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 D 3 on assay performance.

Autor: Wise SA; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA. stephen.wise@nih.gov.; Scientist Emeritus, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA. stephen.wise@nih.gov., Camara JE; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Burdette CQ; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Hahm G; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Nalin F; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Kuszak AJ; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA., Merkel J; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA., Durazo-Arvizu RA; Biostatistics Core, The Sabin Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90027, USA., Williams EL; Imperial Healthcare NHS Trust, London, W6 8RF, UK., Hoofnagle AN; Department of Laboratory Medicine, University of Washington, Seattle, WA, 98185, USA., Ivison F; Central Manchester Foundation Trust, Manchester, M13 9WL, UK., Fischer R; Chromsystems Instruments & Chemicals GmbH, 82166, Gräfelfing, Germany., van den Ouweland JMW; Canisius Wilhelmina Hospital (CWZ), 6532, SZ, Nijmegen, The Netherlands., Ho CS; Biochemical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, 999077, Hong Kong., Law EWK; Biochemical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, 999077, Hong Kong., Simard JN; Endoceutics Inc., Québec, G1P 4P5, Canada., Gonthier R; Endoceutics Inc., Québec, G1P 4P5, Canada., Holmquist B; Endocrine Sciences, LabCorp Specialty Testing Group, Agoura Hills, CA, 91301, USA., Meadows S; 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., Cox L; 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., Robyak K; College of Medicine, Penn State University, Hershey, PA, 17033, USA., Creer MH; College of Medicine, Penn State University, Hershey, PA, 17033, USA., Fitzgerald R; Health Clinical Laboratories, University of California at San Diego, La Jolla, CA, 92093, USA., Clarke MW; Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, WA, 6009, Australia., Breen N; Waters Technologies Ireland Ltd., Wexford, Y35 D431, Ireland., Lukas P; Clinical Chemistry, University of Liège, CHU de Liège, B-4000, Liège, Belgium., Cavalier É; Clinical Chemistry, University of Liège, CHU de Liège, B-4000, Liège, Belgium., Sempos CT; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA.; Vitamin D Standardization Program LLC, Havre de Grace, MD, 217078, USA.
Jazyk: angličtina
Zdroj: Analytical and bioanalytical chemistry [Anal Bioanal Chem] 2022 Jan; Vol. 414 (1), pp. 333-349. Date of Electronic Publication: 2021 Aug 25.
DOI: 10.1007/s00216-021-03576-1
Abstrakt: 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 D 2 (25(OH)D 2 ) and 25-hydroxyvitamin D 3 (25(OH)D 3 ). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D 2 , 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 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)D 3 . 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)D 3 and 25(OH)D 3 on assay performance, particularly with regard to mean % bias.
(© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)
Databáze: MEDLINE
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