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

被引：16

作者：

Camara, Johanna E. ^{[1
]}

Wise, Stephen A. ^{[2
,3
]}

Hoofnagle, Andrew N. ^{[4
]}

Williams, Emma L. ^{[5
]}

Carter, Graham D. ^{[5
]}

Jones, Julia ^{[5
]}

Burdette, Carolyn Q. ^{[1
]}

Hahm, Grace ^{[1
]}

Nalin, Federica ^{[1
]}

Kuszak, Adam J. ^{[3
]}

Merkel, Joyce ^{[3
]}

Durazo-Arvizu, Ramon A. ^{[6
]}

Lukas, Pierre ^{[7
]}

Cavalier, Etienne ^{[7
]}

Popp, Christian ^{[8
]}

Beckert, Christian ^{[8
]}

Schultess, Jan ^{[8
]}

Van Slooten, Glen ^{[9
]}

Tourneur, Carole ^{[10
]}

Pease, Camille ^{[10
]}

Kaul, Ravi ^{[11
]}

Villarreal, Alfredo ^{[11
]}

Ivison, Fiona ^{[12
]}

Fischer, Ralf ^{[13
]}

van den Ouweland, Jody M. W. ^{[14
]}

Ho, Chung S. ^{[15
]}

Law, Emmett W. K. ^{[15
]}

Simard, Jean-Nicolas ^{[16
]}

Gonthier, Renaud ^{[16
]}

Holmquist, Brett ^{[17
]}

Batista, Marcelo Cidade ^{[18
]}

Pham, Heather ^{[19
]}

Bennett, Alex ^{[19
]}

Meadows, Sarah ^{[20
,21
]}

Cox, Lorna ^{[20
,21
]}

Jansen, Eugene ^{[22
]}

Khan, Dilshad Ahmed ^{[23
]}

Robyak, Kimberly ^{[24
]}

Creer, Michael H. ^{[24
]}

Kilbane, Mark ^{[25
]}

Twomey, Patrick J. ^{[25
]}

Freeman, James ^{[26
]}

Parker, Neil ^{[26
]}

Yuan, Jinyun ^{[27
]}

Fitzgerald, Robert ^{[28
]}

Mushtaq, Sohail ^{[29
]}

Clarke, Michael W. ^{[30
]}

Breen, Norma ^{[31
]}

Simpson, Christine ^{[32
]}

Sempos, Christopher T. ^{[3
,33
]}

机构：

[1] NIST, Div Chem Sci, Gaithersburg, MD 20899 USA

[2] NIST, Gaithersburg, MD 20899 USA

[3] NIH, ODS, Bldg 10, Bethesda, MD 20892 USA

[4] Univ Washington, Dept Lab Med, Seattle, WA 98185 USA

[5] Imperial Healthcare NHS Trust, London W6 8RF, England

[6] Univ Southern Calif, Biostat Core, Sabin Res Inst, Keck Sch Med, Los Angeles, CA 90027 USA

[7] Univ Liege, Clin Chem, CHU Liege, B-4000 Liege, Belgium

[8] ADD Wiesbaden Abbott GmbH, Abbott Labs, D-65205 Wiesbaden, Germany

[9] Awareness Technol Inc, Palm City, FL 34990 USA

[10] BioMerieux, F-69280 Marcy Letoile, France

[11] BioRad Labs, Clin Diagnost, Hercules, CA 94547 USA

[12] Cent Manchester Fdn Trust, Manchester M13 9WL, Lancs, England

[13] Chromsyst Instruments & Chem GmbH, D-82166 Grafelfing, Germany

[14] Canisius Wilhelmina Hosp CWZ, NL-6532 SZ Nijmegen, Netherlands

[15] Chinese Univ Hong Kong, Biomed Mass Spectrometry Unit, Dept Chem Pathol, Prince Wales Hosp,Shatin, Hong Kong 999077, Peoples R China

[16] Endoceutics Inc, Quebec City, PQ G1P 4P5, Canada

[17] Endocrine Sci, LabCorp Specialty Testing Grp, Agoura Hills, CA 91301 USA

[18] Hosp Israelita Albert Einstein, Clin Lab, BR-05652900 Sao Paulo, Brazil

[19] Immunodiagnost Syst IDS, Boldon NE35 9PD, England

[20] Med Res Council MRC Elsie Widdowson Lab, Cambridge CB2 0SL, England

[21] Univ Cambridge, NIHR BRC Nutr Biomarker Lab, MRC Epidemiol Unit, Cambridge CB2 0SL, England

[22] Natl Inst Publ Hlth & Environm RIVM, NL-3720 BA Bilthoven, Netherlands

[23] Natl Univ Med Sci NUMS, Rawalpindi 46000, Punjab, Pakistan

[24] Penn State Univ, Coll Med, Hershey, PA 17033 USA

[25] St Vincents Univ Hosp, Clin Chem, Elm Pk, Dublin D04 T6F4 4, Ireland

[26] Siemens Healthineers, Tarrytown, NY 10591 USA

[27] SNIBE, Shenzhen 518122, Peoples R China

[28] Univ Calif San Diego, Hlth Clin Labs, La Jolla, CA 92093 USA

[29] Univ Chester, Chester CH1 4BJ, Cheshire, England

[30] Univ Western Australia, Metabol Australia, Ctr Microscopy Characterisat & Anal, Perth, WA 6009, Australia

[31] Waters Technol Ireland Ltd, Wexford Y35 D431, Ireland

[32] Yale Univ, Sch Med, 333 Cedar St, New Haven, CT 06510 USA

[33] Vitamin D Standardizat Program LLC, Havre De Grace, MD 21078 USA

来源：

ANALYTICAL AND BIOANALYTICAL CHEMISTRY | 2021年 / 413卷 / 20期

基金：

美国国家卫生研究院;

关键词：

25-HydroxyvitaminD(3); 25-HydroxyvitaminD(2); Total; 25-hydroxyvitaminD; Liquid chromatography-tandemmass spectrometry (LC-MS/MS); Ligand binding assay; Vitamin D Standardization Program(VDSP); WORKING GROUP RECOMMENDATIONS; D METABOLITES; LINE ASSESSMENT; US POPULATION; D-3; PROTOCOLS; HEALTH;

D O I：

10.1007/s00216-021-03470-w

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard ReferenceMaterials (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 referencemeasurement procedures (RMPs). SRMand PT/EQA samples evaluated included SRM972a (four levels), SRM2973, 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.

引用

页码：5067 / 5084

页数：18

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