Real-time COVID-19 testing | Cue

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Cue’s COVID‑19 Diagnostic Test

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.

Lab-quality results, including for emerging variants for COVID‑19, delivered to your mobile smart device in about 20 minutes.

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).

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.

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.

Product support & documentation for Cue's COVID‑19 tests

Visit our Help & Support page for product labeling, instructions for use, and other helpful documentation.

See documentation

COVID-19 Product Updates

The shelf-life of Cue COVID-19 Test Cartridge Packs are extended from 4 months to 9 months, based on results from Cue’s latest product stability tests. All Cue COVID-19 Test Cartridge Packs with a Use By (expiration) date between July 1, 2021, and November 1, 2021, will expire 5 months after the original Use By date printed on the Cue COVID-19 Test Cartridge Pack and the Cue COVID-19 Test Cartridge Pouch labels.

As part of our continued commitment to ensure that Cue offers the highest quality products that are easy, safe, and convenient to use, Cue is continuing to test product stability. Additional expiration dating extensions and other enhancements will be posted on our website and shared with customers as they become available.

Read notice

Cue Health received Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for the company’s fast, portable, point-of-care COVID-19 test for use by authorized laboratories and healthcare providers. The Cue COVID-19 Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that causes COVID-19, in about 20 minutes using a nasal swab sample taken from the lower part of the nose.

The Cue COVID-19 Test runs on the compact and portable Cue Health Monitoring System. A single-use Cue COVID-19 Test kit includes a Cue Sample Wand nasal swab and a COVID-19 Test Cartridge. The system performs rapid molecular analysis at point-of-care and transmits test results to the Cue Health App on a connected mobile smart device.

This FDA EUA allows the Cue COVID-19 Test to be used anywhere under the supervision of qualified medical personnel.

Read letter

Cue Health received Emergency Use Authorization (“EUA”) for home and over the counter use from the U.S. Food and Drug Administration (“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 to consumers for home use and to enterprise users and 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 by consumers at home and in other non-clinical settings.

Read letter

The Cue COVID-19 Test has received the CE mark, authorizing it for sale and distribution in the European Union (EU) for professional use at point-of-care.

The Cue COVID-19 Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that causes COVID-19, in about 20 minutes using a nasal swab sample taken from the lower part of the nose.

The Cue COVID-19 Test runs on the compact and portable Cue Health Monitoring System. A single-use Cue COVID-19 Test kit includes a Cue Sample Wand nasal swab and a COVID-19 Test Cartridge. The system performs rapid molecular analysis at point-of-care and transmits test results to the Cue Health App on a connected mobile smart device.

Read letter

Cue ranked at the top of the dry swab tests in FDA reference panel, currently with the lowest level of detection. 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.

PRODUCT LoD (NDU/mL*)

DEVELOPER

TEST

60000
Cue Health Inc.
Cue COVID-19 Test
180000
Atila BioSystems, Inc.
iAMP COVID-19 Detection Kit
300000
Abbott Diagnostics Scarborough, Inc.
ID NOW COVID-19
540000
Quidel Corporation
Lyra Directs SARS-CoV-2 Assay
* NDU/mL = NAAT Detectable Units/mL
Read the report

Abstract

Point-of-care (POC) tests are in high demand in order to facilitate rapid care decisions for patients suspected of SARS-CoV-2. We conducted a clinical validation study of the Cue Health POC nucleic acid amplification test (NAAT) using the Cue lower nasal swab, compared to a reference NAAT using standard nasopharyngeal swab, in 292 symptomatic and asymptomatic outpatients for SARS-CoV-2 detection in a community drive-through collection setting. Positive percent agreement between Cue COVID-19 and reference SARS-CoV-2 test was 91.7% (22/24); or 95.7% (22/23) when one patient with no tie-breaker method was excluded. Negative percent agreement was 98.4% (239/243), and there were 25 (8.6%) invalid or canceled results. The Cue COVID-19 Test demonstrated very good positive and negative percent agreement with central laboratory tests and will be useful in settings where accurate POC testing is needed to facilitate management of patients suspected of COVID‑19.

Read the report

The Cue Integrated Care Platform was built with data security at its core

We protect all health data in accordance with the highest industry standards, including HIPAA and FERPA.

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