Guidance for SARS-CoV-2 Point-of-Care Testing

Guidance for SARS-CoV-2 Point-of-Care Testing

Updated Feb. 5, 2021
Summary of Recent Changes

Revisions were made on January 28, 2021 to reflect the following:

  • Edited to add language about antibody testing.

Revisions were made on December 30, 2020 to reflect the following:

  • Edited “Specimen Collection and Handling Point-of-Care Tests” section to add language which clarifies the personal protective equipment (PPE) recommended for personnel collecting point-of-care (POC) specimens versus the PPE recommended for personnel handling POC specimens but not directly involved in collection and not working within 6 feet of patients.

Revisions were made on December 26, 2020 to reflect the following:

  • To whom staff at long-term care facilities (LCTFs) should report point-of-care antigen testing data under “Reporting Requirements for Point-of-Care Testing”.

Revisions were made on December 10, 2020 to reflect the following:

  • New “Help with Performing Point-of-Care Tests” section added, which includes training resources for performing POC tests.

Revisions were made on December 2, 2020 to reflect the following:

  • Modified page to include Frequently Asked Questions about Point-of-Care Testing

Point-of-care tests, such as some rapid tests for diagnosing an infectious disease, provide results within minutes of the test being administered, allowing for rapid decisions about patient care. POC tests can also extend testing to people residing in communities who cannot readily access care. POC tests are used to diagnose current or detect past SARS-CoV-2 infections in various settings, such as:

  • Physician offices
  • Urgent care facilities
  • Pharmacies
  • School health clinics
  • Long-term care facilities and nursing homes
  • Temporary locations, such as drive-through sites managed by local organizations

Summary: This CDC Web resource provides guidance on the regulatory requirements for SARS-CoV-2 POC testing, using POC tests safely, and information on reporting POC test results.

Regulatory Requirements for POC Testing

Who can do POC testing?

Sites that perform POC testing are required to have a Clinical Laboratory Improvement Amendments (CLIA) certificate (see this brochurepdf iconexternal icon). There are four different types of CLIA certificates, any one of which is appropriate for POC testing. See this Centers for Medicare & Medicaid Services (CMS) documentpdf iconexternal icon that describes the different types of CLIA certificates. A CLIA Certificate of Waiver is appropriate for POC testing and can be obtained as follows:

  1. Complete an application (Form CMS-116pdf iconexternal icon), available on the CMS CLIA websiteexternal icon or from a local State Agency.
  2. Send the completed application to the address of the local State Agencyexternal icon for the state where testing will be performed.
  3. Pay the CLIA Certificate of Waiver fee, following instructions provided by the State Agency.

See How to Obtain a CLIA Certificate of Waiverpdf iconexternal icon for more information. POC testing can be performed after the laboratory or testing site has received a CLIA certificate number.

The laboratory or testing site must keep its certificate information current. The State Agency should be notified of any changes to the laboratory or testing site ownership, name, address, or director within 30 days.

What tests can be used for POC?

See the US Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 POC tests that have received Emergency Use Authorization (EUA)external icon. Tests that have been authorized for use in a POC setting will have a W, for Waived, in the Authorized Settings column of the FDA table. The laboratory or testing site must use a test authorized for POC use by FDA and must follow the manufacturer’s instructions for each POC test. The instructions for use provide specific information on how to perform the test, which specimens can be used, and the people who may be tested. All of the FDA-authorized tests for current SARS-CoV-2 infection are for use on symptomatic people. However, CMS has indicatedpdf iconexternal iconthat CLIA will temporarily allow CLIA laboratories and other CLIA testing sites to use SARS-CoV-2 POC antigen tests on asymptomatic people for the duration of the COVID-19 public health emergency.

For more information and additional resources for POC testing, see CDC’s Waived Tests Web page.