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

Hassle Free Clinic, TorontoCommunity-based inner city sexual health clinic (1973)Funded by City of Toronto, Ontario Ministry of Health and Long-term Care (MOHLTC) and donationsApproximately 18,000 client visits per year (non HIV)Offers anonymous HIV testing (since 1985)Legislated in 1992, guidelines developed by MOHVoluntary testing, counseling and reporting system>5000 tests per yearFirst Canadian clinic to offer HIV Point of Care testingMale (70%)Female (30%)

Rationale for HIV POC testingUptake and access high client and provider satisfactionRequires only one appointment for pre and post-test counseling for non-reactive results (>98%)Ensures continuity with clientBetter reinforcement of harm reduction strategiesIncreased acceptance of negative resultsEasier to deliver preliminary reactive resultsFollow-up appointment for confirmatory resultsMay require additional support during wait periodIf high risk, clinic begins referral process before confirmatoryIncreased clinic capacity (25% more clients), better workflow

INSTI HIV TestProduced by bioLytical Laboratories Inc., Richmond, BC2 years of Canadian clinical trials, 16,000 testsLicensed as Class IV Medical Device by Health Canada, 2005CE MarkedUSAID PEPFAR waiver listedPackage insert performance characteristicsSensitivity (fingerstick) 99.6% [CI 98.9 99.5%]Specificity (fingerstick) 99.3% [CI 98.9 99.5%]

INSTI Test SystemHuman IgGIgG capture/ blue labeledIgG captureControl SpotTest SpotIgG capture/ blue labeledAnti-HIV 1/2HIV 1/2 Antigens

INSTI Procedure:

INSTI ProcedureAdd Developer (2)

INSTI ProcedureAdd Clarifying Solution (3)

INSTI Interpretation

INSTI Interpretation2

INSTI Interpretation3

INDETERMINATE:INSTI Interpretation4

ObjectiveTo evaluate the efficacy of HIV POC testing at Hassle Free ClinicTo set standards of care for HIV POC testingTo monitor client uptake and satisfactionTo evaluate provider satisfaction

MethodsClients attending HFC for anonymous HIV testing were offered routine lab based or POC testing during pre-test counselingRoutine HIV testing was performed by the Central Public Health Laboratory (CPHL)POC testing was done using INSTI HIVPOC Negative clients received post-test counselingPOC Reactive clients were counseled and offered lab-based confirmatory testingConfirmatory testing (EIA, p24, WB) was done STAT by CPHLFinal post-test counseling and referrals in 1-2 weeks

ResultsBetween May 15, 2006 and September 30, 2007

6545 clients attended HFC for HIV anonymous testing

4721 Male (53% MSM,

Results Proportion choosing POCMales 96.5% (4560/4721)

Females 87.1% (1615/1824)

Overall 94.3% (6175/6545)

Results POC Testing

MalesN=4560FemalesN=1615Negative44721606Reactive787Indeterminate102

Results Follow-up testingMales 78 Reactive + 10 Indeterminate = 88 81 accepted confirmatory testing7 declined follow-up testing5 had a previous HIV diagnosis1 opted to go to primary care physician for confirmatory1 declined confirmatoryFemales 7 Reactive + 2 Indeterminate = 9 8 accepted confirmatory testing1 declined follow-up testing1 had a previous HIV diagnosis

Results Confirmatory Testing for POC Reactive Clients

Males*N= 81FemalesN= 8HIV Positive716HIV Ind3 (all HIV +)0HIV Negative72

Conclusions - INSTI PerformanceSpecificity

6079/6087 x 100 = 99.85% [CI 99.7-99.9]

Positive Predictive Value

80/89 x 100 = 89.89%

ConclusionsBased on HFC experience and INSTI HIV performance, the MOH is expanding rapid HIV POC testing to 60 anonymous HIV and sexual health clinics in OntarioImplementation 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

AcknowledgementsHassle Free ClinicJane Greer, Leo Mitterni, Craig Stephen, Amy LinAIDS Bureau, Ontario Ministry of Health and Long-term CareFrank McGeeKen EnglishPublic Health LaboratoriesCarol SwanteeOntario HIV Treatment NetworkCarol MajorMcMaster UniversityBethany Henrick

Thank organizers for the invitation to present our findingsHFC made a point of using the terminology

male identifiedfemale identified

I didnt put it in as it might confuse this audience.HIV POC testing has been available in Canada during clinical trials for the test devices and during the tenure of another device, which is no longer available.HFC has had considerable experience with HIV POC testing and both the clients and providers have been very satisfied. Canadian trials took place in several sites across the country.CE marked means approved in the European UnionUSAID PEPFAR waiver listed (not sure)

Performance is for FINGERSTICK slightly different for serum and plasma. In brackets is the 95% confidence interval (you dont need to quote it)On the molecular level, this is how the test works:It is based on IMMUNO-FILTRATION.A nitrocellulose membrane has two spots A control spot which contains an IgG capture antigenA test spot with HIV1 (gp41) and HIV2 (gp36) recombinant proteins.In Step 1 (red dot) the whole blood mixed in lysis buffer is added to the device. HIV antibodies (if present) will bind to the HIV antigens on the test spot (green and orange markers), and IgG will bind to the control spot (dark blue markers). This step takes about 20 seconds.In Step 2 (blue dot) the colour developer is added which will attach to an antibodies that have attached to the membrane. This step also takes about 20 seconds.

This is one test kit:Everything is included for one test:Package Insert-Alcohol Prep pad-easy cleaning of fingerLancet-One time use; engineered to puncture finger for 50uLPipette-calibrated to collect exact desired amountThree reagent vialsSample Diluent (lysis buffer)Colour developerClarifying solutionThe plastic device containing with the antigen coated membrane. Note the tab at the bottom of the device this marks the side of the device with HIV antigens.After counselling:1. The test finger is wiped with an alcohol swab and dried.4. The lancet is pressed down against finger, it is spring loaded and will retract5. The finger is massaged to produce a droplet of blood which is collected with the pipette.

(if questioned the pipette pictured is not the pipette currently distributed with the device the new one is a capillary pipette that is easier to use)This slide comes in from left to right one pic at a time.

Pic 1 - 50 ul of blood is added to Vial 1 (sample diluent)It is mixed by inverting several times to ensure lysis

Pic 2 - Then poured directly onto the membrane.

Pic 3 - Once the sample has gone through the membrane Vial 2 (colour developer is added)

After the colour developer has passed through the membrane Vial 3 which is a clarifying solution is added.

Then the result is read immediately.

Total time about 1 minute*How to read the results:In order for the test to be valid the control dot (indicating presence of IgG in the sample) must be BLUE. This dot is at the top of the reading frame.A Non-reactive result with have a control dot, but no test dot indicating that.-no HIV-1/HIV-2 antibodies were detected*Reactive:Two discernible dots above the background-Please note: these dots can be of varying intensity (one dot can be darker then the other)Considered Reactive for HIV antibodies: Confirmatory test must be done.*Invalid result:There are no dots or only HIV-positive dot.This case:-POC test should be repeated.Usually happens when insufficient sample to put into the system.*Indeterminate:This happens when there is a faint shadow or ring around the test spot. It is somewhat subjective.These are to be considered to be reactive and further confirmatory testing is required.These are examples of specimens tested with the Insti kit.

From Left strong positive

weak positive

Indeterminate

negativeThere were several objectives to the pilot program undertaken at HFC, however, we will only report on the efficacy of the testing.This is updated information - abstract was until May 15 now we have included up to September 30.

The population for male clients is predominantly (53%) gay or bisexual men. Our definition of high risk heterosexual includes those with female sexual partners that may be HIV + or at high risk for HIV infection such as IDU, sex workers, from endemic areas, etc.,For females the clients are predominantly low risk heterosexual with 8 % being high risk (partner HIV+ or at high risk for HIV (IDU, endemic area) and this also includes sexual assault.For those choosing POC testing these are the results----For those who had venous blood sent for confirmatory testing at the CPHL:For Males there were 81 confirmatory tests done- 71 were western blot positive all of these had been clearly reactive on Insti 3 were reported HIV indeterminate, but in fact were very early in HIV seroconversion and were seropositive at the next test these had been indeterminate on the Insti test 7 were HIV antibody negative (these had also been indeterminate on Insti)For Females there were 8 confirmatory tests done- 6 were western blot positive these were all Insti reactive- 2 were HIV antibody negative these were the 2 indeterminate Insti resultsWe have not included the 8 reactive Insti tests that did not go for confirmatory testing from our calculations.These are the observed results for Specificity and Positive predictive value based on the performance of the test at HFC for 16 months.

The specificity is the number identified as negative over the number that truly were negative.

The positive predictive value is the proportion of true positives amongst the number identified as reactive.

Our data does not allow us to calculate the observed sensitivity.