HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome

Updated February 2008

HIV Testing

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.

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)

Frequently Asked Questions (FAQs) about HIV Testing
CDC Fact Sheet - HIV and AIDS: Are You at Risk?
Where can I get tested? (National HIV Testing Resources)

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