—Alan Franciscus, Editor-in-Chief - HCV Advocate

In July 2010 the Food and Drug Administration approved the first rapid HCV antibody test in the United States—OraQuick® HCV Rapid Antibody Test.  The approval is for the venous whole blood test that will be used in medical clinics.  Orasure is expected to file for marketing approval of their ‘finger prick’ and ‘oral swab’ at the end of 2010 or the beginning of 2011.  The finger prick and oral swab antibody tests are the most eagerly awaited tests because they will allow for testing high risk populations at testing events and outreach programs such as needle exchanges.

The venous whole blood test kit will require a phlebotomist to draw the blood, but the advantage of this test over current HCV antibody tests is that the test results will be available after 20 minutes.  This means that in addition to providing people pre- and post-test counseling messages, now the clinic can provide confirmatory testing and aftercare.  One of the most important follow-up tests to a positive HCV antibody test is the HCV RNA or viral load test to confirm that the hepatitis C virus is actively replicating in the body or if the body’s immune system has been able to clear the virus.  This is vital because about 25 to 45% of people acutely infected with hepatitis C are able to naturally rid the body of the hepatitis C virus.  Testing for hepatitis C in clinics will also mean that patients receive follow-up care for medical testing, monitoring, and treatment. 

Although the price and availability of the kits has not been confirmed, the kits are expected to be available by the end of 2010.  The kit will include Orasure’s collection Loop (for the blood sample), developer solution (mixed with the blood sample), and a device that has a window to interpret the results.  The various OraQuick HCV Rapid Antibody Tests have the potential to dramatically change the landscape of HCV testing, diagnosis, management and treatment.

The Biosensor
Another exciting development is a hand-held device that is capable of testing HIV, hepatitis and other pathogens.  The device is called the Biosensor and was developed by the University of New Mexico Health Sciences Center and Sandia National Laboratories.  It is estimated that the device will cost approximately $5,000 and the chips will cost about $10 each.  Here’s how it works:

• The chip is loaded into the device
• The fluid  (blood, saliva, urine) is injected into a small hole in the device
• Results are ready in as little as 5 seconds. 

Here’s the most interesting part – the device works by weighing the fluid sample – specific viruses and bacteria have DNA or RNA that is a certain weight.  The device is able to measure the weight of the DNA and RNA samples and give off a signal, and the results are transferred to a computer or smartphone.  The potential for this device is enormous for HCV and other pathogens.  The scientists are already working on using the device to identify cancer cells.   According to the article published in the Albuquerque Journal (July 9, 2010) it is expected that the device will be available in about 2 years.

http://www.hcvadvocate.org/news/newsLetter/2010/advocate0810.html#2

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