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Sempos CT, Williams EL, Carter GD, et al. Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions. Anal Bioanal Chem. 2021;doi: 10.1007/s00216-021-03742-5.
Sempos, C. T., Williams, E. L., Carter, G. D., Jones, J., Camara, J. E., Burdette, C. Q., Hahm, G., Nalin, F., Duewer, D. L., Kuszak, A. J., Merkel, J., Hoofnagle, A. N., Lukas, P., Cavalier, �. �., Durazo-Arvizu, R. A., Crump, P. M., Popp, C., Beckert, C., Schultess, J., Van Slooten, G., Tourneur, C., Pease, C., Kaul, R., Villarreal, A., Ivison, F., Fischer, R., van den Ouweland, J. M. W., Ho, C. S., Law, E. W. K., Simard, J. N., Gonthier, R., Holmquist, B., Batista, M. C., Meadows, S., Cox, L., Jansen, E., Khan, D. A., Robyak, K., Creer, M. H., Kilbane, M., Twomey, P. J., Freeman, J., Parker, N., Yuan, J., Fitzgerald, R., Mushtaq, S., Clarke, M. W., Breen, N., Simpson, C., & Wise, S. A. (2021). Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions. Analytical and bioanalytical chemistry, . https://doi.org/10.1007/s00216-021-03742-5
Sempos, Christopher T, et al. "Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions." Analytical and bioanalytical chemistry vol. (2021). doi: https://doi.org/10.1007/s00216-021-03742-5
Sempos CT, Williams EL, Carter GD, Jones J, Camara JE, Burdette CQ, Hahm G, Nalin F, Duewer DL, Kuszak AJ, Merkel J, Hoofnagle AN, Lukas P, Cavalier É, Durazo-Arvizu RA, Crump PM, Popp C, Beckert C, Schultess J, Van Slooten G, Tourneur C, Pease C, Kaul R, Villarreal A, Ivison F, Fischer R, van den Ouweland JMW, Ho CS, Law EWK, Simard JN, Gonthier R, Holmquist B, Batista MC, Meadows S, Cox L, Jansen E, Khan DA, Robyak K, Creer MH, Kilbane M, Twomey PJ, Freeman J, Parker N, Yuan J, Fitzgerald R, Mushtaq S, Clarke MW, Breen N, Simpson C, Wise SA. Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions. Anal Bioanal Chem. 2021 Nov 09; doi: 10.1007/s00216-021-03742-5. Epub 2021 Nov 09. PMID: 34750644.
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Anal Bioanal Chem. 2021 Nov 09; doi: 10.1007/s00216-021-03742-5. Epub 2021 Nov 09.

Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions.

Analytical and bioanalytical chemistry

Christopher T Sempos, Emma L Williams, Graham D Carter, Julia Jones, Johanna E Camara, Carolyn Q Burdette, Grace Hahm, Federica Nalin, David L Duewer, Adam J Kuszak, Joyce Merkel, Andrew N Hoofnagle, Pierre Lukas, Étienne Cavalier, Ramón A Durazo-Arvizu, Peter M Crump, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille Pease, Ravi Kaul, Alfredo Villarreal, Fiona Ivison, Ralf Fischer, Jody M W van den Ouweland, Chung S Ho, Emmett W K Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Marcelo Cidade Batista, Sarah Meadows, Lorna Cox, Eugene Jansen, Dilshad Ahmed Khan, Kimberly Robyak, Michael H Creer, Mark Kilbane, Patrick J Twomey, James Freeman, Neil Parker, Jinyun Yuan, Robert Fitzgerald, Sohail Mushtaq, Michael W Clarke, Norma Breen, Christine Simpson, Stephen A Wise

Affiliations

  1. Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA.
  2. Vitamin D Standardization Program LLC, Havre de Grace, MD, 21078, USA.
  3. Imperial Healthcare NHS Trust, London, W6 8RF, UK.
  4. Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA.
  5. Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, 98185, USA.
  6. Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium.
  7. Biostatistics Core, The Sabin Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90027, USA.
  8. Computing and Biometry, University of Wisconsin-Madison, Madison, WI, 53706, USA.
  9. Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany.
  10. Awareness Technology, Inc., Palm City, FL, 34990, USA.
  11. bioMérieux, 69280, Marcey-l'Étoile, France.
  12. Bio-Rad Laboratories, Clinical Diagnostics, Hercules, CA, 94547, USA.
  13. Central Manchester Foundation Trust, Manchester, M13 9WL, UK.
  14. Chromsystems Instruments & Chemicals GmbH, 82166, Gräfelfing, Germany.
  15. Canisius Wilhelmina Hospital (CWZ), 6532 SZ, Nijmegen, The Netherlands.
  16. Biochemical Mass Spectrometry Unit, Department of Chemical Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, 999077.
  17. Endoceutics, Québec, G1P 4P5, Canada.
  18. Endocrine Sciences, LabCorp Specialty Testing Group, Agoura Hills, CA, 91301, USA.
  19. Clinical Lab, Hospital Israelita Albert Einstein, São Paulo, 05652-900, Brazil.
  20. Medical Research Council (MRC) Elsie Widdowson Laboratory (Closed Dec. 2018), Cambridge, CB2 0SL, UK.
  21. NIHR BRC Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, CB2 0SL, UK.
  22. National Institute of Public Health and the Environment (RIVM), 3720 BA, Bilthoven, The Netherlands.
  23. National University of Medical Sciences (NUMS), Rawalpindi, 46000, Punjab, Pakistan.
  24. College of Medicine, Penn State University, Hershey, PA, 17033, USA.
  25. Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland.
  26. Siemens-Healthineers, Tarrytown, NY, 10591, USA.
  27. SNIBE, Shenzhen, 518122, People's Republic of China.
  28. Health Clinical Laboratories, University of California at San Diego, La Jolla, CA, 92093, USA.
  29. University of Chester, Chester, CH1 4BJ, UK.
  30. Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, WA, 6009, Australia.
  31. Waters Technologies Ireland Ltd., Wexford, Y35 D431, Ireland.
  32. School of Medicine, Yale University, New Haven, CT, 06510, USA.
  33. Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA. [email protected].
  34. Scientist Emeritus, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA. [email protected].

PMID: 34750644 DOI: 10.1007/s00216-021-03742-5

Abstract

The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at -40 °C prior to distribution and the participants are instructed to store the samples frozen at -20 °C or lower after receipt; however, the samples are shipped to participants at ambient conditions (i.e., no temperature control). To address the question of whether shipment at ambient conditions is sufficient for reliable performance of various 25(OH)D assays, the equivalence of DEQAS human serum samples shipped under frozen and ambient conditions was assessed. As part of a Vitamin D Standardization Program (VDSP) commutability study, two sets of the same nine DEQAS samples were shipped to participants at ambient temperature and frozen on dry ice. Twenty-eight laboratories participated in this study and provided 34 sets of results for the measurement of 25(OH)D using 20 ligand binding assays and 14 liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Equivalence of the assay response for the frozen versus ambient DEQAS samples for each assay was evaluated using multi-level modeling, paired t-tests including a false discovery rate (FDR) approach, and ordinary least squares linear regression analysis of frozen versus ambient results. Using the paired t-test and confirmed by FDR testing, differences in the results for the ambient and frozen samples were found to be statistically significant at p < 0.05 for four assays (DiaSorin, DIAsource, Siemens, and SNIBE prototype). For all 14 LC-MS/MS assays, the differences in the results for the ambient- and frozen-shipped samples were not found to be significant at p < 0.05 indicating that these analytes were stable during shipment at ambient conditions. Even though assay results have been shown to vary considerably among different 25(OH)D assays in other studies, the results of this study also indicate that sample handling/transport conditions may influence 25(OH)D assay response for several assays.

© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

Keywords: 25-Hydroxyvitamin D2; 25-Hydroxyvitamin D3; Ligand binding assay; Liquid chromatography–tandem mass spectrometry (LC–MS/MS); Total 25-hydroxyvitamin D; Vitamin D External Quality Assessment Scheme (DEQAS)

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