HCP Cue® Tube Pack
$99.00
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Product Details
About the Cue Tube Pack:
One hundred (100) paired tube pouches. Each pouch contains two (2) tubes with paired QR code
One hundred (100) paired tube pouches. Each pouch contains two (2) tubes with paired QR code
How to use Cue Tubes
The Cue Sample Wand must be used with the Cue Health Monitoring System and the Cue COVID-19 Test Cartridge. To collect a direct nasal swab sample, both nostrils are swabbed with the same Cue Sample Wand. While swabbing in both nostrils do not attempt to scrape or remove excess mucus.
- Insert the tip of the Cue Sample Wand into one nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.
- Then, insert the same Cue Sample Wand into the other nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.
Specs
Includes 100 tube pouches, each containing 2 tubes with paired QR code.
- Package Specifications: 11.25 x 22.5 x 6.5 inches; 4 lb.
- SKU: 9100143
Documentation & Disclaimers
The Cue COVID-19 Test has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
VIEW PRODUCT DOCUMENTATION FOR THE CUE COVID-19 TEST FOR OVER-THE-COUNTER USE
Clinical Studies
Cue has participated in or commissioned several clinical studies to demonstrate the safety, efficacy and accuracy of our molecular tests. For study details, see links below.
Independent Mayo Clinic Evaluation of the Cue COVID-19 Test
Cue COVID-19 Test Instructions for Use (IFU)
(Includes Limit of Detection Study, Cross-Reactivity Study, and Prospective Clinical Study in Emergency Departments)
Independent Mayo Clinic Evaluation of the Cue COVID-19 Test
Cue COVID-19 Test Instructions for Use (IFU)
(Includes Limit of Detection Study, Cross-Reactivity Study, and Prospective Clinical Study in Emergency Departments)
Return Policy
Because Cue has stringent quality assurance requirements as a medical device and product, returns and exchanges are not permitted. See the Cue Terms of Use and End User License Agreement for more details.
Frequently Asked Questions
What professional training is required to administer Cue Tests?
The Cue COVID-19 test is streamlined, easy-to-use, and doesn’t require any specific training to operate.
For directions, conditions of authorization, precautions, and additional information, please see the Cue COVID-19 test Instructions For Use (IFU).
For directions, conditions of authorization, precautions, and additional information, please see the Cue COVID-19 test Instructions For Use (IFU).
Which payors are currently offering or covering Cue Tests?
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 your CPT® code advisors for guidance.
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 your CPT® code advisors for guidance.
What regulatory authorizations have the Cue COVID-19 tests received?
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.
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.
What are the FDA requirements for Authorized Laboratories that use the Cue COVID-19 test?
Authorized Laboratories must follow the Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories 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 must include all authorized fact sheets along with test result reports. Fact sheets for patients and for healthcare providers are available at cuehealth.com/docs.
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 above information is for informational purposes. Please also confirm your legal obligations within your organization
Authorized laboratories must include all authorized fact sheets along with test result reports. Fact sheets for patients and for healthcare providers are available at cuehealth.com/docs.
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 above information is for informational purposes. Please also confirm your legal obligations within your organization
What is the reimbursement CPT® code?
The reimbursement CPT code for Cue’s COVID-19 test may be: 87635 — Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrom e 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.
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 many Cue Readers can be connected to one compatible device?
Up to six (6) Cue Readers can connect to a compatible device. To connect additional Readers, follow the simple instructions below:
- When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen.
- Tap on “Manage Readers”.
- Confirm that the BLUETOOTH wireless technology of your mobile device is enabled.
- Tap on “+”.
- Follow on-screen instructions to pair the additional Cue Reader. The Cue Reader is now paired to the mobile device.
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