The rapid test uses a molecular amplification technology to detect the virus in people with known or suspected COVID-19 and can return results in 30 minutes, the FDA said. Negative results do not preclude SARS-CoV-2 infection. We also provide a video demonstration at the top of this page. What comes in the Lucira COVID-19 Test Kit? The first and only at-home test authorized by Health Canada for both Covid and Flu, the Lucira COVID-19 & Flu Test provides 99% accurate results compared to highly sensitive lab-based tests, but in only 30 minutes - at home. It delivers PCR quality molecular accuracy in 30 minutes or less at home and is expected to be available online for Canadians to order by June 2021 for approximately $75.00 CAD, excluding applicable taxes and delivery charges. It is a priority for CBC to create products that are accessible to all in Canada including people with visual, hearing, motor and cognitive challenges. Having underlying medical conditions may also increase ones risk for severe illness from COVID-19. How much does the Flowflex COVID-19 Antigen Home Test cost? The test has been designed to minimize the likelihood of false positive test results. 347-620-7010 "We need to get these tests in the community in a way that is easy to use with not a lot of cost or barriers to using them.". We know that no one has time to wait in line at the pharmacy. The swab is then stirred in the sample vial, and the vial is pressed down in the test unit to start the test. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/c3d39964-d38a-4986-afcb-472da6f8300c, https://www.globenewswire.com/NewsRoom/AttachmentNg/9dd32dc0-c1ef-4bd0-b819-9a71bcfa0222, https://www.globenewswire.com/NewsRoom/AttachmentNg/313060d2-cba9-459c-a995-abe5d0ea8ceb, 1985 - 2023 BioSpace.com. First COVID and flu at-home test OK'd by Food and Drug Administration Here are the features of the two kits: The Lucira Check It COVID-19 Test Kit is a self-collection test that provides PCR-quality results within 30 minutes. Full content visible, double tap to read brief content. Variants can impact the performance of a test. Rapid Test & Trace Canada Adds Lucira COVID-19 & Flu Combo Tests This can include tests to distribute to provinces and territories, northern and Indigenous communities, federal organizations, or other organizations for workplace screening. Trouble breathing Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. How many Flowflex COVID-19 Antigen Home Test kits can I purchase? Variants of a virus are versions of the virus in which the nucleic acids are different. Canada continues to receive shipments of rapid tests on a regular basis. The swab is then stirred in the sample vial, which is then gently pressed into the test unit to start the test. As with Canada, the LUCIRA CHECK IT COVID-19 test kit is the first and only U.S. FDA Emergency Use Authorization (EUA) over-the-counter, single-use, PCR quality molecular test for. In a Community Trial setting, LUCIRA CHECK IT results were compared with the Hologic Panther Fusion, considered one of the highest sensitivity molecular tests due to its low Limit of Detection (LOD). Numbers current as of: September 20, 2022. Lucira performs routine surveillance of emerging SARS-CoV-2 strains and will continue to monitor emerging variants. Device identifiers are assigned to entire test kits, such as a pack of tests, or a test kit component, such as a swab. The Lucira Check It COVID-19 Test Kit comes with everything needed to perform a single COVID19 test. Distribution of the COVID-19 & Flu Test in Canada will be prioritized along with the current COVID-19 Test and is available to institutions, agencies, and consumers in advance of the approaching fall and winter COVID and Flu season. These standing offers are a way of ensuring the Government of Canada can secure rapid tests for immediate needs without delay. Patient management should be made by a healthcare provider and follow current CDC guidelines. Kevin Knight VERSA 10 GENE - Aurora Biomed The Lucira COVID-19 & Flu test is a molecular at-home test utilizing the same platform and device design as Lucira's COVID-19 tests to provide independent diagnoses for COVID-19, Flu A, and Flu B . You will not receive a reply. Extensions for shelf life may be granted: For more information on tests that may have an expanded use indication, please visit: Health Canada continues to work closely with our federal, provincial and territorial partners, and the manufacturing community, to support additional shelf life extensions. The Check-It COVID-19 test kit costs $75 for a single test. Positive results are indicative of the presence of SARS-CoV-2. The first two cost about $20 to $25 US for a pack of two tests, while the latter is about twice as expensive. To add the following enhancements to your purchase, choose a different seller. The Lucira Check It COVID-10 Test Kit arrives with everything you need to collect a sample and get results within 30 minutes. Within the authorization, each device is listed separately. The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab. Currently, the test kit has a 6-month expiration, meaning you can keep one on hand for 6 months in case you need a PCR-quality test at home. Luciras testing platform produces lab quality molecular testing in a single-use, consumer-friendly, palm size test kit powered by two AA batteries. Q: QuantuMDx Group Ltd.: , , Lucira Health's COVID-19 & Flu At-Home Molecular Test Shows Positive The list price is $89 with a $14 coupon available on amazon.com. The List of Medical Devices for Expanded Use in Relation to COVID-19 provides additional information on the expansion of use for specific COVID-19 testing devices. No single vaccine is 100 per cent effective, some people can't or won't get a vaccineand COVID-19 boosters could be needed as immunity wears off. Lucira Health's PCR-Quality At-Home COVID-19 Test Now - Insider Lucira Health president and chief executive officer Erik Engelson said: When influenza and Covid-19 co-circulate this winter, millions who dont feel well will be asking is it Covid-19 or flu? so they can take the appropriate action to get better. EASY TO USE, RAPID RESULTS: Includes a shallow nasal swab with easy-to-follow instructions. Lucira Health's PCR-Quality At-Home COVID-19 Test Now Available Direct FDA Unveils Plan to End COVID-19 Test EUAs