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Cue COVID-19 Rapid Molecular OTC 10-Pack Tests
From: $1,250.00 per package (10 tests per package)
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.
Test anyone, anywhere, anytime
With a fast, easy-to-use test, the Cue COVID‑19 Test Kit offers convenience, privacy, and the ability to test frequently. You can read the instructions for use here.
- 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: US, EU, Canada, India In the US, 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).
- PORTABLE: The COVID-19 Test Kit includes a single-use Cue COVID-19 Cartridge and Cue Wand and runs on our Cue Reader. The test is completely self-contained — no mixing of fluids or complex testing procedure required. With built-in safety features and quality checks, the test can be administered safely and reliably. 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 smart 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.
- EASY: The COVID-19 Test Kit includes a single-use Cue COVID-19 Cartridge and Cue Wand and runs on our Cue Reader. The test is completely self-contained — no mixing of fluids or complex testing procedure required. With built-in safety features and quality checks, the test can be administered safely and reliably. 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 smart 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.
The Cue Health COVID-19 Test for Home and Over-The-Counter (OTC) Use
No prescription is required. This Cue Health COVID test is a molecular diagnostic test for the virus that causes COVID-19 in nasal swab samples collected with the Cue Sample Wand. It is intended for use in adults (self-swabbing) or children over 2+ years old (swabbed by an adult). The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand nasal swab, and the Cue Health Mobile Application.
This test is for use with the Cue Cartidge Reader (not included) and the Cue Health Mobile Application installed on a compatible mobile smart device. Please see the information for us for more information here.
- What should I do if my mobile smart device runs out of charge during the test?
If your mobile smart device loses battery charge while performing the test, the test on the Cue Cartridge Reader will still run to completion. The test result will be saved. Plug your mobile device into charge and turn it back on. Make sure your mobile smart device is close to the Cartridge Reader after a test completes so you can view the result on the screen in the Cue Health App.
- What is an Emergency Use Authorization (EUA)?
The United States FDA has made the Cue COVID-19 Test for Home and Over The Counter (OTC) Use available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless the declaration is terminated or authorization is revoked (after which the test may no longer be used)
- Do any of the 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 our 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 mutations below affect the sensitivity of the CUE COVID-19 test:
- B.1.1.7 (Alpha)
- B.1.351 (Beta)
- P.1 (Gamma)
- B.1.617.2 (Delta)
- C.37 (Lambda)
- B.1.427 (California)
- B.1.429 (California)
- B.1.526 (New York)
Here are some relevant, important documents:
Nasal (AN) swab
- Credit Card
- HSA Card
- PO Number
Note: These products and services are not returnable. Check your kit expiration date upon receipt. Using expired test kits is not recommended because they may provide inaccurate results.