Due to the sensitivity of self-collected anterior nares samples and the room for error in the self-swabbing technique, the US Food & Drug Administration (FDA) has provided recommendations for health care providers to successfully guide patients in self-swabbing for SARS-CoV-2 testing.1

The FDA considers anterior nares specimens to be comparable to nasopharyngeal specimens for SARS-CoV-2 testing in terms of accuracy. The organization noted that anterior nares specimens have several advantages including being less invasive for the patient and posing a lower risk of exposure for clinicians. Current evidence is available that states testing for SARS-CoV-2 with self-collected anterior nares samples have a similar testing performance, provided that adequate self-collected samples are obtained.2

The FDA recommends that clinicians provide a visual, step-by-step instructions to patients who are self-collecting samples for SARS-CoV-2 testing. There are multiple formats in which providers can guide patients through the self-collection process, including written, video, and verbal. Written instructions can be provided on paper or electronically; the FDA suggested using examples such as Audere’s HealthPulse Communication or the Centers for Disease Control and Prevention. When available, video or animated instructions may provide additional clarity for patients.


Continue Reading

The following instructions from the FDA should be incorporated into any visual or animated guidance:

  • Place the entire tip of the swab (usually 1/2 to ¾ of an inch) inside the nose and rub the side of the swab with moderate pressure against the wall or the anterior nares region, moving the tip through a large circular path inside the nose.
  • Perform at least 4 circles inside each nostril using the same swab.
    • Twirling the swab against one part inside the nose or leaving the swab in the nose for 10 to 15 seconds is not proper technique. It may result in an insufficient sample.

This guidance is specifically intended for 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.

References

1. 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. U.S. Food and Drug Administration. October 7, 2020. Accessed October 14, 2020. https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample?utm_medium=email&utm_source=govdelivery.

2. Péré H, Podglajen I, Wack M, et al. Nasal swab sampling for SARS-CoV-2: a convenient alternative in times of nasopharyngeal swab shortage. J Clin Microbiol. 2020;58(6):e00721-20.