The Fingerstick project aims to develop and define clear analytical validity study designs for Point of Care devices (quantitative and qualitative) that use fingerstick capillary blood specimens. The current ecosystem has a need for scientifically sound and practical study design recommendations when evaluating analytical performance characteristics of POC devices using capillary whole blood specimens.
Through fingerstick, patients can receive expedited access to less invasive and more accessible diagnostic medical device technologies and the industry can decrease time and cost of analytical testing for POC devices which use fingerstick capillary blood specimens. This assists the FDA with providing improved data quality for regulatory submissions that include capillary samples.
