HIV
and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
Updated August 2008
HIV Testing
Finding a testing site
National
HIV Testing Database
Find an HIV test site near you from the National HIV Testing Database, a CDC-sponsored
service available 24 hours a day.
Approved Test Kits
- Licensed / Approved HIV, HTLV and
Hepatitis Tests The FDA Center for Biologics Evaluation and Research
(CBER) regulates the medical devices involved in the collection, processing,
testing, manufacture and administration of licensed blood, blood components
and cellular products. CBER also regulates all HIV test kits used both
to screen donor blood, blood components and cellular products, and to diagnose,
treat and monitor persons with HIV and AIDs.
- FDA-Approved
Rapid HIV Antibody Screening Tests (Centers for Disease Control and
Prevention)
Home Test Kits
- Vital Facts About HIV
Home Test Kits FDA Consumer Update explaining HIV home testing. 1/29/2008
- Home-Use Tests - HIV, Questions
and answers providng an overview of the HIV home-use collection kit. 2/1/2003
- 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.
- Home Access HIV-1 Test System manufactured
by Home Access Health Corp., Hoffman Estates, IL is a home-use blood spot
collection kit for self-use by adult population, eighteen years or older,
who have no training or experience in drawing blood specimens. The system
is intended to provide education about HIV infection and risk reduction and
to offer counseling medical/psychosocial referrals, and assistance in partner
notification. - 7/22/96
Rapid HIV Antibody Test Kits
- Frequently Asked Questions About the
OraQuick Rapid HIV-1 Antibody Test
- Multispot HIV-1/HIV-2 Rapid Test, manufactured
by Bio-Rad Laboratories, Redmond, WA, for the detection and differentiation
of circulating antibodies associated with HIV-1 and HIV-2 in human plasma
and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2
- November 12, 2004
- OraQuick ADVANCE Rapid HIV-1/2 Antibody
Test, manufactured by OraSure Technologies, Bethlehem, PA, for detection
of HIV-2 antibodies in oral fluid - June 22, 2004. CLIA waiver for use
of OraQuick ADVANCE Rapid HIV-1/2 Antibody Test granted June
25, 2004. Original Oraquick Rapid HIV-1 Antibody test approved November
7, 2002. CLIA (Clinical Laboratory Improvement
Amendments) waiver for use of HIV-1 test granted February
3, 2003. (Link to complete CLIA
regulations)
- MedMira Reveal Rapid HIV-1 Antibody Test,
manufactured by MedMira Laboratories, Inc, Canada, for detection of antibodies
to HIV-1 in human serum or plasma specimens -April 16, 2003
- Trinity Biotech Uni-Gold Recombigen HIV,
Uni-Gold Recombigen HIV Positive and Negative Controls, manufactured
by Trinity Biotech plc, Wicklow, Ireland, for detection of antibodies to
HIV-1 in human serum, plasma or whole blood (venipuncture) - December 23,
2003
Unapproved Home Test Kits
- FDA issued a talk paper in
February, 2005 warning consumers not to use unapproved home-use diagnostic
test kits that have been marketed nationwide via the Internet by Globus Media,
Montreal, Canada. No home-use test kits intended for diagnosing HIV are approved
for sale in the U.S. The tests were sold through web sites and distributed
throughout the U.S., usually by overnight delivery services. FDA has not
approved or evaluated the performance of any of Globus Media's products.
As a result, consumers cannot know with any degree of certainty that test
results are correct.
- FDA Warning Letters for Unapproved HIV/AIDS Test
Kits, January 19, 2000
- 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)]
- Internet Sales of Bogus HIV Test
Kits Result in First-of-Kind Wire Fraud Conviction, Paula Kurtzweil, FDA
Consumer, July-August 1999
- Businessman Sentenced to Over Five Years for Selling
Bogus HIV-Testing Kits (February 17, 1999)
- FDA Warns Consumers About Two
Unapproved HIV Home-Use Test Kits, FDA is advising consumers and pharmacists
about two unapproved, fraudulently marketed home-use test kits distributed
by Lei-Home Access Care. (September 6, 1997)
Clinical Tests
- FDA Licensed or Approved HIV, HTLV
and Hepatitis Tests, updated with each new approval
- FDA approved Visible Genetics, Inc., TrueGene
HIV-1 Genotyping Kit and Open Gene DNA Sequencing System to be used
to identify drug resistance in HIV patients on September 26, 2001.
- FDA Approves First Nucleic
Acid Test (NAT) systems to Screen Plasma for Human Immunodeficiency Virus
(HIV) and Hepatitis C Virus (HCV), September 21, 2001. The FDA has
licensed the first nucleic acid test (NAT) systems intended for screening
of plasma donors. These test systems are expected to further ensure the
safety of plasma-derived products by permitting earlier detection of HIV
and HCV infections in donors.
- 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)
- 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)
- OraSure HIV-1 Western Blot Kit
- Cambridge Biotech HIV-1 Western
Blot, new indication for urine specimen testing
Industry Information
- Guidance for Industry: Use of Nucleic
Acid Tests on Pooled and Individual Samples from Donors of Whole Blood
and Blood Components (including Source Plasma and Source Leukocytes) to
Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and
HCV [10/21/2004] on the use of nucleic acid tests (NAT) to screen blood
donors for HIV-1 ribonucleic acid (RNA), and HCV RNA. These licensed tests
can detect evidence of infection at a significantly earlier stage than
is possible under previously approved tests using antibody or antigen detection
technology; including the HIV-1 p24 antigen test.
- Final Rule on Donor
Eligibility for Human Tissues and Cells (Eligibility Determination for
Donors of human Cells, Tissues, and Cellular and Tissue-Based Products) [May
20, 2004], requiring human cell, tissue, and cellular and tissue-based
product (HCT/P) establishments to screen and test cell and tissue donors
for risk factors for, and clinical evidence of, relevant communicable disease
agents and diseases, including HIV. The rule expands the types of human-derived
products that come under FDA regulation in an effort to prevent the transmission
of diseases through transplantation. The final rule becomes effective on
May 25, 2005. Also see: Questions
and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance.
- Draft Guidance for Industry Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products) related to donor screening and eligibility, [May 20, 2004]
provides recommendations for complying with the requirements in the donor
eligibility rule (above). Also see: Questions
and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance.
- Final Guidance final guidance on the "Use
of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole
Blood and Blood Components (including Source Plasma and Source Leukocytes)
to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1
and HCV." The guidance informs blood collecting and processing
establishments that: FDA has licensed nucleic acid tests (NAT) as tests
to screen blood donors for HIV-1 ribonucleic acid (RNA), and HCV RNA; and
that these licensed tests can detect evidence of infection at a significantly
earlier stage than is possible under previously approved tests using antibody
or antigen detection technology; including the HIV-1 p24 antigen test.
This guidance combines and finalizes the draft guidance "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"
dated December 2001 (January 31, 2002, 67 FR 4719) and the draft guidance
"Use of Nucleic Acid Tests
on Pooled and Individual Samples from Donors of Whole Blood and Blood Components
for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission
of HIV-1 and HCV."
- Guidance for Industry, In the Manufacture
and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid
Sequences of Human Immunodeficiency viruses Types 1 and 2, Center for
Biologics Evaluation and Research, December 1999. In recent years,
several technical advances have been made in methodologies for direct detection
of viral nucleic acid. This document provides guidance on manufacturing
and clinical trial design issues pertaining to the validation of tests
based on nucleic acid detection either in the presence or absence of an
amplification step.
- Draft Guidance for Industry: In the Manufacture
and Clinical Evaluation of In Vitro
Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Types
1 & 2 - December, 1999 (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 - July,
1998
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.
- 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.
General Information about HIV Testing from the U.S. Centers for Disease Control
and Prevention (CDC)
HIV/AIDS
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