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Rapid HIV Testing
Trinity Uni-Gold Performance Evaluation
Policy & Regulatory Issues
AFAO National ForumOctober 2014
Phillip [email protected]
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Background
• HIV diagnoses among gay and bisexual men (GBM) have increased in the past decade
• HIV testing and treatment is a key prevention focus
• ~10% of GBM have never tested (ARTB, CSRH)
• Only 20% of high risk GBM have re-tested after 6 months (Guy, 2010)
• Barriers to HIV testing include time constraints, not wanting to return for results
• Rapid testing aims to increase the acceptability and convenience of HIV testing
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Immunochromatography (ICT)(lateral flow)
Sample
IgG Ab
α-HIV Ab
HIV-Ag
α –hu-IgG
label
HIV Ab Hu-IgG
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Rapid HIV testing in NSWPhase 1 Phase 22011-2012 2013-2014Sydney Rapid HIV Testing study NSW Rapid Test Evaluation FrameworkNHMRC Program Grant NSW MoH, NHMRC Program Grant FeasibilityAcceptabilityTest performance
Acceptability & SustainabilityTest performanceCostImpact
4 sexual health clinics 13 sexual health clinics/hospitals6 community-based sites (4 peer-led partnerships with SHCs)1 general practice
Determine Ag/Ab HIV 1/2 Combo Conventional serology in parallel
Trinity Uni-GoldConventional serology in parallel
GBM, aged 18+ years GBM, aged 18+ years
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Acceptability of rapid testing (after result)Duration of clinic visit today vs last time (%)
Shorter 27.2About the same 35.9Longer 36.8
Stress & anxiety of testing today vs last time (%)
More stress & anxiety 7.1Similar to last time 33.5Less stress & anxiety 59.4
Comfort of f/prick vs venipuncture today (%)
Less comfortable 13.7About the same 24.6More comfortable 58.2
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Acceptability of rapid testing (after result)
%
Satisfied with rapid test result delivery 98.6
Satisfied with rapid testing overall 98.6
Would recommend rapid testing to others 88.5
Would prefer a rapid test next time 78.7
Damian Conway, ASHM 2012. Sydney Rapid HIV Testing Study
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Rapid HIV testing in NSWPhase 1 Phase 22011-2012 2013-2014Sydney Rapid HIV Testing study NSW Rapid Test Evaluation FrameworkNHMRC Program Grant NSW MoH, NHMRC Program Grant FeasibilityAcceptabilityTest performance
AcceptabilityTest performanceCostImpact
4 sexual health clinics 13 sexual health clinics/hospitals6 community-based sites (4 peer-led partnerships with SHCs)1 general practice
Determine Ag/Ab HIV 1/2 Combo Conventional serology in parallel
Trinity Uni-GoldConventional serology in parallel
MSM, aged 18+ years MSM, aged 18+ years
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Performance of the Trinity Biotech Uni-Gold HIV 1/2 rapid test as a first-line screening
assay for gay and bisexual men
Keen P, Conway DP, Cunningham P, McNulty A, Couldwell DL, Davies SC, Smith DE, Gray J, Holt M, O’Connor CC, Finlayson R, McAllister J, Hughes B, Carmody C, Varma R, Smith D, Read P,
Callander D, Guy, R.
Kirby Institute, UNSW
Australasian Sexual Health Conference, Sydney, October 2014
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Adapted from McMichael AJ etal Nature Rev Immuno 2010
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Adapted from McMichael AJ etal Nature Rev Immuno 2010
4th Gen
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Adapted from McMichael AJ etal Nature Rev Immuno 2010
4th GenRapid Tests
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4th Gen Test Reactive
4th Gen Test Reactive
ACUTE ESTABLISHED
Positive Western blot
Negative or Indeterminate Western blot
+Positive
p24antigen OR HIV-1 RNA
Negative HIV test <3 months
or
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Performance overallReference test results
TotalPositive Negative
Trinity Unigoldresult
Positive 50 5 55
Negative 11 7179 7190
Total 61 7184 7245
False positiveTrue positive
False negative True negative
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Reference test
Acute Established Overall
Uni-Gold Pos 12 38 50
Neg 11 0 11
Total 23 38 61
Sensitivity in acute and established cases
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Sensitivity in acute and established cases
% 95% CI
Acute 52.2 26.8-69.4
Established 100 90.1-100*
Overall 82.0 70.0-90.6
* one-sided 97.5% confidence interval
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% 95% CI
Sensitivity 82.0 70.0-90.6
Specificity 99.9 99.8-100
Positive predictive value 90.9 80.0-97.0
Negative predictive value
99.9 99.7-99.9
Performance overall
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Conclusions/discussion
• In this population Trinity failed to detect 48% of acute infections
• 38% of men diagnosed with HIV were acute infections
Can people at risk of recent infection be effectively identified if only rapid tests are used?
Should all who have rapid tests have parallel lab tests?
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What will happen when the current NSW trial ends?
• NSW HIV PoCT Framework
• Regulatory obstacles
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NSW MoH HIV PoCT Framework – in Development
• Will provide guidance to NSW Health supported non-laboratory services for offering HIV PoCT post-trials
• Will establish a quality framework for procurement, batch release testing, other quality management processes
• Guidance and supporting materials for:– Worker training and competency assessment– Eligibility – Client information– Data collection – Standard operating procedures
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Regulatory Issues – Some Barriers Remain
• Current TGA licensing conditions preclude eg. Peer educators from administering rapid HIV tests – To date, peer educators have been able to participate in
community-based rapid HIV testing services through research trials with TGA waivers
• Performance benchmarks for licensing of rapid HIV tests – Australian Committee on Medical Devices: advice to TGA that
rapid tests should be 100% sensitive in western blot positive specimens
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Acknowledgments
Funding• NSW Ministry of Health• NHMRC Program Grant• In-kind support from study sites
Steering Committee/Investigators• A/Prof Rebecca Guy, Kirby Institute, UNSW• Dr Damian Conway, Kirby Institute, UNSW• A/Prof Martin Holt, Centre for Social
Research in Health, UNSW• A/Prof Anna McNulty, Sydney Sexual Health
Centre• Dr Deborah Couldwell, Western Sydney
Sexual Health Centre• Prof Don Smith, Albion Street Centre• Dr Stephen Davies, North Shore Sexual
Health Service• Philip Cunningham, St Vincent’s Hospital
Darlinghurst• James Gray, ACON• Phillip Keen, Kirby Institute, UNSW
Study Investigators • A/Prof Catherine O’Connor, RPA Sexual Health
Centre• Dr Robert Finlayson, Taylor Square Private Clinic• John McAllister, Immunology & Infectious
Diseases Unit, St. Vincent’s Hospital• Dr Brian Hughes, Hunter New England Health
Services• Dr Chris Carmody, Liverpool Sexual Health Clinic• Dr Rick Varma, Nepean and Blue Mountains
Sexual Health Clinics • Dr David Smith, Lismore Sexual Health Service• Dr Phillip Read, Kirketon Road Centre• Dr Rob Pickles, Newcastle Sexual HealthService • A/Prof Lewis Marshall, Fremantle Hospital• A/Prof Jenny McCloskey, Ainslie House, Royal
Perth Hospital• Dr David Baker, East Sydney Doctors• Dr Denton Callander, The Kirby Institute, UNSW
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AcknowledgmentsTraining Support• Philip Cunningham, Paula Runnals, Timmy
Lockwood, Craig Leeman, Vickie Knight, Levinia Crooks, Kim Wilson, Karen Seager, Damian Conway, Brent Clifton, Terry Walkinshaw, James Gray, Karl Johnson, Jane Costello, Linda Deriu, Walter Shepherd
Data Analysis Support• Muhammad Jamil, Denton Callander, Rebecca
Guy
Rapid Testing Site Coordinators• Timmy Lockwood• Vickie Knight• Chanelle Stowers• Nicky Sharp• Elizabeth Griggs• Terry Walkinshaw• James Gray• Amanda Townsend• Karen Biggs• Pradeep Kumar
Rapid Testing Site Coordinators (cont’.)• Sangeetha Eswarappa• Sandhya Goundar• Sharon Doughty• Rachel Poga• Simon Wright• Maggie Smith• Anthony Price• Mary Florance• Andrew Koh• Michael O’Reilly• Katherine Allardice• Leah Akierman• Ian McLoughlin• Kate Salisbury• Sarah Holliday• Brett Dubois
Lab support• Craig Leeman, Mee Ling Munier, Syddpath,
SEALS South, SEALS North, Pathology North, Hunter, Northern Rivers Pathology, Pathology West, ICPMR Westmead Hospital, Royal Prince Alfred Hospital
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False negative acute cases
Previous HIV test RNA p24 Antigen HIV Antibody Western
Blot
1 <3M N/A + - -
2 >3m + + - -
3 Never + + - -
4 >3M N/A + - +/-
5 Never + + + -
6 >3M + + + +/-
7 <3M N/A + + +/-
8 >3M + + + +/-
9 >3M + + + +/-
10 >3M + invalid + +/-
11 <3M + + + +
+ = Positive - = Negative-/+ = Indeterminate
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© ASHM 2013
Relative sensitivity (Acute HIV)
Biorad H
IV-1 p24 antigen
Abbott A
rchitect HIV-1/2 A
g/Ab (4
th gen)G
enscreen HIV-1/2 A
b (3rd gen)
Alere H
IV-1/2 Ag/A
b combo
Alere H
IV-1/2 Ab
Trinity Unigold H
IV-1/2 Ab
Biorad H
IV-1/2 Multispot A
b
Insti HIV-1/2 A
b
Orasure O
raQuick H
IV-1/2 Ab
Sensitivity (%)
100 90 80 70 60 50 40H
IV-1 Western B
lot
Cunningham etal ASHM 2013
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SAN FRANCISCO AIDS FOUNDATION / MAGNET
33
Magnet Express Model
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Magnet, SF: Additional Diagnoses Detected by RNA Testing
Rapid Tests RNA Test Additional infections detected
%
2010-2011 88 10 11.4
2011-2012 103 19 18.4
2012-2013 71 15 21.2
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A Key Challenge in Introducing Rapid HIV PoCT
• Rapid HIV tests are not suitable for testing in people who have had a very recent risk exposure
• Recent risk exposure is a key reason why some men present for HIV testing
• Testing services need to explain the longer window period required by rapid HIV tests
• 4th Generation laboratory tests preferred for recent exposure
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Adapted from McMichael AJ etal Nature Rev Immuno 2010
RNA
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Opportunities
• The strength of rapid tests is in screening HIV negative people
• 98-99% of gay men will get a true negative result, with no need to return for results
• Opportunity to increase the convenience of testing for most gay men and reinvigorate HIV testing
• Opportunity to create new types of testing services through introducing peer testing staff
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Limitations
• Longer window periods• Should all who have rapid tests have parallel lab tests?• Can people at risk of recent infection be screened?
• Some results will be false-reactive (‘false-positive’)
• Requires more work at the point of care
• Rapid HIV tests are screening tests• Lab testing is required on reactive rapid HIV tests to confirm
an HIV diagnosis
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Conclusions/discussion
• Uni-Gold had sensitivity similar to Determine Ag/Ab HIV 1/2 Combo – Uni-Gold overall sensitivity: 82.0% (95%CI: 70.0-90.6)– Determine Combo overall sensitivity: 87.2% (95%CI: 72.6-95.7)
• 100% sensitivity in established infections
• Excellent specificity
• High PPV
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Rapid HIV testing in NSWPhase 1 Phase 22011-2012 2013-2014Sydney Rapid HIV Testing study NSW Rapid Test Evaluation FrameworkNHMRC Program Grant NSW MoH, NHMRC Program Grant FeasibilityAcceptabilityTest performance
AcceptabilityTest performanceCostImpact – uptake and frequency
4 sexual health clinics 13 sexual health clinics/hospitals6 community-based sites (4 peer-led partnerships with SHCs)1 general practice
Determine Ag/Ab HIV 1/2 Combo Conventional serology in parallel
Trinity Uni-GoldConventional serology in parallel
MSM, aged 18+ years MSM, aged 18+ years
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% 95% CI
Sensitivity 82.0 70.0-90.6
Specificity 99.9 99.8-100
Positive predictive value 90.9 80.0-97.0
Negative predictive value
99.9 99.7-99.9
Performance overall
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% 95% CI
Sensitivity 82.0 70.0-90.6
Specificity 99.9 99.8-100
Positive predictive value 90.9 80.0-97.0
Negative predictive value
99.9 99.7-99.9
Performance overall
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Trinity Uni-Gold HIV 1/2 rapid test
Non-reactive
(negative)
Reactive Invalid
Finger-stick blood 10-minute incubation time
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Rapid tests as screening tests• Rapid tests are used as first-line screening tests in many
countries
• If reactive, confirmation by:• Lower income countries: 2 or 3 different rapid tests
(second/third tests more specific)• Higher income countries: Conventional HIV serology
• First line test should be highly sensitive
• Few evaluations of the performance of Trinity Uni-Gold as first line screening assay
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Why Introduce Rapid HIV Testing in Australia?
• Highly sensitive and specific tests are important features of a high quality testing system.
• The testing process only starts when someone presents for, or is offered an HIV test.
• Many structural and psychological barriers to HIV testing among gay men and MSM may be reduced by rapid HIV testing
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Rapid HIV Tests at PoCT: Advantages
• Robust and easy to use– Most require:
• 10-20 mins to perform• Minimal equipment• Minimal technical skill
• Increased access to HIV testing
• Results available quickly; can speed diagnosis, counselling and linkage to care
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Do homosexual men have HIV tests more frequently
if offered rapid point-of-care HIV testing in a sexual
health centre? Read T1,2, Morrow A2 , Hocking J3, Bradshaw C1,2,4, Grulich A5, Fairley CK1,2* and Chen M1,2*1.Melbourne School of Population Health, University of Melbourne
2.Melbourne Sexual Health Centre, Alfred Health, Melbourne
3.Centre for Women’s Health, Gender and Society, School of Population Health, University of Melbourne
4.School of Social and Preventive Medicine, Monash University, Melbourne
5.Kirby Institute, University of New South Wales, Sydney
*joint last authors
47
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Time to first test (years)
0.00
0.25
0.50
0.75
1.00
Pro
por
tion
test
ed o
nce
0 .5 1 1.5Time
arm = control arm = rapid
Proportion having first HIV test over time
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A Key Challenge in Introducing Rapid HIV PoCT
• Rapid HIV tests are not suitable for testing in people who have had a very recent risk exposure
• Recent risk exposure is a key reason why some men present for HIV testing
• Testing services need to explain the longer window period required by rapid HIV tests
• 4th Generation laboratory tests preferred for recent exposure
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Background• HIV diagnoses among gay and bisexual men (GBM) have
increased in the past decade
• HIV testing and treatment is a key prevention focus
• ~10% of GBM have never tested (ARTB, CSRH)
• Only 20% of high risk GBM have re-tested after 6 months (Guy, 2010)
• Barriers to HIV testing include time constraints, not wanting to return for results
• Rapid testing aims to increase the acceptability and convenience of HIV testing
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Test performance evaluation• June 2013 – 30 June 2014 • 20 study sites across NSW• HIV Reference Testing
– 4th generation Ab/Ag combo assay• p24Antigen (separately)• HIV Antibody (separately)• Western Blot
• Analysis• Trinity Uni-Gold v’s reference tests
– Sensitivity: overall, acute and established– Specificity: overall
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Performance of the Trinity Biotech Uni-Gold HIV 1/2 rapid test as a first-line screening
assay for gay and bisexual men
Keen P, Conway DP, Cunningham P, McNulty A, Couldwell DL, Davies SC, Smith DE, Gray J, Holt M, O’Connor CC, Finlayson R, McAllister J, Hughes B, Carmody C, Varma R, Smith D, Read P,
Callander D, Guy, R.
Kirby Institute, UNSW
Australasian Sexual Health Conference, Sydney, October 2014
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In the era of effective antiretroviral treatment, HIV testing serves as the gateway to improved health and survival among persons with HIV infection and decreased transmission within communities.
(Branson, B. et. al. JAAIDS 2013)