Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2-Part 2 ligand binding assays - impact of 25-hydroxyvitamin D2 and 24R,25-dihydroxyvitamin D3 on assay performance

被引：15

作者：

Wise, Stephen A. ^{[1
,2
]}

Camara, Johanna E. ^{[3
]}

Burdette, Carolyn Q. ^{[3
]}

Hahm, Grace ^{[3
]}

Nalin, Federica ^{[3
]}

Kuszak, Adam J. ^{[1
]}

Merkel, Joyce ^{[1
]}

Durazo-Arvizu, Ramon A. ^{[4
]}

Williams, Emma L. ^{[5
]}

Popp, Christian ^{[6
]}

Beckert, Christian ^{[6
]}

Schultess, Jan ^{[6
]}

Van Slooten, Glen ^{[7
]}

Tourneur, Carole ^{[8
]}

Pease, Camille ^{[8
]}

Kaul, Ravi ^{[9
]}

Villarreal, Alfredo ^{[9
]}

Batista, Marcelo Cidade ^{[10
]}

Pham, Heather ^{[11
]}

Bennett, Alex ^{[11
]}

Jansen, Eugene ^{[12
]}

Khan, Dilshad Ahmed ^{[13
]}

Kilbane, Mark ^{[14
]}

Twomey, Patrick J. ^{[14
]}

Freeman, James ^{[15
]}

Parker, Neil ^{[15
]}

Mushtaq, Sohail ^{[16
]}

Simpson, Christine ^{[17
]}

Lukas, Pierre ^{[18
]}

Cavalier, Etienne ^{[18
]}

Sempos, Christopher T. ^{[1
,19
]}

机构：

[1] NIH, Off Dietary Supplements ODS, Bldg 10, Bethesda, MD 20892 USA

[2] NIST, Gaithersburg, MD 20899 USA

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

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

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

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

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

[8] bioMerieux, F-69280 Marcy Letoile, France

[9] Biorad Labs, Clin Diagnost, Hercules, CA 94547 USA

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

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

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

[13] Natl Univ Med Sci NUMS, Rawalpindi 46000, Pakistan

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

[15] Siemens Healthineers, Tarrytown, NY 10591 USA

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

[17] Yale Univ, Sch Med, New Haven, CT USA

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

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

来源：

ANALYTICAL AND BIOANALYTICAL CHEMISTRY | 2022年 / 414卷 / 01期

基金：

美国国家卫生研究院;

关键词：

25-Hydroxyvitamin D-3 [25(OH)D-3; 25-Hydroxyvitamin D-2 [25(OH)D-2; Total 25-hydroxyvitamin D [25(OH)D; 24R; 25-Dihydroxyvitamin D-3 [24R; 25(OH)(2)D-3; Liquid chromatography-tandem mass spectrometry (LC-MS/MS); Ligand binding assay; TANDEM MASS-SPECTROMETRY; BASE-LINE ASSESSMENT; D METABOLITES; AUTOMATED IMMUNOASSAYS; CLINICAL-EVALUATION; 25(OH)-VITAMIN D; US POPULATION; 25(OH) D; ACCURACY;

D O I：

10.1007/s00216-021-03577-0

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of ligand binding assays (Part 2) for the determination of serum total 25-hydroxyvitamin D [25(OH)D]. Fifty single-donor samples were assigned target values for concentrations of 25-hydroxyvitamin D-2 [25(OH)D-2], 25-hydroxyvitamin D-3 [25(OH)D-3], 3-epi-25-hydroxyvitamin D-3 [3-epi-25(OH)D-3], and 24R,25-dihydroxyvitamin D-3 [24R,25(OH)(2)D-3] using isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 2 includes results from 17 laboratories using 32 ligand binding assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 50% of the ligand binding assays achieved the VDSP criterion of mean % bias <= |+/- 5%|. For the 13 unique ligand binding assays evaluated in this study, only 4 assays were consistently within +/- 5% mean bias and 4 assays were consistently outside +/- 5% mean bias regardless of the laboratory performing the assay. Based on multivariable regression analysis using the concentrations of individual vitamin D metabolites in the 50 single-donor samples, most assays underestimate 25(OH)D-2 and several assays (Abbott, bioMerieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH)(2)D-3. The results of this interlaboratory study represent the most comprehensive comparison of 25(OH)D ligand binding assays published to date and is the only study to assess the impact of 24R,25(OH)(2)D-3 content using results from a reference measurement procedure.

引用

页码：351 / 366

页数：16

共 41 条

[41] Simultaneous analysis of circulating 25-hydroxy-vitamin D3, 25-hydroxy-vitamin D2, retinol, tocopherols, carotenoids, and oxidized and reduced coenzyme Q10 by high performance liquid chromatography with photo diode-array detection using C18 and C30 columns alone or in combination
Franke, Adrian A.
Morrison, Cynthia M.
Custer, Laurie J.
Li, Xingnan
Lai, Jennifer F.
JOURNAL OF CHROMATOGRAPHY A, 2013, 1301 : 1 - 9

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