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H2020H2020H2020H2020----DSRDSRDSRDSR----4444----2014201420142014
This project has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement No 652868
Unmet diagnostic needs in pandemics: lessons from recent epidemics and opportunities for the future
Olga Vybornova, PhD, Anne-Sophie Piette, PhDJL Gala, MD, PhD- UCL, Brussels
Diagnostic and Situational awareness
Questionnaire
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1. Ontology and Decision Support (Sp)2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
February, 2016
Decision support in a fieldable laboratory management
during an epidemic outbreak of disease
Olga Vybornova and Jean-Luc Gala
December 2016
Decision Sp: common ontology and semantics
LIMS: SOP, Guidelines, Procedures, Methods, ….
Reference Lab Deployable lab
- Patient data acquisition(personal, epidemiological, clinical, biological)
- Sample(number, type, matrix, analytical request)
Heterogenous data(technologies, methods, reagents, format)
Caregivers
Decision makers
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1. Ontology and decision support2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
Develop Laboratory networks: interoperability and scalability
Inside and outside de EU
Interaction Joint - Exercise – Modularity
Sharing Knowledge / Material / Staff
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1. Ontology and decision support2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
Handwritten results, no data formatting, no shared da tabase
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• Location & health status of individual patients / Mecial or logistic Capacities
• GeoSearch directly on the map (Powered by Google search engine)
• Customizable background layers (Google Road/Terrain/Hybrid/Satellite)
• Print in PDF format
• Earth Observation or UAV imagery can be integrated
• Additional (pre-defined) POI’s/layers can be visualized
• Functionalities from other maps can be integrated
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Interactive maps through
website and/or mobile solution
EPIDEMIOLOGIC MAPPING: Data visualisation
Sample Reception &
Identification
Geolocalisation-
real-time
mapping
LIMS
CLOUD
Wireless (ICT-based)
Track & Trace
& Decision support
LIMS – ICT / Integrated solution
POCT NGS
Sample Analysis
Users - Crisis managers -
Health authorities
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1. Ontology and decision support2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
Disaster Medicine journal,
10:121-143.2015
Yet unmet need for POCT /RDT safely usable on-site
Lessons learned ?The Ebola Spatial Care PathTM: Accelerating point-o f-care diagnosis, decision making, and community resilienc e in outbreaks
Gerald J. Kost, MD, PhD, MS, FACB; William J. Ferguson, MS; Jackie Hoe; Anh-Thu Truong; AriratBanpavichit, MS, MBA; Surin Kongpila, MS
ORIGINAL ARTICLE
Conclusions: POCT is facilitating global health. Now, globalhealth problems are elevating POCT to new levels ofimportance for accelerating diagnosis and evidence-baseddecision making during disease outbreaks. Authorities concurthat rapid diagnosis has potential to stop disease spread.
The United States is not yet adequately prepared foroutbreaks of such an infectious and dangerous disease.
Harvard Business Review
August , 2016GOVERNMENT
The Fight Against Zika Can’t Wait for a Vaccine
The next best thing is widespread testing of at-risk populations so new cases can be identified immediately and prevented from transmitting to others. Widespread testing can also pinpoint “hot spots” where community-wide measures likemosquito spraying should be targeted.
by Ranu S. Dhillon, Devabhaktuni Srikrishna, and David BeierAUGUST 18, 2016
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POCT / RDT• Medical testing at or near the site of patient care
� >< centralization of testing in the lab
� complementary to (much slower) confirmatory methods
� Low cost, TAT, non-expert operator
• Different formats� Strip or conjugate pad: Lateral flow Assay (LFA)
� Cartridge
� Lab-on-a-chip (LOAC)
• Different Targets� Diagnosis: Protein >RNA / DNA isothermal ampl.: NASBA, RPA, LMAP, CRISPR….
� Biochem markers: Glucose,bloodgas, electrolytes, acid-base,….
FLUORIMETER
Isothermal amplification
(30-65°C)
LOAC
Ag or Abs detection using
Mpx Lateral Flow DeviceLaboratory-guided
clinical care
POCT GAPS – IMPROVEMENTS
� POCT rarely adapted to « syndromic diagnosis »
� Miss new emerging or rapidly changing agents (genetic drift; Ebola, Zika, YF…)
� Not safely applicable on-site due to biosafety issues
� Lack of standardization/ quality control and lack of concordance with laboratory testing;
� Technical characteristics (sensitivity, specificity, positive and negative predictive values) not always sufficiently determined or not representative of real conditions
� Sensitive to decontamination
POCT / RDT
i-STAT
Lateral flow assay
(malaria)
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1. Ontology and decision support2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
From Sanger to Next Generation Sequencing
Illumina
MiSeq
ABI
Sanger
Sequencing
MinION
Oxford Nanopore
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Several genes in a single sequencing reaction
• Multilocus Sequence Typing (MLST): 7, 15, more
• Antimicrobial resistance: known / unknown variant genes
• Virulence
• Shift / Drift surveillance
4.000.0000 – 5.000.0000 bp
icdA pabB uidA trpA
Gaps and need for improvement• Optimization of pre-analytical and analytical steps
• Bioinformatics and biostatics
Efficient NGS characterization of pathogens
1. Ontology and decision support2. Optimizing the functional networking of laboratories and
scaling up of diagnostic capacity in time of crisis3. Ensure an optimal transportation, tracking and tracing
(traceability) of the samples and related data 4. Use of new diagnostic tools for rapid detection of emerging
diseases at point-of-care5. Integrate NGS analyses in the routine surveillance and
response6. Improve biosafety and biosecurity
Diagnostic
Improvements – Innovations needed
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Sample Reception &
Identification
Geolocalisation-
real-time
mapping
LIMS
CLOUD
Wireless (ICT-based)
Track & Trace
& Decision support
BIOSECURITY
Sample & Data
protection
BIOSAFETY
Decontamination
LIMS – ICT / Integrated solution
POCT NGS
Sample Analysis
Users - Crisis managers -
Health authorities
Irenge LM, Dindart JM, Gala JLOn-site biochemical testing in a laboratory tent and semi-intensive care of Ebola patients in a remote part of Guinea: a paradigm shift based on bleach-sensitive point-of-care device CCLM in press 2017
Optimal characteristics of a POCT device to be used in highly contagious epidemic outbreaks: Biosafety ? SOP for Decontamination ?
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BC-Probe: non-contact LIDAR sensor
Handheld device: - Efficient decontamination ?
- Residal hazard ?
Site restoration and repatriation
Efficient and safe assessment
of Bio-contamination and decontamination
Post Earthquake- Cholera (water)- Norovirus (water)- Hantaan virus (endemic)
EU CBRN TrgC EU CBRN Cluster
MODEX
Ebola HF (outbreak) >< endemic Lassa HF Yellow Fever (imported cases )
ERCC
EERC / VP
DG SANTE
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