Laboratory Capacity

Key concepts

• HHS coordinates COVID-19 testing. 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. 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:

• Guidance – Proposed Use of Point-of-Care (POC) Testing Platforms for SARS-CoV-2 (COVID-19) [62 KB, 3 pages]
• Information for Laboratories
  This page includes interim guidance and resources for laboratory professionals working with specimens from persons under investigation (PUI) for coronavirus disease 2019 (COVID-19).
• International Reagent Resources (IRR)
  The IRR acquires, authenticates, and produces reagents that scientists need to carry out basic research and develop improved viral tests, vaccines, and detection methods. The Federal Emergency Management Agency (FEMA) and HHS have simplified the process for states and territories to help public health labs access diagnostics supplies and reagents for COVID-19 testing free of charge through the IRR.
• Interim Guidelines for COVID-19 Antibody Testing
  Serologic methods have been developed and will have important public health and clinical uses to monitor and respond to the COVID-19 pandemic. Recommendations on the use of serologic tests to determine protective immunity and infectiousness among persons recently infected with SAR-CoV-2 will be updated as new information becomes available.
• Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
  Proper collection of specimens is the most important step in the laboratory diagnosis of infectious disease. A specimen that is not collected correctly may lead to false negative test results. These specimen collection guidelines follow standard recommended procedures.
• Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
  Until more information becomes available, precautions should be taken in handling specimens that are suspected or confirmed for SARS-CoV-2. Timely communication between clinical and laboratory staff is essential to minimize the risk incurred in handling specimens from patients with possible SARS-CoV-2 infection. Such specimens should be labeled accordingly, and the laboratory should be alerted to ensure proper specimen handling. General and specific biosafety guidelines for handling SARS-CoV-2 specimens are provided in these guidelines.
• Testing in the US
  This page provides a map of states and territories with one or more laboratories that have successfully verified and are currently using COVID-19 viral tests. It also provides the number of specimens tested for SARS CoV-2 by CDC labs and U.S. public health laboratories.
• What CDC Is Doing
  CDC laboratory scientists are a key line of defense in emerging health threats such as SARS-CoV-2. This page describes key CDC laboratory activities.

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:

• BEI Resources Repository
  This repository was established by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health to provide reagents, tools and information for studying Category A, B, and C priority pathogens, emerging infectious disease agents, non-pathogenic microbes and other microbiological materials of relevance to the research community including diagnostic developers. Centralizing these functions within BEI Resources facilitates access to these materials by the scientific community and ensures quality control of the reagents.
• FDA: FAQs on Diagnostic Testing for SARS-CoV-2
  Provides answers to frequently asked questions relating to the development and performance of viral tests for SARS-CoV-2.
• Information about HHS and Rapid Point of Care Test
  The U.S. Department of Health and Human Services is purchasing the ID NOW COVID-19 rapid point-of-care test, developed by Abbott Diagnostics Scarborough Inc., for state, territorial and tribal public health labs.

Private sector, non-governmental organizations and academia

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

• Association of Public Health Laboratories
  APHL is supporting member laboratories during the COVID-19 pandemic by assisting with quality testing, reporting, technical assistance and communications.