PMID- 34184102
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20240403
IS  - 1618-2650 (Electronic)
IS  - 1618-2642 (Print)
IS  - 1618-2642 (Linking)
VI  - 413
IP  - 20
DP  - 2021 Aug
TI  - 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.
PG  - 5067-5084
LID - 10.1007/s00216-021-03470-w [doi]
AB  - An interlaboratory study was conducted through the Vitamin D Standardization 
      Program (VDSP) to assess commutability of Standard Reference Materials(R) (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.
CI  - (c) 2021. This is a U.S. government work and not under copyright protection in the 
      U.S.; foreign copyright protection may apply.
FAU - Camara, Johanna E
AU  - Camara JE
AD  - Chemical Sciences Division, National Institute of Standards and Technology 
      (NIST), Gaithersburg, MD, 20899, USA.
FAU - Wise, Stephen A
AU  - Wise SA
AD  - Scientist Emeritus, National Institute of Standards and Technology (NIST), 
      Gaithersburg, MD, 20899, USA. stephen.wise@nih.gov.
AD  - Office of Dietary Supplements (ODS), National Institutes of Health (NIH), 
      Bethesda, MD, 20892, USA. stephen.wise@nih.gov.
FAU - Hoofnagle, Andrew N
AU  - Hoofnagle AN
AD  - Department of Laboratory Medicine, University of Washington, Seattle, WA, 98185, 
      USA.
FAU - Williams, Emma L
AU  - Williams EL
AD  - Imperial Healthcare NHS Trust, London, W6 8RF, UK.
FAU - Carter, Graham D
AU  - Carter GD
AD  - Imperial Healthcare NHS Trust, London, W6 8RF, UK.
FAU - Jones, Julia
AU  - Jones J
AD  - Imperial Healthcare NHS Trust, London, W6 8RF, UK.
FAU - Burdette, Carolyn Q
AU  - Burdette CQ
AD  - Chemical Sciences Division, National Institute of Standards and Technology 
      (NIST), Gaithersburg, MD, 20899, USA.
FAU - Hahm, Grace
AU  - Hahm G
AD  - Chemical Sciences Division, National Institute of Standards and Technology 
      (NIST), Gaithersburg, MD, 20899, USA.
FAU - Nalin, Federica
AU  - Nalin F
AD  - Chemical Sciences Division, National Institute of Standards and Technology 
      (NIST), Gaithersburg, MD, 20899, USA.
FAU - Kuszak, Adam J
AU  - Kuszak AJ
AD  - Office of Dietary Supplements (ODS), National Institutes of Health (NIH), 
      Bethesda, MD, 20892, USA.
FAU - Merkel, Joyce
AU  - Merkel J
AD  - Office of Dietary Supplements (ODS), National Institutes of Health (NIH), 
      Bethesda, MD, 20892, USA.
FAU - Durazo-Arvizu, Ramon A
AU  - Durazo-Arvizu RA
AD  - Biostatistics Core, The Sabin Research Institute, Keck School of Medicine, 
      University of Southern California, Los Angeles, CA, 90027, USA.
FAU - Lukas, Pierre
AU  - Lukas P
AD  - Clinical Chemistry, University of Liege, CHU de Liege, 4000, Liege, Belgium.
FAU - Cavalier, Etienne
AU  - Cavalier E
AD  - Clinical Chemistry, University of Liege, CHU de Liege, 4000, Liege, Belgium.
FAU - Popp, Christian
AU  - Popp C
AD  - Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany.
FAU - Beckert, Christian
AU  - Beckert C
AD  - Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany.
FAU - Schultess, Jan
AU  - Schultess J
AD  - Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany.
FAU - Van Slooten, Glen
AU  - Van Slooten G
AD  - Awareness Technology, Inc., Palm City, FL, 34990, USA.
FAU - Tourneur, Carole
AU  - Tourneur C
AD  - bioMerieux, 69280, Marcy-l'Etoile, France.
FAU - Pease, Camille
AU  - Pease C
AD  - bioMerieux, 69280, Marcy-l'Etoile, France.
FAU - Kaul, Ravi
AU  - Kaul R
AD  - Clinical Diagnostics, Bio-Rad Laboratories, Clinical Diagnostics, Hercules, CA, 
      94547, USA.
FAU - Villarreal, Alfredo
AU  - Villarreal A
AD  - Clinical Diagnostics, Bio-Rad Laboratories, Clinical Diagnostics, Hercules, CA, 
      94547, USA.
FAU - Ivison, Fiona
AU  - Ivison F
AD  - Central Manchester Foundation Trust, Manchester, M13 9WL, UK.
FAU - Fischer, Ralf
AU  - Fischer R
AD  - Chromsystems Instruments & Chemicals GmbH, 82166, Grafelfing, Germany.
FAU - van den Ouweland, Jody M W
AU  - van den Ouweland JMW
AD  - Canisius Wilhelmina Hospital (CWZ), 6532 SZ, Nijmegen, The Netherlands.
FAU - Ho, Chung S
AU  - Ho CS
AD  - Biomedical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese 
      University of Hong Kong, Prince of Wales Hospital, Shatin, 999077, Hong Kong.
FAU - Law, Emmett W K
AU  - Law EWK
AD  - Biomedical Mass Spectrometry Unit, Department of Chemical Pathology, The Chinese 
      University of Hong Kong, Prince of Wales Hospital, Shatin, 999077, Hong Kong.
FAU - Simard, Jean-Nicolas
AU  - Simard JN
AD  - Endoceutics Inc., Quebec, G1P 4P5, Canada.
FAU - Gonthier, Renaud
AU  - Gonthier R
AD  - Endoceutics Inc., Quebec, G1P 4P5, Canada.
FAU - Holmquist, Brett
AU  - Holmquist B
AD  - LabCorp Specialty Testing Group, Endocrine Sciences, Agoura Hills, CA, 91301, 
      USA.
FAU - Batista, Marcelo Cidade
AU  - Batista MC
AD  - Clinical Lab, Hospital Israelita Albert Einstein, Sao Paulo, 05652-900, Brazil.
FAU - Pham, Heather
AU  - Pham H
AD  - Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK.
FAU - Bennett, Alex
AU  - Bennett A
AD  - Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK.
FAU - Meadows, Sarah
AU  - Meadows S
AD  - Medical Research Council (MRC) Elsie Widdowson Laboratory (closed Dec. 2018), 
      Cambridge, CB2 0SL, UK.
AD  - NIHR BRC Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of 
      Cambridge, Cambridge, CB2 0SL, UK.
FAU - Cox, Lorna
AU  - Cox L
AD  - Medical Research Council (MRC) Elsie Widdowson Laboratory (closed Dec. 2018), 
      Cambridge, CB2 0SL, UK.
AD  - NIHR BRC Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of 
      Cambridge, Cambridge, CB2 0SL, UK.
FAU - Jansen, Eugene
AU  - Jansen E
AD  - National Institute of Public Health and the Environment (RIVM), 3720 BA, 
      Bilthoven, The Netherlands.
FAU - Khan, Dilshad Ahmed
AU  - Khan DA
AD  - National University of Medical Sciences (NUMS), Rawalpindi, Punjab, 46000, 
      Pakistan.
FAU - Robyak, Kimberly
AU  - Robyak K
AD  - College of Medicine, Penn State University, Hershey, PA, 17033, USA.
FAU - Creer, Michael H
AU  - Creer MH
AD  - College of Medicine, Penn State University, Hershey, PA, 17033, USA.
FAU - Kilbane, Mark
AU  - Kilbane M
AD  - Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 
      T6F4, Ireland.
FAU - Twomey, Patrick J
AU  - Twomey PJ
AD  - Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 
      T6F4, Ireland.
FAU - Freeman, James
AU  - Freeman J
AD  - Siemens-Healthineers, Tarrytown, NY, 10591, USA.
FAU - Parker, Neil
AU  - Parker N
AD  - Siemens-Healthineers, Tarrytown, NY, 10591, USA.
FAU - Yuan, Jinyun
AU  - Yuan J
AD  - SNIBE, Shenzhen, 518122, People's Republic of China.
FAU - Fitzgerald, Robert
AU  - Fitzgerald R
AD  - University of California at San Diego, Health Clinical Laboratories, La Jolla, 
      CA, 92093, USA.
FAU - Mushtaq, Sohail
AU  - Mushtaq S
AD  - University of Chester, Chester, CH1 4BJ, UK.
FAU - Clarke, Michael W
AU  - Clarke MW
AD  - Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The 
      University of Western Australia, Perth, WA, 6009, Australia.
FAU - Breen, Norma
AU  - Breen N
AD  - Waters Technologies Ireland Ltd., Wexford, Y35 D431, Ireland.
FAU - Simpson, Christine
AU  - Simpson C
AD  - School of Medicine, Yale University, New Haven, CT, 06510, USA.
FAU - Sempos, Christopher T
AU  - Sempos CT
AD  - Office of Dietary Supplements (ODS), National Institutes of Health (NIH), 
      Bethesda, MD, 20892, USA.
AD  - Vitamin D Standardization Program LLC, Havre de Grace, MD, 21078, USA.
LA  - eng
GR  - Z99 OD999999/ImNIH/Intramural NIH HHS/United States
PT  - Journal Article
DEP - 20210628
PL  - Germany
TA  - Anal Bioanal Chem
JT  - Analytical and bioanalytical chemistry
JID - 101134327
RN  - 1406-16-2 (Vitamin D)
RN  - A288AR3C9H (25-hydroxyvitamin D)
SB  - IM
MH  - Humans
MH  - Reference Standards
MH  - Societies, Medical/*standards
MH  - Specimen Handling
MH  - Vitamin D/*analogs & derivatives/blood/*chemistry
PMC - PMC8431775
MID - NIHMS1734808
OTO - NOTNLM
OT  - 25-Hydroxyvitamin D2
OT  - 25-Hydroxyvitamin D3
OT  - Ligand binding assay
OT  - Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
OT  - Total 25-hydroxyvitamin D
OT  - Vitamin D Standardization Program (VDSP)
COIS- Conflict of Interest S.A. Wise is an Editor of the journal Analytical and 
      Bioanalytical Chemistry and was not involved in peer reviewing this manuscript. 
      Several of the coauthors on the manuscript are employees of companies who 
      produced the assays evaluated in this study. There are no financial or 
      nonfinancial conflicts of interest for any of the coauthors.
EDAT- 2021/06/30 06:00
MHDA- 2021/11/20 06:00
PMCR- 2022/08/01
CRDT- 2021/06/29 06:35
PHST- 2021/04/06 00:00 [received]
PHST- 2021/06/09 00:00 [accepted]
PHST- 2021/05/29 00:00 [revised]
PHST- 2021/06/30 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2021/06/29 06:35 [entrez]
PHST- 2022/08/01 00:00 [pmc-release]
AID - 10.1007/s00216-021-03470-w [pii]
AID - 10.1007/s00216-021-03470-w [doi]
PST - ppublish
SO  - Anal Bioanal Chem. 2021 Aug;413(20):5067-5084. doi: 10.1007/s00216-021-03470-w. 
      Epub 2021 Jun 28.