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FDA Issues Letter to Healthcare Providers as Patient COVID-19 Self-Collection Affects Specimen Quality

FDA maze of regulations

Healthcare providers need to provide clear instructions and at least these three teaching points for patients performing their own nasopharyngeal sample collection

The US Food and Drug Administration (FDA) issued a letter to healthcare providers Oct. 7, 2020, addressing the poor specimen quality of some patients who self-collected nasal COVID-19 samples in a healthcare setting.

In this letter, the FDA made specific recommendations for healthcare providers. “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,” the FDA letter said. “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.”

3 Teaching Points for Self-Collecting SARS-CoV-2 Specimens

The FDA specifically recommended three distinct teaching points that healthcare providers should be including when providing patient education:

  1. “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.”
  2. “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.”
  3. “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.”

The FDA also recommended providing written or video instructions in addition to verbal instructions.

Related Resources:

FDA Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020

Letter to Health Care Providers