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HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
HIV Testing
Home Test Kits
Home Diagnostic Tests: The Ultimate
House Call?, by Carol Lewis, FDA Consumer magazine November-December
2001. Home diagnostic tests offer convenience and privacy. However,
health-care professionals warn that the tests have limitations and are not
a replacement for regular visits to your health-care provider.
Testing Yourself for HIV-1,
the Virus that Causes AIDS: Home Test Systems Are Available (revised May 6,
1999)
Home Specimen Collection Kit Systems Intended for
Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing: Revisions
to Previous Guidance, Federal Register Notice, February 23, 1995. This is
the revised FDA guidance for approval of home specimen collection kit systems
intended for the detection of antibodies to HIV-1.
FDA Approves First Home Test
for Hepatitis C Virus, manufactured by Home Access Health Care,
April 29, 1999. The test kit does not require a prescription.
The user collects a sample of blood at home and mails it to a designated laboratory
for analysis. The results are available anonymously by phone through
a unique identification number.
EZ MedTest (HIV rapid home-use test kit): In a joint investigation
conducted by FDA and the Federal Trade Commission, an unapproved HIV rapid
home-use test kit promoted on the Internet and sold domestically was tested
by FDA and, in some cases, gave false negative results. FDA is notifying consumers
who purchased the "EZ MedTest" marketed by Cyberlinx Marketing,
Inc. on the Internet that the test results given by the test are unreliable.
Kit purchasers are advised to consult with a health professional regarding
other available FDA approved tests that detect antibodies to HIV. The "EZ
MedTest" website has been removed from the Internet by Cyberlinx Marketing,
Inc. and the firm has voluntarily turned over all remaining test kits to FDA's
Office of Criminal Investigations. [July 9, 1999 (FDA
Letter)]
On 11/19/01, FDA approved NucliSens HIV-1
QT, Applicant: bioMerieux, Inc., Durham, NC, PMA number: BP010001/0. The
Indication for Use is: in conjunction with clinical presentation and other
laboratory markers of disease progression for prognostic assessment of HIV-1
infected patients, and for monitoring the effects of anti-retroviral therapy
by serial measurements of plasma HIV-1 RNA for pediatric and adult patients
with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral
RNA/mL respectively.
On March 2, 1999, FDA approved a supplement to AMPLICOR HIV-1 MONITOR Test
(Roche Molecular Systems, Inc.). This supplemental
approval extends the lower limit of quantitation from 400 HIV RNA copies/mL
down to 50 copies/mL; the upper limit of quantitation, 750,000 HIV RNA copies/mL
remains the same. It is intended for use in conjunction with clinical presentation
and other laboratory markers of disease progress for the clinical management
of HIV-1 infected patients. On the same date, another
supplement was approved for patient monitoring and it can be used as an
aid in management of patients on anti-viral therapy for HIV disease. The original
application, approved June 3, 1996, was for disease prognosis in conjunction
with clinical presentation and other laboratory markers.
(Labeling, 53 pages in PDF)
Draft Guidance for Industry: Use
of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately
and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV , Issue
Date: 12/4/2001.
On March 2, 1999, FDA approved a supplement to AMPLICOR HIV-1 MONITOR Test
(Roche Molecular Systems, Inc.). This supplemental
approval extends the lower limit of quantitation from 400 HIV RNA copies/mL
down to 50 copies/mL; the upper limit of quantitation, 750,000 HIV RNA copies/mL
remains the same. It is intended for use in conjunction with clinical presentation
and other laboratory markers of disease progress for the clinical management
of HIV-1 infected patients. On the same date, another
supplement was approved for patient monitoring and it can
be used as an aid in management of patients on anti-viral therapy for HIV
disease. The original application, approved June 3, 1996, was for disease
prognosis in conjunction with clinical presentation and other laboratory markers.
(Labeling, 53 pages in PDF)
Draft Guidance for Industry: In the Manufacture and Clinical Evaluation
of In Vitro
Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type
1 - 7/10/98
Draft Points to Consider in the Manufacture and Clinical Evaluation of In
Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type
1 - 8/8/89 [Information about HIV Tests]
FDA Meetings centered around discussion related to HIV viral resistance testing:
Blood Products Advisory Committee
(BPAC) meeting on September 17, 1999 to discuss regulatory classification
of drug sensitivity tests.
FDA Discussion with the Community
about the role of HIV resistance testing in new drug development. This meeting
will follow the BPAC meeting on the afternoon of September 17, 1999.
Input from this meeting are expected to contribute to the agenda for the Antiviral
Drugs Advisory Committee in November.
Antiviral Drugs Advisory Committee
meeting on November 2 and 3, 1999 to discuss the role of HIV resistance testing
in new drug development for HIV/AIDS.
