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A Novel HCV Antigen Test System for One-step Screening and Diagnosing Viremic HCV Infection Using Serum or Urine Specimens
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Chronic hepatitis C virus (HCV) infection affects approximately 170 million people worldwide, and 4 million people in this country. Chronic HCV infection causes liver injury that could progress to cirrhosis and increase risk for liver cancer. Recent research advances have made chronic hepatitis C highly curable. However, studies indicate HCV infection remains under screened and under diagnosed. Accordingly, the US CDC has updated its recommendation to screen for HCV infection in at-risk individuals and all individuals born between 1945 and 1965.
Current practice in diagnosing for HCV infection is based on a two-steps approach, anti-HCV test for screening, and HCV RNA PCR for confirming the diagnosis. This approach is inconvenient, time-intensive, expensive, and not widely available and affordable globally. Additional limitations to current anti-HCV tests include the requirement of blood samples and the dependence on a host's immune status, which may result in false negatives in immune compromised subjects.
HCV core antigen (HCVcAg) tests may represent the most suitable candidate replacement to current anti-HCV tests for possible one-step diagnosis. However, currently available HCVcAg tests are not sensitive and specific enough for clinical utility. Dr. Ke-Qin Hu, a hepatologist and research scientist at UC Irvine's School of Medicine, has worked with his research team and made a significant progress in overcoming this important issue. They have reported a very sensitive and specific novel HCV antigen test system to concurrently screen and diagnose HCV infection using either serum or urine sample in AASLD meeting, San Francisco, Nov. 14-16. Dr. Hu indicated that the results by their test system are highly sensitive and specific with 100% concordance to HCV RNA PCR test results, making one-step diagnosis of HCV infection possible, using either blood or urine samples.
The ability to detect infection using urine rather than blood avoids needle stick and blood sample collection, a main part of their invention, greatly reduces the cost and necessary clinical infrastructure for screening and diagnosis, helping to promote widespread adoption of the test on a global scale.
Effective screening and diagnosis are critical for treatment and controlling transmission. Those who are HCV infected can now be cured, before further liver injury and complications develop, but only if they are diagnosed.
Finding a more convenient, easy-to-use and cost-effective screening alternative is imperative, because HCV is significantly under-screened and under-diagnosed. The HCV antigen test system reported by Dr. Hu's research team well meet the urgent needs in this field, and will provide a convenient and cost-effective way to improve screening and diagnosis of HCV infection in this country and worldwide.
This novel test system has been exclusively licensed to DiligenMed Inc, a biotechnology company in Irvine, California. For further information, please contact Ke-Qin Hu, MD, kqhu@uci.edu, or 714-456-6926.
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