Respiratory Test Kit Cue® COVID-19 Test for Home and OTC 10 Tests

Features

• The Cue™ COVID-19 Test for Home and Over The Counter (OTC) Use 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
• The Cue COVID-19 Test for Home and Over the Counter (OTC) Use is a molecular diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand
• Cue COVID-19 Test for Home and Over the Counter (OTC) Use is intended for use in adults (self-swabbing) or children ≥ 2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19
• Positive results indicate the presence of viral RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
• Positive results do not rule out a bacterial infection or co-infection with other viruses
• Negative results in an asymptomatic individual are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary, for patient management may be performed
• Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions
• Test results will be reported to relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC
• The test is used with the Cue Reader (sold separately) and the Cue Health App

More Information

• Cue COVID-19 Test for OTC and Home Use FDA EUA Letter
• Cue COVID-10 Test For OTC and Home Use IFU
• Cue COVID-19 Test for OTC and Home Use Healthcare Professionals Fact Sheet
• Cue COVID-19 Test For OTC and Home Use Individuals Fact Sheet
• Cue COVID-19 Test for Home and OTC Use FAQ