Presentation to: 2007 HIV Diagnostics Conference Atlanta, December 5-7, 2007

1. Results of a Pilot Point-of-Care (POC) HIV Testing Program using INSTI HIV in an Urban Sexual Health Clinic in Canada Presentation to: 2007 HIV Diagnostics Conference Atlanta, December 5-7, 2007

2. Hassle Free Clinic, Toronto • Community-based inner city sexual health clinic (1973) • Funded by City of Toronto, Ontario Ministry of Health and Long-term Care (MOHLTC) and donations • Approximately 18,000 client visits per year (non HIV) • Offers anonymous HIV testing (since 1985) • Legislated in 1992, guidelines developed by MOH • Voluntary testing, counseling and reporting system • >5000 tests per year • First Canadian clinic to offer HIV Point of Care testing • Male (70%) • Female (30%)

3. Rationale for HIV POC testing • Uptake and access – high client and provider satisfaction • Requires only one appointment for pre and post-test counseling for non-reactive results (>98%) • Ensures continuity with client • Better reinforcement of harm reduction strategies • Increased acceptance of negative results • Easier to deliver preliminary reactive results • Follow-up appointment for confirmatory results • May require additional support during wait period • If high risk, clinic begins referral process before confirmatory • Increased clinic capacity (25% more clients), better workflow

4. INSTI HIV Test • Produced by bioLytical Laboratories Inc., Richmond, BC • 2 years of Canadian clinical trials, 16,000 tests • Licensed as Class IV Medical Device by Health Canada, 2005 • CE Marked • USAID PEPFAR waiver listed Package insert performance characteristics • Sensitivity (fingerstick) 99.6% [CI 98.9 – 99.5%] • Specificity (fingerstick) 99.3% [CI 98.9 – 99.5%]

5. 1 1 2 2 INSTI Test System IgG capture/ blue labeled Control Spot Human IgG IgG capture IgG capture/ blue labeled Anti-HIV 1/2 Test Spot HIV 1/2 Antigens

7. INSTI Procedure:

8. INSTI Procedure… Add Developer (2)

9. INSTI Procedure… Add Clarifying Solution (3)

10. INSTI Interpretation • NON-REACTIVE: • One blue dot, clearly discernible above any background tint on the membrane. • This is the IgG Control Spot: shows test has been performed correctly and sample has been added. • The control is located towards the top of the read frame, furthest from the plastic tab on the Membrane Unit. • No reaction should be visible at the test spot, located below the control. • This result indicates antibodies to HIV-1/HIV-2 were not detected. CONTROL TAB

11. INSTI Interpretation…2 • REACTIVE: • Two blue dots discernible above any background tint indicate possible presence of HIV-1/HIV-2 antibodies. • One dot may be darker than the other. • A sample giving this pattern is considered a preliminary reactive. • Following a reactive rapid test result, a venous blood sample must be drawn for laboratory-based confirmatory testing. CONTROL CONTROL CONTROL TEST TEST TEST TAB TAB TAB

12. TAB TAB TEST INVALID results: A. There is no dot on the membrane B. The test dot appears without the control dot Recommendation: INVALID tests with finger-stick blood samples in POC settings should be repeated with a fresh sample using a new membrane unit, kit components, and support materials. INSTI Interpretation…3

13. INSTI Interpretation…4 • The test is INDETERMINATE if a faint background ring appears on the test area. • Following an indeterminate test result, a venous blood sample must be drawn in an EDTA collection tube (for whole blood or plasma) or red-top tube (for serum), and forwarded to a laboratory for HIV confirmatory testing. CONTROL TEST TAB INDETERMINATE:

15. Objective • To evaluate the efficacy of HIV POC testing at Hassle Free Clinic • To set standards of care for HIV POC testing • To monitor client uptake and satisfaction • To evaluate provider satisfaction

16. Methods • Clients attending HFC for anonymous HIV testing were offered routine lab based or POC testing during pre-test counseling • Routine HIV testing was performed by the Central Public Health Laboratory (CPHL) • POC testing was done using INSTI HIV • POC Negative clients received post-test counseling • POC Reactive clients were counseled and offered lab-based confirmatory testing • Confirmatory testing (EIA, p24, WB) was done STAT by CPHL • Final post-test counseling and referrals in 1-2 weeks

17. Results • Between May 15, 2006 and September 30, 2007 • 6545 clients attended HFC for HIV anonymous testing • 4721 Male (53% MSM, <1% High Risk Heterosexual (HRH)) • 1824 Female ( 8% HRH, <1% IDU)

18. Results – Proportion choosing POC • Males – 96.5% (4560/4721) • Females – 87.1% (1615/1824) • Overall – 94.3% (6175/6545)

19. Results – POC Testing

20. Results – Follow-up testing Males – 78 Reactive + 10 Indeterminate = 88 81 accepted confirmatory testing 7 declined follow-up testing • 5 had a previous HIV diagnosis • 1 opted to go to primary care physician for confirmatory • 1 declined confirmatory Females – 7 Reactive + 2 Indeterminate = 9 8 accepted confirmatory testing 1 declined follow-up testing • 1 had a previous HIV diagnosis

21. Results – Confirmatory Testing for POC Reactive Clients

22. Conclusions - INSTI Performance • Specificity 6079/6087 x 100 = 99.85% [CI 99.7-99.9] • Positive Predictive Value 80/89 x 100 = 89.89%

23. Conclusions • Based on HFC experience and INSTI HIV performance, the MOH is expanding rapid HIV POC testing to 60 anonymous HIV and sexual health clinics in Ontario • Implementation includes new counseling guidelines, training for providers, rigorous quality assurance policies and procedures including kit controls and external quality assessment, and a system to collect epi data on all testers. • Anticipated volume – 60,000 tests per year

24. Acknowledgements Hassle Free Clinic • Jane Greer, Leo Mitterni, Craig Stephen, Amy Lin AIDS Bureau, Ontario Ministry of Health and Long-term Care • Frank McGee • Ken English Public Health Laboratories • Carol Swantee Ontario HIV Treatment Network • Carol Major McMaster University • Bethany Henrick