Finding a testing site

Find an HIV testing site near where you live or work.

• 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 HIV Test Kits

• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• FDA-Approved Rapid HIV Antibody Screening Tests

Rapid HIV Antibody Test Kits

• OraQuick Rapid HIV-1 Antibody Test Questions and Answers
• OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
• Multispot HIV-1/HIV-2 Rapid Test Bio-Rad Laboratories
• MedMira Reveal Rapid HIV-1 Antibody Test MedMira Laboratories, Inc
• Trinity Biotech Uni-Gold Recombigen HIV Uni-Gold Recombigen HIV Positive and Negative Controls Trinity Biotech plc
• Clinical Laboratory Improvement Amendments (CLIA)
  All laboratory testing (except research) performed on humans in the U.S. is regulated under CLIA

Home Test Kits

• First Rapid Home-Use HIV Kit Approved for Self-Testing
• At-Home Rapid HIV Testing: An Interview With FDA
• FDA approves first over-the-counter home-use rapid HIV test
• Testing for HIV
• Home Diagnostic Tests: The Ultimate House Call?
• HIV Home Test Kits
• Summary of Safety and Effectiveness, July 3, 2012 - OraQuick Rapid Home Use Test Kit (PDF - 424KB)

Unapproved Home Test Kits

• Businessman Sentenced to Over Five Years for Selling Bogus HIV-Testing Kits (February 17, 1999)
• InVitro Diagnostics Untitled Letter 6/29/2009

Clinical Tests

• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System
  Used to identify drug resistance in HIV patients
• Roche Amplicor HIV-1 Monitor Test
  Ultrasensitive Processing, an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma
• Amplicor HIV-1 Monitor Test Labeling (PDF - 3.5MB)
• NucliSens HIV-1 QT
  For use 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
• OraSure HIV-1 Western Blot Kit
  In-vitro qualitative assay for the detection of antibodies to HIV-1
• Cambridge Biotech HIV-1 Urine Western Blot
  Western Blot 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
• Final Rule on Donor Eligibility for Human Tissues and Cells (Eligibility Determination for Donors of human Cells, Tissues, and Cellular and Tissue-Based Products)
• 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
• 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."
• 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)
• 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
• Draft 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
• Draft Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro (PDF - 55KB)
• 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 (PDF - 50KB)

FDA Meetings centered around discussion related to HIV viral resistance testing

• Blood Products Advisory Committee
• Antiviral Drugs Advisory Committee

General Information about HIV Testing from the U.S. Centers for Disease Control and Prevention (CDC)

• CDC Fact Sheet - HIV and AIDS: Are You at Risk?