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Get up-to-the-minute news sent straight to your device. 0000014860 00000 n
For a crash course on what is meant by expiration in this context, and how to make sure your test is still OK, we spoke to Emily Volk, president of the College of American Pathologists, and Matthew Pettengill, director of clinical microbiology at Thomas Jefferson University Hospital. 0000004396 00000 n
Rapid antigen tests offer several important benefits. We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. Antigen tests detect proteins of the SARS-CoV-2 virus that form during the infection cycle and indicate that a person has an active infection. More than 800,000 rapid COVID-19 tests passed their expiration date recently in a Florida warehouse, prompting concerns that they would go to waste.
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Abbott also developed separate lab-based serology blood teststo detect IgM and IgG antibodies that identify if a person has been previously exposed to the virus that causes COVID. The shelf lives for tests from some other manufacturers have been extended as well. All three versions of the test pair with our optional mobile app foriPhoneandAndroiddevices, NAVICATM. o Abbott Panbio COVID -19 AG Rapid Test Device (nasal) (December 31, 2020) . 864 0 obj
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ECRI, a Plymouth Meeting-based nonprofit that evaluates the safety and quality of health care, recently ranked seven common tests on their user-friendliness, at www. Serology testing: For more information on how testing for antibodies works, check out this infographic. Abbott says its tests can be stored between 36 to 86 degrees Fahrenheit, but that the kits should be at room temperature at the time they are used. CHECK OUT THESE HELPFUL LINKS. 0000013781 00000 n
The ID NOW COVID-19 test is a rapid, molecular point-of-care test that detects COVID-19 in 13 minutes or less. x]>q"%>Ip]=i>lMn'l2I,nfgMKIS|(|_^}_Cg=~WW/^{xx/^|W=5m_~r3{2trS~S[7{iOo5OWo?O4j-te/m.Ue6~w|7~y~8]Mo^s?_;95qf{aKqrKx-yc|.?]nK{F;knC{a5OUH{` The website that you have requested also may not be optimized for your screen size. H\j0~ hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;? )`D0cq7tLO\ &/ Read more about ARCHITECT: https://abbo.tt/3abd0eq *sOi:o1_o7&}9t_bv4]S=dy*]?moi,T|*iwM1=)?uc>fX1gY%'xM^7
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They are highly portable, scalable, easy-to-use and provide a flexible approach to helping more people in more places get access to reliable testing in a cost effective way. Our tests are all important tools in the broader comprehensive testing effort. This is the name that will be displayed next to your photo for comments, blog posts, and more. 0000007821 00000 n
HOW DO YOU PERFORM AN ID NOW COVID-19 TEST? pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht
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As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. H\j >w%PrNReby6l*s)do@q;@. The U.S. Food and Drug Administration has increased the shelf life for one of the most popular at-home COVID-19 test kits. We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. IS THERE ANY RISK OF CONTAMINATION FOR LAB WORKERS WHO ARE OPERATING ID NOW? [!1~t8Cwvl3Skjn~4'r)eT_7Wq=*pd uzLa?H3yz|s. There are a variety of different tests being deployed and a whole ecosystem is needed to support testing in different healthcare settings. hXMWF+L|B1,C#
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ID NOW is a lightweight and portable instrument (just 6.6 pounds and the size of a toaster) that allows testing to occur near the patient to get rapid results including in physicians' offices, urgent care settings, and hospital emergency departments. A second, earlier date the day the test kit was assembled is typically printed below that, next to a mysterious-looking icon with a jagged line. endstream
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In some cases, the expiration date for a test may be extended. endstream
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This test is used on our ID NOW instrument. ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu
In some cases, the companies have inserted notices into the packages with the updated info. Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. ID NOW has been in use since 2014 to detect flu, strep, and RSV. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. Testing has been completed to support a shelf-life (expiration date) of up to 15 months. Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. Read more about BinaxNOW COVID-19 Ag Card:https://abbo.tt/3hZPfNx. This how-to video also helps explain how molecular point-of-care testing on ID NOW works. But stick to the recommended temperatures as much as possible. Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. endstream
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Choosing a selection results in a full page refresh. HVMo8W(CR(E&i]4E xref
As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. They have a shelf life. 0000010349 00000 n
https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. WHAT'S THE TURN-AROUND TIME FOR YOUR TESTS? Results may be delivered in 13 minutes or less. OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test 9-month to 12-month self-life extension granted by the FDA August 3, 2022 Lot Number Tests with this printed expiration date (Year-month-day) Were continuing to ramp up our ID NOW manufacturing and plan to increase capacity to 2 million tests a month by June and are working to expand beyond that. 0000015920 00000 n
Make sure youre looking at the expiration date. The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. If coronavirus proteins are present in the sample, the antibodies bind to them in such a way that the strip changes color, said Volk, chief medical officer of Baptist Health Floyd Hospital in New Albany, Indiana. hbbbf`b``30
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If you're with a hospital, lab or healthcare provider, please see the contact details below. R, So here's how to know if your at-home test kits are still. A single at-home COVID-19 test by Quidel sits on a drugstore shelf on Sept. 14, 2021, in Chicago. endstream
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kdv1_2x/ Press the space key then arrow keys to make a selection. With the number of cases still high, youll likely be using the test long before that date anyway. 0000075543 00000 n
To be on the safe side, use a test that has not expired. For more information on our IgM antibody test, check out this news release: https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. 21-48: Expiration Dates of Abbott BinaxNOW COVID-19 Antigen Tests Extended to 12 Months Origination Date: June 25, 2021 Revision Dates (List All Revision Dates): . And when its time to use the test, read the instructions carefully then, too. 109 51
Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. endstream
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All BinaxNOW COVID-19 Ag Card Kits currently have a fifteen-month expiry date. {]Tuvpnl/'|PZge~MDlegn{O:>'S9kDI#LqGTj?#]aT?!8y+vX4[{cWLh7qqrR_~ibzcDjbkU Molecular tests that run on our m2000 system are already located in hospital and academic medical center labs, and reference laboratories, where patients are presenting for care. % Check out our most recent progress update here. expiration date (Year-Month-Day) Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Self Test 15-month to 22-month shelf-life extension granted by the FDA December 21, 2022 Use left/right arrows to navigate the slideshow or swipe left/right if using a mobile device, OnJan 11, 2023, the FDA granted another three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth testsf. We will continue to apply to FDA for shelf-life extensions every three months based on our stability studies, and the new shelf-lives for our tests will apply to tests already produced as well as future production. H\j@}l/4 `t Even Abbott, which has years of experience making similar tests for other purposes, has extended the expiration dates on its COVID tests several times, after demonstrating that the components remain stable. 0000001933 00000 n
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The direct swab method is the best way to ensure the test performs as expected. Biolabs International LLC / GriffMaier LLC, Paramount Sourcing LLC (exclusively partnered with Office Depot), Sunshine Paper LLC / Marketing Promotion Image Inc. Please disable your ad blocker, whitelist our site, or purchase a subscription. This test has been authorized by FDA under an EUA for use by authorized laboratories. 0000020161 00000 n
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Create a password that only you will remember. wK8 |vX@:) Such tests which work by detecting antigens (pieces of viral proteins) on the patients swab sample will eventually expire. Results are encrypted and available only to you and those you choose to share them with. This type of knowledge could help support research about how the virus spreads within communities and immune responses to vaccines. 0000126232 00000 n
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BinaxNOW COVID-19 Self Tests are available at major U.S. food, drug and mass merchandiser retailers across the country. 0000105562 00000 n
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Read more about m2000: https://abbo.tt/2U1WMiU Click here for more info: https://abbo.tt/2X7xwZo, Please check the CDC resources on how to protect yourself and what to do if you think you are sick: https://abbo.tt/3hJSINd, Learn more about Abbott's approach to tackling the coronavirus: https://abbo.tt/2WHMDco The tests are available on our ARCHITECT and Alinityi systems. 0000105492 00000 n
Since the launch of the BinaxNOW COVID-19 Ag Card, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. All of our tests met all testing criteria under the FDA's emergency use authorization (EUA) and we're continuing to collect more data in the field. %PDF-1.5
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Invalid password or account does not exist. Most of these antigen tests have a pretty good shelf life, he said. Abbott and the regulatory approval of Panbio Covid-19 Version NP test Abbott is an American company that holds 365 medical device licenses in Canada under 19 . Theyre pretty stable for over a year.. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. It may seem obvious, but read the instructions. Generally, the tests are designed to be stable at a wide range of temperatures. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. In the case of Abbotts BinaxNOW tests, the date is printed alongside a small icon of an hourglass. The agency typically authorizes at-home tests for four to. In others, new expiration dates are posted on company websites, organized by lot number, but finding them can be a challenge. 0000105677 00000 n
This allows for fast test results since they dont need to be sent out. Since the start of the pandemic, Abbott has produced and shipped more than 2 billion COVID-19 tests. :x$eh Learn more. agr. Low 33F. We created a Global Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and have a long-standing discovery program to identify new or unknown pathogens. :x$eh Read more about Alinity i: https://abbo.tt/2SWCvtU f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. ID NOW: THE FOREFRONT OF COVID-19 TESTING, ID NOW COVID-19 TESTING QUESTIONS ANSWERED. Clinicians and lab professionals have been using the same ID NOW instrument, collection swabs, and consumables (such as the sample receiver and transfer cartridge) to safely test respiratory viruses during this time. Our lab serology blood tests running on ARCHITECT and Alinity i systems are used for the detection of antibodies, IgG and IgM, and to identify if a person was previously infected with the virus that causes COVID-19. Learn more about Alinity m here: https://abbo.tt/2zrt52N, ID NOW delivers positive results in as little as 5 minutes and negative results in 13 minutes. This test is used on our ID NOW instrument. It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. market. The expiration dates of the lot numbers listed in the referenced link have been extended to 12 months. hb```)_@( .MyG/n. 0000166958 00000 n
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@[ X"@)]JiZB 5qy_MkmBVBv.e:aIQn O/f%Sok^kVs>pbZrP}`J{bO]^WS|*wKcaC i+d*>e/NiW. To optimize results, do not use viral transport media (VTM), which could reduce the sensitivity of the test through dilution. 0000004645 00000 n
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Low 33F. Learn more. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19? They are not all the same, and they can be confusing. If there is any doubt, stick with the date on the package.
The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. Both components, the reagent and the antibodies, start to degrade at some point, Pettengill said. iHealth Rapid . Since the launch of the ID NOW COVID-19 test kit, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Currently, the ID NOW COVID-19 test is available only in the U.S. under emergency use authorization (EUA) as this is where the majority of our ID NOW instruments are in use today. We won't share it with anyone else. Expiration Date Extension by Dingchao Liao February 13, 2023 On Jan 11, 2023, the FDA granted another three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests from 6 months to 15 months. Data transmitted in the app is encrypted and users only share name, birthdate, phone number, zip code and email address which is used for creating your personal profile in the app. For our rapid antigen tests, BinaxNOW is available in the U.S. and Panbio is available in many countries outside of the U.S. This article helps explain how the ID NOW molecular point-of-care test for COVID-19 works. The EUA is supported by the Secretary of Health and Human Services' declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 0
For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. 0000152529 00000 n
ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid molecular results including physicians' offices, urgent care settings, and hospital emergency departments. 0000105378 00000 n
It can be used at home, by healthcare professionals at the point-of-care and or at home using a virtually guided service for the detection of antigens that form in the early stage of active infections. Press release announcing launch of the ID NOW COVID-19 test here. endstream
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But for certain tests, that expiration date may have been extended beyond what is stamped on the package provided the manufacturer has demonstrated to the FDA that the components remain stable. For more information on m2000, check out this article: https://abbo.tt/2U1WMiU, We also have a molecular test for our Alinity m system under the FDA's Emergency Use Authorization. An extended expiration date means the manufacturer provided. HOW LONG HAS THE ID NOW INSTRUMENT BEEN IN USE? Another test, called the QuickVue SARS Antigen Test, is designed to be stored at 59 to 86 degrees. Q4{y4(L7M&e~XzhkHAj!USV{{eE =BXoZ(BMr2d+)2rElxJE:t_h_Y9e*r yP/t !N Learn more about COVID-19 testing on BinaxNOW here:https://abbo.tt/3hZPfNx, Our serology tests on the ARCHITECT and Alinity i systems can run up to 100-200 tests per hour. The expiration date is set at the end of the shelf-life. :C1lr"wiUog-+Wu4W_*_EVqX~/,Lgj>Am=1-ij [)l+vr}H\b5&k?~s?YJgX?9n/t(8,?zzIc^|vxH>_{$HH>X{F)"y$sDmA=Jd:"'Vvu;;iX[g endstream
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This test has been authorized by FDA under an EUA for use by authorized laboratories. We are producing 50,000 COVID-19 tests a day for our ID NOW system. Winds light and variable.. A clear sky. Learn more. 0000001630 00000 n
Your account has been registered, and you are now logged in. D XC!mo 8sK.~?>utxnlYTCu}wtt:wic|c;?aMnkS*WI]1_/)SMU;\obw_O{5fe/+q 3"[#W9 =%y .=XW7
XWWWWWWWWWWWWl`:a_r>#p>'`>nnnnnnnnnn::::::::::aFEFeFEFeFEFsVUU>gC]]]]]o7o7o7WU,yY>k}d}__C?t The iHealth COVID-19 Antigen Rapid Test, for examplethe one sent . Organizations like employers and schools have the option to use the app to view and verify the information on a mobile device to facilitate safer entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing. We have always made highly reliable and accurate tests for other infectious diseases such as HIV and hepatitis, and we're highly confident in our tests since weve used the same approach to development. The FDA advises against using at-home Covid tests past their expiration date, because tests and their parts can break down over time. 0000001804 00000 n
The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). hXMWF+L|B1,C#
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cJCfD1P_qPS!Bo0C&GP(AD4PD[K4( Read more about Alinity m: https://abbo.tt/2zrt52N ? The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. It can be used in three different ways. Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU. 848 0 obj
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hbbd``b`$gfD\@m`m,N Dp~! This follows a request by the company to provide a longer shelf life for its test, after it reported stability studies that showed the tests remained . "An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized," the FDA says. If you are an individual, please reach out to your healthcare provider. It can be self-administered at home, performed by healthcare professionals at the point-of-care, or it can be used at home with a virtually guided collection and testing process in partnership with eMed, an online digital health service, making it an important tool to diagnose COVID-19. "Ds>f`bdd100"M`
You can find more information on BinaxNOW COVID-19 Ag Card and NAVICA here. XsVxIRvD/-QUdv}S j%/=C5uT#L7hfGnBJwD|
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BinaxNOW is also a rapid test. You have permission to edit this article. HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS? No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Please be cautious of the following situations: Below is a list of iHealths authorized distributors (in alphabetical order): If you want to verify whether a seller not on the list is authorized to distribute iHealth tests, please contact us at legal@ihealthlabs.com. endstream
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Page 1 of 4 Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID -19 Ag Card Home Test 12-month to 15-month shelf-life extension granted by the FDA on January 7, 2022 These tests have not been FDA cleared or approved. agr. Ourm2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. 0000007689 00000 n
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This test has not been FDA cleared or approved. Its really no different than when your medications expire, Volk said. Click on the bell icon to manage your notifications at any time. Fx J+-'[^(0V*JCIZ$V.$?gS,|6 FgRQ4:Gh#^zKgmyE1VQz^}[|(>wiqp_wWPOztK=z|1w|35_,NK#uYapFYsr2V)o;lQi9}w|1IY\6v0Ok!o+E./8?
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In August 2021, the !}TO'Y7@O/+Ol&i5`W]bq0!nA^C>VKjMp:J}C a:!F Testing has been completed to support a shelf-life (expiration date) of up to 15 months. a %PDF-1.6
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Learn more about all of Abbott's testing solutions to tackle the coronavirus. Our ID NOW molecular point-of-care test met all testing criteria in the FDA's emergency use authorization (EUA) and were continuing to collect more clinical data in the field.