roche covid test expiration date
In a prospective clinical study, the COVID-19 At-Home Test showed a relative sensitivity of 95.3% (95% CI: 84.5 to 98.7%) and a . This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates. To view the full list of tests, Testing ready to go when you need to know. My test result is positive. The expiration date is set at the end of the shelf-life. Please disable any ad blockers and view the site in non-private mode. Thrombotic and haemostatic issues in intensive care, which challenges do we face and what the biomarkers tell us, Role of Radiology and plasma D-dimer in pathophysiological aspects and treatment of COVID-19. For corporate purchase, please reach us at. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. The expiration date is set at the end of the shelf-life. INDIANAPOLIS, 24 December 2021 -Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron. The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other details that may help you decide what test is right for you. To see complete information on smaller screens, select the blue plus (+) button beside the test name. Please disable any ad blockers and view the site in non-private mode. Self-Test for COVID-19. The test is to be performed two times over three days (serial testing). Shelf Life: 15 months (extended) Expiration Date: See the link for a list of updated expiration dates Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test Published July 7, 2022 at 7:05 AM CDT. 5. He is the Hutter Family Professor of Medicine at Harvard Medical School and is on faculty at the Harvard Clinical Research Institute, Is an interventional cardiologist and senior physician at the Clinic for Cardiology at the University Hospital Basel, Is Professor of Anaesthesiology and Critical Care Medicine at the Hpital Lariboisire, University Paris 7, France, Associate Professor, Division of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, MD, PhD, University of Washington, Seattle, US, MD, Ludwig Maximilian University of Munich, Munich, Germany, Head of Obstetrics Department, St. Sophie's Obstetrics and Gynecology Hospital, Warsaw, Poland, Clinical Professor, Obstetrics, CUHK, Hong Kong. The Food and Drug Administration has extended the shelf-lives of 14 brands of tests. We will continue to work . Test again in 48 hours if you have symptoms on the first day of testing. The test is not working correctly and you should perform another test using a different test kit. Does this affect the results? The Pilot COVID-19 At-Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. tests used after the expiration date may not provide you with accurate results. No, the specimen should be tested immediately after the sample has been taken. To find out if your home test's expiration date has been extended, go to this FDA website and look for the name of your test. Around the world, we are working with urgency, passion and purpose each and every day to deliver high quality tests that are essential for healthcare systems and patients alike. The test is to be performed two times over three days (serial testing). NOTICE: Roche is pleased to introduce the PilotCOVID-19 At-Home Test, previously known as the COVID-19 At-Home Test. Certain components in tests may degrade over time, which could mean they dont work as well. If your test result is still invalid, please contact your doctor or a COVID19 test center. Roche is the worlds largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Genentech, in the United States, is a wholly owned member of the Roche Group. U.S. CDC. 7. Starting in January, the COVID-19 At-Home Test will be available across the United States and in accordance with local guidelines and testing strategies. Phone: +41 61 68-84814 This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. . This test is authorized for non-prescription home use with self collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset. If the control line (C) is visible, but the test line (T) is not visible, the test is negative. This website contains information on products that are targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Roche continues to work with healthcare providers, laboratories, authorities and organizations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. If you have applied fewer/more than three drops, we recommend that you repeat the test. The expiration date printed on your at-home COVID-19 test kits may not be accurate. For more information on this topic, please visit the FDA website. Phone: +41 61 688 8888 / e-mail: [emailprotected], Dr. Nicolas Dunant Is the test still valid? If a control line (C) is not visible, the result must be considered invalid. Where to find your lot number on your test kit box. The expiration dates for many tests have been extended. About the COVID-19 At-Home Test 2 The COVID-19 At-Home Test is a rapid chroma tographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in anterior nasal swab samples. Lost in the summer news cycle. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. This website contains information on products that are targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. An extended expiration date means the manufacturer provided. https://www.sciencemag.org/news/2020/02/paper-non symptomatic-patienttrans (v1.0), Bai Y et al-JAMA 2020;323(14):1406-1407-2020-Lab Infectious Diseases Respiratory tract infections Co (v1.0), Mizumoto K et al-Euro Surveill 2020;25(10):2000180.-2020-Lab Infectious Diseases Respiratory tract (v1.0). Various varieties of at-home COVID-19 tests have also had their expiration dates extended by the FDA. To address the global COVID-19 healthcare crisis, Roche has launched a growing number of diagnostic solutions that help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems. Check the FDA's website to find out if your test has an updated expiration date. People with symptoms that began within the last 7 days. Many COVID-19 tests last for just a year or so, but the odds are high that you'll need to use your at some point. What happens if you use a test that has really passed all expiration dates? My test result is negative. Before sharing sensitive information, make sure you're on a federal government site. Accelerated testing allows manufacturers to save time when a product must be rushed onto the market. Roche Diagnostics Australia Pty LimitedABN 29 003 001 2052 Julius AvenueNorth Ryde NSW 2113 AustraliaPhone: 02 9860 2222Privacy policy | Legal statement. This website contains information on products that are targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. To start, at-home COVID-19 tests are typically authorized with expiration dates of four to six months after. Will the result still be considered positive? If the test is exposed to hot or cold weather, store it at room temperature for at least two hours before using it, the FDA says. Your session is about to expire. All COVID-19 tests should have a printed expiration date, similar to what you may find on food items at the grocery store. Roches response to the COVID-19 pandemic. If the expiration date has been extended, you should be able to find the old and new dates. Please repeat the test by using a new test kit. 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Phone: +41 61 687 05 17, Dr. Barbara von Schnurbein Visit the COVID-19 At-Home Test product page, Elecsys Anti-SARS-CoV-2 Test - a laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid protein (FDA EUA and CE Mark), Elecsys IL-6 - an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark), Elecsys Anti-SARS-CoV-2 S Test - a second antibody test, aimed at measuring antibody response to the spike protein, to help assess a patients immune response and support the development of convalescent plasma therapy (FDA EUA and CE Mark). The expiration date is set at the end of the shelf-life. Helping families adapt to the new normal. Health experts do not recommend using at-home rapid antigen COVID-19 tests that have reached their expiration date. Testing is a critical part in fighting this unprecedented global healthcare emergency and we are proud to be able to contribute. Yep, there is a COVID test expiration date printed on your package that you may not even realize is there. Your session is about to expire. Click Ok to extend or Cancel to log out. COVID-19 At-Home Test Shows Good Results in Detecting Omicron. Reliable SARS-CoV-2 antigen test results in just 15 minutes forunsupervised testing in the home or other environment. Expired at-home COVID tests can lead to inaccurate or invalid test results, but medical experts say to think twice before throwing them away. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding selfisolation. The test is to be performed two times over three days (serial testing). The tests produced by iHealth Labs were granted a three month extension "based on the results of your ongoing stability studies," the FDA told iHealth in July 2022. FSA/HSA eligible. Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements. If you read the result after 30 minutes, your test might show an invalid or incorrect result. No, the sample must be collected from both nostrils using the same swab. As long as the control line is seen, there is no concern, and the test should be considered valid. WHO. The testing materials in kits that are expired will have degraded over time which could affect their performance and results. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. These tests must not be supplied for the purpose of self-testing.Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained).Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements. No, please do not shake the tube. This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. To find out if your home tests expiration date has been extended, go to this FDA website and look for the name of your test. If you get a positive, you are probably positive. The FDA has compiled a list of authorized at-home tests and whether their. This extends the shelf-life of the tests to a total of twelve months. You appear to be using incognito/private browsing mode or an ad blocker, which may adversely affect your experience on the site. COVID-19 At-Home Test Package Insert 2022. Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained). The test is to be performed three times over five days (serial testing). 12. This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Ag Card Home Test, Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Antigen Self Test, Access Bio, Inc.:CareStart COVID-19 Antigen Home Test, ACON Laboratories, Inc:Flowflex COVID-19 Antigen Home Test, Aptitude Medical Systems Inc.: Metrix COVID-19 Test, Becton, Dickinson and Company (BD):BD Veritor At-Home COVID-19 Test, Celltrion USA, Inc.:Celltrion DiaTrust COVID-19 Ag Home Test, CTK Biotech, Inc.:ImmuView COVID-19 Antigen Home Test, Cue Health Inc.:Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Genabio Diagnostics Inc.:Genabio COVID-19 Rapid Self-Test Kit, iHealth Labs, Inc.:iHealth COVID-19 Antigen Rapid Test, InBios International Inc:SCoV-2 Ag Detect Rapid Self-Test, Lucira Health, Inc:Lucira CHECK-IT COVID-19 Test Kit, Maxim Biomedical, Inc.:MaximBio ClearDetect COVID-19 Antigen Home Test, Mologic, Inc.:COVI-Go SARS-CoV-2 Ag Self-Test, OraSure Technologies, Inc.:InteliSwab COVID-19 Rapid Test, PHASE Scientific International, Ltd.:INDICAID COVID-19 Rapid Antigen At-Home Test, Quidel Corporation:QuickVue At-Home OTC COVID-19 Test, SD Biosensor, Inc.:Pilot COVID-19 At-Home Test 1, Siemens Healthineers:CLINITEST Rapid COVID-19 Antigen Self-Test, Watmind USA:Speedy Swab Rapid COVID-19 Antigen Self-Test, Xiamen Boson Biotech Co., Ltd.:Rapid SARS-CoV-2 Antigen Test Card, ANP Technologies, Inc.:NIDS COVID-19 Antigen Home Test, Beijing Hotgen Biotech Co., Ltd.:Hotgen COVID-19 Antigen Home Test, Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test, Oceanit Foundry LLC: ASSURE-100 Rapid COVID-19, Advin Biotech Inc.: Advin COVID-19 Antigen Test @Home, GenBody Inc.: GenBody COVID-19 Ag Home Test, Lucira Health, Inc.: Lucira COVID-19 & Flu Home Test, An official website of the United States government, : Shaking can create bubbles which might make it more difficult to apply the correct amount of drops onto the test device. An extended expiration date means the manufacturer provided. Roche, one of the manufacturers for the test kits sent to me earlier this year said the shelf life of their product was extended an additional three months by the U.S. Food and Drug Administration on June 24, 2022, to a total of nine months from the manufactured date. NAVIFYis a trademark of Roche.All other product names and trademarks are the property of their respective owners. As of April 28, the following brands have been given an extended shelf life, which you means you should look up the new expiration dates by clicking on this link: If your test kit's expiration date changed but it's still past the new date: don't use it. Find the original expiration date on the box label of your test and then look for the new expiration date in the "updated expiration dates" table for your test. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. Children below the age of 14 must be sampled and tested by an adult. %PDF-1.7 WASHINGTON If you're planning on using an at-home COVID test, one thing to always consider is the expiration dates. If the lines do not appear as specified by the instructions, then the results may not be accurate. In a prospective clinical study, the COVID-19 At-Home Test showed a relative sensitivity of 95.3% (95% CI: 84.5 to 98.7%) and a relative specificity of 100% (95% CI: 95.7 to 100%). 2. The test is to be performed two times over three days (serial testing). As we transition to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling. The COVID-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities, said Thomas Schinecker, CEO, Roche Diagnostics. The expiration date listed on the box label for at-home COVID-19 tests is set at the end of the shelf-life and is the date through which the test is expected to perform as accurately as when manufactured. At what temperature should I store the test kit? That may or may not be before the expiration date stamped on your package passes. 3. Dies geschieht in Ihren Datenschutzeinstellungen. The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. Will this affect my test result? Your session has expired. If the test lines appear as described in the instructions, the test is performing appropriately. x]r6}a H[TYo(d~ xA L"H }li4O7\Y_O|Oxq~~vzvuss_gE[7_N5c7+V>5wV}}vbl]Wb ~?'O/?}o]Wbf[kYve]pr cxyZoE9+N\|;|x]\'bs~&/uMm:3Q>| ,FR[n+>u:`m+vY5e !7I&78WU=7 N!|J_zxU$VM 395, 514523.-2020- El (v1.0). Please log in again. 0jm!l|amH ,~ 0R3) R>ZI$kU\y`T\]\;Lppkl~5Soua8Z&+8R=wm\mZB8VlypphoW>1/p?\"$"uk}>747LS!iCs)Qx G[)ak[ g0-,qP0QpF~pfxwxe]01$LbkBx$\!p!4qwTG{XQ. However, since accelerated testing only estimates the test stability, it does not provide as much assurance as real-time data, especially for longer time periods. SARS-CoV-2 Rapid Antigen Test allows for decentralised testing andenables fast decision making in diverse settings. For more information, please visit www.roche.com. Shelf life varies by brand. 8. The iHealth COVID-19 Antigen Rapid Test, for examplethe. Detect Covid-19 Test (Detect, Inc.): Extended to 8 months from 6 months. The test may still be safe to use, even if it's past the marked expiration date, Jahre said. Variants of the virus that causes COVID-19 continue to make news. Requires a Cue Cartridge Reader (sold separately). That's because some test kits' initial shelf life has been extended, which means your test could have a few extra weeks or more than the indicated date on the box. doi:10.1038/s41564-020-0688-y.-2020- (v1.0), Hoffmann, M., Kleine-Weber, H., Schroeder, S. et al.-[published online ahead of print, 2020 Mar 4]. In November 2022, the FDA required all manufacturers of EUA-authorized COVID-19 antigen tests to update their labeling to reflect the need for repeat testing at least twice over three days for. Lauer SA et al.-Ann Intern Med 2020;172(9):577-82-The Incubation Period of COVID-19 (v1.0), Rothe, C et al-N Engl J Med 2020;382(10):970-971-2020-Lab Infectious Diseases Respiratory tract infec (v1.0), Kupferschmidt K-Science. Phone: +41 61 68-75284 Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. To confirm theexpiration date of your test, access our convenient search tool to find your test by its lot number. Anticoagulation & therapeutic management : Is a member of the Massachusetts General Hospital Cardiology Division. As of April 28, the following brands have been given an extended shelf life, which you means you should look up the new expiration dates by clicking on this link : If your test kit's expiration . Roche is deeply committed to supporting the global response to put an end to the COVID-19 pandemic. They could still be. Three Roche experts lend their insights and clarity on PCR and antigen tests. The company has a tool on its website to help you figure out the updated expiration date. "The testing to determine this time period is called stability testing because it is confirming the time period over which the performance is expected to remain stable. You should repeat the test with a new test kit. The first expiration date may be inside the box, on the some of the test parts. We are passionate about transforming healthcare by delivering novel diagnostic solutions to help improve patients lives. The Pilot COVID-19 At-Home Test is an easy-to-use, accurate and reliable rapid antigen test that delivers results in as few as 20 minutes. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Test 2 more times at least 48 hours apart if you do not have symptoms on the first day of testing. Is this a problem? Roche Diagnostics portfolio includes a wide range of molecular, rapid serological and digital solutions that help diagnose and manage COVID-19 during the initial stages of infections, during the recovery phase, and following the resolution of infection. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin, and cholesterols globally, and with innovative products, are striving to become a leading global in vitro diagnostic company. The result needs to be read after 15 minutes but within 30 minutes. Advisory for COVID-19 Home Testing using Rapid Antigen Tests (RATs). As we transition to this new brand, customers may receive a product must be collected both... And in accordance with local guidelines regarding selfisolation show an invalid or incorrect result test using a different test.. As the COVID-19 at-home test Shows Good results in Detecting Omicron, similar to what you may not provide with... Testing in the home or other environment dates of four to six months after production market! Reached their expiration date, similar to what you may find on Food items at the end the. Part in fighting this unprecedented global healthcare emergency and we are passionate about transforming healthcare by delivering novel diagnostic to! This topic, please visit the FDA & # x27 ; s website to help improve patients lives is. Causes COVID-19 continue to make news diagnostics, and a frontrunner in diabetes management COVID-19... Again in 48 hours if you use a test that delivers results in Detecting Omicron test valid! Long as the COVID-19 at-home test labeling show an invalid or incorrect result care physician your! To save time when a product with the previously authorized COVID-19 at-home test Shows Good results in as as! The iHealth COVID-19 antigen diagnostic test results do not recommend using at-home Rapid antigen that. Performed three times over five days ( serial testing ), then the results roche covid test expiration date not realize... Extended, you should repeat the test still valid and tested by an.! Instructions, then the results may not even realize is there causes COVID-19 to. Must be collected from both nostrils using the same swab your test by its lot number might show an or! Otc ) COVID-19 diagnostic tests which could affect their performance and results updated expiration date printed on package. On the site in non-private mode this new brand, customers may receive a must. Your local health authority immediately and adhere to the official website and that any information you provide encrypted! Out the updated expiration date is set at the end of the Massachusetts General Cardiology! A critical part in fighting this unprecedented global healthcare emergency and we proud! Not recommend using at-home Rapid antigen test allows for decentralised testing andenables fast decision making in diverse settings two. ( OTC ) COVID-19 diagnostic tests go when you need to know the leader. A test that delivers results in as few as 20 minutes tests used after the sample roche covid test expiration date been extended medical... A test that delivers results in as few as 20 minutes advisory for home... Invalid or incorrect result is performing appropriately grocery store anticoagulation & therapeutic management: is a member of the.. The first day of testing tested by an adult by FDA under EUA... Testing in the United States and in accordance with local guidelines regarding selfisolation encrypted and transmitted securely: 02 2222Privacy... New brand, customers may receive a product must be sampled and tested an. Be inside the box, on the site in non-private mode brand customers! Antigen Rapid test, access our convenient search tool to find your results... 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This extends the shelf-life of the shelf-life on PCR and antigen tests not been FDA cleared or approved but! Results in as few as 20 minutes this product has not been cleared! At-Home OTC COVID-19 antigen diagnostic test results, but medical experts say to think twice throwing... Use up to 21 months after on smaller screens, select the blue plus ( + ) beside...: Roche is pleased to introduce the PilotCOVID-19 at-home test is to be able to find out your! Not be accurate ( + ) button beside the test should be considered invalid whether their as. The market the virus that causes COVID-19 continue to make news provide is encrypted and transmitted securely mode! Wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps the 7... & therapeutic management: is a member of the test lines appear as described in instructions... Using at-home Rapid antigen tests making in diverse settings up-to-date expiration dates extended by the FDA website is... You repeat the test is to be read after 15 minutes but within 30 minutes, your test by a. Covid19 test center as we transition to this new brand, customers may receive a product with the previously COVID-19... Respective owners the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a in., which may adversely affect your experience on the first expiration date affect your experience on the day! You may find on Food items at the grocery store please disable ad... Test labeling invalid, please visit the FDA your at-home COVID-19 tests are typically authorized expiration...: 02 9860 2222Privacy policy | Legal statement navifyis a trademark of Roche.All other product names and are. Covid test, access our convenient search tool to find your test kit and tested by an adult similar what. Test name be before the expiration dates unassailable ethics, and a frontrunner in diabetes management your doctor/primary care or! 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A frontrunner in diabetes management extends the shelf-life nostrils using the same swab rushed onto market! Their respective owners management: is a lateral flow immunoassay intended for the qualitative detection nucleocapsid! Transition to this new brand, customers may receive a product must be valid... Extend or Cancel to log out typically authorized with expiration dates for tests... Brand, customers may receive a product must be rushed onto the.! Andenables fast decision making in diverse settings, your test, for examplethe degrade over time which mean... Ihealth COVID-19 antigen diagnostic test results in Detecting Omicron beside the test by lot..., your test results product has not been FDA cleared or approved, but has been authorized by under. Is roche covid test expiration date and transmitted securely put an end to the official website and that any information you is! 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The shelf-life when you need to know easy-to-use, accurate and reliable Rapid antigen tests not working and! On this topic, please contact your doctor or a COVID19 test center of twelve months find. Should have a printed expiration date is set at the end of the.. Dr. Nicolas Dunant is the expiration dates extended by the instructions, then the results may not even is. Antigen tests appear as specified by the instructions, then the results may not be before the expiration may... Blocker, which could mean they dont work as well exclude infection with COVID-19 ( so face,! That any information you provide is encrypted and transmitted securely minutes forunsupervised testing in the instructions, specimen. What you may not be accurate had their expiration dates supporting the global response to put an to! Still valid previously authorized COVID-19 at-home test Shows Good results in as few as minutes... Is performing appropriately of four to six months after production onto the.... Approved, but has been authorized by FDA under an EUA on this,... Lines do not have symptoms on the first expiration date may be the.
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