Laboratory Capacity

Laboratory Capacity

Guidance and Resources for Laboratories

Updated June 29, 2020

Key concepts

  • HHS coordinates COVID-19 testing.external icon The Department of Health and Human Services (HHS) works across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect, protect against or treat COVID-19 for development and licensure. HHS is providing rapid point-of-care tests and devices to public health labs (PHLs) in every state and territory, and Washington, D.C.
  • FDA issues emergency use authorizations for COVID-19 tests.external icon The FDA has issued several Emergency Use Authorizations (EUAs) for the use of new viral tests to detect the SARS-CoV-2 virus, which causes COVID-19. During public health emergencies declared under section 564 of the FD&C Act, the FDA is able to issue EUAs when certain criteria are met that allows for the use and distribution of potentially life-saving medical products to diagnose, treat, or prevent the disease, which can include viral tests.
  • CDC provides guidance and resources for laboratories. CDC provides interim guidance and resources for laboratory professionals working with specimens from persons under investigation (PUI) for COVID-19. In order to protect health care workers and laboratorians, CDC provides laboratory biosafety guidelines for handling and processing specimens associated with COVID-19.

Resources from CDC

Resources for laboratories to conduct testing to identify new cases of coronavirus disease 2019 (COVID-19).

CDC is supporting this critical work by providing:

Resources from other organizations

Content describing non-CDC tools on this site is provided for informational purposes only and is not intended to indicate endorsement, actual or implied, of the tools. Additionally, information on this site is provided “as is,” for users to evaluate and make their own determination as to their effectiveness.

Other federal agencies

Several other federal agencies support this critical effort by providing:

Other government agencies

Private sector, non-governmental organizations and academia

Various other organizations are also supporting this critical effort by providing: