Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 — Part 1 liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays — impact of 3-epi-25-hydroxyvitamin 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 1 liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays — impact of 3-epi-25-hydroxyvitamin D3 on assay performance
Analytical and Bioanalytical Chemistry ( IF 4.3 ) Pub Date : 2021-08-25 , DOI: 10.1007/s00216-021-03576-1
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 , Andrew N Hoofnagle ₆ , Fiona Ivison ₇ , Ralf Fischer ₈ , Jody M W van den Ouweland ₉ , Chung S Ho ₁₀ , Emmett W K Law ₁₀ , Jean-Nicolas Simard ₁₁ , Renaud Gonthier ₁₁ , Brett Holmquist ₁₂ , Sarah Meadows _{13,

14} , Lorna Cox _{13,

14} , Kimberly Robyak ₁₅ , Michael H Creer ₁₅ , Robert Fitzgerald ₁₆ , Michael W Clarke ₁₇ , Norma Breen ₁₈ , Pierre Lukas ₁₉ , Étienne Cavalier ₁₉ , Christopher T Sempos _{1,

20}

Affiliation

Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA.
Scientist Emeritus, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, 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.
Department of Laboratory Medicine, University of Washington, Seattle, WA, 98185, USA.
Central Manchester Foundation Trust, Manchester, M13 9WL, UK.
Chromsystems Instruments & Chemicals GmbH, 82166, Gräfelfing, Germany.
Canisius Wilhelmina Hospital (CWZ), 6532, SZ, Nijmegen, The Netherlands.
Biochemical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, 999077, Hong Kong.
Endoceutics Inc., Québec, G1P 4P5, Canada.
Endocrine Sciences, LabCorp Specialty Testing Group, Agoura Hills, CA, 91301, USA.
Medical Research Council (MRC) Elsie Widdowson Laboratory (closed Dec. 2018), Cambridge, UK.
NIHR BRC Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, CB2 0SL, UK.
College of Medicine, Penn State University, Hershey, PA, 17033, USA.
Health Clinical Laboratories, University of California at San Diego, La Jolla, CA, 92093, USA.
Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, WA, 6009, Australia.
Waters Technologies Ireland Ltd., Wexford, Y35 D431, Ireland.
Clinical Chemistry, University of Liège, CHU de Liège, B-4000, Liège, Belgium.
Vitamin D Standardization Program LLC, Havre de Grace, MD, 217078, USA.

An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25-hydroxyvitamin D (25(OH)D), which is the sum of 25-hydroxyvitamin D₂ (25(OH)D₂) and 25-hydroxyvitamin D₃ (25(OH)D₃). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D₂, 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 1 includes results from 14 laboratories using 14 custom LC-MS/MS 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 53% of the LC-MS/MS assays met the VDSP criterion of mean % bias ≤ |±5%|. For the LC-MS/MS assays not meeting the ≤ |±5%| criterion, four assays had mean % bias of between 12 and 21%. Based on multivariable regression analysis using the concentrations of the four individual vitamin D metabolites in the 50 single-donor samples, the performance of several LC-MS/MS assays was found to be influenced by the presence of 3-epi-25(OH)D₃. The results of this interlaboratory study represent the most comprehensive comparison of LC-MS/MS assay performance for serum total 25(OH)D and document the significant impact of the lack of separation of 3-epi-25(OH)D₃ and 25(OH)D₃ on assay performance, particularly with regard to mean % bias.

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) 比较研究 2 - 第 1 部分液相色谱 - 串联质谱 (LC-MS/MS) 测定 - 3-epi-25-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，以评估用于测定血清总 25-羟基维生素 D (25(OH) D)，它是25-羟基维生素D ₂ (25(OH)D ₂ )和25-羟基维生素D ₃ (25(OH)D ₃ )的总和。_{为一组 50 个单供体样品分配了 25(OH)D 2}、25(OH)D ₃、3-epi-25-羟基维生素 D ₃ (3-epi-25(OH)D ₃ )浓度的目标值, 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 (ID LC-MS/MS)。VDSP 比对研究 2 第 1 部分包括来自 14 个实验室使用 14 种定制 LC-MS/MS 测定的结果。使用与指定目标值相比的平均 % 偏差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 53% 的 LC-MS/MS 分析符合平均 % 偏差 ≤ |±5%| 的 VDSP 标准。对于不满足 ≤ |±5%| 的 LC-MS/MS 分析标准，四次检测的平均偏差百分比在 12% 和 21% 之间。基于使用 50 个单供体样品中四种单独维生素 D 代谢物浓度的多变量回归分析，发现几种 LC-MS/MS 测定的性能受到 3-epi-25(OH) 存在的影响3 _{_}. 该实验室间研究的结果代表了血清总 25(OH)D 的 LC-MS/MS 测定性能的最全面比较，并记录了 3-epi-25(OH)D ₃和 25缺乏分离的显着影响(OH)D ₃对分析性能的影响，特别是在平均百分比偏差方面。

图形概要

更新日期：2021-08-26

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