SARS Coronavirus Detection - PowerPoint PPT Presentation

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SARS Coronavirus Detection

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For rapid introduction of diagnostic assay. Need to mobilize resources quickly ... Availability of clinical samples for assay development and evaluation ... – PowerPoint PPT presentation

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Title: SARS Coronavirus Detection


1
SARS Coronavirus Detection
  • Karen K. Y. Young, Ph.D.
  • Roche Molecular Diagnostics
  • Thomas Emrich, Ph.D.
  • Roche Applied Sciences

2
Critical Issues
  • Logistical challenges
  • Nature of epidemic not well understood
  • Seasonal?
  • Reservoir?
  • For rapid introduction of diagnostic assay
  • Need to mobilize resources quickly
  • Need partnership with regulatory agencies
  • Sample acquisition
  • IP landscape

3
Critical Issues
  • Technical challenges
  • Optimal sample type?
  • Blood/serum/plasma
  • Respiratory specimen
  • Stool/urine
  • Sample preparation issues
  • Removal of inhibitors
  • Efficient lysis/preservation of RNA
  • Viral sequence heterogeneity
  • Mutation
  • Recombination
  • Standardization/reference material

4
Roches Response
  • Rapid development of research assay
  • Quantitative real-time PCR
  • LightCycler
  • Sample preparation defined by user
  • Development of IVD assay if warranted
  • Regulatory guidance needed for performance
    requirements
  • Lessons learned from research assay
  • Automated sample preparation
  • TaqMan PCR
  • Full-process controls

5
Research Assay Status
  • LightCycler-based assay
  • Real-time PCR
  • Quantitative, external calibration standards
  • Internal control
  • User-defined sample preparation
  • In-house evaluation of positive samples completed
  • World-wide trial at beta sites on-going

6
Research Assay Performance
  • In-house evaluation
  • Positive samples from Hong Kong (N40)
  • Sample types
  • Nasal-pharyngeal aspirates
  • Stool
  • Urine
  • Throat swabs

7
Research Assay PerformanceIn-house evaluation
8
Challenges to SARS diagnosis
  • Many unknowns
  • Nature of epidemic?
  • Natural history of infection?
  • Most appropriate sample type?
  • Optimal sample handling?

9
Challenges to SARS diagnosis
  • To effect rapid introduction of diagnostic assay
  • Requires dedicated resources
  • Co-operation from regulatory/public health
    agencies needed
  • Definition of performance requirements
  • Standardization for assessment of assay
    performance
  • Availability of reference standards
  • Availability of clinical samples for assay
    development and evaluation
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