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

Published on Jun 28, 2021in Analytical and Bioanalytical Chemistry4.157
· DOI :10.1007/S00216-021-03470-W
Graham D. Carter12
Estimated H-index: 12
,
J. Jones15
Estimated H-index: 15
Sources
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.
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References29
Newest
#1Uliana Danilenko (CDC: Centers for Disease Control and Prevention)H-Index: 2
#2Hubert W. Vesper (CDC: Centers for Disease Control and Prevention)H-Index: 33
Last. W. Greg Miller (VCU: Virginia Commonwealth University)H-Index: 31
view all 6 authors...
Manufacturers of in vitro diagnostic medical devices, clinical laboratories, research laboratories and calibration laboratories require commutable reference materials that can be used in the calibration hierarchies of medical laboratory measurement procedures used for human specimens to establish metrological traceability to higher order reference systems. Commutable materials are also useful in external quality assessment surveys. In order to achieve these goals, matrix-based reference material...
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Context.— The goal of the College of American Pathologists' Accuracy-Based Proficiency Testing Program is to promote the quality, standardization, and harmonization of clinical laboratory results t...
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#1Martina Rabenberg (RKI: Robert Koch Institute)H-Index: 10
#2Christa Scheidt-Nave (RKI: Robert Koch Institute)H-Index: 59
Last. Gert B. M. Mensink (RKI: Robert Koch Institute)H-Index: 61
view all 11 authors...
Background Comparability of 25-hydroxyvitamin D (25(OH)D) measurements is hampered by method-related differences in measurement values. International standardization of laboratory assays has been suggested to solve this problem.
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#1W. Greg Miller (VCU: Virginia Commonwealth University)H-Index: 31
#2Heinz SchimmelH-Index: 31
Last. Hubert W. Vesper (CDC: Centers for Disease Control and Prevention)H-Index: 33
view all 16 authors...
Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and results for clinical samples (CSs) when measured by ≥2 measurement procedures (MPs). Commutability of RMs used in a calibration traceability scheme is an essential property for them to be fit for purpose. Similarly, commutability of trueness controls or external quality assessment samples is essential when those materials are used to assess trueness of results for CSs...
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#1Göran NilssonH-Index: 6
#2Jeffrey R. Budd (Beckman Coulter)H-Index: 5
Last. W. Greg Miller (VCU: Virginia Commonwealth University)H-Index: 31
view all 15 authors...
A process is described to assess the commutability of a reference material (RM) intended for use as a calibrator, trueness control, or external quality assessment sample based on the difference in bias between an RM and clinical samples (CSs) measured using 2 different measurement procedures (MPs). This difference in bias is compared with a criterion based on a medically relevant difference between an RM and CS results to make a conclusion regarding commutability. When >2 MPs are included, the c...
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Abstract Recent years have seen a substantial increase in demand for 25-hydroxyvitamin D (25-OHD) assays. DEQAS (the Vitamin D External Quality Assessment Scheme) has been monitoring the performance of these assays since 1989. The first DEQAS distribution was in June 1989 and results were submitted by 13 laboratories in the UK, two of which used HPLC/UV; the rest used ligand binding assays with a tritium tracer. Inter-laboratory CVs (ALTM) ranged from 29.3% (42.7 nmol/L) to 53.7% (20.0 nmol/L). ...
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#1Jeffrey R. Budd (Beckman Coulter)H-Index: 5
#2Cas WeykampH-Index: 32
Last. W. Greg Miller (VCU: Virginia Commonwealth University)H-Index: 31
view all 14 authors...
A process is described to assess the commutability of a reference material (RM) intended for use as a calibrator based on its ability to fulfill its intended use in a calibration traceability scheme to produce equivalent clinical sample (CS) results among different measurement procedures (MPs) for the same measurand. Three sources of systematic error are elucidated in the context of creating the calibration model for translating MP signals to measurand amounts: calibration fit, calibrator level ...
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#3Ramon Durazo-Arvizu (LUC: Loyola University Chicago)H-Index: 36
#7J. Jones (Imperial College London)H-Index: 15
Abstract Substantial variability is associated with laboratory measurement of serum total 25-hydroxyvitamin D [25(OH)D]. The resulting chaos impedes development of consensus 25(OH)D values to define stages of vitamin D status. As resolving this situation requires standardized measurement of 25(OH)D, the Vitamin D Standardization Program (VDSP) developed methodology to standardize 25(OH)D measurement to the gold standard reference measurement procedures of NIST, Ghent University and CDC. Importan...
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#4Graham D. Carter (Imperial College Healthcare)H-Index: 12
The Vitamin D Standardization Program (VDSP) has collaborated with numerous groups and agencies to assemble a set of tools, i.e., a reference measurement system, that can be used to establish the traceability of 25-hydroxyvitamin D [25(OH)D] assays to relevant reference measurement procedures and reference materials. This is done with the goal of verifying end-user laboratory performance using precise statistical criteria to determine whether a specific assay is standardized. The purpose of this...
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#6Graham D. Carter (Imperial College Healthcare)H-Index: 12
: Until recently, the Vitamin D External Quality Assessment Scheme (DEQAS) assessed the performance of various assays for the determination of serum total 25-hydroxyvitamin D [25(OH)D] by using a consensus mean based on the all-laboratory trimmed mean (ALTM) of the approximately 1000 participants' results. Since October 2012, the National Institute of Standards and Technology (NIST), as part of the Vitamin D Standardization Program, has participated in DEQAS by analyzing the quarterly serum samp...
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Cited By2
Newest
#1Christopher T. Sempos (NIH: National Institutes of Health)H-Index: 70
#2Emma L WilliamsH-Index: 7
Last. Stephen A. Wise (NIH: National Institutes of Health)H-Index: 6
view all 50 authors...
The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at −40 °C prior to distribution and the participants are instructed to store the samples frozen at −20 °C or lower after receipt; however, the samples are shipped to participants at ambient conditions (i.e., no temperature control). To address the question of w...
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#1Stephen A. Wise (NIST: National Institute of Standards and Technology)H-Index: 6
#2Johanna E. Camara (NIST: National Institute of Standards and Technology)H-Index: 14
Last. Andrew N. Hoofnagle (UW: University of Washington)H-Index: 67
view all 28 authors...
An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatography - tandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25-hydroxyvitamin D (25(OH)D), which is the sum of 25-hydroxyvitamin D2 (25(OH)D2) and 25-hydroxyvitamin D3 (25(OH)D3). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D2, 25(OH)D3, 3-epi-25-hydroxyvitamin D3 (3-epi-25(OH)D3...
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