The U.S. Food and Drug Administration requires that all blood be tested for transfusion-transmissible diseases. Unfortunately, current tests cannot provide rapid support for field medical emergencies that require blood in excess of the tested supply, especially when additional blood needs to be drawn from the available """"""""walking"""""""" pool. Intelligent Optical Systems (IOS) proposes to develop and construct an optically-based rapid infectious diseases screening system, based on a disposable disk with an array of wash-free, one-step membrane strips, to quantify transmissible disease panels in parallel with high specificity, high sensitivity, and operational simplicity. During preliminary experiments, IOS will demonstrate the quantitative results for hepatitis C over the concentration range of 2 ng/ml to 100 ng/ml, and demonstrate rapid testing capability (3- 5 minutes). IOS will extend the work to screen multiple infectious diseases including anti-HCV, anti-HBc, HBsAg, anti-HAV, HIV; HTLV-l & 2, and syphilis under FDA guidelines using the selected format to verify the required sensitivity and specificity.
Approximately 14 million units of blood are donated by volunteers each year; a rapid and sensitive method for the quantitative detection and identification of pathogens is needed. Blood banks, infectious disease clinical screening, and point of care diagnostic industries can all benefit from this technology.
