Lucira COVID-19 and Influenza (Flu) A & B Point of Care Test

Description

• 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
• 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 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
• 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.