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

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

7INSTI Procedure:

8INSTI Procedure…

Add Developer (2)Add Developer (2)

9INSTI Procedure…

Add Clarifying Solution (3)

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

CONTROLCONTROL

TABTAB

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.

TESTTEST

CONTROLCONTROL

TABTAB

CONTROLCONTROL

TESTTEST

TABTAB

TESTTEST

CONTROLCONTROL

TABTAB

12

TABTAB

TABTAB

TESTTEST

A. There is no dot on the membrane

INVALID results:

B. The test dot appears without the control dot

Recommendation:Recommendation:

INVALID tests with finger-INVALID tests with finger-stick blood samples in POC stick blood samples in POC settings should be repeated settings should be repeated with a fresh sample using a with a fresh sample using a new membrane unit, kit new membrane unit, kit components, and support components, and support materials.materials.

INSTI Interpretation…3

13

TABTAB

TESTTESTCONTROLCONTROL

• 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:INDETERMINATE:

INSTI Interpretation…4

14

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

Males

N=4560

Females

N=1615

Negative 4472 1606

Reactive 78 7

Indeterminate 10 2

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

21Results – Confirmatory Testing for POC Reactive Clients

Males*

N= 81

Females

N= 8

HIV Positive 71 6

HIV Ind 3 (all HIV +) 0

HIV Negative 7 2

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 LinAIDS Bureau, Ontario Ministry of Health and Long-term Care

• Frank McGee

• Ken EnglishPublic Health Laboratories

• Carol SwanteeOntario HIV Treatment Network

• Carol MajorMcMaster University

• Bethany Henrick