Testing for Acute HIV Testing for Acute HIV Infection in North Infection in North Carolina Carolina Myra Brinson, MT(ASCP) Myra Brinson, MT(ASCP) Virology/Serology Unit Manager Virology/Serology Unit Manager North Carolina State Laboratory of Public Health North Carolina State Laboratory of Public Health Ph: 919-807-8835 Ph: 919-807-8835 E-mail: [email protected]E-mail: [email protected]
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Testing for Acute HIV Infection in Testing for Acute HIV Infection in North CarolinaNorth CarolinaBuilding The BSL-3 Facility At The
NC State Laboratory Of Public Health
Or … Stop Bugging Me!
Bath Building 306 North Wilmington Street Raleigh, NC
Myra Brinson, MT(ASCP) Myra Brinson, MT(ASCP) Virology/Serology Unit Manager Virology/Serology Unit Manager
North Carolina State Laboratory of Public HealthNorth Carolina State Laboratory of Public Health
A significant portion of all HIV infections in a US A significant portion of all HIV infections in a US routine testing population are missed by routine HIV routine testing population are missed by routine HIV Ab testing.Ab testing.
HIV-1 viral RNA is present in large copy numbers HIV-1 viral RNA is present in large copy numbers during acute infection.during acute infection.
With multistage pooling, NAATs can efficiently With multistage pooling, NAATs can efficiently diagnose acute infection with good positive predictive diagnose acute infection with good positive predictive value in low prevalence populations. value in low prevalence populations.
It is feasible for laboratories with high testing volume It is feasible for laboratories with high testing volume such as commercial and state public health labs to such as commercial and state public health labs to perform widespread screening for acute infection.perform widespread screening for acute infection.
Background
HIV-1 Testing Timeline: HIV-1 Testing Timeline:
0 1 2 3 4 5 6 7 8 9 10
Symptoms
p24 AntigenHIV RNA
HIV ELISA
Weeks Since Infection
2001 Pilot Study Design2001 Pilot Study Design All consecutive routine HIV All consecutive routine HIV
tests submitted to the NC State tests submitted to the NC State Laboratory of Public Health Laboratory of Public Health over 4 weeks from 110 publicly over 4 weeks from 110 publicly funded counseling and testing funded counseling and testing sites (CTS) [n=8505]sites (CTS) [n=8505]
Initial Ab testing - OT Initial Ab testing - OT Vironostika HIV-1 Viral Lysate Vironostika HIV-1 Viral Lysate Microelisa (State Lab)Microelisa (State Lab)
Manual pooling of Ab NR Manual pooling of Ab NR samples (State Lab)samples (State Lab)
Roche Amplicor HIV-1 Monitor Roche Amplicor HIV-1 Monitor (UNC) – Standard and US (UNC) – Standard and US
Master Pool (1:90)
Intermediate Pools (1:10)
Figure 1: Schema for pooling Ab-negative specimens
Individual Specimens Master Pool (1:90)
Intermediate Pools (1:10)
Figure 1: Schema for pooling Ab-negative specimens
Individual Specimens
2001 Pilot Study Results2001 Pilot Study Results
Acute infection: 5 per 10,000Acute infection: 5 per 10,000
Chronic infection: 44 per Chronic infection: 44 per 10,00010,000
Pilcher CD et al, JAMA, Vol. 288/No. 2, July 10, 2002Pilcher CD et al, JAMA, Vol. 288/No. 2, July 10, 2002
Implementation of NC STAT Implementation of NC STAT
Since 2002, NC has identified AHI using NAAT Since 2002, NC has identified AHI using NAAT through the NC Screening & Tracing Active through the NC Screening & Tracing Active Transmission (STAT) programTransmission (STAT) program
Statewide collaboration to detect AHI in publicly Statewide collaboration to detect AHI in publicly funded testing sitesfunded testing sites
240,000 HIV samples/year240,000 HIV samples/year 2 to 3 week TAT for test results2 to 3 week TAT for test results Rapid notification/confirmatory testingRapid notification/confirmatory testing Rapid tracing/prospective screening of partnersRapid tracing/prospective screening of partners
The STAT Program: GoalsThe STAT Program: Goals Identify acute HIV infections in the routine HIV CTS population in NCIdentify acute HIV infections in the routine HIV CTS population in NC
Individual healthIndividual health Improve prognosis with Improve prognosis with
acute treatment?acute treatment? Early entry into care and Early entry into care and
prevention servicesprevention services Opportunity to avoid Opportunity to avoid
unwitting transmission to unwitting transmission to partnerspartners
Public HealthPublic Health Recognized previously Recognized previously
missed infectionsmissed infections Access sexual networks: Access sexual networks:
• Identify groups being Identify groups being actively infected in a actively infected in a communitycommunity
• Identify partners at high Identify partners at high proximate risk of proximate risk of infectioninfection
• IIdentify dentify individuals/groups individuals/groups actively transmitting in a actively transmitting in a communitycommunity
• Maximize impact of all Maximize impact of all interventions to reduceinterventions to reduce
transmissiontransmission
Nov. 2007
Jan. 2008
Mar. 2
005
Nov. 2003
Vironstika HIV-1 enzyme immunoassay (bioMérieux)
HIV-1/HIV-2 Plus O EIA Antibody Assay (BioRad)
NucliSENS HIV-1 QL assay
(bioMérieux)
Procleix HIV-1 assay (GenProbe)
NucliSENS EasyQ® HIV-1 assay (bioMérieux)
APTIMA HIV-1 RNA Qualitative Assay (GenProbe)
Nov. 2002
STAT Testing at NCSLPHSTAT Testing at NCSLPH
All clients presenting at approx. 135 publicly-funded All clients presenting at approx. 135 publicly-funded voluntary testing & counseling (VCT) sites are voluntary testing & counseling (VCT) sites are tested for HIV RNA using specimen poolingtested for HIV RNA using specimen pooling
Screen for antibodies to Screen for antibodies to HIV-1, HIV-2 Plus O HIV-1, HIV-2 Plus O using BioRad EIA assay using BioRad EIA assay with EVOLIS automation with EVOLIS automation
HIV antibody negative HIV antibody negative serum samples are serum samples are pooled for HIV-1 NAAT pooled for HIV-1 NAAT using Hamilton STARletusing Hamilton STARlet
Pooling SchemaPooling Schema80 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
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 were not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008Population 2003-2008
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 (cont.)Population 2003-2008 (cont.)
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
North Carolina Voluntary Testing and Counseling Testing North Carolina Voluntary Testing and Counseling Testing Population 2003-2008 (cont.)Population 2003-2008 (cont.)
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcuteN N (%)(%) NN (%)(%) NN (%)(%)
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.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 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 periodwere not available for this 2 month period
Initial HIV Testing Patterns of Acute Patients Initial HIV Testing Patterns of Acute Patients Stratified by EIA Generation TypeStratified by EIA Generation Type
††2nd Generation EIA: Vironstika HIV-1 (bioMérieux)2nd Generation EIA: Vironstika HIV-1 (bioMérieux)‡3rd Generation EIA: HIV-1/HIV-2 Plus O (BioRad)‡3rd Generation EIA: HIV-1/HIV-2 Plus O (BioRad)
HIV Prevalence in Voluntary Testing and HIV Prevalence in Voluntary Testing and Counseling Testing Population Stratified by Counseling Testing Population Stratified by Calendar YearCalendar Year
No. HIV Tests‡No. HIV Tests‡ ChronicChronic AcuteAcute
‡‡From NC CTS -- number of HIV Tests performed, previous positives removed.From NC CTS -- number of HIV Tests performed, previous positives removed.
ConclusionsConclusions
In total, 3.2% of infections identified by the STAT In total, 3.2% of infections identified by the STAT Program for Antibody-plus-RNA HIV testing Program for Antibody-plus-RNA HIV testing were AHI, which would have been missed using were AHI, which would have been missed using standard antibody based testing procedures.standard antibody based testing procedures.
The program’s success at identifying new HIV The program’s success at identifying new HIV infections has led to significant policy changes in infections has led to significant policy changes in NC, including universal reflex RNA testing for NC, including universal reflex RNA testing for EIA-negative specimens and mandatory re-EIA-negative specimens and mandatory re-testing of pregnant women in the 3testing of pregnant women in the 3rdrd trimester. trimester.
ConclusionsConclusions
The yield of AHI cases varied by site type and The yield of AHI cases varied by site type and type of antibody tests performed. Improved type of antibody tests performed. Improved sensitivity of current EIAs has resulted in a sensitivity of current EIAs has resulted in a decreased number of cases presenting as EIA (-) decreased number of cases presenting as EIA (-) and HIV-1 RNA (+). and HIV-1 RNA (+).
Decreased proportion of infected individuals in Decreased proportion of infected individuals in
NC testing population may be due to increased NC testing population may be due to increased testing among low risk populations following the testing among low risk populations following the adoption of the CDC opt-out testing in 2007.adoption of the CDC opt-out testing in 2007.
ConclusionsConclusions Testing for AHI is especially important in high risk Testing for AHI is especially important in high risk
populations such as young MSM of color for whom these populations such as young MSM of color for whom these infections would have been missed. The recent increase infections would have been missed. The recent increase in AHI detection may be due to increased testing from in AHI detection may be due to increased testing from targeted outreach programs, to increased AHI/HIV targeted outreach programs, to increased AHI/HIV education, or to increased high risk behaviors such as education, or to increased high risk behaviors such as internet partner meeting.internet partner meeting.
Although nearly 2/3 of people tested for HIV were Although nearly 2/3 of people tested for HIV were women, a smaller percentage of women are detected women, a smaller percentage of women are detected during AHI than men. Plausible explanations include during AHI than men. Plausible explanations include lower perceived risk among clients and providers, and lower perceived risk among clients and providers, and greater barriers to care and prevention services among greater barriers to care and prevention services among high-risk women.high-risk women.
Thank You!Thank You!
North Carolina State Laboratory of North Carolina State Laboratory of Public HealthPublic Health
HIV Serology Laboratory StaffHIV Serology Laboratory Staff
North Carolina Department of North Carolina Department of Health and Human ServicesHealth and Human Services
Lynne SampsonLynne Sampson
John BarnhartJohn Barnhart
Evelyn FoustEvelyn Foust
Rhonda AshbyRhonda Ashby
Peter LeonePeter Leone
University of North Carolina – University of North Carolina – Chapel HillChapel Hill
JoAnn KurucJoAnn Kuruc
Ashley MayoAshley Mayo
Cynthia GuyCynthia Guy
Joseph EronJoseph Eron
RTI InternationalRTI International
Sandra McCoySandra McCoy
University of California – University of California –