-
For Consumers
-
HIV Testing
-
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.
-
-
Home Test Kits
-
-
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
-
-
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
- FDA Licensed or Approved HIV, HTLV and Hepatitis Tests
updated with each new approval - 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 - 3536KB)
- 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- Also see: Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance.
- Draft Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products) related to donor screening and eligibility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
- 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
-
-
General Information about HIV Testing from the U.S. Centers for Disease Control and Prevention (CDC)
-
-
-