Acute myocardial infarction (MI) is the biggest killer in the western world and is the cause of death for nearly 500,000 Americans each year. The symptoms of MI can be vague and non- specific;for this reason 6 to 9 million adults present to hospital Emergency Departments in the US and are worked up for suspected MI annually. Advances in cardiac biomarkers have had a large impact on the diagnosis, risk stratification and management of suspected MI patients and rapid and sensitive testing of cardiac biomarkers, specifically troponin, has become the cornerstone for diagnostic workup and care of suspected MI patients. Rapid troponin testing can decrease time to appropriate treatment for MI patients and allow for faster MI rule-out, which will help decrease the $10 to $13 billion expended annually for the care of non-MI patients in coronary care units. Yet, despite the clear need for sensitive and rapid cardiac troponin measurements to quickly diagnose and manage patients, there is no POC system that can match the analytical performance of contemporary sensitive laboratory systems. Further, the need for speed will become even more important for emergency department as a CMS indicator will be implemented in 2013 which specifies that cardiac troponin results must be available within 1 hour of patient presentation. In this project we will produce and demonstrate a fully integrated POC immunoassay platform, based on a CMOS microchip, that is as easy to use as an over the counter pregnancy test and as accurate as state-of-the-art laboratory tests (15pg/mL with 10% CV). In addition to troponin, which is critically important, the system will be able to measure a myriad of other biomarkers for heart failure, pulmonary embolism and deep vein thrombosis, sepsis and other conditions where speed, convenience and in the field measurement of biomarkers is important.
The lack of laboratory quality point-of-care (POC) tests forces providers to implement inefficient testing protocols or make decisions based on incomplete information. This effects outcomes and causes the healthcare system as a whole to spend billions of dollars each year on unnecessary treatments. In this project we demonstrate a microchip-based assay platform that performs assays with laboratory precision and a one-step protocol and which can be mass- produced using existing foundry capacity.