Minimally Invasive, Self-Collection of Large Volume Biospecimens

Human plasma offers the promise of a revolution in biomarker-based disease diagnosis and therapeutic monitoring. Absence of a trained phlebotomist in remote locations limits the diagnostic potential of the human proteome, as current self-administered point-of-care extraction volumes are insufficient for the detection of many of the low abundance biomarkers. Current devices for monitoring glucose levels are useful because glucose concentration is high enough for detection from microliters of blood, but biomarkers for many potentially life threatening conditions, are well below 10000 copies or molecules per milliliter, and thus require at least 100µL volumes of blood for reliable diagnosis and clinical action. Extraction of larger volumes is possible using lancets but requires sample transfer and is therefore prone to contamination in remote locations when operated by an inexperience user. Consequently, many potentially life-threatening conditions are undetectable in remote locations, and therefore present a danger to the health of military personnel. The Bio-Fluid Self-Extraction (BioFLEX) system addresses this problem by combining the simplicity of finger stick blood collection with a manual pumping system for storage of biofluid at volumes up to 500 & #956;L, sufficient for downstream point of care diagnostics on low abundance biomarkers.