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SARS Coronavirus Detection

SARS Coronavirus Detection . Karen K. Y. Young, Ph.D. Roche Molecular Diagnostics Thomas Emrich, Ph.D. Roche Applied Sciences. Critical Issues. Logistical challenges Nature of epidemic not well understood Seasonal? Reservoir? For rapid introduction of diagnostic assay

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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

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