HCP Assessment Bundle
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Product Details
About the Cue Assessment Kit:
The Cue Assessment Kit is designed to help healthcare professionals thoroughly evaluate the Cue system and COVID-19 tests in their point-of-care setting as part of the decision making process. It includes: 50 Cue COVID-19 tests
The Cue COVID-19 test is the first compact, portable molecular COVID-19 self-testing system issued with an Emergency Use Authorization by the FDA for use at home or on the go, without a prescription.
About the Cue Reader:
The Cue Reader is an elegantly designed, automated processor of test results and is used with Cue tests (sold separately), the Cue Health App, and the Cue Dashboard.
Once the Cue Wand with the nasal sample is inserted into the pre-heated Cue Test Cartridge, the Cue Reader will process the test and communicate the result directly to the Cue Health App on your mobile device and Cue Dashboard (if applicable) via Bluetooth®. No mixing of fluids required.
Each Cue Reader can process one test at a time; however, up to 6 Cue Readers can be connected to the same Cue Health account for running multiple tests simultaneously.
The Cue Reader is compatible with all Cue tests, including future offerings.
About the Cue External Control Swabs Pack:
The Cue COVID-19 External Control Swabs Pack contains positive and negative control swabs that are used for external quality control with Cue COVID-19 Test Cartridges and the Cue Reader (both sold separately).
Each Cue COVID-19 External Control Swabs Pack contains three (3) Cue COVID-19 Test Positive Control Swabs and three (3) Cue COVID-19 Test Negative Control Swabs. Similar to Cue’s COVID-19 test, results from the Cue Control Swabs are delivered to a mobile device and the Cue Dashboard (if applicable) in 20 minutes via the Cue Health App.
About the Cue COVID-19 Training Cartridge Pack:
Created to help facilitate training and demonstrations, this pack contains 3 Cue COVID-19 Training Cartridges: one generates a positive result, one generates a negative result, and one generates an invalid result. Not for diagnostic use.
About Cue Sample Wands:
Designed for use with the Cue COVID-19 test and Cue Reader, the streamlined Sample Wands are used for easy specimen collection. These replacement Sample Wands are intended as supplements, in the event that existing Sample Wands are rendered unusable or contaminated (e.g. Sample Wand is dropped on floor)
The Cue Assessment Kit is designed to help healthcare professionals thoroughly evaluate the Cue system and COVID-19 tests in their point-of-care setting as part of the decision making process. It includes: 50 Cue COVID-19 tests
- 5 Cue Readers
- 2 Cue External Control Swab Packs
- 1 Cue Training Cartridge Pack
- 1 10-pack Cue Sample Wands
The Cue COVID-19 test is the first compact, portable molecular COVID-19 self-testing system issued with an Emergency Use Authorization by the FDA for use at home or on the go, without a prescription.
- Lab-quality results are delivered directly to a mobile device and the Cue Health Dashboard (if applicable) in 20 minutes via the Cue Health App.
- Cue's molecular COVID-19 test is a nucleic acid amplification test (NAAT), designed to detect the genetic material in SARS-CoV-2.
- For use in symptomatic and asymptomatic adults and children.
- Can detect all known variants and subvariants of concern.
- In an independent study conducted by Mayo Clinic, testing administered by professionals in point-of-care settings demonstrated 97.8% agreement with central lab PCR testing.
- Used by world-class organizations like the NBA, Mayo Clinic, MLB, NASA, as well as the U.S. Departments of Health & Human Services and Defense.
- Designed for use at point-of-care, in the community, or at home.
- Can be used to test a direct nasal swab. Healthcare providers or authorized laboratories may also use Cue’s COVID-19 Test on a previously collected nasal sample stored in viral transport media (VTM) (not included).
- No training needed. No mixing of fluids or calibration required.
About the Cue Reader:
The Cue Reader is an elegantly designed, automated processor of test results and is used with Cue tests (sold separately), the Cue Health App, and the Cue Dashboard.
Once the Cue Wand with the nasal sample is inserted into the pre-heated Cue Test Cartridge, the Cue Reader will process the test and communicate the result directly to the Cue Health App on your mobile device and Cue Dashboard (if applicable) via Bluetooth®. No mixing of fluids required.
Each Cue Reader can process one test at a time; however, up to 6 Cue Readers can be connected to the same Cue Health account for running multiple tests simultaneously.
The Cue Reader is compatible with all Cue tests, including future offerings.
About the Cue External Control Swabs Pack:
The Cue COVID-19 External Control Swabs Pack contains positive and negative control swabs that are used for external quality control with Cue COVID-19 Test Cartridges and the Cue Reader (both sold separately).
Each Cue COVID-19 External Control Swabs Pack contains three (3) Cue COVID-19 Test Positive Control Swabs and three (3) Cue COVID-19 Test Negative Control Swabs. Similar to Cue’s COVID-19 test, results from the Cue Control Swabs are delivered to a mobile device and the Cue Dashboard (if applicable) in 20 minutes via the Cue Health App.
About the Cue COVID-19 Training Cartridge Pack:
Created to help facilitate training and demonstrations, this pack contains 3 Cue COVID-19 Training Cartridges: one generates a positive result, one generates a negative result, and one generates an invalid result. Not for diagnostic use.
About Cue Sample Wands:
Designed for use with the Cue COVID-19 test and Cue Reader, the streamlined Sample Wands are used for easy specimen collection. These replacement Sample Wands are intended as supplements, in the event that existing Sample Wands are rendered unusable or contaminated (e.g. Sample Wand is dropped on floor)
How to Use Cue
Using Cue is easy and requires no formal training to begin. Just follow the step-by-step guide in your Cue Health App. You can also reference the official Instructions For Use (IFU) for complete details.
01
Insert the Cartridge into the Reader
02
Use the Wand to collect a sample from the lower part of each nostril
03
Insert the Wand into the cartridge
04
Get results from the Cue Health App on your mobile device in 20 minutes
Specs
COVID-19 Test:
Each test includes a self-contained COVID-19 Test Cartridge and a Sample Wand (for lower nasal swab).
Each Cue COVID-19 External Control Swabs Pack contains three Cue COVID-19 Test Positive Control Swabs and three Cue COVID-19 Test Negative Control Swabs.
Each test includes a self-contained COVID-19 Test Cartridge and a Sample Wand (for lower nasal swab).
- The shelf life of Cue COVID-19 Cartridges is 9 months from manufacture date.
- The test is used with the Cue Reader and the Cue Health App.
- Test Cartridges and components made in the USA.
- Package Specifications (10 pack): 7.75 x 7.00 x 4.94 inches; 0.90 lb.
- SKU: 9100015
- Rechargeable battery can process approximately 10 tests on a full charge
- Power Specifications: 5V DC, 1.5A
- Product Specifications: 2.9 in x 2.9 in x 1.5 inches; 5.29 oz.
- Package Specifications: 4.07 x 4.07 x 4.07 inches; 1.03 lb.
- SKU: 9000207
Each Cue COVID-19 External Control Swabs Pack contains three Cue COVID-19 Test Positive Control Swabs and three Cue COVID-19 Test Negative Control Swabs.
- Package Specifications: 5.75 x 3.0 x 2.0 inches; 1.8 oz.
- SKU: 9200001
- Package Specifications: 5 x 7 x 0.5 inches; 3.6 oz
- SKU: 2900009
- Package Specifications: 5.75 x 3.0 x 2.0 inches; 1.03 lb.
- SKU: 9100366
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.
HCP Cue Reader
$99.00
HCP COVID-19 Tests - 10 Pack
$500.00
HCP COVID-19 Test External Control Swabs Pack
$99.00
HCP 20 COVID-19 Tests & Cue Reader
$1,099.00
HCP 50 COVID-19 Tests & 3 Cue Readers
$2,797.00
HCP Cue Reader
$99.00
HCP COVID-19 Tests - 10 Pack
$500.00
HCP COVID-19 Test External Control Swabs Pack
$99.00
HCP 20 COVID-19 Tests & Cue Reader
$1,099.00
HCP 50 COVID-19 Tests & 3 Cue Readers
$2,797.00
