CUE Test for Home and Over The Counter (OTC) Use

Cue Health

INDICATION FOR USE: Qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand.

Intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. For Home and OTC use
authorized for non-prescription home use.

ADDRESSING UNMET NEED: First molecular OTC diagnostic test to continue to expand access to testing to help us in the fight against the pandemic


  • For qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand
  • Test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader the Cue Health Mobile Application (App)
  • Battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes


  • Correctly identified 96% of positive samples from individuals known to have symptoms
  • Correctly identified 100% of positive samples from individuals without symptoms



New COVID-19 EUA FAERS Public Dashboard 

Launch of FDA Adverse Event Reporting System (FAERS) Public Dashboard to access data on adverse events

  • User-friendly search tool for adverse events associated with the use of drugs and biologics
  • Provides weekly updates of adverse event reports and increases transparency and provide more efficient access to safety information.


Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test

False positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System

  • Assay tubes may sporadically leak, causing an obstructed optical path in the Liat analyzer, producing abnormal PCR growth curves
  • Abnormal PCR cycling in the reaction tubes may also produce abnormal PCR growth curves, leading to erroneous results


  • Monitor for unexpected clusters of positive Flu B results
  • Repeat tests when two or three analytes are positive
  • Stop using the cobas Liat System and contact Roche if you suspect issues


Ivermectin should not be used treat or prevent COVID-19

Ivermectin has not been approved for treating or preventing COVID-19

  •  Approved to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms
  • Different formulation used in animals to prevent heartworm disease and certain internal and external parasites 
  • FDA has not reviewed data to support use in COVID-19 patients; some initial research is underway
  • Taking ivermectin is dangerous: Interaction with other medications e.g. blood-thinners, potential to overdose with nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death


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Learn about treatment options available today

Image credit: Cue, Roche, FDA