01/19/2022 | Press release | Distributed by Public on 01/19/2022 16:06
Summary of Recent Changes
Key Points
Point-of-care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested or their parent or guardian and can be performed in a variety of settings. Rapid tests used in point-of-care settings can be NAAT, antigen, or antibody tests.
These tests can be used to diagnose current or detect past SARS-CoV-2 infections in various point-of-care settings, including but not limited to:
Regulatory Requirements for Rapid Testing in Point-of-Care Settings
There are four different types of CLIA certificatespdf icon external icon , any one of which is appropriate for point-of-care testing. A CLIA certificate is required to perform point-of-care testing. A CLIA Certificate of Waiver is appropriate if SARS-CoV-2 point-of-care testing is the only testing being performed. It can be obtained as follows:
See How to Obtain a CLIA Certificate of Waiverpdf icon external 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.
CMS has provided specific guidance for the use of FDA authorized OTC self-tests when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian. In these circumstances, the tests are not considered self-tests and the point-of-care testing site that performs the testing or interprets the test results needs a CLIA certificate and must report results as described below. See Over The Counter (OTC) Home Testing and CLIA Applicabilitypdf icon external icon for more information from CMS.
Tests That Can Be Used in Point-of-Care Settings
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.
OTC tests can be purchased and used in a point-of-care setting. However, when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian, then the CLIA reporting requirements for waived tests must be followed.
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COVID-19 Viral Testing Tool
A tool to help healthcare providers quickly access the most relevant, actionable information to determine what type(s) of COVID-19 testing they should recommend. After test results are in, the tool can help interpret test results and guide next steps.
Reporting Requirements for Rapid Testing in Point-Of-Care Settings
A CLIA-certified laboratory or testing site must report all SARS-CoV-2 diagnostic and screening test results 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 SARS-CoV-2 test results to their respective state, tribal, localexternal icon , and territorial health department's website in accordance with the Coronavirus Aid, Relief, and Economic Security (CARES) Act; refer to the CMS interim final rule for regulatory reporting requirementspdf icon external 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, antibody, and nucleic acid amplification test (NAAT) 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 LTC facilities. Test data submitted to NHSN will be reported to appropriate state, tribal, local, and territorial 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 icon external icon to meet the reporting requirements.
Specimen Collection & Handling of Rapid Tests in Point-of-Care Settings
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 an inaccurate or unreliable test result.
Personnel collecting specimens or working within 6 feet of patients suspected to be infected with SARS-CoV-2 should 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.
Personnel handling specimens but not directly involved in the collection (e.g., self-collection) and not working within 6 feet of the patient should 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 information about the proper collection and handling of each of the specimen types, please refer to CDC's Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing.
Disinfect surfaces within 6 feet of the specimen collection and handling area at these times:
CDC recommends the following practices when performing tests in point-of-care settings:
Before the Test
During the Test
After the Test
Learn More About Performing Rapid Tests in Point-of-Care Settings
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 Rapid Testing in Point-of-Care Settings
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! is 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 SARS-CoV-2 specimens on CDC's Preparing and Supporting Laboratories Responding to COVID-19 web page.
Training Resources from Test Manufacturers for COVID-19 Rapid Testing in Point-of-Care Settings
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, the test manufacturers listed below, 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.
Becton, Dickinson and Company (B.D.)
* 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.