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.

Proposed Commercial Applications

NOT AVAILABLE

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI051919-01
Application #
6492133
Study Section
Special Emphasis Panel (ZRG1-SSS-K (10))
Program Officer
Hall, Robert H
Project Start
2002-04-01
Project End
2003-06-30
Budget Start
2002-04-01
Budget End
2003-03-31
Support Year
1
Fiscal Year
2002
Total Cost
$272,000
Indirect Cost
Name
Handylab, Inc.
Department
Type
DUNS #
City
Ann Arbor
State
MI
Country
United States
Zip Code
48105
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Lok, Anna S F; Lai, Ching-Lung; Leung, Nancy et al. (2003) Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 125:1714-22