What's Included
One Cue Reader. Designed to be re-used. No shelf life.
Not Included
Cue Tests are not included but are required for testing. Available here.
What is the Cue COVID-19 test?
- The Cue COVID-19 test is the first molecular diagnostic test approved for use both over-the-counter and via healthcare professionals. No prescription or license needed.
- The Cue COVID-19 Test has been selected by organizations like the NBA and Johnson & Johnson to test their people. Cue recently received a $481 Million award from the United States government.
- Portable for Travel, Education, Healthcare, Government, Corporations, Sports & Entertainment, Remote Employees.
PCR-Comparable Results in 20 Minutes
- Gold standard results comparable to PCR delivered straight to you in minutes.
- Cue’s molecular test matched central lab results (PCR) with 97.8% accuracy in an independent study by Mayo Clinic.
- Cue ranked at the top of the dry swab tests in FDA reference panel, currently with the lowest level of detection (LoD). A lower LoD represents a test's ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. (See chart in images.)
- Both Cue’s COVID-19 test and laboratory tests are molecular nucleic acid amplification tests (NAAT) that detect the SARS-CoV-2 virus genetic material. Molecular tests are more accurate than other methods such as antigen tests.
- The Cue COVID-19 test uses isothermal nucleic acid amplification technology for the molecular amplification reaction that is an equivalent alternative amplification method to polymerase chain reaction (PCR).
Easy & Portable
- The test and reader weigh less than most books.
- The test is completely self-contained — no mixing of fluids or complex testing procedure required. No calibration required.
- No training required. Bluetooth reader connects to the Cue app that guides a step-by-step simple testing process.
- Secure and private results appear in-app. If you choose, share or display results for convenient proof-of-test.
Connected & Scalable
- Cue’s molecular test eliminates the need to send samples to a lab, hire healthcare professionals, or perform additional confirmatory tests.
- Quick results and actionable data on location helps save valuable time and prevent larger, costly outbreaks.
- Connect up to six Cue Readers to one mobile device to easily scale up testing when needed.
- For enterprise and professional users, Cue’s API integrations with existing systems enable streamlined health and data management.
What's Included?
- The Cue Reader is sold on this page. Order tests separately here.
- Each reader connects via Bluetooth to the HIPAA-compliant Cue Health app. The app is used for step-by-step testing instructions and reviewing/sharing results of each test. Available for free download on iPhone, iPad and Android.
Over-The-Counter Use
- Cue Health received Emergency Use Authorization (“EUA”) for home and over the counter use from the FDA for the company’s easy-to-use, fast, portable COVID-19 test.
- The Cue COVID-19 Test for Home and Over the Counter (OTC) Use (“Cue OTC Test”) is the nation’s first molecular diagnostic test available without a prescription as well as by healthcare professionals without CLIA certification.
- The Cue OTC Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that causes COVID-19, using a nasal swab sample taken from the lower part of the nose.
- Results are displayed directly on a connected mobile smart device in about 20 minutes via the Cue Health App.
- This FDA EUA allows the Cue OTC Test to be used in non-clinical settings.
Do mutations affect the sensitivity of the Cue COVID-19 test?
- Many of the mutations to date have been located in the part of the virus’ genome that codes for spike protein - which is used to gain entry into human cells.
- The Cue COVID-19 test detects a different region of the virus genome that is more stable and conserved. This means the Cue test will likely continue to perform with a high level of sensitivity, even if the virus continues to mutate in the future.
- At this time, none of the following mutations below affect the sensitivity of the CUE COVID-19 test: Alpha, Beta, Gamme, Delta, Lambda
Shelf Life
- Cue Test Readers have no shelf life.
Authorized in USA, EU, Canada, India
- FDA emergency use authorized for both professional use at point-of-care and over-the-counter without a doctor or prescription.
- Authorized for professional use in the European Union (CE Mark), Canada (Health Canada Interim Order), and India (CDSCO).
