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Testing for Acute HIV Infection in
         North Carolina




          Myra Brinson, MT(ASCP)
            Virology/Serol...
Background
   A significant portion of all HIV infections in a US
    routine testing population are missed by routine HI...
HIV-1 Testing Timeline:

Symptoms

p24 Antigen
HIV RNA

HIV ELISA

      0       1    2   3   4   5   6   7   8   9   10

...
2001 Pilot Study Design
   All consecutive routine HIV
    tests submitted to the NC
    State Laboratory of Public
    H...
2001 Pilot Study Results
                                         Figure 2 : Disposition of Specimens
   Acute infection:...
Implementation of NC STAT
   Since 2002, NC has identified AHI using NAAT
    through the NC Screening & Tracing Active
 ...
The STAT Program: Goals
    Identify acute HIV infections in the routine HIV CTS population in NC

    Individual health ...
STAT Testing at NCSLPH
                                                                               HIV-1/HIV-2 Plus O
 ...
All clients presenting at approx. 135 publicly-funded
    voluntary testing & counseling (VCT) sites are
     tested for H...
Pooling Schema
80 HIV-1/HIV-2 Plus O
 Nonreactive Samples

                                                               ...
GenProbe APTIMA HIV-1 NAAT
        RNA assay
               FDA-cleared HIV-1
                RNA qualitative NAAT
      ...
NC HIV Testing Algorithm
The STAT System
                                                        Disease Intervention
State Laboratory             ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing
Population 2003-2008
                              No. HIV Tests‡ ...
North Carolina Voluntary Testing and Counseling Testing Population
2003-2008 (cont.)
                                No. H...
North Carolina Voluntary Testing and Counseling Testing Population
2003-2008 (cont.)
                                No. H...
Initial HIV Testing Patterns of Acute Patients Strati
by EIA Generation Type

                     2nd Generation†        ...
HIV Prevalence in Voluntary Testing and
Counseling Testing Population Stratified by
Calendar Year
                       N...
Conclusions
   In total, 3.2% of infections identified by the STAT
    Program for Antibody-plus-RNA HIV testing
    were...
Conclusions
   The yield of AHI cases varied by site type and
    type of antibody tests performed. Improved
    sensitiv...
Conclusions
   Testing for AHI is especially important in high risk
    populations such as young MSM of color for whom t...
Thank You!
North Carolina State Laboratory of   University of North Carolina –
  Public Health                         Cha...
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Impact of hiv naat in texas nine months and counting-myra brinson - texas hiv-std conference

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Transcript of "Impact of hiv naat in texas nine months and counting-myra brinson - texas hiv-std conference"

  1. 1. Testing for Acute HIV Infection in North Carolina Myra Brinson, MT(ASCP) Virology/Serology Unit Manager North Carolina State Laboratory of Public Health Ph: 919-807-8835 E-mail: Myra.Brinson@dhhs.nc.gov
  2. 2. Background  A significant portion of all HIV infections in a US routine testing population are missed by routine HIV Ab testing.  HIV-1 viral RNA is present in large copy numbers during acute infection.  With multistage pooling, NAATs can efficiently diagnose acute infection with good positive predictive value in low prevalence populations.  It is feasible for laboratories with high testing volume such as commercial and state public health labs to perform widespread screening for acute infection.
  3. 3. HIV-1 Testing Timeline: Symptoms p24 Antigen HIV RNA HIV ELISA 0 1 2 3 4 5 6 7 8 9 10 Weeks Since Infection
  4. 4. 2001 Pilot Study Design  All consecutive routine HIV tests submitted to the NC State Laboratory of Public Health over 4 weeks from 110 publicly funded counseling and Figure 1: Schema for pooling Ab-negative specimens testing sites (CTS) [n=8505] Individual Specimens Intermediate Pools Master Pool  Initial Ab testing - OT (1:10) (1:90) Vironostika HIV-1 Viral Lysate Microelisa (State Lab)  Manual pooling of Ab NR samples (State Lab)  Roche Amplicor HIV-1 Monitor (UNC) – Standard and US
  5. 5. 2001 Pilot Study Results Figure 2 : Disposition of Specimens  Acute infection: 5 per 10,000 8505 Total Specimens 12 Previously  Chronic infection: 44 per Tested HIV+ 10,000 152 with Data Incomplete or 2 HIV+, Status  Overall specificity: 99.99% Questionable Unknown 8341 Persons at Risk 38 EIA Repeat  Estimated additional cost per Reactive Sera 37 Newly Diagnosed specimen: $2.01 WB+ Chronic 8298 EIA negative & 5 1 WB Negative Infections  Estimated total testing EIA Unconfirmed Pos. v costs/additional case 1 False + diagnosed: $4,109 299 Specimens RNA Test Insufficient Vol. 4 True Positive Acute 8005 Ab Neg. Specimens Pooled 5 RNA Positive Infections Pilcher CD et al, JAMA, Vol. 288/No. 2, July 10, 2002
  6. 6. Implementation of NC STAT  Since 2002, NC has identified AHI using NAAT through the NC Screening & Tracing Active Transmission (STAT) program  Statewide collaboration to detect AHI in publicly funded testing sites  240,000 HIV samples/year  2 to 3 week TAT for test results  Rapid notification/confirmatory testing  Rapid tracing/prospective screening of partners
  7. 7. The STAT Program: Goals Identify acute HIV infections in the routine HIV CTS population in NC  Individual health  Public Health  Improve prognosis with  Recognized previously acute treatment? missed infections  Early entry into care and  Access sexual networks: prevention services • Identify groups being  Opportunity to avoid actively infected in a unwitting transmission to community partners • Identify partners at high proximate risk of infection • Identify individuals/groups actively transmitting in a community • Maximize impact of all interventions to reduce transmission
  8. 8. STAT Testing at NCSLPH HIV-1/HIV-2 Plus O EIA Antibody Assay (BioRad) Vironstika HIV-1 enzyme immunoassay (bioMérieux) APTIMA HIV-1 RNA Qualitative Assay (GenProbe) NucliSENS EasyQ® HIV-1 assay (bioMérieux) Procleix HIV-1 assay (GenProbe) NucliSENS HIV-1 QL assay (bioMérieux)
  9. 9. All clients presenting at approx. 135 publicly-funded voluntary testing & counseling (VCT) sites are tested for HIV RNA using specimen pooling HIV antibody negative Screen for antibodies to serum samples are HIV-1, HIV-2 Plus O pooled for HIV-1 NAAT using BioRad EIA assay using Hamilton STARlet with EVOLIS automation
  10. 10. Pooling Schema 80 HIV-1/HIV-2 Plus O Nonreactive Samples 1 B Pool (containing 120 µl x 10 A Pools) = 1200 µl 10 A Pools (containing 20 µl x 8 samples) = 160 µl X X X X X X X X X X X X X X X X
  11. 11. GenProbe APTIMA HIV-1 NAAT RNA assay  FDA-cleared HIV-1 RNA qualitative NAAT for serum/plasma  Detects HIV-1 subtypes (Groups M, N, and O)  Analytical sensitivity: 30 copies/ml (98.5%)  Clinical specificity: 99.83%
  12. 12. NC HIV Testing Algorithm
  13. 13. The STAT System Disease Intervention State Laboratory Specialist Team Laboratory Notification, Interviews, Identification Confirmatory Testing, Transportation UNC Weekly Case- to Clinic Conference (Surveillance, Lab, DIS, UNC Evaluation Teams) Data collection UNC Acute HIV Program UNC/Duke Research Database Collaborative UNC Specimen Repository Free Urgent clinical evaluation -surveillance/research testing Recruitment to studies
  14. 14. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  15. 15. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  16. 16. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  17. 17. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  18. 18. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  19. 19. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Total 891,210 -- 3,766 0.42% 125 0.014% Sex Male 279,914 31% 2,631 70% 99 79% Female 600,399 67% 1,076 29% 26 21% Median Age (Range) 25 (0-99) 33 (0-84) 26 (16-56) Age ≤21 288,998 32% 524 14% 35 28% >21 597,395 67% 3,226 86% 90 72% Race Black 395,825 44% 2,578 68% 79 63% White, Non-Hispanic 284,931 32% 663 18% 34 27% Hispanic 162,901 18% 327 9% 10 8% American Indian 9,536 1% 24 1% 1 1% Missing 9,667 1% 34 1% 1 1% Sexual Risk Group Female 600,399 67% 1,076 29% 26 21% Heterosexual Male 231,575 26% 1,084 29% 22 18% MSM 26,870 3% 1,277 34% 73 58% Unknown Male 21,469 2% 270 7% 4 3% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  20. 20. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 (cont.) No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Site Type CHC/PHC 17,189 2% 109 3% 3 2% Drug Treatment 9,944 1% 31 1% 0 0% Family Planning 156,981 18% 61 2% 0 0% Field Visit 12,819 1% 316 8% 8 6% HIV CTS 62,056 7% 872 23% 23 18% Hosp/PMD 138 0% 3 0% 0 0% Other 43,996 5% 380 10% 15 12% Outreach 24,043 3% 153 4% 1 1% Prenatal/OB 148,996 17% 96 3% 2 2% Prison/Jail 28,836 3% 231 6% 5 4% STD 348,896 39% 1,386 37% 54 43% TB 6,872 1% 14 0% 0 0% Missing 30,439 3% 114 3% 14 11% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  21. 21. North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 (cont.) No. HIV Tests‡ Chronic Acute N (%) N (%) N (%) Site Type CHC/PHC 17,189 2% 109 3% 3 2% Drug Treatment 9,944 1% 31 1% 0 0% Family Planning 156,981 18% 61 2% 0 0% Field Visit 12,819 1% 316 8% 8 6% HIV CTS 62,056 7% 872 23% 23 18% Hosp/PMD 138 0% 3 0% 0 0% Other 43,996 5% 380 10% 15 12% Outreach 24,043 3% 153 4% 1 1% Prenatal/OB 148,996 17% 96 3% 2 2% Prison/Jail 28,836 3% 231 6% 5 4% STD 348,896 39% 1,386 37% 54 43% TB 6,872 1% 14 0% 0 0% Missing 30,439 3% 114 3% 14 11% ‡From NC CTS -- number of HIV Tests performed, previous positives removed. Note: Table excludes 2 Acute cases identified from 11/1/2002-12/31/2002 as the number of HIV tests and chronic cases were not available for this 2 month period
  22. 22. Initial HIV Testing Patterns of Acute Patients Strati by EIA Generation Type 2nd Generation† 3rd Generation‡ (2003-2007) (2008) N (%) N (%) EIA(-); NAAT(+) 80 85% 17 57% EIA(+); WB(Ind.) 12 13% 10 33% EIA(+); WB(-) 2 2% 3 10% †2nd Generation EIA: Vironstika HIV-1 (bioMérieux) ‡3rd Generation EIA: HIV-1/HIV-2 Plus O (BioRad)
  23. 23. HIV Prevalence in Voluntary Testing and Counseling Testing Population Stratified by Calendar Year No. HIV Tests‡ Chronic Acute N N % N % Calendar Year 2003 106,994 581 0.54% 22 0.021% 2004 118,885 552 0.46% 21 0.018% 2005 130,440 590 0.45% 21 0.016% 2006 145,396 645 0.44% 15 0.010% 2007 175,341 670 0.38% 16 0.009% 2008 214,154 728 0.34% 30 0.014% ‡From NC CTS -- number of HIV Tests performed, previous positives removed.
  24. 24. Conclusions  In total, 3.2% of infections identified by the STAT Program for Antibody-plus-RNA HIV testing were AHI, which would have been missed using standard antibody based testing procedures.  The program’s success at identifying new HIV infections has led to significant policy changes in NC, including universal reflex RNA testing for EIA-negative specimens and mandatory re- testing of pregnant women in the 3rd trimester.
  25. 25. Conclusions  The yield of AHI cases varied by site type and type of antibody tests performed. Improved sensitivity of current EIAs has resulted in a decreased number of cases presenting as EIA (-) and HIV-1 RNA (+).  Decreased proportion of infected individuals in NC testing population may be due to increased testing among low risk populations following the adoption of the CDC opt-out testing in 2007.
  26. 26. Conclusions  Testing for AHI is especially important in high risk populations such as young MSM of color for whom these infections would have been missed. The recent increase in AHI detection may be due to increased testing from targeted outreach programs, to increased AHI/HIV education, or to increased high risk behaviors such as internet partner meeting.  Although nearly 2/3 of people tested for HIV were women, a smaller percentage of women are detected during AHI than men. Plausible explanations include lower perceived risk among clients and providers, and greater barriers to care and prevention services among high-risk women.
  27. 27. Thank You! North Carolina State Laboratory of University of North Carolina – Public Health Chapel Hill HIV Serology Laboratory Staff JoAnn Kuruc Ashley Mayo Cynthia Guy Joseph Eron North Carolina Department of Health and Human Services RTI International Lynne Sampson Sandra McCoy John Barnhart Evelyn Foust University of California – Rhonda Ashby San Francisco Peter Leone Chris Pilcher
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