Rapid/point of care Rapid/point of care Diagnostic Tests for HIV andDiagnostic Tests for HIV andDiagnostic Tests for HIV and Diagnostic Tests for HIV and syphilis: where are we at in syphilis: where are we at in ypyp

Alberta? Alberta? Ameeta Singh, BMBS (UK), MSc, FRCPCAmeeta Singh, BMBS (UK), MSc, FRCPCClinical Professor, Division of Infectious Clinical Professor, Division of Infectious ,,

Diseases, University of AlbertaDiseases, University of AlbertaCIHR Rapid Diagnostics Workshop, CIHR Rapid Diagnostics Workshop,

Montreal (by teleconference)Montreal (by teleconference)( y )( y )

NOVEMBER 30, 2010NOVEMBER 30, 2010SLIDE 1

Which of the following statements is/are true Which of the following statements is/are true about the availability of rapid diagnostic about the availability of rapid diagnostic y p gy p g

tests for HIV/STI in Alberta?tests for HIV/STI in Alberta?

1 R id HIV t t il bl t th i t1. Rapid HIV tests are available at the point of care at STI Clinics

2. Rapid HIV tests are available through select hospital laboratories for acute care settings

3. Rapid diagnostic tests for syphilis are p g ypcoming to Edmonton!

SLIDE 2

Background to rapid testing for Background to rapid testing for HIV i C dHIV i C dHIV in CanadaHIV in Canada

• Previous HIV kit in Canada (Biochem)Previous HIV kit in Canada (Biochem) removed from market in 2002 due to “performance” difficultiesperformance difficulties

• Vancouver: test kit did not detect some early HIV infectionsearly HIV infections

htt // h /dh / d ff/http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2002/fast_check_hiv-vih_hpc-cps-eng.php

SLIDE 3

INSTIINSTI™ HIV test kit™ HIV test kitINSTIINSTI HIV test kit HIV test kit

• INSTI™ HIV Test kit (bioLyticalINSTI HIV Test kit (bioLytical Laboratories, Richmond, British Columbia) approved for use by Health Canada in pp yOctober 2005– Serum, plasma and whole blood– Detects both HIV 1 & HIV 2– Storage at ambient temperature– May be performed outside of laboratory

setting (e.g., clinics, ER departments, etc)

SLIDE 4

SLIDE 5

I 2006/7 i i l di iI 2006/7 i i l di iIn 2006/7, provincial discussions In 2006/7, provincial discussions about how to use the new kitabout how to use the new kit

-- needed to weigh the unknown needed to weigh the unknown performance of kit in “real life” butperformance of kit in “real life” butperformance of kit in real life but performance of kit in real life but make available in clinical settings.make available in clinical settings.

Decision made to introduce pilot to Decision made to introduce pilot to evaluate kit in acute care settings evaluate kit in acute care settings

where immediate medical care would where immediate medical care would change based on test resultchange based on test resultchange based on test result.change based on test result.

SLIDE 6

Albert Rapid HIV Testing Policy/Guidelines: Albert Rapid HIV Testing Policy/Guidelines: Clinical Decision MakingClinical Decision Making

• Negative Rapid HIV test resultNegative Rapid HIV test result– Parallel testing to be performed – Consideration of “window period” for HIV testingConsideration of window period for HIV testing

• Preliminary positive Rapid HIV test result:– Requires confirmatory testing– Requires confirmatory testing– Urgent medical intervention as required

depending on clinical situationp g– HIV epidemiology and public health

considerations

SLIDE 7

Alberta Rapid HIV PilotAlberta Rapid HIV Pilot

SLIDE 8

Alberta Rapid HIV Pilot:Alberta Rapid HIV Pilot:SitesSites

Pil t d t 5 h it l

S esS es

-Piloted at 5 hospitals in Alberta

2 urban/3 non urban-2 urban/3 non-urban

-Sites selection based on provincial HIVon provincial HIV epidemiology patterns

SLIDE 9

Alberta Rapid HIV Pilot: MethodsAlberta Rapid HIV Pilot: Methods• Used the INSTI Kit (BioLytical)• Performed in hospital labs (not POC) and using serum p ( ) g

(blood draw) not whole blood (fingerprick)• Run in parallel to routine serology testing (ProvLab)

U d f 3 li i l it i l• Used for 3 clinical criteria only:1. Pregnant woman at delivery or close-to-term

• no previous prenatal HIV test orno previous prenatal HIV test or• previous negative HIV tests with ongoing risk for

HIV2 S i bl d d b d fl id (2. Source in blood and body fluid exposure (e.g.

needlesticks)3. Acutely ill patient with risk factors or clinical y

suspicions for HIV infection

SLIDE 10

Alberta Rapid HIV Pilot: Start Alberta Rapid HIV Pilot: Start D t b SitD t b SitDates by SiteDates by Site

RHA Hospital Start date 1st specRHA Hospital Start date 1 spec collected

Capital Royal Alexandra Hospital, Edmonton

30-Apr-07 2-May-07Edmonton

Palliser Brooks Hospital,Brooks

15-May-07 4-Jun-07

Northern Lights

Northern Lights Health Centre, Fort McMurray

20-Jun-07 13-Jul-07

Peace Queen Elizabeth II 11-Jun-07 14-Jun-07Country Hospital, Grande PrairieCalgary Peter Lougheed Hospital,

Calgary1-Dec-07 5-Dec-07

Calgary

SLIDE 11

Alberta Rapid HIV Pilot: Reason for Testing by SiteAlberta Rapid HIV Pilot: Reason for Testing by Site

Reason for Rapid HIV Testing by Site (n=1737)1000

700

800

900

Test

s

Pregnant Woman

400

500

600

of R

apid

HIV

Source Patient

Acutely Ill

Needlestick

100

200

300

400

Num

ber o Needlestick

recipient Not provided

0

100

Brooks HealthCentre

NorthernLights Health

Centre

PeterLougheed

Centre

QueenElizabeth II

RoyalAlexandraHospitalCentre Centre Hospital

*data reported up to November 23, 2009

SLIDE 12

Alberta Rapid HIV Pilot: ResultsAlberta Rapid HIV Pilot: Resultspp• 25 Reactive Rapid Tests

24/1737 (1 4%) C fi d iti (W t Bl t)– 24/1737 (1.4%) – Confirmed positives (Western Blot)– One false-positive test

Clinical Category New Positive Previous PositiveClinical Category New Positive(n=11)

Previous Positive (n=13)

Acutely Ill Patient 10 4Acutely Ill Patient 10 4

Source of BBFE1 1 * 9

Pregnant Women 0 0

* From Northern site – usual transportation time >24 hrs

1Blood and body fluid exposureSLIDE 13

Alberta Rapid HIV Pilot: Alberta Rapid HIV Pilot: P f Ch t i ti f T tP f Ch t i ti f T tPerformance Characteristics of TestPerformance Characteristics of Test

• In Comparison to Standard HIV Testing- One False-Positive- No False-Negatives

– Sensitivity (24/24) =100%– Specificity (1702/1703) =99.9%

P iti P di ti V l (24/25) 96%– Positive Predictive Value (24/25)=96%– Negative Predictive Value (1702/1702)=100%

SLIDE 14

Alberta Rapid HIV Pilot: Quality Alberta Rapid HIV Pilot: Quality A i t tA i t tAssurance importantAssurance important

Study coordinatorStudy coordinator• rapid test inventory • lot releaselot release• distribution of kits to pilot sites• proficiency testing• proficiency testing • follow-up with the manufacturers in case of

issues with the assayissues with the assay• training on the use of the kit was provided to

testing sites using a train-the-trainer modeltesting sites using a train the trainer model

SLIDE 15

Alberta Rapid HIV Pilot: Results Alberta Rapid HIV Pilot: Results and Recommendationsand Recommendationsand Recommendationsand Recommendations

• Significant Decrease in Median Turn-around-TimeRapid Results reported back in ~ 1 hour– Rapid Results reported back in ~ 1 hour

– Standard specimens received at ProvLab: 5-45 hrs• - Urban: 5 hrs ( <1-41 hrs) - Non-Urban: 44 hrs (3-318 hrs)

• Direct feedback and questionnaires from participating• Direct feedback and questionnaires from participating sites– Rapid HIV testing enhanced clinical care and provided results

in a clinically helpful timeframein a clinically helpful timeframe.– Would like this program to continue past the pilot phase

• Recommended to provincial authorities: – Review re continuation of the program at existing sites – Expansion to other sites ( e.g. other hospitals, STI clinics)– Continue to confirm all positives in parallel with routine

l ? N d t ti l d t ll l t ti f llserology; ? Need to routinely conduct parallel testing for all negatives vs samples for QA only

SLIDE 16

Rapid/point of care tests Rapid/point of care tests for Syphilis and HIV for Syphilis and HIV

j t i Alb tj t i Alb tproject in Albertaproject in Alberta

SLIDE 17

Rapid/Point of Care Syphilis Rapid/Point of Care Syphilis d HIV P j t B k dd HIV P j t B k dand HIV Project: Backgroundand HIV Project: Background

- Alberta – ongoing syphilis outbreakAlberta ongoing syphilis outbreak - Syphilis and HIV cases affecting similar

populations; many cases co-infectedpopulations; many cases co infected

- Syphilis POC tests widely used internationally –Syphilis POC tests widely used internationally no test approved for use in N. America

- “Test and treat” – infectious syphilis easilyTest and treat infectious syphilis easily treated with one dose of penicillin

SLIDE 18

Rapid Syphilis/HIV Project: MethodsRapid Syphilis/HIV Project: Methods- Syphilis and HIV POCT will be offered at

Edmonton STI clinic and outreach servicesEdmonton STI clinic and outreach services using fingerprick (whole blood) specimensParallel standard HIV and Syphilis testing- Parallel standard HIV and Syphilis testing (7-10 days TAT) Obj ti- Objectives:- Evaluate performance characteristics of POC

Examine correlates of positive HIV and Syphilis tests- Examine correlates of positive HIV and Syphilis tests- Evaluate use of POC tests and for syphilis, improving

syphilis treatmentyp

SLIDE 19

Alberta ProvLab evaluation of Alberta ProvLab evaluation of SD Bi li S hili 3 0 kitSD Bi li S hili 3 0 kitSD Bioline Syphilis 3.0 kitSD Bioline Syphilis 3.0 kit

• 90 serum samples tested: p10 negatives

• Crude sensitivity: 92% (declines with low EIA(declines with low EIA values)

• Specificity: 100%Q i k t t 2 5 i f• Quick test: 2-5 mins for a positive, and 20 mins for a negative (complete by 10 i f t10mins; manufacturer states 20mins is max cutoff time for reading)

Courtesy: Dr. Kevin Fonseca, Alberta ProvLab, 2009SLIDE 20

Rapid Syphilis/HIV Project :Current Rapid Syphilis/HIV Project :Current St tSt tStatusStatus

• Approvals in place:Approvals in place:– Health Canada Therapeutics Products

Directorate to use SD BioLine Syphilis 3 0 kitDirectorate to use SD BioLine Syphilis 3.0 kit– Ethics – University of Alberta and Health

CanadaCanada• Funding from:

Pubic Health Agency of Canada and the– Pubic Health Agency of Canada and the Edmonton Inner City Health Research Network (EICHREN)Network (EICHREN)

SLIDE 21

Rapid Syphilis/HIV Project :Current Rapid Syphilis/HIV Project :Current St tSt tStatusStatus

• Kits ordered from KoreaKits ordered from Korea• Note: Canadian distributor (Affinity

Diagnostics) in place but unable to provideDiagnostics) in place but unable to provide kits at previously agreed price

• Tentative start date: February 1, 2011• Proposed project duration: 2 years

SLIDE 22

Which of the following statements is/are true Which of the following statements is/are true about the availability of rapid diagnostic about the availability of rapid diagnostic y p gy p g

tests for HIV/STI in Alberta?tests for HIV/STI in Alberta?

1 R id HIV t t il bl t th i t1. Rapid HIV tests are available at the point of care at STI Clinics

2. Rapid HIV tests are available through select hospital laboratories for acute care settings

3. Rapid diagnostic tests for syphilis are p g ypcoming to Edmonton!

SLIDE 23

ConclusionsConclusionsConclusionsConclusions

• Reliable rapid diagnostic tests for HIV areReliable rapid diagnostic tests for HIV are available in Canada and have the potential to provide a preliminary test result at theto provide a preliminary test result at the point of care within ½ hour

• Rapid diagnostic tests are available on the• Rapid diagnostic tests are available on the global market for syphilis and we hope to try them in the not too distant future!try them in the not too distant future!

SLIDE 24

AcknowledgmentsAcknowledgmentsAcknowledgmentsAcknowledgmentsAlberta:

D B it LPublic Health Agency of Canada

D T W• Dr. Bonita Lee • Dr. Sabrina Plitt, • Dr. Jutta Preiksaitis• Jayne Fenton (Senior

• Dr. Tom Wong• Dr. Gaya Jayaraman• Dr. Chris Archibald

y (Technologist, ProvLab)

Alberta Health and Wellness London School of Hygiene and Tropical Medicine

Edmonton Inner City Health Research Network (EICHREN)

Tropical Medicine• Dr. Rosanna Peeling

Colleagues across the province of Alberta who contributed to the development and implementation of the rapid HIVimplementation of the rapid HIV pilot

SLIDE 25