Guidance for SARS-CoV-2 Rapid Testing in Point-of-Care Settings

Summary of recent changes

Updates as of April 4, 2022

• HHS and CDC's new guidance no longer requires reporting of negative results for non-NAAT tests (rapid or antigen test results).
• This update also no longer requires reporting of antibody test results, positive or negative.
• The CLIA regulations requiring reporting of SARS-CoV-2 test results expired at the end of the PHE.
• Previous updates may be found in the Recent Updates section below.

Point-of-care testing

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 or antigen tests.

These tests can be used to diagnose SARS-CoV-2 infections in various point-of-care settings, including but not limited to:

• 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 rapid testing in point-of-care settings

There are four types of CLIA certificates [47 KB, 1 page], 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:

1. Complete an application (Form CMS-116 [311 KB, 10 pages]), available on the CMS CLIA website or from a local State Agency.
2. Send the completed application to the address of the local State Agency 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 Waiver [1.4 MB, 9 pages] 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 after receipt of the certificate, and as long as they meet any additional state licensure requirements that apply. 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.

Centers for Medicare and Medicaid Services (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.

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) and/or granted Traditional Marketing Authorization by FDA.

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 requirements for waived tests must be followed.

Reporting requirements for rapid testing in point-of-care settings

Depending on the test manufacturer's instructions for use, which can be found on FDA's EUA website or the Traditional Marketing Authorization website, the laboratory or testing site may report a negative test result as a "presumptive negative." Testing sites can find out more about reporting at CDC's How to Report COVID-19 Laboratory Data.

CMS-certified and other long-term care (LTC) facilities may 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). Test data submitted to NHSN is available to appropriate state, tribal, local, and territorial health departments.

Effective May 1, 2024, hospitals are no longer required to report Hospital Respiratory Pathogen, Bed Capacity, and Supply Data (i.e., 'COVID-19 Hospital' data) to HHS through NHSN. However, given the value of these data for patient safety and public health, CDC strongly encourages ongoing, voluntary reporting of the data through NHSN.

On April 10, 2024, CMS issued the fiscal year 2025 Medicare hospital inpatient prospective payment system and long-term care hospital prospective payment system proposed rule.

Within this rule, CMS is proposing to update the hospital and critical access hospital (CAH) infection prevention and control and antibiotic stewardship programs' Conditions of Participation (CoPs) to extend a subset of the currently discontinued COVID-19 and influenza data reporting requirements.

Specifically, CMS is proposing to replace the COVID-19 and Seasonal Influenza reporting standards for hospitals and CAHs with a new standard that will address acute respiratory illnesses.

This new standard would require that beginning on October 1, 2024, hospitals and CAHs would have to electronically report certain data elements about COVID-19, influenza, and respiratory syncytial virus (RSV). The proposed information for which reporting would be required includes confirmed infections of respiratory illnesses, including COVID-19, influenza, and RSV, among hospitalized patients; hospital bed census and capacity; and limited patient demographic information, including age. CMS is proposing that, outside of a public health emergency PHE, hospitals and CAHs would have to report these data on a weekly basis.

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 from 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) should follow Standard Precautions. It is recommended that personnel wear well-fitting masks, (cloth, 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:

• 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 tests in point-of-care settings:

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
  • Implement appropriate control measures to prevent these potentially negative outcomes from happening.
  • Find more information at CDC's Biological Risk Management for Point-of-Care Testing Sites.
  • Find more information on Risk Assessment Best Practices and Risk Assessment templates [2.2 MB, 69 pages].
  • Learn more about CDC's Guidelines for Handling and Processing Specimens Associated with COVID-19.
• 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 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. To avoid cross-contamination, change gloves before putting a new specimen into a testing device.

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.
• Always discuss used and unused COVID-19 test kit waste with your facility leadership, facility waste management contractor, your State Department of Public Health, and the test manufacturer's technical support. All waste disposal must comply with your local, tribal, regional, state, national, and/or international regulations. Waste disposal regulations may vary at the state and local levels; see Environmental Protection Agency Regulations and State Universal Waste Programs in the United States for more information.

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 available at Waived Tests | CDC.

More point-of-care resources

CDC

• Performing Facility-wide SARS-CoV-2 Testing in Nursing Homes
• SARS-CoV-2 (COVID-19) Fact Sheet: Guidance – Proposed Use of Point-of-Care Testing Platforms for SARS-CoV-2 (COVID-19) [63 KB, 3 pages]
  

CMS

• CMS COVID-19 FAQs on Medicare Fee-for-Service Billing
• CMS CLIA Post-Public Health Emergency (PHE) Guidance
• CMS CLIA FAQs: Post-PHE Guidance

FDA

• U.S. Food and Drug Administration (FDA) FAQs on Testing for SARS-CoV-2
• FDA COVID-19 Emergency Use Authorizations (EUAs) for Medical Devices
• COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
• FDA Medical Device Reporting (MDR) Information

Recent updates