Using Capillary Whole Blood to Quantitatively Measure Ferritin: A Validation Trial of a Point-of-Care System

Abstract

Iron deficiency is a public health problem with devastating health, developmental and behavioral effects which often exacerbated due to affordability and access to screening and diagnosis. Using IronScan™ a portable, point-of-care diagnostic system capable of quantitatively measuring ferritin in blood, we validated IronScan™ ferritin measurements using whole blood and serum with a lab-based, regulator-approved analytical device for measuring ferritin in venous serum. Capillary (finger stick) and venous whole blood samples were obtained from 44 male and female volunteers. Venous serum (vSer) ferritin concentrations were measured on Immulite 2000 Xpi (gold standard). Capillary whole blood (cWB), venous whole blood (vWB), and vSer ferritin levels were measured by IronScan™. cWB ferritin concentrations from IronScan™ were significantly correlated (R2 = 0.86) with vSer measured with the FDA-approved Immulite system. The results from the multiple regression analysis indicate that 10% of the variability was due to the method of blood collection (venous vs. capillary) and 6% was due to the form of blood analysis (whole blood vs. serum). The sensitivity of diagnosing iron deficiency using the WHO cutoff of <30 ng/mL is 90%, with a specificity of 96%. In conclusion, IronScan™ is a rapid viable option for measuring ferritin as a point-of-care system.