COMMENTARY

Five Things to Know about Point-of-Care Testing for SARS-CoV-2

Reynolds M Salerno, PhD

Disclosures

July 30, 2021

Editorial Collaboration

Medscape &

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Throughout the COVID-19 pandemic, healthcare providers have gone above and beyond to work on the front lines of the response. As the virus spread across the globe, the demand for quick and convenient testing increased. Patients and healthcare providers sought test results that could be returned in minutes rather than in hours or days.

Point-of-care (POC) testing is performed at or near where the patient specimen is collected. This makes it easier to get test results quickly, as many healthcare providers are asked to support testing activities in addition to other responsibilities. If your organization performs POC testing for COVID-19, here's what you need to know:

1. Make sure your facility or testing site has a CLIA Certificate.

In order to perform POC testing for SARS-CoV-2, your facility will need a Clinical Laboratory Improvement Amendments (CLIA) certificate from the Centers for Medicare & Medicaid Services (CMS). Many COVID-19 POC tests are considered waived tests, which can be performed at a testing site under a CLIA Certificate of Waiver. To obtain a CLIA Certificate of Waiver, POC testing sites should complete the following steps:

  • Complete an application using Form CMS-116, which is available from CMS and state agencies.

  • Send the completed application to the state agency where the testing will be performed.

  • Follow the instructions provided by the state agency to pay the CLIA Certificate of Waiver fee.

2. Perform a risk assessment before you begin testing.

  • First, identify which POC test you will use and what equipment you will need.

  • Next, protect your staff by performing a site- and activity-specific risk assessment to identify potential negative outcomes, such as breathing in infectious material or touching contaminated objects and surfaces.

  • It's also important to implement appropriate control measures to prevent these potentially negative outcomes from occurring and to have a plan in place so that staff are trained to respond appropriately to any of these outcomes should the need arise.

You can find information on risk assessment best practices and templates here. Additionally, CDC offers guidelines for safe handling and processing of COVID-19 specimens and a self-assessment checklist that you can use to help ensure good testing practices and provide reliable, high-quality test results.

3. Be prepared to report test results.

CLIA-certified testing sites must report all COVID-19 diagnostic and screening test results for current or past infections to the person who was tested or to that person's healthcare provider.

CLIA-certified testing sites 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 requirements

Visit How to Report COVID-19 Laboratory Data for more information on test result reporting.

4. Take advantage of CDC resources designed to support your work.

CDC offers infographics, lessons-learned documents, and free online training courses on working with COVID-19 specimens. Test-specific documents can help ensure that your facility is prepared to correctly perform rapid antigen tests, such as the BD Veritor™ Plus System, BinaxNOW™, and Quidel Sofia® 2 tests.

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

5. Receive communications from CDC's Laboratory Outreach Communication System (LOCS) to stay updated on the latest COVID-19 testing information.

LOCS provides timely information to facilities that perform COVID-19 testing. Topics include POC testing, specimen collection, antigen testing, biosafety, laboratory data reporting, regulatory requirements, and training and resources to support emergency preparedness and response. Sign up for updates here

As the COVID-19 response continues and the landscape shifts, CDC is committed to developing tools, resources, and information to support the evolving needs of people who are performing COVID-19 testing. We hope you will share the above resources with your partners and colleagues, and we invite you to submit any feedback or suggestions to LOCS@cdc.gov.

Web Resources

Waived POC Testing

COVID-19 Point-of-Care Batch Testing Tips Infographic

Ready? Set? Test! booklet, also available in Spanish

Centers for Medicare & Medicaid Services CLIA site

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