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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.
• Home Access HIV-1 Test System
  • Approval Letter [PDF file]
  • Summary of Approval [PDF file]
  • Product Labeling [PDF file]

Unapproved Home Test Kits

• 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 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, 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: 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.

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