TB Notes 1, 2005
No. 1, 2005
Updates from the Clinical and Health Systems Research
A Rapid HIV Test for Use in the Field with Oral
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
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
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
- Where to obtain further information and, if applicable, HIV
- 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
- 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.
- 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.
- CDC. Revised guidelines for HIV counseling, testing, and referral
and revised recommendations for HIV screening of pregnant women.
MMWR 2001; 50(RR-19): 36.
- CDC. Reported Tuberculosis in the United States, 2003.
Atlanta, GA: US Department of Health and Human Services, CDC;
September 2004. Table 13, page 23.
- CDC. Unpublished analysis by Dr. Paul Farnham and colleagues,
- CDC. HIV CT Client Record Report, 2000 U.S. Total. Unpublished
- Branson B, Burstein G. Retarding HIV Prevention: Initial results
from OraQuick postmarketing surveillance. Presentation, August
National Center for HIV, STD, and TB Prevention, Division of HIV/AIDS
- CDC, NCHSTP, DHAP. OraQuick
Rapid HIV Test for Oral Fluid – Frequently Asked Questions.
- CDC. Notice
to Readers. Protocols for confirmation of reactive rapid HIV test.
MMWR 2004; 53 (10): 221-222.
NCHSTP, DHAP website.
- FDA. Tests
waived by FDA from January 2000 to present.