MIL-OSI USA: Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing – Letter to Health Care Providers

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Source: US Food and Drug Administration

October 7, 2020

The U.S. Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.

Recommendations

The FDA recommends health care providers provide visual (written or video) step-by-step instructions, in addition to verbal instructions, to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Written instructions may be provided on paper or electronically and health care providers can access publicly available written instructions to give to patients. Two examples of written instructions are available from Audere’s HealthPulse communication or the Centers for Disease Control and Prevention. When available, video or animated instructions may provide added clarity for patients.  For example, Lower Nasal Swab Collection instructions, which was developed by Audere, contains an animation to demonstrate proper technique.  Audere, a Washington State nonprofit corporation, has granted a general right of reference to any organization who wishes to access and use these instructions for lower nasal swabs administered at a testing site. These recommendations apply specifically to patients who are self-collecting in a health care setting. Any test being used with home collected specimens, and the corresponding home collection kits, must be specifically authorized for such use in an Emergency Use Authorization.

The instructions provided to patients should incorporate the following information:

  • The entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose.
  • At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10-15 seconds per nostril.
  • Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose for 10-15 seconds, is not proper technique and may result in an insufficient sample.

Background

Anterior nares specimens have numerous benefits as compared to other upper respiratory specimens such as nasopharyngeal specimens. They are less invasive and generally more comfortable for patients, they can be self-collected by adult patients, and they can decrease the risk of exposure to health care providers. There is scientific evidence1 that SARS-CoV-2 testing utilizing anterior nares specimens has a similar performance to testing that utilizes nasopharyngeal specimens, provided that a good quality anterior nares specimen is collected. Without clear instructions, however, patients who, in a health care setting, are self-collecting anterior nares (nasal) samples may not collect an adequate sample for testing, which may decrease the sensitivity of the test. Health care providers have a critical role in helping patients perform self-collection accurately.

In addition to proper instructions, it is important that a swab type that is appropriate for the specimen collection type be used, and an appropriate specimen type be used for a particular test.  Also note that nasopharyngeal and oropharyngeal specimens are not appropriate for self-collection. More information on these areas can be found in the FDA Frequently Asked Questions.

FDA Actions

The FDA is providing recommendations for health care providers on the best way to provide clear instructions to patients that are self-collecting anterior nares (nasal) samples in a health care setting for SARS-CoV-2 testing.

The FDA will continue to keep health care providers and the public informed as new information becomes available about obtaining quality SARS-CoV-2 specimens for accurate test results.  The FDA will continue to work with other agencies, such as the Centers for Disease Control and Prevention (CDC), to harmonize sample collection best practices for SARS-CoV-2 diagnostic testing. 

Additional Resources

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with SARS-COV-2 testing.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact COVID19DX@fda.hhs.gov.


1 See for example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7269411/ or https://www.nejm.org/doi/full/10.1056/NEJMc2016321

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