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FDA Approves 20-Minute Bloodless HIV Test

Have you been tested this year?  It just got easier with the approval of an oral swab test that can detect antibodies to HIV in only 20 minutes. 

3-31-04

On March 26, 2004, the Food and Drug Administration announced the approval of an oral HIV antibody test that can deliver accurate results in 20 minutes, without the use of needles or blood testing.  OraSure Technologies, Inc., a Pennsylvania-based medical diagnostics company, made headlines in 2002 when its 20-minute HIV antibody test was approved for rapid HIV testing with only a drop of blood from the finger.

The most recent approval of the OraQuick® will extend HIV testing to many additional testing sites unable or unwilling to work with blood testing.  Using the device, which has an absorbent swab on one end, the person being tested, holds the swab between the cheek and the teeth for 2-5 minutes, collecting a fluid called Oral mucosal transudate (OMT), which contains antibodies to the HIV infection.  In as little as 20 minutes, if the person is HIV-positive, two small colored lines will appear in a window on the device. 

Explaining the limitations to the OraQuick test, the FDA noted in a statement,” Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional more specific test. The OraQuick test has not been approved to screen blood donors. Although the test is approved to detect antibodies to HIV-1 and –2 when used on blood, today’s approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1.”

So there are limitations, if you test positive, you have to test again.  And the test may not catch infection with the HIV-2 strain.  In a fair balance statement, the company also noted that the test’s accuracy ranges from 97.7% in high risk subjects to 99.6% in low risk populations.  These drawbacks are put into perspective when we realize that approximately one quarter of the estimated 900,000 people infected with HIV in the United States are not aware that they are infected.  Any development that will extend testing opportunities that are minimally intrusive and provide rapid results should be brought to as many people as possible.

The struggle to provide low-cost and rapid testing in developing countries is of greater importance.  In a statement released by the company on the day of the approval, George W. Haley, former U.S. Ambassador to the Republic of the Gambia, stated, "Countries battling the war against AIDS should have complete access to the same technology that we use on ourselves and our families here in America. Because of its design, OraQuick can be used virtually anywhere, at anytime, and by anyone, with minimal cost, training and safety issues. Now is the time to scale up rapid testing and this simple test is one of the answers."

When we know exactly how bad it is, can we still behave irresponsibly on the personal and political level?  Only when we are fully aware of the extent of the HIV epidemic, both nationally and globally, can we contain the deadly spread of this disease. 

References

“OraSure Receives FDA Approval of OraQuick Oral Fluid and Plasma Claims; First and Only Oral Fluid Rapid HIV Test Approved in U.S. by the FDA,” Press Release, Orasure Technologies, Inc.

http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=OSUR&script=410&layout=-6&item_id=508658

“FDA Approves First Oral Fluid Based Rapid HIV Test Kit.” FDA News (3/26/04)

http://www.fda.gov/bbs/topics/news/2004/NEW01042.html

“Human Immunodeficiency Virus Type 2,” Centers for Disease Control and Prevention. National Center for HIV, STD and TB Prevention. Divisions of HIV/AIDS Prevention.

http://www.cdc.gov/hiv/pubs/facts/hiv2.htm