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

Description

Lucira offers a PCR-quality molecular test for Covid and flu to speed accurate patient diagnosis anywhere at the point-of-care. With positive results in as little as 11 minutes and negative results in 30 minutes, patients can be diagnosed in-visit, helping to get your patients to better, faster.

• 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.

Specifications

• Accuracy: 99% accurate compared to highly sensitive lab PCR tests
• CE Marker: Self-declared
• Clia Complexity: Waived (FDA, EUA)
• Detectable Analytes: Influenza A and B, SARS-CoV-2
• Format: Kit
• Sample Type: Nasal Swab
• Disposable: Single-use
• For Use With (Application): RT-PCR, Rapid PCR
• Form: Ready-to-Use (RTU)