Users get the test device, two AA batteries, sample vial, swab and simple instructions. No prescription necessary. 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. Each Lucira test kit contains everything needed to run one COVID-19 test. Q: Please try again. You will receive a text back with a link to submit your test results. What does it mean if I have a positive test result from the Flowflex COVID-19 Antigen Home Test? Lucira COVID-19 & Flu Rapid PCR Test, Health Canada Authorized at-Home Molecular Test, Results in 30 Minutes or Less, 99% Accurate Brand: Lucira 1 rating $9800 MOLECULAR TEST, NOT AN ANTIGEN TEST: Like lab-based PCR tests, this test amplifies virus genetic material for accurate, early detection. "That's where we need to be, if we really want to keep people safe and keep the economy open," he said. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Media Contact Suppliers deliver rapid tests based on the schedule outlined in each specific contract. The Lucira Check It COVID-19 Test Kit comes with everything needed to perform a single COVID19 test. The Food and Drug Administration issued an emergency use authorization on Friday for the first at-home test that can simultaneously detect both COVID-19 and the flu. Review the full CADTH report titledSelf-collection of nose and throat swab samples for SARS-CoV-2 antigen testing. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. For example, an authorization can have a nasal version and a nasopharyngeal version, each with its own device identifier and IFU. You may also access LUCI by going to luci.lucirahealth.com from your smartphone. These testing devices only apply to point-of-care and lab-based tests, as self-tests do not require supervision by a health care provider. Ships from and sold by Lucira Health, Inc.. Sold by THINKA CANADA and ships from Amazon Fulfillment. The list of authorized testing devices has been updated to include the available instructions for use for COVID-19 tests. Each test costs $89 discounted to $29 with free shipping, or you can pay extra for expedited shipping. 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. Have trouble accessing our 44544 text code? 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. This item: Lucira CHECK-IT COVID-19 Test Kit, 1 Pack, 1 Test Total, The Only FDA Authorized Molecular Test, Results at Home in 30 Minutes or less, 98% Accurate $34.99 iHealth COVID-19 Antigen Rapid Test, 1 Pack, 5 Tests Total, FDA EUA Authorized OTC at-Home Self Test, Results in 15 Minutes with Non-invasive Nasal Swab, Easy to Use & No Discomfort Collect your own sample using a nasal swab, follow kit instructions, and wait 15-30 minutes for your result. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 and influenza test kits; our expected future growth; our ability to obtain and maintain regulatory approval for our test kits, including our existing Emergency Use Authorization for our COVID-19 and influenza test kits and LUCI Pass; the size and growth potential of the markets for our test kits, including the COVID-19 and influenza diagnostic testing market, and our ability to serve those markets; our ability to accurately forecast demand for our test kits; the rate and degree of physician and market acceptance of our test kits; the expected future growth of our sales and marketing organization; coverage and reimbursement for our test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; our ability to accurately forecast, and Jabils ability to manufacture, appropriate quantities of our COVID-19 and influenza test kits to meet commercial demand; regulatory developments in the United States and foreign countries; our research and development for any future test kits; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others; and our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russias military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on managements assumptions and estimates as of such date. Lucira performs routine surveillance of emerging SARS-CoV-2 strains and will continue to monitor emerging variants. Authorization of COVID-19 testing devices Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. The instructions tell you how to collect a sample and take the test. Negative results are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary, for patient management may be performed. With respect to accuracy, the British government last week trumpeted an independent study indicating that one of the home tests it approved had a 100 per cent rate of specificity compared with PCR lab tests and a 96.4 per cent rate with respect to sensitivity. A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Lucira COVID-19 & Flu Test is the first and only combination over-the-counter (OTC) self-test with fast, molecular lab-quality results enabling mass testing of symptomatic residents, staff and . Inability to wake up or stay awake We offer two over-the-counter COVID-19 Test Kits, the Flowflex COVID-19 Antigen Home Test and the Lucira Check It COVID-19 Test Kit. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider and negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular test. They are written specifically for that type of kit. New confusion You may also report your concern directly to Health Canada. Yes, it detects the double mutant L452R, E484Q (India/California), B.1.1.7 (UK), B.1.351 (South Africa), P.1 (Brazil), and B.1.427/B.1.429 (Southern California) SARS-CoV-2 variants. Rapid tests for COVID-19 screening in the workplace, ACON Flowflex SARS-CoV-2 Antigen Rapid Test, SD Biosensor tests and SARS-CoV-2 Rapid Antigen Self Test NASAL. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. The LUCIRA CHECK IT test kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests. About Us; Contact; Careers; These forward-looking statements, including but not limited to, statements regarding the distribution of the COVID-19 & Flu Tests in Canada, the upcoming winter respiratory disease season in Canada, accuracy of our COVID-19 & Flu Test, the demand of our COVID-19 & Flu Test by Canadian consumers, ; are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These standing offers help ensure a reliable supply chain and better position the federal government to respond to increased testing demands in the future. LUCI uses your phones camera to digitally verify your test result. We are proud our self-test was the first one authorized for use within this vast country. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. It is a provides a positive or negative result for Covid-19, Influenza A (Flu A), and Influenza B (Flu B) with 99% accuracy, under 30 minutes, said the company. People with or without symptoms can use themselves to see if they may have COVID-19. We are doctors, nurses, nurse practitioners, pharmacists, and physician assistants who are passionate about providing patient care. This list is updated every day by 5 a.m. EST. This test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Luciras COVID-19 & Flu Test is available now for online ordering at: www.lucirahealth.ca. A COVID-19 rapid test kit produced by Abbott is shown at Humber River Hospital in Toronto in November. The LUCIRA CHECK IT (OTC) and LUCIRA COVID-19 All-In-One Test Kit (RX) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection. With antigen tests a positive result is usually highly accurate but a negative result may have missed an infection, especially in the presymptomatic phase. Only the Lucira Covid-19 & Flu Test, a single at-home test with 99% accuracy, can answer this question immediately. It can represent a part or combination of parts. MATTERS: With Lucira, avoid appointments wait times, and lab delays. Patient management should be made by a healthcare provider and follow current CDC guidelines. Lucira Check It COVID-19 Test; Rapid Tests . Within the authorization, each device is listed separately. If an IFU is available in only 1 official language, contact the manufacturer to request it in the other official language. Test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. struggled to deploythe full allocation of rapid tests, CBC's Journalistic Standards and Practices. The emergency use of this test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Don't see the answer that you're looking for? We are sorry. "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.". Note that Lucira is not yet approved for travel to the State of Hawaii. 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 began making its COVID-19 & Flu test available in Canada in August 2022 . The manufacturer defines what each unique device identifier represents for their device. The LUCIRA CHECK IT COVID-19 test kit is designed to deliver polymerase chain reaction (PCR) quality molecular accuracy in 30 minutes or less at home, and is available online at. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. To help consumers use COVID-19 testing devices safely and effectively, we have published available authorized instructions for use (IFU) for authorized devices. Current centralized laboratory tests can typically take two to 14 days to generate similarly accurate test results. Box 500 Station A Toronto, ON Canada, M5W 1E6. Only the Lucira COVID-19 & Flu Test, a single at-home test with 99% accuracy, can answer this question immediately, said Erik Engelson, President and Chief Executive Officer of Lucira Health. If an issue is identified, we will work quickly with manufacturers and public health laboratories to mitigate those risks. There was a problem completing your request. The Government of Canada continues to pursue agreements to procure rapid tests for provinces and territories, northern and Indigenous communities, and federal organizations. The user then opens the test swab packet and rotates the swab in each nostril five times. The table also indicates if the following apply to any of the authorized devices: Results of the COVID-19 test can be displayed: The testing information column indicates if the test can be read on an instrument or visually as follows: Some COVID-19 testing devices allow for other respiratory viruses (for example, influenza A and B and RSV) to be detected at the same time. Health Canadas decision is based on performance data reviewed under Health Canadas expedited authorization pathway, Interim Order No. Is the Lucira COVID-19 Test Kit authorized by the FDA? One writer, from MIT Technology Review, expressed worries about user error creating false positives that, if amplified by stories in the media, could discourage their widespread use. Its important to carefully read and follow the instructions for the test to work properly. Health Canada, European Medicines Agency, and other regulatory authorities are planned for the second quarter of 2022 with decisions expected before this upcoming flu season. We have recently upgraded our technology platform. Test once, at home. 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. The list price is $89 with a $14 coupon available on amazon.com. The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations. 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. Words such as "can," "will," expect, and similar expressions are intended to identify forward-looking statements. The swab is then stirred in the sample vial, and the vial is pressed down in the test unit to start the test. A combined total of 677 samples were tested across both studies, of which 425 samples were included in the Retrospective Remnant Study and an additional 252 subjects enrolled in the Prospective Study. "Although molecular (PCR) laboratory testing is the gold standard in diagnostic testing, numerous technologies and testing methods are emerging that could supplement diagnostic testing," the Health Canada sitestates. Health Canada said last year it wouldn't consider at-home tests due to concerns about accuracy, though it later changed that stance. Harvard epidemiologist Dr. Michael Mina, an advocate for home tests, has outlined scenarios where they could be of use, includingwhen a person is deciding whether to attend an event where there are large crowds or a more intimate gathering where there will be vulnerable persons, or when a child comes home from school with symptoms that could portend COVID-19, influenza or the common cold. For example: Refer to the point-of-care or self-testing webpage for more information. These tests have been procured to fulfil immediate, emerging and long-term requirements. In both the studies a total of 677 samples were tested, with 425 samples in the retrospective remnant study and 252 subjects enrolled in the prospective study. You can view previously submitted tests by texting Results to 44544 or visiting luci.lucirahealth.com. (Photo: Business Wire). ${cardName} not available for the seller that you chose. Bates said he is not aware of any impending Health Canada approval of home tests which is not unusual, he says but it would be a logical next step. Javascript must be enabled for the correct page display. The Lucira COVID-19 Test Kit is a diagnostic test intended to detect the novel coronavirus SARS-COV-2 that causes COVID-19. The Lucira COVID-19 All-In-One Test Kit is authorized for use with certain respiratory specimens collected from individuals consistent with the Emergency Use Authorization (EUA). Part 1.1 of the Medical Devices Regulations permits the authorization of new COVID-19 uses for devices already approved in Canada when scientific data supports this. They are a onetime usage. . 619-929-1275, Investor Relations Results are 93% accurate for people infected with COVID-19. Rapid Antibody Test Kit LUCIRA CHECK IT COVID-19 Test Kit Rapid antigen combo kit (COVID-19/Flu A&B) Canada Travel Test. A simple solution for COVID-19 infection detection, with rapid results in the convenience of your home. Please use a different way to share. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted an environmental scan related to sample collection for testing during the Omicron variant. The table below outlines Canada's agreements with suppliers for rapid tests. Sensitivity values are presented to provide transparency around clinical performance data that were filed with Health Canada at the time of submission. How does the Lucira COVID-19 Test Kit work? LUCIRA CHECK IT COVID-19 Self-Test Receives Interim Order Authorization, Health Canada issues Authorization with Conditions for LUCIRA CHECK IT COVID-19 Self-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, Fed decision, Apple earnings, April jobs report: What to know this week, JPMorgan buys First Republic Bank's assets - Quotes, Biopharma firm Acelyrin seeks $1.5 bln valuation in US IPO, Stock futures muted as JPMorgan Chase takes over First Republic : Stock market news today, American Airlines pilots vote to authorize strike. Last week, the FDA authorized the Lucira COVID-19 & Flu Home Test for emergency use. It has reviewed clinical data from both retrospective remnant samples and prospective clinical studies of the Lucira Covid-19 & Flu Test, compared to established PCR tests. Canada continues to receive shipments of rapid tests on a regular basis. Prime Minister Justin Trudeau last week proudly announced a partnership with the Ontario government to provide more rapid COVID-19 tests for employees in key businesses, but it's still unclear at this time whetherfederal health officials believe there's a place for tests that can be obtained by all Canadians on pharmacy shelves and used at home. But it appears it will be several months before most Canadian teens and adolescents will be vaccinated, and it's not clear when kids under 12 could follow. The ready light will blink until a positive or negative green light is illuminated within 30 minutes. Since not all parts of a medical device require an IFU, some device identifiers will not have one. For use under the Food and Drug Administrations Emergency Use Authorization only. Holder, and Package Insert. What does it mean if I have a positive test result from the Lucira COVID-19 Test Kit? The Check-It COVID-19 test kit costs $75 for a single test. For additional information please refer to the following instructions and fact sheet: Lucira Check It COVID-19 Test Kit Instructions for Use. This test is authorized for over-the-counter (OTC) use with self-collected nasal swab samples in individuals with or without COVID-19 symptoms aged 14 and older, and in children aged 2-13 collected by an adult. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. PSPC has put in place contracts for the procurement of rapid tests totaling approximately $5 billion. Rapid tests are procured through these standing offers to meet Health Canada's requirements. Advocates say there's a place for self-administered tests to screen for infection even as vaccinations progress. Our payment security system encrypts your information during transmission. Lucira Health, 1315 63rd St, Emeryville, CA 94608, (888) 582-4724, Nasal swab, Batteries, Testing Device, Testing Solution. We appreciate Health Canada for its careful and thorough assessment of the Lucira COVID-19 & Flu Test. Each test is authorized for: specific age groups (adults or children) the way samples should be collected (nasal or saliva) who should be collecting them (health professional or individual) For enquiries,contact us. Home tests deliver clear results in 15-30 minutes (depending on the test) giving you the knowledge you need to take care of yourself and protect others, or get on with your life. US-based medical technology company Lucira Health has received the Health Canada authorisation for its at-home test for detection of Covid-19 and Influenza (Flu). A false negative result can occur with any test. Is this some type of reuseable device? Promis Diagnostics EarlyTect BCD test gets FDA breakthrough device status, Quest Diagnostics to acquire Haystack Oncology for $450m, GE HealthCare introduces macrocyclic MRI agent Pixxoscan, Intuitive secures FDA approval for da Vinci SP surgical system for prostatectomy, HelpMeSee rolls out simulation-based training for cataract surgery, Nuvo Group plans to go public in US through merger with LAMF. Health Canada, which previously expressed concerns about the tests, has still not indicated whether it will follow suit. Lucira COVID-19 & Flu Test the 99% Accurate At-Home Test for Covid and Flu, Lucira COVID-19 & Flu Test All You Need to Answer Is it Covid or the Flu?, Lucira COVID-19 & Flu Test 99% Molecular Accuracy in 30 Minutes At Home. The Lucira Check-It COVID-19 test is available now at www.checkit.lucirahealth.ca for delivery across Canada. Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. The Lucira COVID-19 and Flu Home Test is a single-use test, which can be purchased without a prescription. Kimberly-Clark PROFESSIONAL N95 Pouch Respirator (53358), NIOSH-Approved, Made in U.S.A., Regular Size, 50 Respirators/Bag, White, THINKA Level 3 FACE MASK with EARLOOPS (50pcs)-Medical Mask - Surgical Mask -ASTM Level 3 Mask. The single-use test fits in the palm of your hand, runs on two AA batteries, and with one nasal swab, provides a positive or negative result for COVID-19, Flu A, and Flu B in 30 minutes or less. For more information, please consult the "instructions for use" on how sample pooling may be used with the relevant testing device. The LUCIRA CHECK IT test kit is designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection. These standing offers are a way of ensuring the Government of Canada can secure rapid tests for immediate needs without delay. 647-577-2624 (local) 1-800-583-0844 (toll-free) contact@ppe-supply.com. Who can use the Flowflex COVID-19 Antigen Home Test? This test has received FDA Emergency Use Authorization for self-testing without the need to ship samples to a lab or for a prescription from your healthcare provider. Lucira is continuing real-time aging studies underway and expects to update the expiration dating every three months. Luciras test kit is also authorized in the U.S. for prescription at-home and point of care use. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Positive results do not rule out bacterial infection or co-infection with other viruses. You will not receive a reply. The test has been designed to minimize the likelihood of false positive test results. The chance of getting an invalid result is low, 2%. These items are shipped from and sold by different sellers. Health Canadas decision is based on performance data reviewed under Health Canadas expedited authorization pathway, Interim Order No. COVID-19 testing technologies are advancing as the pandemic continues. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. These tests have been procured to fulfil immediate . How long does it take to obtain results from the Flowflex COVID-19 Antigen Home Test? Easy to use. As soon as your results are submitted, you will receive your LUCI PASS. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Make sure your phones browser has permission to access the camera. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Luciras amplification method provides a level of accuracy comparable to one of the highest sensitivity lab PCR tests. With a shallow nasal swab, the . A device identifier is like a catalogue number for medical devices. Learn more about our medical team. We are unable to prioritize requests for status updates at this time. The entries in this list represent each individual device identifier included on each authorization. Send an email inquiry to [emailprotected]. Specificity refers to a test's ability to correctly identify those who are not viral, while sensitivity refers to the ability to detect those who are COVID-19 positive. If you have witnessed or experienced a problem with a medical device, including a COVID-19 test, you should report it. These tests are indicated by the term multiplex. To access the relevant IFU for that device, please click on the hyperlink in the "device identifier" column in the following table. The Lucira COVID-19 & Flu Test is a . The single test costs $10 each. Greg Chodaczek We use them to give you the best experience. Persistent pain or pressure in the chest Lucira said that it will prioritise the distribution of its Covid-19 & Flu Test in Canada, along with the current Covid-19 test. Please note that not all device identifiers will have an IFU. Can the Lucira COVID-19 Test Kit detect new SARS-CoV-2 variants? The following table indicates all authorized patient types, along with any differences in the sensitivity values associated with the intended population: The following table indicates the most recently authorized shelf life of a device.