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U.S. Department of Health and Human Services


TB Notes 1, 2005

No. 1, 2005

Updates from the Clinical and Health Systems Research Branch

A Rapid HIV Test for Use in the Field with Oral Fluid Specimens

Following the period of large TB outbreaks among persons infected with the human immunodeficiency virus (HIV) in the late 1980s and early 1990s, CDC recommended that all TB patients and suspects be offered voluntary HIV counseling and testing to improve patient management, to prevent further HIV transmission, and to better track disease trends in this highly susceptible population.1,2 Once highly active antiretroviral treatment (HAART) for HIV became available beginning in 1996, referral of HIV-infected persons to assess the need for and to facilitate initial contact with care and support service providers was added to HIV counseling and testing.3 Over time, the percentage of all TB patients having known HIV status has risen from 30% in 1993 to approximately 52% in 2002.4 Some TB programs know the HIV status of over 90% of patients, but others less than 25%. There is still room for improvement. In addition, knowledge of the HIV status of persons being assessed for latent TB infection (LTBI) can help in decision-making for TB screening and LTBI treatment and, through referrals, can link newly diagnosed HIV-infected persons to HIV care.

Many persons do not return for the results of standard HIV tests: during 2000, 30% of persons who tested HIV positive and 39% of persons who tested HIV negative did not return.6 Rapid diagnostic HIV tests provide results within 20 minutes of specimen collection. Although slightly more expensive to purchase than standard HIV enzyme immunoassays, rapid HIV diagnostic tests increase receipt by patients of their HIV test results and have been shown to be cost-effective.5 In a client satisfaction survey in New York state, 97% of 500 clients chose rapid HIV tests over other tests, with 24% stating that they would not have accepted HIV testing if the rapid test were not being offered.7

OraSure Technologies Inc. manufactures the only rapid HIV test approved by the Food and Drug Administration for use on oral fluid specimens, the OraQuick Advance HIV 1 / 2 Antibody Test. The test uses oral fluid, which is slightly different from saliva. A device to collect oral fluid is swabbed between the lips and gums and then inserted into a vial containing a developer solution. After 20 minutes, the presence of HIV antibodies is indicated by a display of two reddish-purple lines. This test can also be used on plasma or whole blood specimens. The two other FDA-approved rapid tests for nonclinical settings require whole blood specimens obtained through fingerstick or venous blood draw. These are the Uni-Gold Recombigen HIV test for HIV 1 produced by Trinity Biotech and the OraQuick Rapid HIV-1 Antibody test.8 The OraQuick Advance test can be performed in a wider range of operating temperatures (59°F to 99°F) than other rapid tests.9 In addition, the OraQuick Advance HIV 1 / 2 test can detect HIV 2, which is prevalent in persons from West Africa.

Reactive test results using rapid HIV testing technologies are considered preliminary positives and need to be confirmed by Western blot or immunofluorescent assay (IFA). If such confirmatory testing yields negative or indeterminate results, follow-up testing should be performed on a blood specimen collected four weeks after the initial reactive rapid HIV test result.10

For clients tested with a rapid HIV test, counseling should include the same types of information recommended for those tested with a standard EIA:

  • Information about the HIV test, its benefits and consequences.
  • Ways HIV is transmitted and how it can be prevented.
  • The meaning of the test results in explicit, understandable language.
  • Where to obtain further information and, if applicable, HIV prevention counseling.
  • Where to obtain other services including, if applicable, treatment.

In addition, clients tested with rapid HIV tests should be

  • Advised that their rapid test results will be available during the same visit.
  • Informed that confirmatory testing is needed if the rapid test result is reactive.11

Waivers of the Clinical Laboratory Improvements Amendments of 1988 (CLIA) have been granted for the OraQuick Advance HIV 1 / 2 (on June 25, 2004), the Uni-Gold Recombigen HIV test (November 5, 2004), and the OraQuick Rapid HIV-1 Antibody test (January 31, 2003).12 These waivers permit their use in nonclinical settings, rather than only in traditional laboratories. For instance, waived tests can be done in settings such as doctor’s offices, HIV counseling and testing sites, mobile vans, health fairs, or other nonclinical settings.  

Rapid tests have been particularly useful for testing pregnant women of unknown HIV status during labor and delivery to prevent mother-to-child HIV transmission. For TB programs, settings where the rapid HIV test may be particularly useful include sites for targeted TB testing of populations with high HIV prevalence such as at homeless shelters, substance abuse clinics, or correctional institutions, or even for contact investigations in home-based settings. For all waived rapid HIV testing, programs must obtain a certificate of waiver from the CLIA program, follow manufacturer’s instructions for the test procedure, and maintain an adequate quality assurance program. Quality assurance guidelines can be found online.

—Reported by Suzanne Marks, MPH
Div of TB Elimination


  1. CDC. Tuberculosis and human immunodeficiency virus infection: recommendations of the Advisory Committee for the Elimination of Tuberculosis (ACET). MMWR 1989; 38 (17): 236-238, 243-250.
  2. CDC. Essential components of a tuberculosis prevention and control program: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1995; 44 (RR-11): 13.
  3. CDC. Revised guidelines for HIV counseling, testing, and referral and revised recommendations for HIV screening of pregnant women. MMWR 2001; 50(RR-19): 36.
  4. CDC. Reported Tuberculosis in the United States, 2003. Atlanta, GA: US Department of Health and Human Services, CDC; September 2004. Table 13, page 23.
  5. CDC. Unpublished analysis by Dr. Paul Farnham and colleagues, 1996.
  6. CDC. HIV CT Client Record Report, 2000 U.S. Total. Unpublished data.
  7. Branson B, Burstein G. Retarding HIV Prevention: Initial results from OraQuick postmarketing surveillance. Presentation, August 2003.
  8. CDC, National Center for HIV, STD, and TB Prevention, Division of HIV/AIDS Prevention website.
  9. CDC, NCHSTP, DHAP. OraQuick Rapid HIV Test for Oral Fluid – Frequently Asked Questions.
  10. CDC. Notice to Readers. Protocols for confirmation of reactive rapid HIV test. MMWR 2004; 53 (10): 221-222.
  11. CDC, NCHSTP, DHAP website.
  12. FDA. Tests waived by FDA from January 2000 to present.


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination -

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