Transcript SARS Diagnostics and Laboratory Needs: the WHO Perspective C.E. Roth

SARS Diagnostics and Laboratory
Needs: the WHO Perspective
C.E. Roth
Dangerous and New Pathogens
Global Alert and Response
CSR/WHO
WHO Communicable Diseases, Surveillance & Response
1
WHO Alert & Response
Detecting and responding to SARS (1)
1) Virtual laboratory network for
SARS aetiology and
diagnostics

Convened mid-March 2003

13 laboratories in 9 countries, daily telephone
conference

identification of SARS coronavirus

face-to-face/video meeting, 16 April 2003
WHO Communicable Diseases, Surveillance & Response (CSR)
WHO Alert & Response
Detecting and responding to SARS (2)
2) Virtual network of SARS clinicians
3) Virtual network of SARS
epidemiologists
4) Global Outbreak Alert & Response
Network

field teams sent to countries, incl
lab scientists
5) Modelling group

10 institutions, secure web site
WHO Communicable Diseases, Surveillance & Response (CSR)
Lab Network Achievements (1)

Established an international group of experts to determine
aetiology of SARS and to develop diagnostic tests

Creation of laboratory network - communication through
regular teleconferencing and restricted access website

WHO Consultation on the aetiology of SARS and
development of diagnostic tests, 16 April 2003
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Coordinated an international scientific research program
to understand Ab kinetics, routes and pattern of virus
excretion, environmental stability of virus, and animal
reservoir

Sequencing of virus strains
WHO Communicable Diseases, Surveillance & Response (CSR)
Achievements (2)

Evaluations of SARS diagnostic tests
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Prepared guidelines on the use of laboratory tests for
SARS diagnosis

Developed procedures for sampling for SARS diagnosis
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Published results of research on the environmental
stability of the SARS coronavirus

Publication of several scientific papers by the members of
the WHO collaborative network on SARS aetiology and
diagnosis
WHO Communicable Diseases, Surveillance & Response (CSR)
Achievements (3)

WHO training course on SARS diagnosis in Beijing China
26 May to 4 June 2003 - planned for other sites in near
future
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Support to national reference laboratories
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Production and distribution of standard reagents
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Quality assurance
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Access to kits
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Creation of specimen bank - Hong Kong
WHO Communicable Diseases, Surveillance & Response (CSR)
Global Meeting: Laboratory issues 1
Animal models
– Pathogenesis of SARS-CoV
– Evolution of the disease
– Vaccine and antiviral testing
Vaccine strain development
– Evaluation of different vaccine constructs
– Epitope mapping (SARS-CoV & other
coronaviruses)
WHO Communicable Diseases, Surveillance & Response (CSR)
Global Meeting: Laboratory issues 2
Strain diversity / genomics
Antiviral drug screening / human monoclonal antibodies
Diagnostic test development – timely reliable tests
Need for STANDARDIZATION
Need for a well pedigreed panel of specimens to validate
future diagnostic assays
– Blood/serum, sputum, stool/urine, pathology
– Linked to clinical details
– Panel of SARS-CoV strains
WHO Communicable Diseases, Surveillance & Response (CSR)
Global Meeting: Laboratory issues 3
Reagents
– mAbs, polyclonal antisera, expressed antigen
Repository of reagents and isolates
– WHO leadership in establishing repository
– International collaboration
– Need for both live and inactivated virus
Additional sequencing of SARS- and non-SARS
coronaviruses
Guidelines for the distribution of SARS-CoV
Priority – reliable tests for clinical triage (positive within 2-7
days after symptom onset)
WHO Communicable Diseases, Surveillance & Response (CSR)
Current WHO perspective:
Public health priorities for diagnostics
development (1)
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Reliable, early (day 1-2), virus/ag detection assay (lab-based)
– - safe case management, conserve resources
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Reliable, early, near-patient screening assay – commence isolation, contact id and follow-up

Network of reference labs (+ logs) for countries w/o adequate
lab infrastructure
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Sensitive and specific ab assays

Link and analyze epi and clinical data to lab data to answer key
questions relevant to diagnostics development and disease
transmission
WHO Communicable Diseases, Surveillance & Response (CSR)
Process to achieve objectives
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Review and expand lab network
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Sample banks and repositories (sample and reagent)
– Number and location
– Agree and finalize operational and legal aspects
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Standard reagent supply - long-term
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Inventory of current diagnostic assays - within network and
commercial candidates
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Perform international, multi-centre, evaluation
– establish test procedure, incl standard reagents, sample panels
– Analyze and publish results rapidly
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Access/distribution of appropriate assays
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WHO Communicable Diseases, Surveillance & Response (CSR)
Devise process/criteria
for evaluation of new assays
Process to achieve objectives (2)
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Quality assurance and availability of standards reagents, logistics, training support
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Biocontainment issues
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SARS Research Advisory Committee
– to guide WHO on diagnostic/laboratory/clinical/epi/animal
research
– focus on issues of relevance to public health
WHO Communicable Diseases, Surveillance & Response (CSR)
Constraints and Caveats

Funding - value of network approach
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21 July
WHO Communicable Diseases, Surveillance & Response (CSR)
Multidisciplinary PH SARS research - relevant to
archiving and diagnostic development
• Virus origin
• Virus stability under different environmental conditions
• Viral excretion, viral load, routes of transmission, clinical
presentation
• Role of asymptomatic infected individuals
• Role of products of human origin
• Virus pathogenicity
• Identification and use of antiviral drugs
• Vaccine development
• SARS epidemic modelling
WHO Communicable Diseases, Surveillance & Response (CSR)