HCV is a widely prevalent RNA virus with 200 million individuals worldwide, and 4 million Americans are chronically infected with HCV. Patients with chronic HCV infection are at risk of developing cirrhosis, liver failure and hepatocellular carcinoma. Rapid diagnosis of HCV can lead to early treatment and prevention of transmission. While enzyme immunoassays for the detection of hepatitis C antibody are inexpensive and reliable in the screening of HCV infection, they do not differentiate between recovered and chronic infection, and are of no value in monitoring response to treatment. Qualitative and quantitative reverse transcription-PCR (RT-PCR) assays are available for the diagnosis and monitoring of HCV infected patients but these tests have significant drawbacks of high cost, long analysis times, limited range of linearity, and requirement of skilled labor. We propose to develop a portable, self-contained, microfabricated device for the diagnosis of infectious diseases using real-time polymerase chain reaction (PCR) to detect and quantify the levels of HCV viral load. Such a device could significantly reduce costs and dramatically improve the quality of care of HCV infected patients. Our ultimate goal is to develop a self-contained, inexpensive, microfabricated device that can detect the presence as well as concentration of one or more infectious agents in near-patient setting.
Thesaurus Terms: biomedical equipment development, communicable disease diagnosis, diagnosis design /evaluation, hepatitis C, polymerase chain reaction, portable biomedical equipment hepatitis C virus, liver disorder diagnosis, microprocessor /microchip, time resolved data
