- PCR-Quality Accuracy compared to highly sensitive lab tests
- Results in as fast as 11 minutes for a positive result and 30 minutes for a negative result
- One shallow nasal swab tests for Covid and all its variants of concern, Flu A and Flu B
- For prescription use only under FDA Emergency Use Authorization
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.
Is it COVID-19 or Flu?
Now you'll know for sure.
Fever, runny nose, shortness of breath? You can’t tell the difference between COVID and flu based on the symptoms alone. Testing provides a diagnosis and helps determine a best course for treatment.
Lucira Connect empowers you to seek treatment if you test positive for Covid or flu as soon as you complete your Lucira test.
Introducing one of the fastest ways to treatment: Lucira Connect
If you have Covid-19, the faster you can know you are positive and get to treatment the better. Antiviral treatments are more effective the earlier you take them, and must be taken within 5 days of infection to work. Now Lucira provides one of the fastest ways to get to treatment: Lucira Connect. When you upload a Covid positive test result at lucipass.com, our Lucira Connect digital platform presents the option to seamlessly connect with a leading telehealth provider to discuss care and treatment options. If eligible, get medication prescribed for same-day pick-up at your pharmacy or, if available, have it delivered directly to your door.
Frequently Asked Questions
The Lucira COVID-19 & Flu Test is a diagnostic test to detect SARS-CoV-2, which causes COVID-19, Influenza A and Influenza B virus. The test detects if you have an active infection and does not confirm immunity or detect antibodies. It is a molecular test that amplifies the virus’s genetic material while the test is running just like PCR lab tests. Lucira’s amplification method provides a level of accuracy comparable to one of the highest sensitivity lab PCR tests.
The two most common types of influenza are influenza A & B. This test tests for both of these types of flu. If you test positive for either influenza A (Flu A) or influenza B (Flu B), you have the flu
Lucira detects all COVID-19 variants of interest and concern, including Omicron and all BA subvariants of concern. Lucira conducts routine surveillance of emerging SARS-CoV-2 strains and will continue to monitor the situation with emerging variants. For the latest variant information, please visit: https://www.lucirahealth.com/technical-brief.
Each test is a single-use and comes with everything needed to run 1 COVID-19 and flu test.
Lucira offers free, standard ground shipping on all ONLINE orders. We make expedited overnight shipping available at an additional charge.
Orders placed Sunday-Thursday should process within 24 hours. Friday and Saturday orders should process on Monday. After processing, orders are shipped the following business day, STANDARD Shipping orders should arrive within 3 days and EXPEDITED Shipping orders should arrive the next business day. You’ll receive a confirmation email with tracking information when your order ships.