Improved Recognition of 25-Hydroxyvitamin D2 by 2 Automated Immunoassays.

The Journal of Applied Laboratory Medicine
K Aaron GenoRobert D Nerenz

Abstract

Despite recommendations to limit vitamin D testing to specific clinical scenarios, test volume remains high in many clinical laboratories. Automated total vitamin D immunoassays frequently under- or over-recover 25-hydroxyvitamin D2 [25(OH)D2], making accurate assessment of vitamin D status difficult in patients taking high-dose 25(OH)D2 supplements. Mass spectrometry-based methods offer excellent recovery of 25(OH)D2 but are not practical for use in all laboratories. In this study, we evaluated 2 automated immunoassays against an LC-MS/MS method performed at a national reference laboratory. A method comparison against LC-MS/MS was performed for the Roche Elecsys Vitamin D total II assay and the IDS-iSYS 25 VitDS immunoassays using 49 patient specimens submitted for clinical 25(OH)D measurement. Mean bias was calculated, and vitamin D status was determined for each specimen according to the 2011 Endocrine Society clinical practice guidelines. Theil-Sen regression lines relative to LC-MS/MS were y = 0.88x + 2.94 for Roche and y = 1.03x + 2.48 for IDS. Mean bias (±SD) in samples with 25(OH)D2 concentrations less than 5 ng/mL was -0.25 ng/mL (±6.30) for Roche and -1.45 ng/mL (±6.82) for the IDS. Mean bias (±SD) in samples with 25(...Continue Reading

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