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.
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; Batista, Marcelo Cidade; Pham, Heather; Bennett, Alex; Meadows, Sarah; Cox, Lorna; Jansen, Eugene; Khan, Dilshad Ahmed; 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
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Language
en
Date
2021-06-28
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Title
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.
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Anal Bioanal Chem 2021 ; 413(20):5067-84
Abstract
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.