With an estimated one out of four HIV-positive Americans unaware of their infection, increased opportunities for testing are critical. Rapid HIV antibody tests provide new opportunities to improving access to testing in both clinical and non-clinical settings and increasing the number of people who learn their results.

These pages include descriptions of the rapid HIV tests approved by the FDA, how the tests can be implemented in different settings, and research on the effectiveness and possible uses of the tests.

• Overview of Rapid HIV Testing
• Rapid Test Comparison Charts
• Official CDC and FDA Releases
• Laboratory Considerations and Package Inserts
• HIV Counseling with Rapid Tests
• CLIA Waiver
• Rapid HIV Testing of Women in Labor and Delivery
• Studies on Rapid Tests
• Issues with Oral Fluid Rapid Tests
• Rapid Testing Training
• 340B Program Prime Vendors
• Rapid Testing Archive

Overview of Rapid HIV Testing

• A Rapid Review of Rapid HIV Antibody Tests
  Current Infectious Disease Reports 2006;8:125-131
  Reprinted with permission.
• Rapid HIV Testing: 2005 Update
  • View slides in PPT (revised January 20, 2005) (3.50 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. 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.

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Rapid Test Comparison Charts

• FDA-Approved Rapid HIV Antibody Screening Tests – Purchasing Details
• FDA-Approved Rapid HIV Antibody Screening Tests

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Official CDC and FDA Releases

• MMWR: False-Positive Oral Fluid Rapid HIV Tests—New York City, 2005–2008
• MMWR: Rapid HIV Testing in Outreach and Other Community Settings—United States, 2004–2006
• MMWR: Rapid HIV Testing in Emergency Departments—Three U.S. Sites, January 2005–March 2006
• MMWR: Rapid HIV Testing Among Racial/Ethnic Minority Men at Gay Pride Events—Nine U.S. Cities, 2004–2006
• MMWR: Notice to Readers: Protocols for Confirmation of Reactive Rapid HIV Tests
• MMWR: Rapid HIV Test Distribution --- United States, 2003--2005.

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Laboratory Considerations and Package Inserts
(Updated February 2007)

• General and Laboratory Considerations: Rapid HIV Tests Currently Available in the United States
  Requirements for performing the tests, testing procedures, and interpretation of results.
• State of New York Department of Health: Quality Control Requirements for Rapid HIV Testing
• Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988
  • Appendixes: Government Regulations and Sample Forms

• Package Inserts:
  • OraQuick Advance Rapid HIV-1/2 Antibody Test
  • Reveal G3 Rapid HIV-1 Antibody Test
  • Uni-Gold Recombigen HIV Test
  • Multispot HIV-1/HIV-2 RapidTest
  • Clearview HIV 1/2 Stat Pak
  • Clearview Complete HIV 1/2

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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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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
  (Updated March 2007)

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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

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Studies on Rapid Tests

• Post-Marketing Surveillance of OraQuick Whole Blood and Oral Fluid Rapid HIV Testing
  AIDS 2006, 20:1661–1666
  Reprinted with permission.
• Performance of an Oral Fluid Rapid HIV-1/2 Test: Experience from Four CDC Studies
  AIDS 2006, 20:1655–1660
  Reprinted with permission.

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Issues with Oral Fluid Rapid Tests

• Overview of False-Positive Oral Fluid Rapid HIV Tests
• Questions and Answers: False-Positive Oral Fluid Rapid HIV Tests

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Rapid Testing Training

• Strategic Planning Workshops for Implementation of HIV Screening in Acute Care Settings
  CDC promotes routine opt-out HIV testing in all health care settings (including emergency departments) for adults and adolescents aged 13-64 years and rapid HIV testing at the time of labor for women of unknown HIV status. In order to assist health care settings with implementing these new standards of care, CDC has convened two series of regional workshops aimed at implementing rapid HIV testing in two critical settings: labor and delivery units and emergency departments. These workshops will enhance the capacity of hospitals and healthcare providers to increase identification of HIV-infected persons early in their disease progression and to further decrease perinatal HIV transmission in the U.S.
• Satellite Broadcast: Revised Recommendations for HIV Screening of Adults, Adolescents and Pregnant Women in Health Care Settings, November 17, 2005

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340B Program Prime Vendors

• Press Release: Trinity Biotech Signs Agreement with 340B Prime Vendor Program for the Uni-Gold™ Rapid HIV Test

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