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

6. 6

7. 7 INSTI Procedure:

8. 8 INSTI Procedure… Add Developer (2)

9. 9 INSTI Procedure… Add Clarifying Solution (3)

10. 10 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. INSTI Interpretation CONTROL TAB

11. 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. TEST CONTROL TAB CONTROL TEST TAB TEST CONTROL TAB

12. 12 TAB TAB TEST A.There is no dot on the membrane INVALID results : 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. 13 TAB TEST CONTROL 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. INDETERMINATE: INSTI Interpretation…4

14. 14

15. 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. 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. 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. 18 Results – Proportion choosing POC Males – 96.5% (4560/4721) Females – 87.1% (1615/1824) Overall – 94.3% (6175/6545)

19. 19 Results – POC Testing Males N=4560 Females N=1615 Negative44721606 Reactive787 Indeterminate102

20. 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. 21 Results – Confirmatory Testing for POC Reactive Clients Males* N= 81 Females N= 8 HIV Positive716 HIV Ind3 (all HIV +)0 HIV Negative72

22. 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. 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. 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