• Overview of rapid HIV testing
• Official CDC and FDA releases
• HIV counseling with rapid tests
• Rapid HIV testing of women in labor and delivery
• Rapid testing training
• Laboratory considerations and package inserts (Revisions to OraQuick Test September 30, 2003)
• CLIA Waiver
• Studies on rapid tests

Overview of Rapid HIV Testing

• Advancing HIV Prevention Quick Facts: Rapid Testing April 2003 - April 2004
  • View PDF
• OraQuick Rapid HIV Test for Oral Fluid -- Frequently Asked Questions (revised November 1, 2004)
• View PDF (38 KB, 2 pages)
• Rapid HIV Testing: 2003 Update (View slides in PDF – 2.5 MB, 61 slides)
  • View slides in PPT (3.3 MB)
  An overview of what rapid tests can mean for testing and prevention programs, descriptions of current tests, and the results of rapid testing projects.
• Point-of-Care Rapid Tests for HIV Antibodies
  Journal of Laboratory Medicine 2003;27(7/8):288-295.
  Reprinted with permission.
  • View PDF (89 KB, 8 pages)
  This review summarizes available data on the characteristics and performance of individual HIV rapid tests and describes experiences with point-of-care use of rapid HIV tests.
  
  
• Frequently Asked Questions about the OraQuick Rapid HIV-1 Antibody Test
  (revised November 17, 2003)
  • View PDF (35 KB, 4 pages)
  How does it work? How accurate is it? What will it be used for? Where can it be done? What needs to be done before a site is permitted to purchase and use the test?

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Official CDC and FDA Releases

• FDA Approves First Oral Fluid Based Rapid HIV Test Kit (PDF only - 16 KB, 2 pages)
• MMWR: Notice to Readers: Protocols for Confirmation of Reactive Rapid HIV Tests
• FDA News Release: Approval of Uni-Gold Recombigen HIV Rapid HIV Test
• MMWR: Notice to Readers: Approval of a New Rapid Test for HIV Antibody
• Quality Assurance Guidelines for Testing Using the OraQuick® Rapid HIV-1 Antibody Test
  • View PDF - 355 KB, 20 pages
  • Appendixes: Government Regulations and Sample Forms (PDF only - 407 KB, 9 pages)

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HIV Counseling with Rapid Tests

• HIV Counseling with Rapid Tests
  How do you provide counseling when using the rapid HIV tests? What should you tell clients?
• Model Counseling Protocols for Standard and Rapid Test Sessions

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Rapid HIV Testing of Women in Labor and Delivery

• Rapid HIV Testing of Women in Labor and Delivery
  Treatment, even at the time of labor and delivery, can substantially reduce the transmission of HIV from mother to child. Rapid tests can help implement this prevention strategy.
• Rapid HIV-1 Antibody Testing during Labor and Delivery for Women of Unknown HIV Status: A Practical Guide and Model Protocol
  • View PDF - 270 KB, 44 pages

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Rapid Testing Training

• Satellite Broadcast: Rapid Testing: Advances for HIV Prevention November 18, 2004, 1:00 - 3:00 PM Eastern Time
• Flyer - Fundamentals of HIV Testing and Prevention Counseling with the OraQuick Rapid HIV-1 Antibody Test (PDF only - 96 KB, 1 page)
• Registration Form for 2004 Rapid HIV Test Training (PDF only - 57 KB, 1 page)
• Resources Available for Rapid HIV Testing Training
  • View PDF - 359 KB, 16 pages
  HIV rapid testing activities among CDC grantees, including health departments, Community Based Organizations (CBOs), Capacity Building Assistance (CBA) providers, HIV/STD Prevention Training Centers (PTCs) and AIDS Education and Training Centers (AETCs).

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Laboratory Considerations and Package Inserts

• Important Updates for OraQuick Procedures
• General and Laboratory Considerations: Rapid HIV Tests Currently Available in the United States (revised November 1, 2004)
  Requirements for performing the tests, testing procedures, and interpretation of results.
  
  
• Quality Assurance Guidelines for Testing Using the OraQuick® Rapid HIV-1 Antibody Test
  • View PDF - 355 KB, 20 pages
  • Appendixes: Government Regulations and Sample Forms
    (PDF only - 407 KB, 9 pages)
• OraQuick Rapid HIV-1 Antibody Test (Complexity: Waived)
  • Revised Package Insert (September 30, 2003)(PDF only – 274 KB, 16 pages)
  • Step-by-Step Instructions (PDF only 329 KB, 6 pages)
• Package Insert for the Reveal Rapid HIV-1 Antibody Test (PDF only - 2 MB, 13 pages)
• Package Insert for Uni-Gold Recombigen HIV

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CLIA Waiver

• Regulatory Oversight of Laboratory Testing (CLIA)
  The Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). These documents summarize the program and explain how to apply for CLIA certificates.
  
  
• CLIA Certificate of Waiver Fact Sheet

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Studies on Rapid Tests

• CDC Studies of Rapid HIV Testing
  Abstracts, posters, and slide presentations of various CDC studies of rapid HIV testing.

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