Cue

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.

EASY & 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 s

CONNECTED & SCALABLE

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.

COVID-19 Product Updates

CUSTOMER NOTICE OF SHELF-LIFE EXTENSION – CUE COVID-19 TEST CARTRIDGE PACKS

FDA EMERGENCY USE AUTHORIZATION FOR CLIA CERTIFIED HEALTHCARE PROVIDERS AND LABORATORIES

FDA EMERGENCY USE AUTHORIZATION FOR HOME AND OVER THE COUNTER (OTC) USE

CE MARK

FDA REFERENCE PANEL RANKING

MAYO CLINIC EVALUATION OF THE CUE COVID-19 TEST.

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.