Respiratory Test Kit Cue® COVID-19 10 Tests

Features

• The Cue™ COVID-19 Test is for use under an Emergency use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• Cue COVID-19 Test is an isothermal nucleic acid amplification assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in direct anterior nasal swabs or in previously collected anterior nasal swab specimens in viral transport media from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19
• The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand, and the Cue Health App on the compatible mobile smart devices named on the Cue Health website at www.cuehealth.com
• Cue COVID-19 Test is authorized for use 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
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests
• Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
• Negative results in an asymptomatic individual are presumptive and confirmation may be performed for patient management, if necessary, with a different molecular test in a laboratory
• Required materials not provided: Cue Health Monitoring System, Mobile Smart Device, Cue Health Mobile App installed on Mobile Smart Device, and Control Swabs (Ref C2110)

More Information

• Cue COVID-19 Test FDA EUA Letter
• Cue COVID-19 Test IFU
• Cue COVID-19 Test Healthcare Professionals Fact Sheet
• Cue COVID-19 Test Patients Fact Sheet