HIV Diagnostic Algorithm Laboratory Testing

Implementing

Clinical Laboratory Evaluation Program (CLEP)

• Diagnostic Immunology/HIV Laboratory Standards (PDF)
• Test Approval Policy
  • Comprehensive Test Approval Policy and Submission Guidelines
    • FDA-cleared/approved tests
    • Deletion of FDA-approved/cleared tests
    • Non-FDA-cleared/approved tests
    • Deletion of non-FDA-approved tests
      • For deletion of non-FDA-approved tests from your test menu, send an email to: CLEP@health.ny.gov
• Applications and Forms

Laboratory Reporting to the NYSDOH

• NYSDOH Guidance for HIV Public Health Reporting
• ECLRS (Electronic Clinical Laboratory Reporting System
  • Questions regarding ECLRS reporting of HIV-related results should be directed to the Bureau of HIV/AIDS Epidemiology at (518) 474-4284 or by email to bhaelab@health.ny.gov

Reporting to Providers

• Guidance for Reporting Results of the HIV Diagnostic Algorithm (PDF)
• APHL Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm (November 2013)
• Interpreting Clinical Laboratory Results from the HIV Diagnostic Algorithm

Billing/Reimbursement

• Reimbursement
  • Medicaid Fee Schedule
  • Procedure Codes
  • Laboratory Billing Guidelines

Wadsworth Center

• HIV-1 Qualitative RNA Testing Referral
• HIV-2 Qualitative RNA Testing Referral
• Diagnostic HIV Collection and Shipping

FDA-Approved Diagnostic Tests/Devices Not Included in the Recommended HIV Diagnostic Algorithm

• HIV Rapid Testing
  • Alere Determine™ HIV-1/2 Ag/Ab Combo
  • CLIA-Waived Tests
• HIV-1 Western Blot
  • NYSDOH Dear Colleague Letter - Indeterminate WB (October 31, 2014)

As it becomes available, additional information and guidance on the new HIV Diagnostic Testing algorithm will be posted on the NYSDOH website under “HIV Testing”. Questions may be directed to hivtesting@health.ny.gov