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HIV Diagnostics and A New Testing Algorithm

HIV Diagnostics and A New Testing Algorithm. Lorna Seybolt, M.D., M.P.H. Louisiana State University Health Sciences Center Children’s Hospital New Orleans June 23, 2012. Objectives. Describe the evolution of HIV testing from the beginning of the epidemic to the currently available tests

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HIV Diagnostics and A New Testing Algorithm

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  1. HIV DiagnosticsandA New Testing Algorithm Lorna Seybolt, M.D., M.P.H. Louisiana State University Health Sciences Center Children’s Hospital New Orleans June 23, 2012

  2. Objectives • Describe the evolution of HIV testing from the beginning of the epidemic to the currently available tests • Delineate the proposed new testing algorithm • Review recent studies supporting the use of the new algorithm

  3. Considerations • ~half of US adults have been tested • Not much change since 2004 • ~20% of 1 million infected don’t know • ~1/3 have AIDS diagnosis within 1 year of testing positive • 40,000 new infections/yr • 25% unaware  54% new infections • 75% aware  46% new infections

  4. www.kff.org

  5. FDA Timeline • 1985 • ELISA test kit for antibodies • 1987 • Western Blot • 1989 • Virus antigens (HIV-1)

  6. FDA Timeline • 1990 • Recombigen HIV-1 EIA antibody detection • For high volume sites • Novopath HIV-1 immunoblot test for detection of antibody to individual proteins • 1991 • Combo test to detect HIV 1 and 2 antibodies

  7. FDA Timeline • 1992 • SUDS HIV-1 • 10 minute diagnostic test kit • 1994 • Non blood-based collection kit • Utilizes oral fluid for detection of HIV-1 antibody

  8. FDA Timeline1996 • March • Coulter HIV-1 (p24 antigen) • May • Confide HIV Testing System • Can be used at home, purchased OTC • 3 components • OTC home blood collection kit • HIV antibody testing at certified lab • Results, counseling, referral

  9. FDA Timeline1996 • June • AMPLICOR HIV-1 Monitor Test • NAAT for quantitation HIV-1 RNA in plasma • June • HIV-1 WB confirmatory test for oral collection system • August • Urine-based test (ELISA)

  10. FDA Timeline • 1998 • WB for urine specimen testing • 1999 • Supplement to AMPLICOR HIV-1 Monitor • Extend LLQ from 400 50 copies/ml

  11. FDA Timeline2001 • September • First NAT systems to screen plasma donors for HIV and HCV • September • TrueGene HIV-1 Genotyping Kit • Open Gene DNA Sequencing System • Identification of drug resistance • November • NucliSens HIV-1 QT • For prognostic assessment and monitoring

  12. FDA Timeline2002 • September • VERSANT HIV-1 RNA 3.0 Assay • bDNA (quantitation) • November • OraQuick Rapid HIV-1 Antibody Test • First rapid diagnostic test kit • Results in 20 min, drop of blood • No specialized equipment • In 2003 test CLIA waived

  13. ORA-What?

  14. ORA-What? • OraQuick Rapid HIV 1/2 Antibody • Oral fluid, plasma, whole blood (fingerstick, venipuncture) • CLIA waived for all but plasma • OraSure HIV-1 Oral Specimen Collection Device • Collects oral fluid for lab-based EIA screening tests • OraSure HIV-1 WB Kit • Confirmatory assay for specimens collected with oral collection device

  15. FDA Timeline2004 • March • OraSure Rapid Test approved for detection of HIV-2 • March • Oral fluid samples, results in 20 min • OraQuick Rapid HIV-1 Antibody Test (plasma for HIV-1/2) • June • CLIA waiver OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (oral fluid) • December • Multispot HIV-1/HIV-2 Rapid Test • Discriminatory test

  16. FDA Timeline • 2005 • Meeting to discuss home-use rapid HIV test kits • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, oral fluid • 2006 • APTIMA HIV-1 RNA Qualitative Assay • To detect primary HIV infection • Can also be used for confirmation • ADVIA Centaur • 3rd generation format

  17. FDA TimelineMay 2007 • Abbott Real Time HIV-1 Assay • RT-PCR for quantitation • 40-10 million copies/ml • AmpliPrep/COBAS TaqMan HIV-1Test • Automated PCR for quantitation • Procleix Ultrio Assay • Qualitative NAT to screen blood

  18. FDA Timeline2008 • March • VITROS Anti-HIV-1/2 (3rd gen) • Donor screening • December • COBAS TaqScreen MPX Test • First to detect HIV-2 and HIV-1 group O • Donated plasma

  19. FDA Timeline • 2009 • Avioq HIV-1 Microelisa • Oral fluid, DBS • 2010 • Rapid INSTI HIV-1 60 sec antibody test • Abbott Architect 4th gen Ag/Ab Combo • 2011 • Bio-Rad GS HIV Ag/Ab Combo

  20. Where Do Your Specimens Go?

  21. What Happens When They Get There? ???

  22. Generations?

  23. Generations? • 1927-1945 - Silent Generation or Traditionalists • 1946-1964 - Baby Boomers • 1965-1983 - Gen X or the Busters • 1984- 2002 - Gen Y or the Millennials • 2003- Current Gen Z or the Digital Generation

  24. Arch Intern Med. 2010;170(1):66-74

  25. Who Is This Girl?AndWhy Is She Famous?

  26. Available Tests • Conventional blood test • 1st, 2nd, 3rd, 4th generation EIA • Conventional oral fluid test • OraSure (collection device) • Avioq (used with specimens collected with OraSure device)

  27. Available Tests • Rapid tests • OraQuick Advance Rapid HIV-1/2 Antibody Test • Reveal Rapid HIV-1 Antibody Test • Uni-Gold Recombigen HIV Test • Multispot HIV-1/HIV-2 Rapid Test • Clearview HIV 1/2 Stat Pak • Clearview Complete HIV 1/2

  28. Available Tests • Home tests • HomeAccess HIV-1 Test System

  29. Available Tests • Urine test • Calypte ???

  30. Available Tests • Urine test • Maxim HIV-1 Urine EIA • Cambridge Biotech Urine HIV-1 WB

  31. Laboratory Based Tests

  32. Bio-Rad GS HIV Combo Ag/Ab EIA20114th generation

  33. Abbott Architect Ag/Ab Combo Assay20104th Generation

  34. Avioq HIV-1 Microelisa20091st GenerationOral fluid, DBS, Serum, Plasma

  35. VITROS HIV 1/220083rd Generation

  36. ADVIA Centaur HIV 1/O/220063rd Generation

  37. Rapid Test Kits

  38. CDC

  39. OraQuick Advance2002

  40. Reveal G3

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