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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
Analytical and Bioanalytical Chemistry ( IF 3.8 ) Pub Date : 2021-08-25 , DOI: 10.1007/s00216-021-03577-0
Stephen A Wise 1, 2 , Johanna E Camara 3 , Carolyn Q Burdette 3 , Grace Hahm 3 , Federica Nalin 3 , Adam J Kuszak 1 , Joyce Merkel 1 , Ramón A Durazo-Arvizu 4 , Emma L Williams 5 , Christian Popp 6 , Christian Beckert 6 , Jan Schultess 6 , Glen Van Slooten 7 , Carole Tourneur 8 , Camille Pease 8 , Ravi Kaul 9 , Alfredo Villarreal 9 , Marcelo Cidade Batista 10 , Heather Pham 11 , Alex Bennett 11 , Eugene Jansen 12 , Dilshad Ahmed Khan 13 , Mark Kilbane 14 , Patrick J Twomey 14 , James Freeman 15 , Neil Parker 15 , Sohail Mushtaq 16 , Christine Simpson 17 , Pierre Lukas 18 , Étienne Cavalier 18 , Christopher T Sempos 1, 19
Affiliation  

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 D2 [25(OH)D2], 25-hydroxyvitamin D3 [25(OH)D3], 3-epi-25-hydroxyvitamin D3 [3-epi-25(OH)D3], and 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3] 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)D2 and several assays (Abbott, bioMérieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH)2D3. 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)2D3 content using results from a reference measurement procedure.

Graphical abstract



中文翻译:

25-羟基维生素 D 测定的实验室间比较:维生素 D 标准化计划 (VDSP) 相互比较研究 2 - 第 2 部分配体结合测定 - 25-羟基维生素 D2 和 24R,25-二羟基维生素 D3 对测定性能的影响

维生素 D 标准化计划 (VDSP) 进行了一项实验室间比较研究,以评估配体结合试验(第 2 部分)测定血清总 25-羟基维生素 D [25(OH)D] 的性能。50 个单一供体样本被指定为 25-羟基维生素 D 2 [25(OH)D 2 ]、25-羟基维生素 D 3 [25(OH)D 3 ]、3-epi-25-羟基维生素 D 3 [ 3-epi-25(OH)D 3 ]和24R,25-二羟基维生素D 3 [24R,25(OH) 2 D 3] 使用同位素稀释液相色谱-串联质谱法 (ID LC-MS/MS)。VDSP 比对研究 2 第 2 部分包括来自 17 个实验室使用 32 种配体结合分析的结果。使用与指定目标值相比的平均偏差百分比并使用测试测定平均结果和目标值的线性回归分析来评估测定性能。只有 50% 的配体结合测定达到了 VDSP 标准的平均偏差百分比 ≤ |± 5%|。对于本研究中评估的 13 种独特的配体结合测定,只有 4 种测定始终在 ± 5% 的平均偏差范围内,而 4 种测定始终在 ± 5% 的平均偏差范围内,而与执行测定的实验室无关。基于使用 50 个单一供体样本中单个维生素 D 代谢物浓度的多变量回归分析,大多数检测低估了 25(OH)D2和几种检测方法(Abbott、bioMérieux、DiaSorin、IDS-EIA 和 IDS-iSYS)可能与 24R,25(OH) 2 D 3有交叉反应。这项实验室间研究的结果代表了迄今为止发布的 25(OH)D 配体结合测定的最全面比较,并且是唯一使用参考测量程序的结果评估 24R,25(OH) 2 D 3含量影响的研究.

图形概要

更新日期:2021-08-26
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