Point-of-care molecular results in 20 minutes
Bring the unparalleled combination of accuracy, speed, and innovation of the Cue® Integrated Care Platform to your healthcare organization and patients.
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COVID-19 test
Rely on Cue the way your patients rely on you
Cue’s molecular COVID-19 test combines fast results and ease of use with the accuracy of central lab technology to deliver diagnostics that your organization — and patients — can rely on to make timely health decisions.
99% Accurate
When compared to lab-based PCR testing in a clinical study of lay users submitted to the FDA for EUA.
Easy implementation
Ready-to-go right out of the box with minimal set-up or training needed to begin testing.
Future Compatibility
System is fully compatible with all future care offerings, including a wide range of tests.
CPT® code 87635*
Cue's COVID-19 Test is already covered under an existing CPT code.
*The coding information contained here is for informational purposes only, and is not a guarantee of coverage or reimbursement for any product or service.
How Cue compares to other COVID‑19 tests
Cue has the accuracy and early detection benefits of lab-testing and the convenience of a rapid antigen test.
lab test
antigen test
Percent accuracy and sensitivity are estimates based on published information. Individual test performance depends on several factors, including viral load (strength of infection based on time since initial infection or exposure), testing conditions, and vaccination status of individual).
- Based on Cue COVID-19 Test for Home and OTC Use EUA Instructions for Use.
- Range based on competitor Rt-PCR Assay Instructions for Use Claims.
- Based on competitor Antigen Assay Instructions for Use Claims.
- Based on FH Health Inc. Poster “Performance of the Cue COVID-19 Test: prospective clinical verification and operational insights from a multi-centre clinic service delivery model”.
- Based on JAMA Internal Medicine “Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection”.
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The Cue® Integrated Care Platform
How it works
The streamlined Cue system is designed to provide you with the accuracy and speed you need to treat patients in real-time — all from a portable device that fits in the palm of your hand.
Innovative Technology
Cue Reader
Efficient and intelligent, the rechargeable Cue Reader swiftly processes tests and communicates the results to the Cue Health App via Bluetooth®. Up to six Readers can be connected to the Cue Health App at one time for increased testing capacity.
Advanced chemistry
Tests
Our sample-specific, single-use tests are designed with ease of use and safety in mind. All the components for the complex chemistry needed to perform each test are already contained within each cartridge. No mixing required.
Intuitive Dashboard
A connected system
The Cue Health App and Dashboard work together to help you manage patient profiles, communicate results, analyze trends, and comply with reporting.
Future Tests and Services
A holistic approach to health
Designed as a complete diagnostic system, Cue’s future care offerings feature a wide range of tests and services including respiratory health, sexual health, women’s health, and overall wellness — all compatible with the Cue Reader.
A scalable model for modern healthcare
Whether you’re running a large healthcare network or an intimate family practice, Cue streamlines your ability to deliver value-based care with fast, highly accurate test results on demand.
Automated Data Reporting
Streamlined and compliant data reporting you can rely on.
Minimal Training
Easy-to-use system requires no formal training and minimal set up.
High-Efficiency Testing
Fast test processing and the ability to run multiple tests simultaneously.
No Calibration or Servicing
Easy to maintain system with no downtime needed for calibration or servicing.
Portable & Compact
Minimal footprint, easily transported for remote or offsite use.
Scalable Model
Low price of entry and easily scalable within an organization or across a network.
Intuitive Dashboard
Access valuable insights and management tools, including API integration with existing EHR/EMR systems.
Future Tests
Fully compatible with future Cue tests.
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Streamline information
A dashboard that works for you
The Cue Dashboard empowers you with valuable insights and management capabilities, including analytics, reporting solutions, and API integrations with existing EHR/EMR systems.
With several tiers of service, our team can help you find the right solution for your organization. To learn more or purchase the Cue Dashboard, please contact us directly — the Dashboard is not currently included with online orders.
Contact usBehind the science
Research studies
The accuracy and efficacy of Cue’s diagnostic capabilities have been put to the test by some of the most reputable researchers in the industry.
Mayo Clinic conducted an independent study of Cue’s COVID-19 test in a point-of-care setting,
comparing the accuracy of results with lab-based PCR tests.
97.8% of Cue’s results matched those of the PCR tests in the Mayo Clinic study.
Click below to explore the study in more depth.
In a study of lay users conducted at EvergreenHealth, Cue’s COVID‑19 test showed high sensitivity and specificity.
271 participants self-tested with Cue’s test. Results were compared to a lab-based PCR test.
Sensitivity 97.4%
Positive Cue results that matched postive PCR results.
Specificity 99.1%
Negative Cue results that matched negative PCR results.
Click below to explore the study in more depth.
Proven results at point‑of‑care
Interested in bringing Cue to your organization?
Connect with our team to discuss the right solution for your healthcare organization or request a demo of our technology.
Frequently Asked Questions
The Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (Cue COVID-19 Test) is streamlined, easy-to-use, and doesn’t require any specific training to operate.
The Cue COVID-19 Test is authorized for use in point-of-care settings by laboratories or other organizations certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meets the requirements to perform high, moderate, or waived complexity tests. The test is also authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
For directions, conditions of authorization, precautions, and additional information, please see the Cue COVID-19 Test Instructions For Use (IFU).
As of January 15, 2022, private insurance companies in the United States are required to reimburse their members for COVID-19 tests, per a federal requirement.
Methods and amounts of reimbursement vary by payor, and we encourage you to check with specific payors about their policies regarding reimbursement.
Some providers use 87635 as the CPT code for reimbursement: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).
The coding information contained here is for informational purposes only and is not a guarantee of coverage or reimbursement for any product or service. We recommend you consult with our CPT code advisors for guidance.
Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Cue COVID-19 Test for Professional Use. The Cue COVID-19 Test may be used to test symptomatic and asymptomatic individuals for the detection of nucleic acid from SARS-CoV-2. Testing may be performed by CLIA certified laboratories or at the point-of-care (POC), i.e., in patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Cue COVID-19 Test for Home and Over The Counter (OTC) Use
The FDA granted the Cue COVID-19 Test Emergency Use Authorization (EUA) for Home and Over The Counter (OTC) Use for the detection of nucleic acid from SARS-CoV-2 in symptomatic and asymptomatic individuals, ages 2 years and older. Tests may be purchased without a prescription and self-administered by adults or administered on minors with adult assistance.
- Authorized Laboratories using the Cue COVID-19 Test must include all authorized fact sheets along with test result reports. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
- Authorized Laboratories must follow Cue’s COVID-19 Test Instructions For Use. Deviations from the authorized procedures, including authorized clinical specimen types and authorized control materials required to use the Cue COVID-19 Test, are not permitted.
- Authorized Laboratories that receive the Cue COVID-19 Test must notify the relevant public health authorities of their intent to run the product prior to initiating testing.
- Authorized Laboratories using the Cue COVID-19 Test must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
- Authorized Laboratories must collect information on the performance of the Cue COVID-19 Test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and Cue Health Inc. Technical Support (support@cuehealth.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the Cue COVID-19 Test of which they become aware.
- All operators using the Cue COVID-19 Test must be able to perform and interpret the test results, use appropriate personal protective equipment, and use the product in accordance with the authorized labeling.
- Authorized Laboratories using the Cue COVID-19 Test must ensure that any records associated with this EUA are maintained until otherwise notified by the FDA. Such records will be made available to the FDA for inspection upon request.
The reimbursement CPT code for Cue’s COVID-19 Test is: 87635 — Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
The coding information contained here is for informational purposes only, and is not a guarantee of coverage or reimbursement for any product or service.
