SARS Coronavirus Detection - PowerPoint PPT Presentation

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SARS Coronavirus Detection

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SARS Coronavirus Detection

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  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. Roche’s 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 (N=40) • 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