Assessment of serum total 25-hydroxyvitamin D assay commutability of Standard Reference Materials and College of American Pathologists Accuracy-Based Vitamin D (ABVD) Scheme and Vitamin D External Quality Assessment Scheme (DEQAS) materials: Vitamin D Standardization Program (VDSP) Commutability Study 2.

Autor: Camara JE; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Wise SA; Scientist Emeritus, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA. stephen.wise@nih.gov.; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA. stephen.wise@nih.gov., Hoofnagle AN; Department of Laboratory Medicine, University of Washington, Seattle, WA, 98185, USA., Williams EL; Imperial Healthcare NHS Trust, London, W6 8RF, UK., Carter GD; Imperial Healthcare NHS Trust, London, W6 8RF, UK., Jones J; Imperial Healthcare NHS Trust, London, W6 8RF, UK., 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., Lukas P; Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium., Cavalier É; Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium., Popp C; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Beckert C; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Schultess J; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Van Slooten G; Awareness Technology, Inc., Palm City, FL, 34990, USA., Tourneur C; bioMérieux, 69280, Marcy-l'Étoile, France., Pease C; bioMérieux, 69280, Marcy-l'Étoile, France., Kaul R; Clinical Diagnostics, Bio-Rad Laboratories, Clinical Diagnostics, Hercules, CA, 94547, USA., Villarreal A; Clinical Diagnostics, Bio-Rad Laboratories, Clinical Diagnostics, Hercules, CA, 94547, 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; Biomedical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, 999077, Hong Kong., Law EWK; Biomedical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, 999077, Hong Kong., Simard JN; Endoceutics Inc., Québec, G1P 4P5, Canada., Gonthier R; Endoceutics Inc., Québec, G1P 4P5, Canada., Holmquist B; LabCorp Specialty Testing Group, Endocrine Sciences, Agoura Hills, CA, 91301, USA., Batista MC; Clinical Lab, Hospital Israelita Albert Einstein, São Paulo, 05652-900, Brazil., Pham H; Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK., Bennett A; Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK., Meadows S; Medical Research Council (MRC) Elsie Widdowson Laboratory (closed Dec. 2018), Cambridge, CB2 0SL, 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, CB2 0SL, UK.; NIHR BRC Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, CB2 0SL, UK., Jansen E; National Institute of Public Health and the Environment (RIVM), 3720 BA, Bilthoven, The Netherlands., Khan DA; National University of Medical Sciences (NUMS), Rawalpindi, Punjab, 46000, Pakistan., Robyak K; College of Medicine, Penn State University, Hershey, PA, 17033, USA., Creer MH; College of Medicine, Penn State University, Hershey, PA, 17033, USA., Kilbane M; Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland., Twomey PJ; Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland., Freeman J; Siemens-Healthineers, Tarrytown, NY, 10591, USA., Parker N; Siemens-Healthineers, Tarrytown, NY, 10591, USA., Yuan J; SNIBE, Shenzhen, 518122, People's Republic of China., Fitzgerald R; University of California at San Diego, Health Clinical Laboratories, La Jolla, CA, 92093, USA., Mushtaq S; University of Chester, Chester, CH1 4BJ, UK., 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., Simpson C; School of Medicine, Yale University, New Haven, CT, 06510, USA., 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, 21078, USA.
Jazyk: angličtina
Zdroj: Analytical and bioanalytical chemistry [Anal Bioanal Chem] 2021 Aug; Vol. 413 (20), pp. 5067-5084. Date of Electronic Publication: 2021 Jun 28.
DOI: 10.1007/s00216-021-03470-w
Abstrakt: An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard Reference Materials® (SRMs) and proficiency testing/external quality assessment (PT/EQA) samples for determination of serum total 25-hydroxyvitamin D [25(OH)D] using ligand binding assays and liquid chromatography-tandem mass spectrometry (LC-MS/MS). A set of 50 single-donor serum samples were assigned target values for 25-hydroxyvitamin D 2 [25(OH)D 2 ] and 25-hydroxyvitamin D 3 [25(OH)D 3 ] using reference measurement procedures (RMPs). SRM and PT/EQA samples evaluated included SRM 972a (four levels), SRM 2973, six College of American Pathologists (CAP) Accuracy-Based Vitamin D (ABVD) samples, and nine Vitamin D External Quality Assessment Scheme (DEQAS) samples. Results were received from 28 different laboratories using 20 ligand binding assays and 14 LC-MS/MS methods. Using the test assay results for total serum 25(OH)D (i.e., the sum of 25(OH)D 2 and 25(OH)D 3 ) determined for the single-donor samples and the RMP target values, the linear regression and 95% prediction intervals (PIs) were calculated. Using a subset of 42 samples that had concentrations of 25(OH)D 2 below 30 nmol/L, one or more of the SRM and PT/EQA samples with high concentrations of 25(OH)D 2 were deemed non-commutable using 5 of 11 unique ligand binding assays. SRM 972a (level 4), which has high exogenous concentration of 3-epi-25(OH)D 3 , was deemed non-commutable for 50% of the LC-MS/MS assays.
(© 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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