Quest SARS-CoV-2 rRT-PCR test for pooled samples

Quest Diagnostics

Emergency Use Authorization for first diagnostic test use with pooled samples containing up to four individual swab specimens

  • Sample pooling allows for more people to be tested quickly using fewer testing resources
  • Samples collected from four individuals tested in pool or “batch” using one test, rather 4 tests
  • If pool is positive, each of the samples in that pool are tested again individually
  • Fewer tests are run overall, meaning fewer testing supplies and quicker test particulalry in areas with low prevalence, meaning most results are expected to be negative.

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Coronavirus Treatment Acceleration Program

The Coronavirus Treatment Acceleration Program (CTAP) to enable FDA to leverage cross-agency scientific resources and expertise to bear on COVID-19 drugs and biologics development and review

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Resumption of domestic inspections with new risk assessment system

COVID-19 Advisory Rating system (COVID-19 Advisory Level) to assist in determining when and where it is safest to conduct prioritized domestic inspections

  • Uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data
  • Phase of the State, statistics measured at the county level to gauge the current trend and intensity of infection
  •  Goal of restarting on-site inspections during the week of July 20

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FDA Insights podcasts

Insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.

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COVID-19 Resources for Laboratories and Manufacturers

Emergency Use Authorizations for Medical Devices

EUA Authorized Serology Test Performance

Independent Evaluations of COVID-19 Serological Tests

Testing Supply Substitution Strategies: Download the slide show file (PPT – 1.5MB) and click Slide Show > From Beginning.

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