The Lucira COVID-19 & Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens collected from individuals (2 years of age or older) who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and Influenza can be similar.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The Lucira COVID-19 & Flu 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.
Results are for the simultaneous detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in clinical specimens and is not intended to detect Influenza C virus. SARS-CoV-2, Influenza A, and Influenza B viral RNA is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, Influenza A, and/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 pathogens not detected by the test. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.
Negative results for SARS-CoV-2, Influenza A, and Influenza B are presumptive and should be confirmed with an alternative molecular FDA-cleared or authorized assay, if necessary for patient management. Negative results do not preclude SARS-CoV-2, Influenza A, and/or Influenza B infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.
The Lucira COVID-19 & Flu Test is intended for use by operators who have received specific training in the use of the Lucira COVID-19 & Flu Test. The Lucira COVID-19 & Flu Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.