Leading the fight against COVID-19

Cue’s COVID-19 test simplifies the testing process so you can respond to situations quickly, improving the health and workflow of your organization.

COVID-19 test results delivered to your mobile device in about 20 minutes.

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Sensitivity

Low occurrence of false negatives. Average was 98.7% across 4 clinical studies.

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Specificity

Low occurrence of false positives. Average was 97.6% across 4 clinical studies.

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Limit of Detection

Competitively low limit of detection. 20 genome copies per sample.

Flexibility to fit your workflow

No matter what industry you’re in, Cue empowers you to make timely, informed decisions and avoid costly disruptions with our fast, accurate, easy-to-use system.

The Cue Sample Wand goes directly from the patient’s nasal cavity into the Reader with no additional manipulation necessary.

In addition to direct swabs, Cue’s FDA EUA for CLIA Certified Healthcare Providers and Laboratories allows for testing samples collected in VTM.

Product support & documentation
for the Cue COVID‑19 Test

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

COVID-19 Product Updates

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

Cue is committed to keeping health data safe

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

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