General Medicine

FDA Says Cue Health COVID-19 Tests May Be Unreliable

Brian Park, PharmD
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Publish Date
An inspection revealed Cue Health made changes to the tests that reduce their reliability to detect SARS-CoV-2 virus.

The Food and Drug Administration (FDA) has issued a warning letter to Cue Health regarding its COVID-19 tests used in point-of-care settings (Cue COVID-19 Test) and at home (Cue Health COVID-19 Test for Home and Over the Counter Use). These tests were granted Emergency Use Authorization for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens.

According to the FDA, an inspection revealed Cue Health made changes to the tests that reduce their reliability to detect SARS-CoV-2 virus. As such, consumers are being urged not to use the tests because of the increased risk of false results. 

Retesting with a different COVID-19 test should be considered for symptomatic individuals who test negative with a Cue Health COVID-19 test. 

Issues related to SARS-CoV-2 testing should be reported through the FDA’s MedWatch Voluntary Reporting Form.

This article originally appeared on MPR

References:

US Food and Drug Administration. Do not use Cue Health’s COVID-19 tests due to risk of false results: FDA safety communication. Published May 10, 2024. Accessed May 13, 2024. https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication.