HCP Cue® COVID-19 External Control Swabs Pack
$99.00
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Product Details
About the Cue COVID-19 Test 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 the Cue COVID-19 Test Cartridge for Professional Use only 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.
Cue recommends that a Negative Control Swab and a Positive Control Swab be run:
  • Once for each new lot of COVID-19 Test Cartridge packs received
  • When problems with testing are suspected or identified
  • As needed to conform with your internal quality control procedures, with local, state and/or federal regulations, or accrediting group requirements

  • If correct control results are not obtained, repeat the test using a new Control Swab, and a new Test Cartridge. If the control testing continues to fail, do not perform additional clinical specimen tests. Contact Cue Health Customer Support at support@cuehealth.com or call toll-free at 833.CUE.TEST (833.283.8378) before testing additional clinical specimens.

    Intended use

    The Cue COVID-19 Test External Control Swabs Pack is intended for quality control to confirm that the Cue Reader and Cue COVID-19 Test Cartridge are working properly. To be used with the Cue COVID-19 Test Cartridge for Professional Use only.

    CLIA Authorization

    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 that meet 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.
    How to Use Cue
    Using Cue® is easy. Just follow the step-by-step guide in your Cue Health App.
    01
    Insert your 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
    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
    Documentation & Disclaimers
    The Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories 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 PROFESSIONAL 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)
    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 Professional tests
    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).

    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 our 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.

    What are the FDA requirements for Authorized Laboratories that use the Cue COVID-19 Test?
    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 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.
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