COVID-19 updates: Test for pooled samples, CTAP, Domestic inspections, FDA Insights podcasts, Laboratory and Manufacturer resources
![](https://druganddevicedigest.files.wordpress.com/2020/07/capture-7.jpg?w=632)
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.
![](https://druganddevicedigest.files.wordpress.com/2020/07/capture-8.jpg?w=597)
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
- >510 drug development programs
- >230 trials for otential therapies
- email inbox for COVID-19 therapeutic development inquiries, [email protected].
![](https://druganddevicedigest.files.wordpress.com/2020/06/capture.jpg?w=214)
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
![](https://druganddevicedigest.files.wordpress.com/2020/07/capture-9.jpg?w=143)
FDA Insights podcasts
Insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.
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.
Image credit: FDA