS-iSYS）可能与 24R,25(OH)}₂ D ₃有交叉反应。这项实验室间研究的结果代表了迄今为止发布的 25(OH)D 配体结合测定的最全面比较，并且是唯一使用参考测量程序的结果评估 24R,25(OH) ₂ D ₃含量影响的研究.

图形概要

更新日期：2021-08-26

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