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
Authors
Camara, Johanna E.Wise, Stephen A.
Hoofnagle, Andrew N.
Williams, Emma L.
Carter, Graham D.
Jones, Julia
Burdette, Carolyn Q.
Hahm, Grace
Nalin, Federica
Kuszak, Adam J.
Merkel, Joyce
Durazo-Arvizu, Ramón A.
Lukas, Pierre
Cavalier, Étienne
Popp, Christian
Beckert, Christian
Schultess, Jan
Van Slooten, Glen
Tourneur, Carole
Pease, Camille
Kaul, Ravi
Villarreal, Alfredo
Ivison, Fiona
Fischer, Ralf
van den Ouweland, Jody M. W.
Ho, Chung S.
Law, Emmett W. K.
Simard, Jean-Nicolas
Gonthier, Renaud
Holmquist, Brett
Cidade Batista, Marcelo
Pham, Heather
Bennett, Alex
Meadows, Sarah
Cox, Lorna
Jansen, Eugene
Ahmed Khan, Dilshad
Robyak, Kimberly
Creer, Michael H.
Kilbane, Mark
Twomey, Patrick J.
Freeman, James
Parker, Neil
Yuan, Jinyun
Fitzgerald, Robert
Mushtaq, Sohail
Clarke, Michael W.
Breen, Norma
Simpson, Christine
Sempos, Christopher T.
Affiliation
National Institute of Standards and Technology (NIST); National Institutes of Health (NIH); University of Washington; Imperial Healthcare NHS Trust; University of Southern California; University of Liège; Abbott Laboratories; Awareness Technology; bioMérieux; Bio-Rad Laboratories; Central Manchester Foundation Trust; Chromsystems Instruments & Chemicals GmbH; Canisius Wilhelmina Hospital; The Chinese University of Hong Kong; Endoceutics Inc; LabCorp Specialty Testing Group; Hospital Israelita Albert Einstein; Immunodiagnostic Systems (IDS); University of Cambridge; National Institute of Public Health and the Environment (RIVM); National University of Medical Sciences (NUMS); Penn State University; St. Vincent’s University Hospital; Siemens-Healthineers; SNIBE; University of California at San Diego; University of Chester; The University of Western Australia; Waters Technologies Ireland Ltd; Yale University; Vitamin D Standardization Program LLCPublication Date
2021-06-28
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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 D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3] 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)D2 and 25(OH)D3) 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)D2 below 30 nmol/L, one or more of the SRM and PT/EQA samples with high concentrations of 25(OH)D2 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)D3, was deemed non-commutable for 50% of the LC-MS/MS assays.Citation
Camara, J. E., Wise, S. A., Hoofnagle, A. N., Williams, E. L., Carter, G. D., Jones, J., ... Sempos, C. T. (2021). 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. Analytical and Bioanalytical Chemistry, 413, 5067–5084. https://doi.org/10.1007/s00216-021-03470-wPublisher
SpringerAdditional Links
https://link.springer.com/article/10.1007/s00216-021-03470-wType
ArticleDescription
The final publication is available at Springer via http://dx.doi.org/10.1007/s00216-021-03470-wISSN
1618-2642EISSN
1618-2650ae974a485f413a2113503eed53cd6c53
10.1007/s00216-021-03470-w
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