Lucira COVID-19 & Flu Test

Instructions

The Lucira COVID-19 & Flu Test is a single use real-time RT-LAMP test intended for self testing at home for the simultaneous rapid qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A and Influenza B virus from self-collected nasal swab samples in individuals 14 years and older (self- collected) or individuals ≥2 years (collected by an adult) with symptoms of respiratory viral infection consistent with COVID-19, Influenza A and/or Influenza B. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. 

This test is also intended for use at the Point of Care (POC) for individuals with symptoms of respiratory viral infection consistent with COVID-19, Influenza A and/or Influenza B with specimens collected by trained personnel. The Lucira COVID-19 & Flu Test is intended for use as an aid in the differential diagnosis of SARS- CoV-2, Influenza A and Influenza B, in humans, and is not intended to detect Influenza C. 

The SARS-CoV-2, Influenza A or Influenza B RNA is generally detectable in nasal swab samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, Influenza A or Influenza B 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. The agent detected may not be the definite cause of disease. 

Persons who test positive with the Lucira COVID-19 & Flu Test should seek follow up care with their physician, or healthcare provider, as additional testing and public health reporting may be necessary. 

Negative results do not preclude infection from SARS-CoV-2, Influenza A, and/or Influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.