10 COVID-19 Tests & Cue Reader

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Product Details

About Cue’s COVID-19 test:

Cue is the first compact, portable molecular self-testing system authorized by the FDA for use at home or on the go, without a prescription.

Cue’s molecular COVID-19 test is a nucleic acid amplification test (NAAT), designed to detect the genetic material in SARS-CoV-2.

Highly accurate and sensitive, it can detect small amounts of virus, including prevalent variants and subvariants of concern such as BA.5, BQ.1, BQ1.1, and XBB in people with or without symptoms.

Results are delivered in just 20 minutes, right to your mobile device — anytime, anywhere.

Safe for use on adults (self-swabbing) and children ages 2 and up (swabbed by an adult).

How to Use Cue

Using Cue is easy. Just follow the step-by-by step guide in your Cue Health App.

Insert your Cartridge into the Reader.

Use the Wand to collect a sample from the lower part of each nostril.

Insert the Wand into the Cartridge.

Get results from the Cue Health App on your mobile device in 20 minutes.

Specs

COVID-19 Test:

Each test includes a self-contained COVID-19 Test Cartridge and a Sample Wand (for lower nasal swab).

The shelf life of Cue COVID-19 Cartridges is 9 months from manufacture date.
The test is used with the Cue Reader and the Cue Health App.
Test Cartridges and components made in the USA.
Package Specifications (3 pack): 2.40 x 7.00 x 4.94 inches; 0.28 lb.
SKU (3 pack): 9100013
Package Specifications (10 pack): 7.75 x 7.00 x 4.94 inches; 0.90 lb.
SKU (10 pack): 9100015

Cue Reader:

Includes Cue Reader, power adapter, and power cord.

Rechargeable battery provides approximately 8 hours of continuous use.
Product Specifications: 2.9 in x 2.9 in x 1.5 inches; 5.29 oz.
Package Specifications: 4.07 x 4.07 x 4.07 inches; 1.03 lb.
SKU: 9000207

Traveling With Cue

Cue’s COVID-19 test meets the testing requirements for air travel entry into most countries, including the U.S. and Canada, so you can take Cue with you wherever you go. Plus, it’s small enough to slip into your carry-on bag or backpack.

Documentation & Disclaimers

This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

View Product Documentation for Cue COVID-19 OTC Test

Return Policy

Because Cue has stringent quality assurance requirements as it is a medical device and product, returns and exchanges are not permitted. See the Cue Terms of Use and End User License Agreement for more details.

Frequently Asked Questions

How does Cue’s COVID-19 test compare to other COVID-19 tests?

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that combines the diagnostic accuracy of a central lab with the speed and convenience of an at-home test. The Cue COVID-19 OTC Test is self-contained (no need to mix fluids) and easy to run. The portable device fits in the palm of your hand and delivers accurate results directly to your mobile smart device in about 20 minutes.

Cue’s COVID-19 test uses nucleic acid amplification that was found to be equivalent to polymerase chain reaction (PCR) in an independent study conducted by Mayo Clinic. The study found 97.8% agreement between Cue’s COVID-19 test and central lab PCR testing. In a separate clinical study with lay users, the Cue COVID-19 OTC Test demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic.

Most other COVID-19 self-tests are antigen tests. Compared to molecular tests, antigen tests are less sensitive and more likely to give false negative results, especially among people who are infected but asymptomatic. Healthcare providers may suggest a follow-up molecular test to verify the results of an antigen test.

Unlike many other COVID-19 diagnostic tests, with Cue, you don’t need a healthcare professional to administer the test or to analyze the results. And, with lab-quality results, including for emerging variants, there’s no need for additional, confirmatory testing.

How accurate is Cue’s COVID-19 test?

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is highly accurate. In a clinical study with lay users, the Cue COVID-19 OTC Test demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic.

To find study results, see the Cue® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions For Use on the product documentation page of our website.

Does Cue detect Omicron and subvariants like BA.5, BQ.1, BQ1.1, and XBB?

Yes. Cue’s COVID-19 test can detect Omicron, subvariants such as BA.5, BQ.1, BQ1.1, and other prevalent variants of concern. Like other COVID-19 viral diagnostic tests, Cue’s test cannot specify which variant has been detected. The test will only indicate if your result is positive or negative for the SARS-CoV-2 virus.

Will my insurance cover the cost of Cue’s COVID-19 test?

Health insurance plans may cover the costs of at-home COVID-19 tests. Please check with your health plan for information about your policy.

Is Cue’s COVID-19 OTC test approved or authorized by the FDA?

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use has Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for over-the-counter use without a prescription at home and in other non-clinical settings. The test can also be used in professional clinical and point-of-care settings.

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