1. Addressing the Challenges Associated with Current HIV Diagnostic Algorithms Barbara G. Werner, PhD ID Consultant, MA State Laboratory 2007 HIV Diagnostics Conference December 5-7, 2007

2. HIV Testing Algorithms Standard from 1980s for laboratory testing –EIA screen, repeat reactive samples in duplicate, repeatedly reactive samples tested by WB or IFA –Already alternative algorithms in use in blood banks, in some US and international settings POC recommendations –All reactive specimens should be followed up with a WB, IFA, or an HIV RNA test to confirm the result

3. Challenges with Currently Recommended Diagnostic Algorithms More recently FDA approved tests not included Western blot and IFA now less sensitive than some screening assays Questions about how to deal with indeterminates Lack of FDA approved HIV-2 confirmatory tests Developed using assays as screening or confirmatory/supplemental tests not as part of multi-test algorithms Need for laboratory confirmation of POC rapid tests

4. Process for Developing New HIV Testing Algorithms APHL/CDC HIV Steering Committee –Priority to develop new algorithms with directives from APHL Board of Directors, CDC Algorithm Workgroups –Point of care (POC) and Laboratory Data gathering –retrospective and prospective efforts

5. APHL/CDC HIV Algorithm Workgroups’ Goal Develop multiple acceptable HIV testing algorithms, i.e., a menu of options, including recommendations for use, reporting, follow up, and referral

6. Lab and POC Workgroup Members Berry Bennett * Robert Bormisa Bernard Branson * Michael Busch Evan Cadoff Sheldon Campbell Elliot Cowan * David Cross Kevin Delaney Teri Dowling Steven Ethridge Shelley Facente Richard Hodinka Marcia Kalish Jan King Sally Liska * Brian Louie Steve McDougal Duncan Mackellar Eugene Martin

7. Lab and POC Workgroup Members Joanne Mei William Meyer Robert Myers * Robert O’Connell Michele Owen * Mark Pandori Sindy Paul Pragna Patel Sheila Peel *Steering Committee Member Michael Pentella * Liisa Randall Mark Rayfield * Natalie Rice * Travis Sanchez * Susan Stramer Anthony Tran * Barbara Werner *

8. Organizations, Agencies and Groups Represented on Workgroups APHL ACLA ASM Blood Banks CAP CDC Clinical Labs DoD FDA HIV Program Staff

9. Issues to keep in mind with wider use of HIV tests QA in non-laboratory settings Reporting to PH authorities Varying state regulations Appropriate follow up testing and referrals False positives in low risk individuals –PPV can be low in asymptomatic persons Maintenance of laboratory infrastructure Financial support

10. Current Charge Listen to presentations and look at posters Consider –Which proposed algorithms are supported by existing data –What additional information is needed –Where appropriate to use each algorithm –Who else ought to have a say in when and where particular algorithms should be used –Implementation and performance monitoring

11. With thanks to … Steve Ethridge, Amanda Smith, and Laura Wesolowski, CDC Anthony Tran and Natalie Rice, APHL APHL/CDC Steering Committee and Workgroup Colleagues