Cue Health COVID-19 Test Reader
Cue’s molecular COVID-19 test combines fast results and ease of use with the accuracy of central lab technology, all in one device that fits in the palm of your hand.
ACCURATE - Lab-Quality Results
Gold standard results comparable to PCR delivered straight to you in minutes. Cue’s molecular test matched central lab results with 97.8% accuracy in an independent study by Mayo Clinic.
ACCESSIBLE - Testing Simplified
Answers for everyone. Use Cue to test adults and children (ages 2+), with or without symptoms. Our test is designed for both professional use at point-of-care and for use at home, at work, or in the community. No prescription, no training needed.
AUTHORIZED - U.S., EU, Canada, India
In the U.S., Cue’s COVID-19 test is Emergency Use Authorized (EUA) by FDA for professional use at point-of-care and at-home use without a prescription. The test is also authorized for professional use in the European Union (CE Mark), Canada (Health Canada Interim Order), and India (CDSCO).
- Cue Health Monitoring System (Cue Cartridge Reader)
- For use with the Cue Health COVID-19 Test (sold separately)
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.