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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

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

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5 www.kff.org

6 FDA Timeline  1985  ELISA test kit for antibodies  1987  Western Blot  1989  Virus antigens (HIV-1)

7 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

8 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

9 FDA Timeline 1996  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

10 FDA Timeline 1996  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)

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

12 FDA Timeline 2001  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

13 FDA Timeline 2002  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

14 ORA-What?

15  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

16 FDA Timeline 2004  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

17 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  3 rd generation format

18 FDA Timeline May 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

19 FDA Timeline 2008  March  VITROS Anti-HIV-1/2 (3 rd gen)  Donor screening  December  COBAS TaqScreen MPX Test  First to detect HIV-2 and HIV-1 group O  Donated plasma

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

21 Where Do Your Specimens Go?

22 What Happens When They Get There? ???

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24 Generations?

25 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

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

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33 Who Is This Girl? And Why Is She Famous?

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

36 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

37 Available Tests  Home tests  HomeAccess HIV-1 Test System

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39 Available Tests  Urine test  Calypte ???

40 Available Tests  Urine test  Maxim HIV-1 Urine EIA  Cambridge Biotech Urine HIV-1 WB

41 Laboratory Based Tests

42 Bio-Rad GS HIV Combo Ag/Ab EIA 2011 4 th generation

43 Abbott Architect Ag/Ab Combo Assay 2010 4 th Generation

44 Avioq HIV-1 Microelisa 2009 1 st Generation Oral fluid, DBS, Serum, Plasma

45 VITROS HIV 1/2 2008 3 rd Generation

46 ADVIA Centaur HIV 1/O/2 2006 3 rd Generation

47 Rapid Test Kits

48 CDC

49 OraQuick Advance 2002

50 Reveal G3

51 Uni-Gold

52 Multispot HIV-1/HIV-2 Rapid Test

53 Clearview Stat Pak Clearview Complete

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55 Current Testing Algorithm

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59 Limitations of Current Algorithm Newer screening tests are more sensitive than WB for detecting early infection New 4 th generation Ag/Ab tests detect infection during early, antibody negative, highly infectious stage Misdiagnosis of HIV-2 infections as HIV- 1 (60%)

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

61 J Acquir Immune Defic Syndr 2010;55:S102–S105

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63 False Positive OR False Negative ???

64 Paradigm Shift ???

65 Proposed New Diagnostic Algorithm

66 J Acquir Immune Defic Syndr 2010;55:S102–S105

67 Evidence for New Algorithm

68 Performance of an alternative laboratory-based algorithm for HIV diagnosis in a high-risk population  High risk persons  Comparison of multi IA’s and rapid tests with NAAT vs WB  Correct classification of all with few needing NAAT Journal of Clinical Virology 52S (2011) S5– S10

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70 Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections  Acute and established infections  3 rd and 4 th gen IA’s, rapid tests, NAAT, and WB  Improved sensitivity for detecting acute infection while maintaining ability to detect established infection Journal of Clinical Virology 52S (2011) S17– S22

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73 Evaluation of an alternative supplemental testing strategy for HIV diagnosis by retrospective analysis of clinical HIV testing data  Retrospective analysis of test results to compare algorithms  38,257 specimens  Proposed algorithm outperformed current  More sensitive for detecting HIV-1 infection, greater number definitive results, detected HIV-2 more efficiently Journal of Clinical Virology 52S (2011) S35– S40

74 Comparison of Multispot EIA with Western blot for confirmatory serodiagnosis of HIV  Comparison of 3 rd gen IA followed by Multispot vs WB  8,760 specimens  Detected additional 14 HIV-1 infections, differentiated 26 HIV-1 WB positives as HIV-2, detected additional 12 HIV-2 infections Journal of Clinical Virology 52S (2011) S41– S44

75 Performance of an alternative laboratory-based algorithm for diagnosis of HIV infection utilizing a third generation immunoassay, a rapid HIV-1/HIV-2 differentiation test and a DNA or RNA-based nucleic acid amplification test in persons with established HIV-1 infection and blood donors  Evaluation of 3 rd gen IA and Multispot followed by NAAT for IA positive/MS negative  HIV infected, not on therapy  HIV uninfected blood donors  Algorithm had high sensitivity and specificity in specimens from HIV infected and uninfected (blood donors) Journal of Clinical Virology 52S (2011) S45– S49

76 Proposed Algorithm  With current HIV-1/2 differentiation tests turnaround time is less than that with WB  Resolve most positive specimens with only 2 tests  RNA test only for those antibody negative specimens likely to represent acute infection

77 Proposed Algorithm  Decrease cost  Decrease turn around time  Increase detection of acute infections  Increase sensitivity for detecting acute infections while maintaining ability to detect established infections  Reduce or eliminate misclassification of HIV-2 infections

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79 What’s Next?  Revision of HIV surveillance case definition  Feb 2012—consultation convened by CDC  Recommendations regarding testing algorithms, HIV-2, ‘Stage 0’ infection  To be presented to CSTE at annual meeting June 2012  Anticipate MMWR later in 2012

80 What’s Next?  Rapid 4 th generation test  HIV 1/2 rapid line assay  POC fingerstick rapid test  Viral load  CD4

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82 Ability to Detect Infection Earlier More Detected Earlier

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85 Selected References Journal of Clinical Virology : 2011 Supplement – www.journalofclinicalvirology.com MMWR July 21,1989 – Volume 38, Supplement No. 7 Henry J. Kaiser Family Foundation – HIV/AIDS Policy – www.kff.org J Acquir Immune Defic Syndr 2010;55:S102-S105 – The Future of HIV Testing, Bernard M. Branson Expert Rev Anti Infect Ther 2010;8(6):631-633 – 2010 HIV Diagnostics Conference Summary of the 2012 Consultation of Revision of the HIV Surveillance Case Definition – http://www.cdc.gov/hiv/resources/reports/pdf/HIV_Case_Def_Consult_Summary.pdf CDC – http://www.cdc.gov/hiv/topics/testing/index.htm

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