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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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