期刊
JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY
卷 212, 期 -, 页码 -出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jsbmb.2021.105917
关键词
25-Hydroxyvitamin D-3; 25-Hydroxyvitamin D-2; 3-epi-25-hydroxyvitamin D-3; Serum total 25-hydroxyvitamin D; Liquid chromatography-tandem mass spectrometry (LC-MS/MS); Immunoassay; Reference measurement procedure (RMP); Vitamin D Standardization Program (VDSP)
资金
- NIH-ODS
The intralaboratory study assessed the assay variability and bias for determination of serum total 25-hydroxyvitamin D [25(OH)D]. Out of the 13 assays evaluated, 12 met the criteria for CV, while only 9 were within the criteria for mean bias, with Fujirebio Inc. exhibiting the best performance. Samples with high concentrations of 25(OH)D-2 provided a critical performance test for immunoassays, showing that not all assays have equal response or recovery for 25(OH)D-2 and 25(OH)D-3.
An intralaboratory study assessing assay variability and bias for determination of serum total 25-hydroxyvitamin D [25(OH)D] was conducted by the Vitamin D Standardization Program (VDSP). Thirteen assays for serum total 25(OH)D were evaluated in a single laboratory including 11 unique immunoassays and one liquid chromatography - tandem mass spectrometry (LC-MS/MS) assay. Fifty single-donor serum samples, including eight samples with high concentrations of 25(OH)D-2 (> 30 nmol/L), were assigned target values for 25(OH)D-2 and 25(OH) D-3 using reference measurement procedures (RMP). Using four replicate measurements for each sample, the mean total percent coefficient of variation (%CV) and mean % bias from the target values were determined for each assay using the 50 single-donor samples and a 42-sample subset, which excluded 8 high 25(OH)D-2 concentration samples, and compared with VDSP performance criteria of <= 10 % CV and <= +5 % mean bias. All 12 assays achieved the performance criterion for % CV, and 9 of the 12 assays were within <= +5 % mean bias. The Fujirebio Inc. assay exhibited the lowest %CV and highest percentage of individual measurements within <= +5 % mean bias. Ten immunoassays exhibited changes in response due to the high 25(OH)D-2 samples with Abbott, Biomerieux, DiaSorin, DlAsource, and IDS-iSYS assays having the largest deviations. The Fujirebio Inc. and Beckman Coulter assays were only minimally affected by the presence of the high 25(OH)D-2 samples. Samples with high concentrations of 25(OH)D-2 provided a critical performance test for immunoassays indicating that some assays may not have equal response or recovery for 25(OH)D-2 and 25(OH)D-3.
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