Laboratory Tests

This section focuses on FDA-approved diagnostic HIV tests for use in moderate and high complexity laboratories.

Laboratory Testing Guidance

• Revised and updated 2017 APHL Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm
• Full Version of the Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations
• Technical Update on HIV-1/2 Differentiation Assays, August 2016
• Updated October 2017 Technical Update: Use of the Determine HIV 1/2 Ag/Ab Combo Test with Serum or Plasma in the Laboratory Algorithm for HIV Diagnosis

FDA Approved HIV Tests

• Updated September 2017 Advantages and Disadvantages of Different Types of HIV tests
• Updated December 2016 Laboratory Screening Tests
• Updated November 2016 Supplemental Tests for Laboratory Settings
• Updated November 2016 Moderate Complexity Rapid HIV Tests for Clinical Settings
• Updated May 2016 Alere Determine™ HIV-1/2 Ag/Ab Combo Information Sheet for Testing Programs
• Updated November 2016 CLIA-waived rapid HIV tests

Resources

• New Item 2017 Highlights from the 2016 HIV diagnostics conference: The new landscape of HIV testing in laboratories, public health programs and clinical practice
• New item 2017 New HIV Testing Technologies: Implications for your Laboratory
• Association of Public Health Laboratories (APHL) HIV Testing Resources (includes recent manufacturer news)
• Detection of Acute HIV Infection in Two Evaluations of a New HIV Diagnostic Testing Algorithm — United States, 2011–2013
• 2013 Journal of Clinical Virology Supplement: HIV Laboratory Diagnosis: New Tests and a New Algorithm.
  (Select year 2013 then Vol. 58 December, 2013 p.e1-e134-Supplement 1)
• HIV Diagnostic Conference