In the US, the number of new HBV infections has decreased through effective promotion of the hepatitis B vaccine. Yet there were 46,000 people newly infected in 2006, according the Centers for Disease Control and Prevention (CDC), and it is estimated that 1.4 million are chronically infected. For HCV, about 17,000 new infections occur each year in the US and about 3.4 million are affected by chronic infections, according to CDC. Currently, there is no vaccine available for HCV.
Programs are in place in both the US and other areas of the world with goals to increase awareness of these potentially serious infections. An annual campaign sponsored by the World Hepatitis Alliance, a coalition of advocacy groups from around the world, declared May 19, 2010 to be Hepatitis Awareness Day. The American Liver Foundation promoted May as Hepatitis Awareness Month in an effort to educate people about the diseases. Both programs seek to inform people about these potentially silent killers. Though millions are infected, many are not aware they have the disease. Increased testing could help people learn of their status and help stop transmission of the disease. Both the World Health Organization and the United States Institute of Medicine have recently publicized the importance of increasing awareness of these infections and taking steps to recognize people who have these diseases and reduce their spread. In addition, treatments are available that can control or eradicate infection.
While several different types of laboratory tests are currently available to detect these diseases, researchers continue to work to develop faster, simpler, and more cost-effective tests. The number of rapid tests for HBV has increased in recent years. In June, a new rapid test was given regulatory approval by the European Union. Similar to other rapid tests, it employs simple "dipstick" technology to test for the presence of a protein of HBV (called hepatitis B surface antigen (HBsAg)) in blood. The test's convenient and relatively low-tech design makes it suitable for use in areas of the world that lack resources for testing methods that require sophisticated instrumentation and special training. Typical testing methods often require that a blood sample be collected and sent to a laboratory; results can take days to weeks. The new test produces results on-site in half an hour, while a patient waits for the results.
Also in June, the US Food and Drug Administration (FDA) approved the first ever rapid test for HCV. It detects the presence of HCV antibodies in blood and is approved for use in screening individuals 15 years of age or older who have been exposed or who are at an increased risk of infection. The new test employs a test strip so it does not require instrumentation or extensive training to use. It provides results in about 20 minutes. However, a positive test requires confirmation by a second test in order for a diagnosis to be made. An eventual goal is to have the test approved for use with samples of oral fluid to further simplify its use.
"Approval of [this new rapid test] means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease."
Hepatitis B and C continue to be major health threats throughout the world because so many people don't know they have the disease. The simple yet effective design of these and other rapid tests may prove to be helpful in overcoming the barriers that prevent people from getting tested.
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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.
The World Health Organization. Hepatitis C (2002). Available online at http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index.html through http://www.who.int.
World Hepatitis Awareness Day, 19 May 2010. Available online at http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/activities/world-hepatitis-awareness-day,-19-may-2010 through http://www.euro.who.int. Accessed July 2010.
Centers for Disease Control and Prevention. Hepatitis B Factsheet. PDF available for download at http://www.cdc.gov/hepatitis/HBV/PDFs/HepBGeneralFactSheet-BW.pdf through http://www.cdc.gov. Accessed July 2010.
Centers for Disease Control and Prevention. Hepatitis C Factsheet. PDF available for download at http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf through http://www.cdc.gov. Accessed July 2010.
American Liver Foundation. May is Hepatitis Awareness Month. Available online at http://www.liverfoundation.org/chapters/ham through http://www.liverfoundation.org. Accessed July 2010.
(May 24, 2010) Healthcarejobs.co.uk, Medtech News. Rapid Hepatitis B test approved by EU. Available online at http://www.healthcarejobs.co.uk/blog/index.php/2010/05/page/2/ through http://www.healthcarejobs.co.uk. Accessed June 2010.
(May19, 2010) Medical News Today. While-You-Wait Hepatitis B Test Given Green Light By EU. Available online at http://www.medicalnewstoday.com/articles/189223.php through http://www.medicalnewstoday.com. Accessed June 2010.
(June 25, 2010) US Food and Drug Administration News Release. Available online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318.htm through http://www.fda.gov. Accessed July 2010.
(June 25, 2010) Reuters. OraSure gets FDA nod for hepatitis C test. Available online at http://www.reuters.com/article/idUSTRE65O4AR20100625 through http://www.reuters.com. Accessed July 2010.