Sunday, March 26, 2023
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Biodetection

FDA Pandemic Response: States Can Now Approve COVID-19 Diagnostics, Serology Testing

by Global Biodefense Staff
March 16, 2020
The Administration is Setting Up the U.S. to Botch a Pandemic Response

Image Credit: Global Biodefense

The FDA today took unprecedented measures to expand coronavirus disease 2019 (COVID-19) diagnostics testing capacity by modifying policy originally issued on Feb. 29 which addresses laboratories and commercial manufacturers to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.

Under the expanded policy, states may now take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted to the New York State Department of Health last week. States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA and are not required to pursue an Emergency Use Authorization (EUA) with the FDA.

The updated policy also provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.

“We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.”

Tags: COVID-19Editor PickMagazine Edition 24 March 2020Public Health EmergencySARS-CoV-2

Related Posts

New Material Helps Train First Responders on Biothreats
Biodetection

New Material Helps Train First Responders on Biothreats

January 4, 2023
Researcher holds a pipette
Biodetection

These Nanotech Bubbles Burst When They Detect Viruses in the Air

October 25, 2022
Influenza Research
Biodetection

New Way to Identify Influenza A Virus Lights Up When Specific Virus Targets are Present

June 20, 2022
NIH to Further Invest in Point-of-Care Technologies Research Network
Biodetection

NIH to Further Invest in Point-of-Care Technologies Research Network

May 10, 2022
Load More

Latest News

Biodefense Headlines – 26 March 2023

March 26, 2023
Biodefense Headlines – 12 March 2023

Biodefense Headlines – 12 March 2023

March 12, 2023
Partner Therapeutics’ Novel Approach to Stratify Sepsis Patients Gains Backing From BARDA

Biopreparedness Research Virtual Environment (BRaVE) Initiative Backed by $105M DOE Funding

January 25, 2023
Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

January 25, 2023

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC