COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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As Patients Fail to Correctly Self-Collect COVID-19 Tests, FDA Issues Reminder for Healthcare Providers to Provide Clear Collection Instruction

FDA maze of regulations

FDA provides updated resources for healthcare providers teaching COVID-19 testing self-collection and issues reminder to provide teaching

The US Food and Drug Administration (FDA) has issued a reminder to healthcare providers to provide clear, step-by-step instructions to patients who are self-collecting anterior nasal swabs for SARS-CoV-2 testing. The FDA initially issued a letter to healthcare providers on this topic in early October of 2020, as it became evident that poor patient technique during self-collection of COVID-19 swabs was contributing to inaccurate test results. (See FDA Issues Letter to Healthcare Providers as Patient COVID-19 Self-Collection Affects Specimen Quality.)

The FDA’s recent reminder points out, “without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test,” indicating that patients’ self-collection technique is continuing to affect test accuracy.

As the importance of ensuring correct patient self-collection techniques continues to be emphasized, the FDA has included resources that providers can use, including written instructions from the US Centers for Disease Control and Prevention (CDC) and from Audere’s HealthPulse communication. The FDA has also included a link to online instructions containing an animation to help providers to correctly guide patients.

In addition to the resources for health care providers, the FDA’s letter also outlines the pertinent collection steps that providers should emphasize when providing teaching. Clinical laboratories wishing to review the FDA’s instructions and the resources that it includes can do so here.

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