Analytical evaluation of the new Abbott Architect 25-OH vitamin D assay

ObjectivesValidation of the Architect 25-OH vitamin D assay.Design and methodsDetermination of repeatability, reproducibility, accuracy profile and 25(OH)-vitamin D2 recovery on native samples. Comparison with DiaSorin Liaison and RIA.Results and conclusionCoefficients of variation: < 6% (13.6 ng/mL) and 2.2% (78.1 ng/mL). Functional sensitivity: 5 ng/mL. Accuracy profile shows that the method is validated between 13.6 and 78.1 ng/mL. Recovery of 25(OH)D2: 75,8%( 95% CI: 61.9–89.7%). Good correlation with DiaSorin RIA and Liaison < 50 ng/mL; above this threshold a systematic positive bias was observed.

► Architect 25-OH vitamin D assay presents excellent CVs.
► 75% of 25-OH vitamin D2 is recognized.
► The assay presents a positive bias in values >50 ng/mL.