New Guidelines for HIV Diagnosis
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1 New Guidelines for HIV Diagnosis David R Hillyard Patricia Slev September 21, 2012
2 Disclosure None (Dr. Slev) Roche Diagnostics (Dr. Hillyard)
3 Objectives Explain the advances in HIV diagnostics, including fourth generation Ag/Ab combination HIV screening assays. Describe the new CDC HIV diagnostic algorithm. Understand the evidence in support of the new diagnostic algorithm. Use screening and follow-up confirmatory tests appropriately.
4 HIV Globally
5 HIV in the US 1,200,000 1,000, , , , , % 79% 1,106, ,056 59% 655,542 40% 437,028 Estimated that only 19% of HIV-infected individuals in the US have undetectable HIV viral load 32% 24% 19% 349, , ,773 0 Gardner EM, et al. Clin Infect Dis. 2011;52: Clinical Care Options 2012.
6 Awareness of Serostatus Among People with HIV and Estimates of STD Transmission (US) ~25% Unaware of Infection Account for: ~54-70% of New Infections ~75% Aware of Infection ~30-46% of New Infections People Living with HIV/AIDS: 1,039,000-1,185,000 New Sexual Infections Each Year: ~32,000
7 Transmission in Males
8 Transmission in Females
9 Perinatal Transmission
10 2006 CDC Guidelines Universal Testing Routine HIV voluntary, not based on risk Opt-Out option to decline, general consent for care includes HIV testing Population years old Venue inpatient services, ED, urgent care, STD clinics, substance abuse and correctional facilities
11 Human Immunodeficiency Virus Types HIV-1 HIV-2 Groups Major Non M/Non O Outlier Subtypes/Clades Circulating Recombinant Forms (CRF)
12 HIV Distribution HIV-2 HIV O,N Francine E. McCutcham, Henry M. Jackson Foundation (Rockville, Maryland). IAVI Report, August 2003
13 HIV-2 Persons at risk for HIV-2 infection include Sex partners of a person from a country where HIV-2 is endemic Sex partners of a person known to be infected with HIV-2 People who received a blood transfusion or a nonsterile injection in a country where HIV-2 is endemic People who shared needles with a person from a country where HIV-2 is endemic or with a person known to be infected with HIV-2 Children of women who have risk factors for HIV-2 infection or are known to be infected with HIV-2 HIV-2 testing also is indicated for People with an illness that suggests HIV infection (such as an HIV-associated opportunistic infection) but whose HIV-1 test result is not positive People for whom HIV-1 Western blot exhibits the unusual indeterminate test band pattern of gag (p55, p24, or p17) plus pol (p66, p51, or p32) in the absence of env (gp160, gp120, or gp41) CDC
14 HIV Infection Course CD4+ count (cells/mm3) Primary infection Acute HIV syndrome Clinical latency CD4 Viremia Viral load (thousands) Weeks Years Adapted from Roche and Siemens slides
15 HIV Serological Response Typical response following infection 1 HIV p24 Antigen gag anti-hiv env anti-hiv pol anti-hiv Weeks following infection HIV p24 Antigen years
16 Current HIV Diagnostic Algorithm 1 Screen immunoassay (EIA/CIA) rapid tests 2 Confirmation Western blot (98%) IFA APTIMA* *Note: APTIMA, Genprobe (TMA format) qualitative assay only FDA approved nucleic acid amplification test (NAAT) for diagnosis and confirmation
17 Screening Assays - Rapid Antibody Tests (2 nd gen - IgG) Assay Sample Type Sensitivity Specificity OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Oral fluid Whole Blood 99.3% 99.6% 99.8% 100% Plasma Clearview COMPLETE HIV 1/2 Whole Blood 99.6% 99.7% 99.9% 99.9% Clearview HIV ½ STAT-PAK Serum & Plasma Whole Blood 99.7% 99.7% 99.9% 99.9% Reveal G-3 Rapid HIV-1 Antibody Test Uni-Gold Recombigen HIV Serum & Plasma Serum Plasma Whole Blood 99.7% 99.8% 99.8% 100% 99.9% 99.1% 98.6% 99.7% Multispot HIV-1/HIV-2 Rapid Test INSTI HIV-1Antibody Test* Serum & Plasma Serum Plasma Plasma 100% 100% 100% 99.9% 99.8% 99.9% 99.9% 100.0% Whole blood (venipuncture) 99.9% 100.0% Whole blood (fingerstick) 99.8% 99.5%
18 OraQuick Advance Synthetic gp-41 (HIV-1) Synthetic gp-36 (HIV-2) Goat anti-human IgG
19 Multispot HIV-1/HIV-2 Reactive Control HIV-1 HIV-1 Negative HIV-2 Reactive (HIV-1 & HIV-2) Detects and differentiates between HIV-1 and HIV-2
20 HIV Ab Screening Assays ( 3 rd gen IgM and IgG) Relative concentration Third generation assays (IgG/IgM) Detect HIV infection on day 22 Detect HIV-1/HIV-2 and HIV-1 group O depending on the assay Several automated platforms RNA (viral load) 3 rd gen HIV IgG HIV IgM HIV-1 infection weeks months years
21 HIV Antigen/Antibody Combination Assays (4 th gen p24 Ag/IgM/IgG) Detects both HIV -1 (group O) and HIV-2 antibodies and p24 antigen Does not distinguish between Ab+ or Ag+ Only two FDA cleared assays Bentsen et al. Journal of Clinical Virology. 2011
22 Earlier Detection of HIV Infection: (4 th generation) Relative concentration RNA (viral load) 4 th gen HIV IgG p24 HIV IgM HIV-1 infection weeks months years Detects infection at weeks, 5 days earlier than 3 rd gen
23 False Positive Immunoassay Results Vaccinations flu, rabies HIV vaccine trials Autoimmune disease Heterophile Antibodies Other viral infections
24 Confirmation by Western Blot CDC Interpretation Criteria positive - presence of 2 of 3 cardinal bands negative - absence of all bands indeterminate does not meet + or - criteria
25 Western Blot Indeterminate Indeterminate results may be due to infected but in the window advanced disease, AIDS HIV vaccinated infected with HIV-2 uninfected, cross reactivity viral or non-viral bands, recent flu and rabies vaccinations, multiple pregnancies, recipients of multiple transfusions, autoimmune disease study followed 99 blood donors 91 stable indeterminate Western blot patterns over 30 months Indeterminate results require follow-up repeat Western blot nucleic acid amplification test (NAAT)
26 HIV-1 vs HIV-2 and Western Blot Percentage of specimens with each HIV-1 Western blot band in 114 specimens collected from persons infected with HIV-2 and 1761 specimens positive for HIV-1by Western blot and Multispot HIV-1/HIV2 assay. p17 p24 p31 p40 gp41 p51 p55 p66 gp120 gp160 HIV-2 (n=114) Present Present but weak Absent HIV-1 (n=1761) Present Present but weak Absent Adapted from Nasrullah et al. Journal of Clinical Virology
27 HIV-2 Infection Classification by Western Blot Comparison of two HIV-1 Western blot interpretive criteria applied to specimens collected from 114 persons known to be infected with HIV-2,ª Current CDC HIV-1 WB criteriaª Alternative HIV-1 WB criteria Þ, η (%) Negative Indeterminate Positive Total Negative 1 (0.9) 0 (0.00) 0 (0.0) 1 (0.9) Indeterminate 0 (0.0) 60 (52.6) 0 (0.0) 60 (52.6) Positive 0 (0.0) 40 (35.1) 13 (11.4) 53 (46.5) Total 1 (0.9) 100 (87.7) 13 (11.4) 114 (100.0) Adapted from Nasrullah et al. Journal of Clinical Virology 2011.
28 Sensitivity of Current Assays 0-5 Oraquick Unigold Statpak/Complete Reveal G2 & G3 Multispot Days prior to Western blot Rapid Tests (mostly 2 nd gen) GS + O Vitros 3rd gen Advia Architect 4 th gen Aptima -30 NAAT Days before Western blot positive Adapted from Masciotra et al. Journal of Clinical Virology Slide - Anna Gardiner
29 Western Blot Disadvantages Diagnostic Considerations insensitive compared to current screening assays indeterminate/inconclusive results - follow-up HIV-2 misdiagnosis Practical Considerations access expense turn around time
30 CDC Proposed Diagnostic Algorithm 1 2 *Could be an IgM sensitive Ab immunoassay if Ag/Ab combination assay is unavailable AACC. Clinical Laboratory News
31 GS Combo Ag/Ab and Long Standing HIV Infection Sensitivity (4 th generation) Population N GS HIV Combo Ag/Ab Licensed HIV- 1/HIV-2 EIA Repeatedly Reactive EIA Repeatedly Reactive Known HIV-1 Ab (100%) 1000 (100%) positive US Known HIV Ab (100%) 200 (100%) positive, Non-US AIDS (100%) 100 (100%) Known HIV-1 Ab (100%) 40 (100%) positive, pediatric Total (100%) Adapted from Bentsen et al. Journal of Clinical Virology 2011.
32 Low Risk Population Health insurance applicants Normal blood donors Pregnant women Military recruits Healthy pediatric subjects GS HIV Combo Ag/Ab Specificity (4 th generation) Number tested GS HIV Ag/Ab Combo Repeatedly reactive Samples Specificity (#negative/total) Repeatedly Reactive (% Reactive) WB positive (%positive) HIV-2 positive (%positive) (0.30%) 2 0 (0.00%) 99.8% (0.0%) NT NT 100% (0.20%) 1 0 (0.00%) 99.9% (0.30%) 1 0 (0.0%) 99.8% 100 0(0.0%) NT NT 100% Total (0.18%) 4 0 (0.0%) 99.89% Adapted from Bentsen et al. Journal of Clinical Virology 2011.
33 Architect Ag/Ab Combo Performance Data (4 th generation) Result No of samples Sensitivity Specificity HIV-1 infected (n-3386) HIV-1 Uninfected (N=7551) Initial screening Positive Negative Performance 99.94% 98.78% Retest Screening Positive Negative Performance 99.94% 99.50% Result Acute Infection Sensitivity Positive 48 Negative 10 Performance 82.76% Adapted from Chavez et al. Journal of Clinical Virology 2011
34 Multispot vs. Western Blot Multispot Positive Multispot Negative Total N Row % N Row% N WB positive % 8 0.1% 8678 WB negative % % 19 WB indeterminate % % 63 Total % % 8760 Adapted from Torian et al. Journal of Clinical Virology 2011.
35 NAAT for HIV Diagnosis APTIMA HIV-1 Qualitative Assay (FDA approved 2006) TMA, Hybrid capture for RNA purification Screening of high-risk populations Known exposure such as needle-stick Testing patients with acute HIV-1 symptoms and known exposure Screening of newborn babies born to infected mothers HIV vaccine studies Resolution arm for new screening algorithms
36 APTIMA HIV-1 Qualitative Assay Poses dilemma for diagnostic algorithm: Only approved test with diagnostic claim few installations, limited test availability Manual test format 1 st generation chemistry design, ability to see new strains? Hybrid Capture Purification Transcription Mediated Amplification (TMA) Hybridization Protection Dual Kinetic Detection
37 Aptima vs Real-time PCR Tests Sensitivity Genotypes Amplicon control Automation Aptima Gen-Probe 30 copies/ml 40 copies/ml A-O A-O A-G Strand Capture Real Time Abbott closed No (U.S.) yes yes TaqMan 1.0 Roche 43 copies/ml UTP/UNG, closed TaqMan 2.0 Roche 20 copies/ml A-G UTP/UNG closed yes FDA approval Diagnosis Monitor Monitor Monitor Note: bdna (signal amplification assay) has ~1% low positivity rate In negative samples. not suitable for resolution testing
38 Comparative Assay Sensitivities (probit modeling of PI data) Aptima Roche 2.0 Abbott frequency of detection Andrew Wilson
39 Targets, Chemistry, Issues Cobas 1.0, 1.5 end-point PCR Roche CapTaq 2.0 CapTaq 1.0 real-time PCR Roche LTR GAG POL IN ENV LTR Aptima Real Time Abbott Pyne, M. J Clin Microbiol, 48(8), Pyne, M. JOURNAL OF CLINICAL MICROBIOLOG Aug. 2010, p
40 HIV-1 Proviral DNA Testing Whole blood assay, detects RNA and DNA Uses Infants born to HIV-1 infected mothers 2 serially positive RNA or DNA tests necessary for diagnosis in infants < 2 years of age Early diagnosis of infants on prophylactic therapy (RNA suppressed) Whole blood assay (Roche) 1.0 chemistry CAPTAQ robot
41 Expanding HIV Diversity in U.S. Pyne et al 2012
42 Expanding HIV Diversity in U.S. Pyne et al 2012
43 Molecular Take-Home Points Only APTIMA is approved for HIV diagnosis Automation may eventually occur on Panther platform Viral Load tests have equivalent analytic performance compared to APTIMA Guidelines stirred interest in claims for diagnosis Process will be slow Precedent for off-label use molecular tests for confirmation/resolution (HCV) Proviral HIV-1 DNA testing available, not approved Very few LDT HIV-2 RNA assays available
44 Comparing Algorithms Algorithm Sensitivity Specificity % 95% CI % 95% CI Two-test current algorithm Architect/WB GS+O /WB Three-test proposed algorithm Architect or GS+O/Multispot/NAAT Adapted from Masciotra et al. Journal of Clinical Virology 2011.
45 ARUP Offers both third and fourth generation screening assays Acute HIV Case Validating Multispot Multispot Multispot Multispot Total negative HIV-1 positive HIV-2 positive WB negative WB positive 9 9 WB indeterminate HIV-2 confirmed positive 5 5
46 New Algorithm Benefits Improves detection of acute HIV infection Ag/Ab Combo Assay NAAT confirmation Increased detection of HIV-2 infection replacing Western blot with Multispot Eliminate inconclusive/indeterminate results eliminating the Western Blot Decrease turn around time & linkage to care replacing Western blot with Multispot
47 New Algorithm Challenges Only two platforms currently available for Ag/Ab Combo assays Multispot is a rapid test, not approved for confirmation of HIV infection There is only one qualitative molecular assay approved for HIV diagnosis (Aptima) that is not automated and therefore not routinely available High-throughput quantitative or viral load HIV assays are widely utilized but none is approved for diagnosis
48 Clinical Considerations Ag/Ab combination or 4 th assays are the most sensitive screening assays and should be used if acute HIV infection is suspected Multispot discriminates between HIV-1 and HIV-2 infection Both the Multispot and Western blot can detect established HIV infection, majority of HIV diagnoses If a result is positive by 4 th gen screening assay but negative by either the Western blot or Multispot (Ab detection only), further testing by molecular assays (NAAT) is necessary NAAT testing cannot be used as the second step because it can be negative in: HIV-2 infection HIV infected individuals that are elite suppressors/controllers - 0.5%
49 Orly Ardon Jennifer Blackley Scott Griffiths Michael Pyne Melanie Mallory Malissa Jones Jason Metz Thanks
50 Universal Screening? Laws Reimbursement Adapted from JAMA 2011
51 Transmission in Adults
52 US HIV Prevalence CDC Surveillance Data 2012
53 Global HIV Epidemiology 1.3 million 0.23 million 1.6 million 0.76 million 0.38 million 22.5 million 1.6 million 0.80 million 4 million million WHO, UNAIDS. 07 AIDS epidemic update.
54 Detection of HIV by Diagnostic Tests Branson et al. AIDS Therapy 2008.
55 Confirmation for HIV-1 Infection All repeatedly reactive EIA/CIA screening assay results must be confirmed POC results are considered preliminary positive results and must also be confirmed Confirmation for HIV-1 Infection Indirect Immunofluorescence (IFA) Western Blot
56 NA-ACCORD: Increasing Life Expectancy in HIV+ Adults Receiving ART Hogg R, et al. CROI Abstract 137. Clinical Care Options 2012.
57 Acute HIV patient GS Combo Ag/Ab & Acute HIV Infection (4 th generation) Days from 1 st bleed HIV-1 RNA copies (ml) GS HIV Combo Ag/Ab Historical results HIV-1/HIV- 2 EIA HIV-1 EIA WB 1 0 >500,000 R NR NR Neg 56 R R R Pos ,850 R NR NR Neg 16 10,479 R R R Pos 42 R R R Pos 3 0 >500,000 R R Neg 141 R R R Pos 4 0 >500,000 R NR NR Neg 19 R R R Pos 5 0 >500,000 R R R Neg 21 R R R Ind 64 RR R R Pos Adapted from Bentsen et al. Journal of Clinical Virology 2011.
58 Detection of Rare HIV Genotypes Assay Type HIV-1/HIV-2/O Ab (3 rd gen) HIV-1/HIV-2/O Ag/Ab Combination (4 th gen) HIV Non-B Infections HIV-1 group M, non-b HIV-1 group O HIV-2 detected detected detected Ab detected Ag sensitivity is assay dependent Ab detected Ag sensitivity is assay dependent HIV-1 WB detected negative indeterminate Ab detected Ag sensitivity is assay dependent and HIV-2 detection is dependent on cross-reactivity negative indeterminate HIV-1 RNA NAAT (qualitative) detected detected not detected HIV-1 RNA NAAT (quantitative) detected but quantification is assay dependent detection and quantification assay dependent not detected HIV-1 RNA NAAT (genotyping) detected not detected not detected
59 Acute HIV Infection (3 rd gen, 4 th gen, Western blot and NAAT) Adapted from Masciotra et al. Journal of Clinical Virology 2011.
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