Rapid Test Kit Cue™ Molecular Diagnostic COVID-19 Test for Home and OTC Nasal Swab Sample 10 Tests

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