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

Johanna E. Camara; Stephen A. Wise; Andrew N. Hoofnagle; Emma L. Williams; Graham D. Carter; Julia Jones; Carolyn Q. Burdette; Grace Hahm; Federica Nalin; Adam J. Kuszak; Joyce Merkel; Ramón A. Durazo-Arvizu; Pierre Lukas; Étienne Cavalier; 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; Heather Pham; Alex Bennett; 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; Christopher T. Sempos

doi:10.1007/s00216-021-03470-w

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

Johanna E. Camara, Stephen A. Wise, Andrew N. Hoofnagle, Emma L. Williams, Graham D. Carter, Julia Jones, Carolyn Q. Burdette, Grace Hahm, Federica Nalin, Adam J. Kuszak, Joyce Merkel, Ramón A. Durazo-Arvizu, Pierre Lukas, Étienne Cavalier, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille PeaseRavi 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, Heather Pham, Alex Bennett, 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, Christopher T. Sempos

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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. Graphical abstract: [Figure not available: see fulltext.]

Original language	English (US)
Pages (from-to)	5067-5084
Number of pages	18
Journal	Analytical and Bioanalytical Chemistry
Volume	413
Issue number	20
DOIs	https://doi.org/10.1007/s00216-021-03470-w
State	Published - Aug 2021

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Analytical Chemistry
Biochemistry

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Camara, J. E., Wise, S. A., Hoofnagle, A. N., Williams, E. L., Carter, G. D., Jones, J., Burdette, C. Q., Hahm, G., Nalin, F., Kuszak, A. J., Merkel, J., Durazo-Arvizu, R. A., Lukas, P., Cavalier, É., Popp, C., Beckert, C., Schultess, J., Van Slooten, G., Tourneur, C., ... 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(20), 5067-5084. https://doi.org/10.1007/s00216-021-03470-w

Camara, Johanna E. ; Wise, Stephen A. ; Hoofnagle, Andrew N. et al. / 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. In: Analytical and Bioanalytical Chemistry. 2021 ; Vol. 413, No. 20. pp. 5067-5084.

@article{57ed50fa8c394611ac03bce398e8d457,

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",

abstract = "An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard Reference Materials{\textregistered} (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. Graphical abstract: [Figure not available: see fulltext.]",

author = "Camara, {Johanna E.} and Wise, {Stephen A.} and Hoofnagle, {Andrew N.} and Williams, {Emma L.} and Carter, {Graham D.} and Julia Jones and Burdette, {Carolyn Q.} and Grace Hahm and Federica Nalin and Kuszak, {Adam J.} and Joyce Merkel and Durazo-Arvizu, {Ram{\'o}n A.} and Pierre Lukas and {\'E}tienne Cavalier and Christian Popp and Christian Beckert and Jan Schultess and {Van Slooten}, Glen and Carole Tourneur and Camille Pease and Ravi Kaul and Alfredo Villarreal and Fiona Ivison and Ralf Fischer and {van den Ouweland}, {Jody M.W.} and Ho, {Chung S.} and Law, {Emmett W.K.} and Simard, {Jean Nicolas} and Renaud Gonthier and Brett Holmquist and Batista, {Marcelo Cidade} and Heather Pham and Alex Bennett and Sarah Meadows and Lorna Cox and Eugene Jansen and Khan, {Dilshad Ahmed} and Kimberly Robyak and Creer, {Michael H.} and Mark Kilbane and Twomey, {Patrick J.} and James Freeman and Neil Parker and Jinyun Yuan and Robert Fitzgerald and Sohail Mushtaq and Clarke, {Michael W.} and Norma Breen and Christine Simpson and Sempos, {Christopher T.}",

note = "Publisher Copyright: {\textcopyright} 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.",

year = "2021",

month = aug,

doi = "10.1007/s00216-021-03470-w",

language = "English (US)",

volume = "413",

pages = "5067--5084",

journal = "Analytical and Bioanalytical Chemistry",

issn = "1618-2642",

publisher = "Springer Verlag",

number = "20",

}

Camara, JE, Wise, SA, Hoofnagle, AN, Williams, EL, Carter, GD, Jones, J, Burdette, CQ, Hahm, G, Nalin, F, Kuszak, AJ, Merkel, J, Durazo-Arvizu, RA, Lukas, P, Cavalier, É, 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, Pham, H, Bennett, A, 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 & Sempos, CT 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, vol. 413, no. 20, pp. 5067-5084. https://doi.org/10.1007/s00216-021-03470-w

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. et al.
In: Analytical and Bioanalytical Chemistry, Vol. 413, No. 20, 08.2021, p. 5067-5084.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - Vitamin D Standardization Program (VDSP) Commutability Study 2

AU - Camara, Johanna E.

AU - Wise, Stephen A.

AU - Hoofnagle, Andrew N.

AU - Williams, Emma L.

AU - Carter, Graham D.

AU - Jones, Julia

AU - Burdette, Carolyn Q.

AU - Hahm, Grace

AU - Nalin, Federica

AU - Kuszak, Adam J.

AU - Merkel, Joyce

AU - Durazo-Arvizu, Ramón A.

AU - Lukas, Pierre

AU - Cavalier, Étienne

AU - Popp, Christian

AU - Beckert, Christian

AU - Schultess, Jan

AU - Van Slooten, Glen

AU - Tourneur, Carole

AU - Pease, Camille

AU - Kaul, Ravi

AU - Villarreal, Alfredo

AU - Ivison, Fiona

AU - Fischer, Ralf

AU - van den Ouweland, Jody M.W.

AU - Ho, Chung S.

AU - Law, Emmett W.K.

AU - Simard, Jean Nicolas

AU - Gonthier, Renaud

AU - Holmquist, Brett

AU - Batista, Marcelo Cidade

AU - Pham, Heather

AU - Bennett, Alex

AU - Meadows, Sarah

AU - Cox, Lorna

AU - Jansen, Eugene

AU - Khan, Dilshad Ahmed

AU - Robyak, Kimberly

AU - Creer, Michael H.

AU - Kilbane, Mark

AU - Twomey, Patrick J.

AU - Freeman, James

AU - Parker, Neil

AU - Yuan, Jinyun

AU - Fitzgerald, Robert

AU - Mushtaq, Sohail

AU - Clarke, Michael W.

AU - Breen, Norma

AU - Simpson, Christine

AU - Sempos, Christopher T.

PY - 2021/8

Y1 - 2021/8

N2 - 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. Graphical abstract: [Figure not available: see fulltext.]

AB - 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. Graphical abstract: [Figure not available: see fulltext.]

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UR - http://www.scopus.com/inward/citedby.url?scp=85106917471&partnerID=8YFLogxK

U2 - 10.1007/s00216-021-03470-w

DO - 10.1007/s00216-021-03470-w

M3 - Article

C2 - 34184102

AN - SCOPUS:85106917471

SN - 1618-2642

VL - 413

SP - 5067

EP - 5084

JO - Analytical and Bioanalytical Chemistry

JF - Analytical and Bioanalytical Chemistry

IS - 20

ER -

Camara JE, Wise SA, Hoofnagle AN, Williams EL, Carter GD, Jones J et al. 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. 2021 Aug;413(20):5067-5084. doi: 10.1007/s00216-021-03470-w

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