Agenda Part I: Overview of implementation of POC technologies Global Pan Canadian Regional-Quebec Part II: In-view CIHR funded Evidence syntheses HIV

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1 Point--of Point of--care (POC) for HIV and related coco-infections: Quo vadis? Nitika Pant Pai, MD., MPH., PhD Assistant Professor Division of Infectious Disease Division of Clinical Epidemiology Department of Medicine McGill University and Health Center

2 Agenda Part I: Overview of implementation of POC technologies Global Pan Canadian Regional-Quebec Part II: In-view CIHR funded Evidence syntheses HIV oral poc assays Syphilis finger stick assays Hepatitis B and C finger stick assays Part III: Panel discussion i Barriers and challenges Evidence to policy

3 Speakers Dr. Rosanna Peeling (London School of Hygiene & Tropical Medicine, i UK) Dr. Ameeta Singh (University of Alberta, Canada) Dr. Gilles Lambert (INSPQ, Canada) Dr. Pierre-Paul Paul Tellier (McGill Student Health Services, Canada) Dr. Jorge L. Martinez-Cajas (Queen s University, Canada) Dr. Christiane Claessens (INSPQ, Canada) Dr. Nitika Pant Pai (McGill University, Canada)

4 CONTEXT GLOBAL DISEASE BURDEN HIV and related co-infections i contribute greatly to disease burden HIV transmission and disease progression Estimated 350 million individuals are living with Hepatitis B (HBV), 130 million with Hepatitis C (HCV) and 80 million with Syphilis. UNAIDS Report on the Global HIV AIDS Epidemic Nov 2010 Estimated 32.8 million [30.9 million 34.7 million] Nov 2010 individuals are living with HIV infection HIV incidence falling in 22 countries in sub-saharan Africa ( >25%). In 2009, an estimated 2.6 million [2.3 million 2.8 million] people were newly infected with HIV ( 19% -21% fewer in 1999, 1997) ) About 370, 000 [ ] children were newly infected with ( 5% drop from previous years) New HIV infections are on a rise in high risk populations p of North America, Central Asia and Eastern Europe.

5 CONTEXT: UNDIAGNOSED INFECTIONS One in eight infected HIV individuals worldwide are aware of their sero-status status (1) In US, 250, ,000 individuals are living with undetected HIV infection. (2) 40% individuals test late for HIV, receive an AIDS diagnosis within 1 year after their first HIV test result. In Canada, of the estimated 60,000 individuals living with HIV in Canada, about 27% were unaware of their positive status. 3 Public Health Agency of Canada Late testing and treatment has implications for patients, providers and public health care systems 100,000 life years attributed to late presentation.(3) Conventional laboratory testing strategies, which may take a week to deliver results, are often ineffective in engaging high-risk populations into care. 12 a quarter of individuals tested do not return to pick up test results In an era of Universal Access to HAART, and with availability of point-of of-care testing technologies---is this acceptable?

6 POINT OF CARE

7 POINT-OF OF-CARE Diagnosis is not an end in itself. In general, medicine is directed towards the goal of improved health outcome. Fineberg, 1978

8 PART I: POINT-OF-CARE: Point-of of-care is a context specific term defined as at or near the site of patient care Bedside Or in front of the patient implies point-of-contact Key issues Faster turnaround time (TAT) communication of results to the clinical management team at bedside and health care professionals at an outreach/public health setting Results should be fast ideally within an hour or faster than conventional tests rapid /of low to medium complexity level l Ideal TAT minutes to expedite diagnosis and treatment initiation. 14, 15

9 POINT-OF-CARE: Ideally recommended for use in MULTI TEST ALGORITHMS Components- biomarkers, DNA/RNA Platform: Singleton or Multiplex One result at a time or high volume ( batches) Samples- whole blood, sera, urine, oral mucosal fluid, saliva. Potential for use Bedside, Intensive care, operating room Outpatient clinics Physician s office, Labs in public health clinics, outreach setting Primary care, Emergency care, Disaster response

10 POINT-OF-CARE: SIMPLE? FDA s definition iti of a SIMPLE TEST Full automated, unitized, self contained Direct un-processed specimens Non technique dependent sample and reagent manipulation No specialized training, no electronic or mechanical maintenance No operator calibration, interpretation or calculation Test results comparable to a reference standards Tests used in multi-test test algorithms not the sole test for screening or confirmation

11 Point-of-care tests: criteria Ideal diagnostic test characteristics*assured: ACCURATE: High diagnostic accuracy Sensitivity, Specificity>98% User friendly Feasible Rapid: 1-20minute Economical/cost effective *Ref: WHO Tropical Diseases Research STI initiative Nature Microbiology Reviews 11

12 Dr. Rosanna Peeling SPEAKERS

13 Dr. Gilles Lambert SPEAKERS

14 Dr. Christiane Claessens SPEAKERS

15 Dr. Pierre-Paul Paul Tellier SPEAKERS

16 SPEAKERS Dr. Jorge L. Martinez-Cajas

17 Dr. Nitika Pant Pai SPEAKERS

18 Dr. Ameeta Singh SPEAKERS