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.
Low occurrence of false negatives. Average was 98.7% across 4 clinical studies.
Low occurrence of false positives. Average was 97.6% across 4 clinical studies.
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 allows for testing samples collected in VTM.
COVID-19 Test Performance
You can count on Cue to perform when it matters most. See how we stack up in the fight against COVID-19.
COVID-19 Product Updates
June 10, 2020
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. 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.
Cue’s COVID-19 test runs on the compact and portable Cue Health Monitoring System. A single-use COVID-19 Test kit includes a Sample Wand and COVID-19 Test Cartridge. The system performs rapid molecular analysis at the point-of-care and transmits test results to the Cue Health App on a connected mobile device. The current FDA EUA allows the Cue COVID-19 test to be used anywhere under the supervision of qualified medical personnel.Read CUE FDA EUA 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*)
* NDU/mL = NAAT Detectable Units/mLRead the report
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
Innovation at lightning speed
The COVID-19 genome is sequenced and published; Cue begins primer development.
Late February 2020
The first Cue COVID-19 Cartridge prototype is developed and testing begins.
Cue COVID-19 clinical trials are successfully completed in March, followed by FDA EUA submission in April.
Cue receives FDA EUA for its COVID-19 Test and begins production.
Product support & documentation for the Cue COVID-19 Test
Cue is committed to keeping health data safe
We protect all health data in accordance with the highest industry standards, including HIPAA and FERPA.Learn more