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

Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing
Updated Mar. 12, 2021
Summary of Recent Changes

Revisions were made on March 8, 2021 to reflect the following:

  • Edited “Regulatory Requirements for Point-of-Care and Rapid Testing” section to add updated Centers for Medicare & Medicaid Services (CMS) guidance for SARS-CoV-2 point-of-care tests and Clinical Laboratory Improvement Amendments (CLIA) Certificates of Waiver.
  • Added new training resources from manufacturers of SARS-CoV-2 point-of-care and rapid tests

View Previous Updates

Key Points

  • This guidance provides information on the regulatory requirements for SARS-CoV-2 point-of-care and rapid testing, collecting specimens and performing point-of-care and rapid tests safely and correctly, and information on reporting test results.
  • This guidance is intended for individuals and facilities who are setting up and performing point-of-care testing and is not intended for at-home specimen collection and testing.

Point-of-care tests are diagnostic tests performed at or near the place where a specimen is collected, and they provide results within minutes rather than hours. These may be molecular, antigen, or antibody tests.

Rapid point-of-care tests provide results within minutes (depending on the test) and 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

Regulatory Requirements for Point-of-Care and Rapid Testing

There are four different types of CLIA certificatespdf iconexternal icon, any one of which is appropriate for point-of-care testing. A CLIA Certificate of Waiver is appropriate for SARS-CoV-2 point-of-care 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. Laboratories or point-of-care testing sites that have applied for a CLIA Certificate of Waiver to perform SARS-CoV-2 point-of-care testing can begin testing and reporting SARS-CoV-2 results as soon as they have submitted their application to the State Agency, as long as they meet any additional state licensure requirements that apply. A non-certified point-of-care testing site will be treated as operating under a Certificate of Waiver while their application is being processed. The point-of-care 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.

During the COVID-19 public health emergency, CMS allows a laboratory or testing site to use its existing Certificate of Waiver to operate a temporary COVID-19 testing site in an off-site location, such as a nursing home or drive-through location. A temporary COVID-19 testing site can only perform CLIA-waived or FDA-authorized point-of-care tests for SARS-CoV-2 and must be under the direction of the existing laboratory or testing site director.

Tests That Can Be Used for Point-Of-Care and Rapid SARS-CoV-2 Testing

Refer to the U.S. Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 point-of-care and rapid tests that have received Emergency Use Authorization (EUA)external icon. Tests that have been authorized for use in a point-of-care 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 point-of-care use by the FDA and must follow the manufacturer’s instructions for each 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 icon that CLIA will temporarily allow CLIA-certified laboratories and other testing sites to use SARS-CoV-2 point-of-care and rapid antigen tests on asymptomatic people for the duration of the COVID-19 public health emergency.

Reporting Requirements for Point-Of-Care and Rapid Testing

A CLIA-certified laboratory or testing site must report all COVID-19 diagnostic and screening test results for current or past infections to the person who was tested or that person’s healthcare provider. Depending on the test manufacturer’s instructions for use, which can be found on FDA’s EUA websiteexternal icon, the laboratory or testing site may be required to report a negative test result as a “presumptive negative.”

A CLIA-certified laboratory or testing site must also report all COVID-19 test results to their respective state, local, tribal, or territorial health department in accordance with the Coronavirus Aid, Relief, and Economic Security (CARES) Act; refer to the CMS interim final rule for regulatory reporting requirementspdf iconexternal icon. In addition, laboratories and testing sites can find out more about How to Report COVID-19 Laboratory Data.

CMS-certified long-term care (LTC) facilities can submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC’s National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC’s NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities can also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any. While NHSN is the CDC- and CMS-preferred pathway, Medicare and Medicaid-certified LTC facilities can submit data through the other mechanisms described in the Current Methods of Submission section of HHS Laboratory Reporting Guidancepdf iconexternal icon to meet the reporting requirements.

Specimen Collection & Handling of Point-of-Care and Rapid Tests

Each point-of-care test has been authorized for use with certain specimen types and should only be used with those specimen types. Proper specimen collection and handling are critical for all COVID-19 testing, including those tests performed in point-of-care settings. A specimen that is not collected or handled correctly can lead to inaccurate or unreliable test results.

For personnel collecting specimens or working within 6 feet of patients suspected to be infected with SARS-CoV-2, maintain proper infection control and use recommended personal protective equipment (PPE), which could include an N95 or higher-level respirator (or face mask if a respirator is not available), eye protection, gloves, and a lab coat or gown.

For personnel handling specimens but not directly involved in the collection (e.g., self-collection) and not working within 6 feet of the patient, follow Standard Precautions. It is recommended that personnel wear well-fitting cloth masks, facemasks, or respirators at all times while at the point-of-care site where the testing is being performed.

For additional general information about the proper collection and handling of each of the specimen types, please refer to CDC’s Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19.

Disinfect surfaces within 6 feet of the specimen collection and handling area before, during, and after testing and at these times:

  • Before testing begins each day
  • Between each specimen collection
  • At least hourly during testing
  • When visibly soiled
  • In the event of a specimen spill or splash
  • At the end of every testing day

CDC recommends the following practices when performing point-of-care tests:

Before the Test

  • Perform a risk assessment to identify what could go wrong, such as breathing in infectious material or touching contaminated objects and surfaces. Then
  • Use a new pair of gloves each time a specimen is collected from a different person. If specimens are tested in batches, also change gloves before putting a new specimen into a testing device. Doing so will help to avoid cross-contamination.
  • Do not reuse used test devices, reagent tubes, solutions, swabs, lancets, or fingerstick collection devices.
  • Store reagents, specimens, kit contents, and test devices according to the manufacturer’s instructions found in the package insert.
  • Discard tests and test components that have exceeded the expiration date or show signs of damage or discoloration (such as reagents showing any signs of alteration).
  • Do not open reagents, test devices, and cassettes until the test process is about to occur. Refer to the manufacturer’s instructions to see how long a reagent, test device, or cassette can be used after opening.
  • Label each specimen with appropriate information to definitively connect that specimen to the correct person being tested.
  • When transferring specimens from a collection area to a testing area, follow the instructions for the point-of-care test used.

During the Test

  • Follow all of the manufacturer’s instructions for performing the test in the exact order specified.
  • Perform regular quality control and instrument calibration, as applicable, according to the manufacturer’s instructions. If quality control or calibration fails, identify and correct issues before proceeding with patient testing.
  • When processing multiple specimens successively in batches, ensure proper timing for each specimen and each step of the testing process, as specified by the test manufacturer.

After the Test

  • Read and record results only within the amount of time specified in the manufacturer’s instructions. Do not record results from tests that have not been read within the manufacturer’s specified timeframe.
  • Decontaminate the instrument after each use. Follow the manufacturer’s recommendations for using an approved disinfectant, including proper dilution, contact time, and safe handling.
  • Handle laboratory waste from testing suspected or confirmed COVID-19 patient specimens in the same manner as all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that laboratory waste needs additional packaging or disinfection procedures.

Learn More About Performing Point-of-Care and Rapid Tests

CDC has free training and tools to help you learn the basics about performing point-of-care testing. The companies that make the tests and testing systems also have free training resources designed to help you use the tests. Find links in this section to resources and training that will help you get ready to test.

CDC Educational Materials for Point-Of-Care and Rapid Testing

Many COVID-19 point-of-care and rapid tests fall into a category called waived tests, which are tests performed in a laboratory or at a testing site under a CLIA Certificate of Waiver. CDC has free educational and training  resources for waived point-of-care testing, including:

ready-set-test

Ready? Set? Test! an online training course that explains the waived testing process and how to help ensure that test results are accurate and reliable.

A Ready? Set? Test! bookletpdf icon that contains tips, reminders, and resources along with forms and examples for use in your testing site (also available in Spanishpdf icon).

A Self-Assessment Checklistpdf icon you can use to help ensure good testing practices and provide reliable, high-quality test results.

The COVID-19 Point-of-Care Batch Testing Tips Infographic  pdf icon[2 MB, 2 Pages] gives advice for performing batch testing.

Visit CDC’s Waived Tests page for more information and resources.

Laboratories and testing sites can find additional free, online training courses relevant to working with COVID-19 specimens on CDC’s Preparing and Supporting Laboratories Responding to COVID-19 Web page.

Training Resources from Test Manufacturers for COVID-19 Point-of-Care and Rapid Testing

Below are links to trainings developed by manufacturers of COVID-19 testing devices. Linking to these resources does not constitute an endorsement by the Department of Health and Human Services (HHS) or any of its employees of the sponsors or the information and products presented on the site.

This list of tests and associated resources will be updated as more manufacturer-specific training links become available.

ADVAITE

Cepheid™

Abbott

Cue Health*

Becton, Dickinson and Company (B.D.)

LumiraDx

Quidel

* Users might have trouble accessing the Cue™ link with Internet Explorer. For the best experience, Chrome or Edge is recommended.

Tips for Using Rapid Antigen Tests

Below are links to documents for select SARS-CoV-2 specific antigen tests procured in large numbers by the U.S. government. Based on CDC experience with these tests, following  these tips will help to ensure the tests are performed correctly.

More Point-of-Care Resources

CDC

CMS

FDA

Updates from Previous Content

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