Point of care testing (POCT) is performed at or near the site of a patient and provides test results in real time, enabling faster decision-making. Collection of capillary whole blood by fingerstick is one method of sample collection for POCT devices. As the demand for POCT devices that use fingerstick specimens increases, so does the need for scientifically sound and practical study design recommendations for evaluating their analytical performance characteristics.
MDIC’s new resource, Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens, highlights design and data analysis considerations for analytical validity studies of POCT devices that use fingerstick specimens.
