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


METHODS
Determination of repeatability, reproducibility, accuracy profile and 25(OH)-vitamin D2 recovery on native samples. Comparison with DiaSorin Liaison and RIA.


CONCLUSIONS
Coefficients 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.
Department of Clinical Chemistry, University of Liege, CHU Sart-Tilman, Liège, Belgium. Etienne.cavalier@chu.ulg.ac.be
Etienne
E
Cavalier
Agnes
A
Carlisi
Anne-Catherine
AC
Bekaert
Olivier
O
Rousselle
Jean-Paul
JP
Chapelle
Jean-Claude
JC
Souberbielle
D001774:Blood Chemical Analysis / Q000379:methods*; D002112:Calcifediol / Q000097:blood*; D016001:Confidence Intervals; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D011933:Reagent Kits, Diagnostic; D002112:Calcifediol