global lessons on access to testing and linkage · global lessons on access to testing and linkage...
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Global Lessons on Access to
Testing and Linkage
Rosanna W PeelingProfessor and Chair, Diagnostic Research
London School of Hygiene & Tropical MedicineDirector, International Diagnostics Centre
Professor, University of Manitobawww.idx-dx.org
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Land acknowledgement
I would like to acknowledge the Algonquin nation whose traditional and unceded territory we are gathered upon today
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Lessons Learnt in Increasing Access to Testing and Linkage to Care
• The true meaning of leaving no one behind – importance of empowering communities (social and technological innovation)
• Privacy and confidentiality concerns - Dean Street model, MSM testing in China, self testing in rural Malawi
• Quality assurance and the power of connectivity
• The laboratory as a Command Centre
• The long road to adoption of new tests
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Sustainable Development Goals (SDGs):A Global Pledge to Leave No-One Behind
WHO Sustainable Development Goals. http://www.who.int/sdg/targets/en/
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ASSURED Tests
to Improve Global Health
A = Affordable
S = Sensitive
S = Specific
U = User-friendly
R = Rapid and robust
E = Equipment-free
D = Deliverable
✓ Affordability
✓ Accuracy
✓ Accessibility
Mabey D, et al. Diagnostics for the developing world. Nature Rev Microbiol 2: 231-40, 2004.
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prenatal
HAITI: >300,000 screened, 3% +
CHINA: >5,272 screened, 1.9% +
TANZANIA: 58,249 screened, 10.9%+ZAMBIA:
11,460 screened, 9.2%+
BRAZIL: 45,971 screened,1.6% +
PERU: 15,985 screened, 1.0% +
UGANDA: 13,131 screened, 5.3% +
Introduction of Rapid Syphilis Tests in 7 countries:
Social Entrepreneurship for Sexual Health to provide
MSM friendly services in China
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WHAT ARE SOCIAL INNOVATIONS IN HEALTH?
• a new and unconventional solution developed by
various actors (communities, civil society, public
sector, private sector) to a health care delivery
challenge that enables health care delivery to be
more inclusive, effective and affordable for all
• It has a positive effect on people’s life beyond
health (equity, dignity, empowering people)
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Social innovation
research hubs network
Universal Health
Coverage
WHO integrated people -centred health
services framework
A KEY ELEMENT IN THE GLOBAL DEVELOPMENT AGENDA 2030
Social innovation embedded in country
health systems
Research
Capacity
Advocacy
► Vulnerable population
► People-centred
► Community-based
► Partnership-based
► Inter-sectoral
► Multidisciplinary
► Data-driven
• Adding social value?• Political buy-in?• Technologically sound?• Sustainable?
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Lessons Learnt in Increasing Access to Testing and Linkage to Care
• The true meaning of leaving no one behind – importance of empowering communities (social and technological innovation)
• Privacy and confidentiality concerns - Dean Street model, MSM testing in China, self testing in rural Malawi
• Quality assurance and the power of connectivity
• The laboratory as a Command Centre
• The long road to adoption of new tests
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Addressing Privacy and Confidentiality Concerns
• Dean Street Model: an award winning HIV and sexual health NHS clinic in the heart of Soho supplying care that meets the needs of all patients regardless of sex, gender, sexuality or lifestyle. www.dean.st.
• Crowdsourcing video messaging to reach at risk populations to increase uptake of syphilis testing in MSM populations in China
• Kindness is infectious: Pay it forward model for STI testing
• Challenges of HIV self-testing in rural Malawi
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Lessons Learnt in Increasing Access to Testing and Linkage to Care
• The true meaning of leaving no one behind – importance of empowering communities (social and technological innovation)
• Privacy and confidentiality concerns - Dean Street model, MSM testing in China, self testing in rural Malawi
• Quality assurance and the power of connectivity
• The laboratory as a Command Centre
• The long road to adoption of new tests
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ISO 15189: Quality Standards
for Medical Laboratories
Major Sources of Error:
• Proficiency of personnel
• Condition of the specimens
• Controls
• Reagents
• Equipment
• Interpretation of results
• Transcription of results
• Reporting of results
Pre-analytical
• Sample request
• Sample collection
• Sample transport
• Sample reception
• Sample registration
Analytical
• Sample preparation
• Sample processing
• Sample examination
• Recording of results
Post-analytical
• Reporting of results
• Storage of samples
• Disposal of samples
62-76% of errors
6-15% of errors
18-30% of errors
Source: Mike Noble, UBC
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Quality Systems for Diagnostic Tests and Testing
Laboratory Facility ISO 15189
Staff
LicensureExternal Quality
Assessment
Tests
Guidelines
Specimen Accurate Result
+
Harare
Chinhoyi
Kariba
Hwange
Gweru
Beitbridge
Masvingo
Mutare
Bulawayo
Chitungwiza
Binga
Kadoma
Harare
Chinhoyi
Kariba
Hwange
Gweru
Beitbridge
Masvingo
Mutare
Bulawayo
Chitungwiza
Binga
Kadoma
Conventional
POC
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Point-of-Care Tests: Training and Quality Assurance Challenges
District Hospital
Labs, N= ~160
POC Testing SitesN = ~1,500
Reference Lab(s)
Globally, ~140 million HIV RDTs being performed/year;Consider the implications of 1% error…………..
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The Need for Connectivity in Zimbabwe
Harare
Chinhoyi
Kariba
Hwange
Gweru
Beitbridge
Masvingo
Mutare
Bulawayo
Chitungwiza
Binga
KadomaMOH, QA Managers, Reference Labs, NPHL, SCM, ProvincialMedical Directors, District andProvincial Hospitals
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Lessons Learnt in Increasing Access to Testing and Linkage to Care
• The true meaning of leaving no one behind – importance of empowering communities (social and technological innovation)
• Privacy and confidentiality concerns - Dean Street model, MSM testing in China, self testing in rural Malawi
• Quality assurance and the power of connectivity
• The laboratory as a Command Centre
• The long road to adoption of new tests
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Ensuring Quality:The Lab as a Command Centre
Ref: Boeras DI, Nkengasong JN, Peeling RW. Implementation science: the laboratory as a command centre. Curr Opin HIV AIDS 2017: 12:171–174.
The Laboratory needs to take on the
role of a Command Centre that
provides:
• training, quality assurance and
supervision of POC testing sites
• Collate surveillance data and turn data
into intelligence for outbreak alerts
and control interventions
• Conduct research into implementation
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Lessons Learnt in Increasing Access to Testing and Linkage to Care
• The true meaning of leaving no one behind – importance of empowering communities (social and technological innovation)
• Privacy and confidentiality concerns - Dean Street model, MSM testing in China, self testing in rural Malawi
• Quality assurance and the power of connectivity
• The laboratory as a Command Centre
• The long road to adoption of new tests
![Page 19: Global Lessons on Access to Testing and Linkage · Global Lessons on Access to Testing and Linkage Rosanna W Peeling Professor and Chair, Diagnostic Research London School of Hygiene](https://reader033.vdocuments.us/reader033/viewer/2022060719/607f0c77a88efb2038034f8b/html5/thumbnails/19.jpg)
Explosion in Rapid and Accessible Diagnostic Technologies
Source: W. Rodriguez
Laksanasopin et al. A smartphone dongle for diagnosis of infectious diseases at the point of care. Science translational medicine 7 (273), 273re1-273re1, 2015
Priye, A. et al. A smartphone-based diagnostic platform for rapid detection of Zika, chikungunya, and dengue viruses. Sci. Rep. 7, 44778; doi: 10.1038/srep44778 (2017).
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Dare to Dream NG-AMR POCT:
• 33, 431 ceftriaxone treatments are given annually In the UK for gonorrhoea (2014)
• Antibiotic susceptibility testing was performed on all available NG isolates
• A modelling study showed that if a 30 min AMR POC test:
- for NG + penicillin resistance were available , 79% of current tx could be replaced by penicillin
- for GC + ciprofloxacin resistance were available, 66%of current tx could be replaced by ciprofloxacin
-
• AMR POCT can:√ reduce loss to follow up √ extend the life of current last-line treatment√ be cost-saving
Source: US CDC Image Library
Ref: Turner KME, et al. BMJ Open 2017;7:e015447.
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Accuracy Professional Use Over-the-Counter
Minimum Recommended Performance: lower bound of 2-sided 95% CI
Actual Performance
Minimum Recommended Performance for the lower bound of 2-sided 95% CI
Actual Performance
Sensitivity 98% 99.3%
(98.4-99.7%)
95% 92.98%
(86.6-96.9%)
Specificity 98% 99.8%
(99.6-99.9%)
95% 99.98%
(99.9-100%)
FDA Approval OraSure HIV Testin 2012: Accessibility vs Accuracy
A risk-benefit model showed that in the first year of use:~ 4,500 new HIV infections identified among those not aware of their HIV status ~ 2,700,000 who would test negative
~4,000 transmissions would be averted, outweighing the individual risk of ~1,100 false negative resultsThe product would need to have clear messages on the implications of test results
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Accelerating Access to Quality-assured Diagnostics
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Thank you• LSHTM/IDC: David Mabey, Peter Smith, Debi Boeras, Maurine Murtagh,
Ben Cheng, Joe Tucker, Dan Wu, Noah Fongwen, Adrianna Gonsalves, Jack Butterworth, Carlos Gouvea, Helen Kelly
• Syphilis project: Adele Benzaken, Patricia Garcia, Xiang-Sheng Chen, Bill Pape, Dan Fitzgerald, Cathay Wilfert
• SystemOne: Natasha Gous, Brad Cunningham, Jeff Tackle
• Funding: Bill & Melinda Gates Foundation, Grand Challenges Canada, UNITAID, UK EPSRC, European Commission