FDA approves HIV oral fluid-based test

Get ready to implement new advances in your clinical setting: The Food and Drug Administration (FDA) has approved the use of oral fluid samples with a rapid HIV diagnostic test kit to provide accurate screening in as little as 20 minutes. While there are three rapid HIV testing kits now on the market, the OraQuick Rapid HIV Antibody Test is the first to get clearance for use on oral fluid samples, which bypasses the need for needlesticks or fingerpricks for blood samples.

The FDA approved the original version of the test, known as the OraQuick Rapid HIV-1/2 Antibody Test (OraSure Technologies, Bethlehem, PA), in November 2002 for detection of HIV-1. The FDA gave approval in early March 2004 for use of the blood test to test for HIV-2. The new oral fluid test has been approved for detection of HIV-1 only; however, OraSure may seek approval for HIV-2 detection in oral fluid samples as well, says William Bruckner, vice president of strategic marketing.

Unlike the fingerstick rapid HIV test, the new oral test cannot be performed outside of laboratories and physicians’ offices, according to Robert Janssen, MD, director of the Atlanta-based Centers for Disease Control and Prevention’s (CDC’s) Division of HIV/AIDS Prevention.

"However, the availability of a saliva-based test is an advantage for those who don’t like to have their finger pricked," says Janssen. "In addition, health care workers face a much lower risk of exposure to infectious diseases from oral fluid than from blood."

OraSure is in active talks with the FDA to expand the use of the test so it may be performed in a variety of health care settings, Bruckner reports. The company is seeking what is known as a CLIA (Clinical Laboratory Improvement Amendments of 1988) waiver. Many different types of health providers can use a test categorized as a waived test in many more health care settings.

Case in point: The OraQuick Rapid HIV-1/2 test now used on blood samples was classified as a waived test in January 2003; it is now in use at more than 180,000 U.S. sites, including outreach clinics, community-based organizations, and physicians’ offices, according to OraSure.

How does it work?

To perform the OraQuick test on oral fluid samples, the person being tested for HIV-1 takes the device, which has an exposed absorbent pad at one end, and places the pad above the teeth and against the outer gum. After swabbing around the outer gums, both upper and lower, one time around, the tester then takes the device and inserts it into a vial containing a solution. In about 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.1

Bruckner estimates cost of the new test to be between $10 and $12, comparable to that of lab-based tests. As with the OraQuick blood test, the new test can be stored at room temperature and requires no specialized equipment.

Other commercially available reactive rapid HIV tests include the Reveal Rapid HIV-1 Antibody Test (MedMira Laboratories, Halifax, Nova Scotia), approved by the FDA in April 2003, and the Uni-Gold Recombigen HIV Test (Trinity Biotech, Wicklow, Ireland), approved in December 2003. The Recombigen test is used for detection of antibodies to HIV-1 in plasma, serum, and whole blood (venipuncture), while the Reveal test is used on serum and plasma. Both of these tests are categorized as moderate-complexity tests.

All of the reactive rapid HIV tests require confirmatory testing, according to the CDC. The CDC confirmatory protocols recommend:

  • confirmation of all reactive rapid HIV test results with Western blot or immunofluorescent assay, even if an enzyme immunoassay screening test is negative;
  • follow-up testing for persons with negative or indeterminate confirmatory test results, with a blood specimen collected four weeks after the initial reactive rapid test result.2

Do you use rapid tests?

What’s your approach to HIV testing? One-fourth of the approximately 900,000 HIV-infected people in the United States are not aware that they are infected, according to CDC estimates.3 Around the world, that figure may be as high as 95%, according to the Geneva-based World Health Organization.4 (See Resources below for information on rapid testing and National HIV Testing Day, June 27, 2004.)

"I think that what we will find is that there are many people out there who have been at risk for HIV, but for whatever reason have not come in to be tested," says Bruckner. "With the availability of the first oral fluid rapid HIV test, those people are expected to come in and be tested, which will be a tremendous benefit."


1. Food and Drug Administration. FDA approves first oral fluid-based rapid HIV test kit. Accessed at: www.fda. gov/bbs/topics/news/2004/NEW01042.html.

2. Centers for Disease Control and Prevention. Notice to readers: Protocols for confirmation of reactive rapid HIV tests. MMWR 2004; 53:221-222.

3. Centers for Disease Control and Prevention. A glance at the HIV epidemic. Accessed at: www.cdc.gov/nchstp/ od/news/At-a-Glance.pdf.

4. McNeil DG. Fast saliva test for HIV gains federal approval. The New York Times, March 27, 2004:A8.


  • For more information on rapid testing, visit the Centers for Disease Control and Prevention’s web page, www.cdc.gov/hiv/testing.htm. Click on "Rapid HIV Testing" to review such resources as a CLIA Certificate of Waiver Fact Sheet, product insert sheets for rapid tests, and a link to CDC studies on rapid testing.
  • For more information on the OraQuick test, contact: OraSure, 220 E. First St., Bethlehem, PA 18015. Telephone: (610) 882-1820. Fax: (610) 882-1830. E-mail: customerservice@orasure.com. Web: www.orasure.com.
  • Plan to participate in the 10th year of National HIV Testing Day, scheduled this year for June 27. The annual campaign is organized by the Washington, DC-based National Association of People with AIDS (NAPWA-US) to encourage at-risk people to receive voluntary HIV counseling and testing. While the event falls on a Sunday this year, organizers encourage testing site participants to schedule events near June 27, if not on the date itself. To help plan and promote your testing event, visit the NAPWA-US web site, www. napwa.org, and click on "National HIV Testing Day." Download free posters, flyers, campaign kits, and handouts, all available in English and Spanish. For more information, contact the organization at nhtd@napwa.org.