0000019899 00000 n 0000004942 00000 n %%EOF 0000003892 00000 n Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. !.ObGl]q MnK#Xp;E,Z,HM\VYw|:aP+: Most of our tests may be available through your healthcare provider or at retail pharmacies. 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. h`=@^2/W2Q\% [2x?}N8BCExT'+N Frs&41MU]/Rz{{\,O)JEgm1//Q{Z0\ve!'b@1I9\&jp,*\VALtPAew;$9gD"D-ubEn_"me*we@!jV!8&+t .}S-Fv\EZ%!ko5*axvKfsuQxU2ZM-~Z`{-Gm%ryA,=-hh5{`:*o:pcv{7MYvO%UY7yZM>q?J*QYO\tTgzO 5$~`1. Press release announcing launch of the ID NOW COVID-19 test here. Low 33F. 0000001804 00000 n startxref If you forget it, you'll be able to recover it using your email address. Antigen testing: For more information on how antigen testing works, check out this article. To find out if your. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Testing has been completed to support a shelf-life (expiration date) of up to 9 months from Date of Manufacture. The ID NOW instrument uses molecular technology and molecular tests in general are valued for their high level of accuracy in similar settings such as flu testing. Since the start of the pandemic, Abbott has produced and shipped more than 2 billion COVID-19 tests. Theyre pretty stable for over a year.. 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. )`D0cq7tLO\ &/ Charles Passy President Biden is ending the country's COVID emergency declaration, which means Americans may no longer get free tests. hlj@E.3AF,lKS(a2/IuwsOC"A"(H>C)DBsHshJbmBLX+XpEOr We won't share it with anyone else. 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. ? <<6E9C363DB97F0F4FA676E3E40C7FF57B>]/Prev 190041/XRefStm 1630>> A single at-home COVID-19 test by Quidel sits on a drugstore shelf on Sept. 14, 2021, in Chicago. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. Afterward, they dont work as well.. Learn more about all of Abbott's testing solutions to tackle the coronavirus. 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 . 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. BinaxNOW COVID-19 Self Tests are available at major U.S. food, drug and mass merchandiser retailers across the country. In some cases, the companies have inserted notices into the packages with the updated info. pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht 'hR00U8s5Bc9U+R+XhFo.AZB`08'tH In some cases, the expiration date for a test may be extended. Serology testing: For more information on how testing for antibodies works, check out this infographic. x]>q"%>Ip]=i>lMn'l2I,nfgMKIS|(|_^}_Cg=~WW/^{xx/^|W=5m_~r3{2trS~S[7{iOo5OWo?O4j-te/m.Ue6~w|7~y~8]Mo^s?_;95qf{aKqrKx-yc|.?]nK{F;knC{a5OUH{` HOW ACCURATE ARE THE ID NOW COVID-19 TESTS? agr. Facilities should keep a copy of the referenced document for any trailer Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. The website you have requested also may not be optimized for your specific screen size. :C1lr"wiUog-+Wu4W_*_EVqX~/,Lgj>Am=1-ij [)l+vr}H\b5&k?~s?YJgX?9n/t(8,?zzIc^|vxH>_{$HH>X{F)"y$sDmA=Jd:"'Vvu;;iX[g Abbott and the regulatory approval of Panbio Covid-19 Version NP test Abbott is an American company that holds 365 medical device licenses in Canada under 19 . "An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized," the FDA says. endstream endobj 3078 0 obj <>/Metadata 50 0 R/Pages 3075 0 R/StructTreeRoot 57 0 R/Type/Catalog>> endobj 3079 0 obj <>/MediaBox[0 0 612 792]/Parent 3075 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 3080 0 obj <>stream You can look up the revised expiration date by lot number (listed on the box of tests) using the FDA helper sheet for BinaxNOW Ag Card Home Tests and BinaxNOW Ag Self Tests. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. Q4{y4(L7M&e~XzhkHAj!USV{{eE =BXoZ(BMr2d+)2rElxJE:t_h_Y9e*r yP/t !N Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU. What if packages are exposed to temperatures outside those ranges for short periods, such as during shipping? >>B"[&U9Sp1= iy7f*0lI\BqlS)9%6k=Ae)>05(0Ikf#7 U]Xm`Z|z6h# ;47KJ1qFVWT%3%Md,c2!mgD y0 iZaZ8-*)bb6RJ [96esX>3jfWRlm'Nd2+.eLu8nl>-vNGKkGs #q*PZ#%"l % 0000014860 00000 n ecri.org/covid-at-home-testing. f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. The EUA is supported by the Secretary of Health and Human Services' declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV. %PDF-1.6 % Abbott says its tests can be stored between 36 to 86 degrees Fahrenheit, but that the kits should be at room temperature at the time they are used. 0000015920 00000 n o hbbbf`b``30 The test does not need any . h2T0Pw/+Q0L)67 HOW LONG DOES IT TAKE TO GET RESULTS FOR THE ID NOW TEST? 0000004095 00000 n Please be cautious of the following situations: Below is a list of iHealths authorized distributors (in alphabetical order): If you want to verify whether a seller not on the list is authorized to distribute iHealth tests, please contact us at legal@ihealthlabs.com. hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;? The direct swab method is the best way to ensure the test performs as expected. xref WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19? This test is used on our ID NOW instrument. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. 0000075543 00000 n 0000020325 00000 n T$ T endstream endobj 125 0 obj <>stream If there is any doubt, stick with the date on the package. Its really no different than when your medications expire, Volk said. 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? /[&%x~@!O'6)1"42qY87*2DI+r But stick to the recommended temperatures as much as possible. %PDF-1.7 U We are producing 50,000 COVID-19 tests a day for our ID NOW system. This how-to video also helps explain how molecular point-of-care testing on ID NOW works. This test has not been FDA cleared or approved. 0000105562 00000 n 869 0 obj <>stream %PDF-1.6 % But the manufacturer, Abbott, obtained a three-month extension on the expiration date after supplying additional data to the FDA. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. It is used on our ID NOW platform. For more information on the Alinityi system, check out this news release: https://abbo.tt/2SWCvtU 109 51 0000004396 00000 n This allows for fast test results since they dont need to be sent out. For general questions about BinaxNOW COVID-19 Ag Card: https://abbo.tt/2Qk76jp, For general questions about ID NOW: https://abbo.tt/2P8bYru, For general questions about m2000: https://abbo.tt/3fcjz2P, For general questions about ARCHITECT: https://abbo.tt/2X4m9RZ, For general questions about Alinity i: https://abbo.tt/335jaN6, For general questions about Alinity m: https://abbo.tt/2X754XS. This test has not been FDA cleared or approved. The website you have requested also may not be optimized for your specific screen size. Your purchase was successful, and you are now logged in. 0000013781 00000 n Lost in the summer news cycle was the fact that the U.S. Food and Drug Administration approved an. These tests have been authorized by FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. 0000151822 00000 n This test has been authorized by FDA under an EUA for use by authorized laboratories. Q4{y4(L7M&e~XzhkHAj!USV{{eE =BXoZ(BMr2d+)2rElxJE:t_h_Y9e*r yP/t !N 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. 0000002428 00000 n An email message containing instructions on how to reset your password has been sent to the e-mail address listed on your account. The type of Abbott tests in the Florida warehouse are now deemed to have a shelf life of 15 months, up from 12. 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. 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. 0000020161 00000 n 1899 0 obj <>stream 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. Learn more. Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. All BinaxNOW COVID-19 Ag Card Kits currently have a fifteen-month expiry date. h`=@^2/W2Q\% [2x?}N8BCExT'+N Frs&41MU]/Rz{{\,O)JEgm1//Q{Z0\ve!'b@1I9\&jp,*\VALtPAew;$9gD"D-ubEn_"me*we@!jV!8&+t .}S-Fv\EZ%!ko5*axvKfsuQxU2ZM-~Z`{-Gm%ryA,=-hh5{`:*o:pcv{7MYvO%UY7yZM>q?J*QYO\tTgzO 5$~`1. 0000007821 00000 n D We have developed twelve tests for COVID-19 globally. 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. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht 'hR00U8s5Bc9U+R+XhFo.AZB`08'tH Our BinaxNOW Home Test is available through digital health provider, eMed and our BinaxNOW Self Test is available over-the-counter online and in retail stores including CVS, Walgreens and Walmart. These tests have not been FDA cleared or approved. hb```)_@( .MyG/n. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. hbbd``b`$gfD\@m`m,N Dp~! The U.S. Food and Drug Administration has increased the shelf life for one of the most popular at-home COVID-19 test kits. 3077 0 obj <> endobj 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. endstream endobj startxref The shelf lives for tests from some other manufacturers have been extended as well. The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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. Learn more. iHealth Rapid . 848 0 obj <> endobj 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. 159 0 obj <>stream 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. endstream endobj startxref 0000006042 00000 n Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. If you are an individual, please reach out to your healthcare provider. Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. !}TO'Y7@O/+Ol&i5`W]bq0!nA^C>VKjMp:J}C a:!F 5qy_MkmBVBv.e:aIQn O/f%Sok^kVs>pbZrP}`J{bO]^WS|*wKcaC i+d*>e/NiW. agr. 0000105378 00000 n Learn more about COVID-19 testing on ID NOW here:https://abbo.tt/3KI9smQ, BinaxNOW provides results in 15 minutes. 159 0 obj <>stream 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. ID NOW has been in use since 2014 to detect flu, strep, and RSV. With the number of cases still high, youll likely be using the test long before that date anyway. 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. [!1~t8Cwvl3Skjn~4'r)eT_7Wq=*pd uzLa?H3yz|s. Learn more. Both components, the reagent and the antibodies, start to degrade at some point, Pettengill said. XsVxIRvD/-QUdv}S j%/=C5uT#L7hfGnBJwD| D=X\P+/lSD-cXCiT!GwPg0+kmBrh>Che|V4!cXuoHKeKk7lKr/XCLg+VEoGi' R~H}2-yLiQi59\9,bWKBSAP_orkW8h`f$C\*6eM! Generally, the FDA authorizes at-home test kits with a shelf life of about four to six months, but that shelf life could be extended if the manufacturer finds more data that shows the tests are. Please disable your ad blocker, whitelist our site, or purchase a subscription. The chemistry behind the antigen tests typically depends on two key components: a liquid reagent that is used to extract protein fragments from the patient sample, and customized antibodies that are painted on the test strip. But the manufacturer, Abbott, obtained. kdv1_2x/ hXMWF+L|B1,C# X1.}o0%qpEk"CG%I)=\"#'@D #PNz (WA""1DO$(%HDB0T[e( cJCfD1P_qPS!Bo0C&GP(AD4PD[K4( They are still fine, according to WHEC, the NBC affiliate in chilly Rochester, New York, which posed that question to manufacturers. Read more about Alinity m: https://abbo.tt/2zrt52N 159 0 obj <>stream Check out our most recent progress update here. 0000166958 00000 n The iHealth COVID-19 Antigen Rapid Test, for examplethe one sent . If you're with a hospital, lab or healthcare provider, please see the contact details below. They have a shelf life. 0000010349 00000 n Invalid password or account does not exist. Cqv1Xpl%3,QC~:?[>27C 8Bc u6{Wn7:gZk"W8'4 xdtN=$cM0.zuFTu%@"($O~p_7MeLq'{(0KdkJ1PQ? 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. Low 33F. *sOi:o1_o7&}9t_bv4]S=dy*]?moi,T|*iwM1=)?uc>fX1gY%'xM^7 dNrNrdvdJ|ZZKOOZ;>&TnnNV&|zr9a_LaL}p,K/A_})nJ7MtS)nJG+jH7\bL:b:L}0 EQ Generally, the tests are designed to be stable at a wide range of temperatures. Read more about ARCHITECT: https://abbo.tt/3abd0eq 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. 0000127178 00000 n When the seller offers the pricing below market rates; When the seller claims that they can import iHealth tests directly from China. hb```b``a`c`bb@ !V da ^Tf0ierg B AA!/SZ11K>KK 8K'6Un7',. hXnF}L @[ X"@)]JiZB Rapid antigen tests offer several important benefits. 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. 0000105492 00000 n A clear sky. 0 It will provide a better understanding of the virus, including how long antibodies stay in the body. 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. 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 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) 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. Make sure youre looking at the expiration date. iHealth Rapid . Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;? HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS? To be on the safe side, use a test that has not expired. Winds light and variable. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. endstream endobj 161 0 obj <>stream LOOKING FOR MORE INFO? 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. An extended expiration date means the manufacturer provided. The Food and Drug Administration (FDA) has authorized an expiry extension for BinaxNOW tests for three months from the current expiration date listed on the external box. The Philadelphia Inquirer (TNS), Subscriber Verification(Must be Logged In Using Free Account). Results are encrypted and available only to you and those you choose to share them with. :yt8t$6;-lFh -/WG]w;Z]uN Generally, the expiration dates are stamped on the back of the package. Learn more about m2000 here: https://abbo.tt/3b8bASF, Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours, helping to meet the increasing demand for testing. You have permission to edit this article. %PDF-1.5 % It can also be performed at home using a virtually guided service in partnership with eMed. Your e-mail address will be used to confirm your account. To optimize results, do not use viral transport media (VTM), which could reduce the sensitivity of the test through dilution. T$ T For more information on Alinity m, check out this news release: https://abbo.tt/2zrt52N, Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. h2T0Pw/+Q0L)67 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. This article helps explain how the ID NOW molecular point-of-care test for COVID-19 works. {]Tuvpnl/'|PZge~MDlegn{O:>'S9kDI#LqGTj?#]aT?!8y+vX4[{cWLh7qqrR_~ibzcDjbkU Since the U.S. Centers for Disease Control and Prevention began allowing inbound travelers to fly into the United States with a negative result from an at-home instant COVID-19 test in May, just two tests have been approved for use Abbott's BinaxNow COVID-19 Home Test and Ellume's COVID-19 Home Test.. On Oct. 1, Ellume voluntarily recalled more than 2 million tests, citing "higher-than . 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. Here's how to tell, By Tom Avril This type of knowledge could help support research about how the virus spreads within communities and immune responses to vaccines. Biolabs International LLC / GriffMaier LLC, Paramount Sourcing LLC (exclusively partnered with Office Depot), Sunshine Paper LLC / Marketing Promotion Image Inc. Abbott received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the ID NOW COVID-19 test in March 2020. That guidance is based on how the products were tested. ID NOW is an FDA approved CLIA-waived instrument, which means that the technology can be used in settings outside the traditional hospital setting. 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 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. Results may be delivered in 13 minutes or less. kdv1_2x/ H\j0~ The expiration dates of the lot numbers listed in the referenced link have been extended to 12 months. #cQR 0000001933 00000 n endstream endobj 123 0 obj <> endobj 124 0 obj <>stream o Abbott Panbio COVID -19 AG Rapid Test Device (nasal) (December 31, 2020) . The expiration date is set at the end of the shelf-life. 0000166652 00000 n Start your subscription for just $5 for 3 months Subscribe. %%EOF The ID NOW testing process is safe and does not endanger operators as long as the collection and processing of samples follow the universal precaution techniques outlined by CDC guidelines. %PDF-1.6 % 2021, Health Canada authorized an amendment for a shelf life extension from 12 to 24 months. This letter is to notify you the BinaxNOW COVID-19 Ag Card, part number 195- 000, in your possession may now have a longer than labeled product expiry date. We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. 3097 0 obj <>/Filter/FlateDecode/ID[<73077F0332DFC546A603ACCCBFE5DB0E><5254CB85EB97834C824171E9511E2BBD>]/Index[3077 54]/Info 3076 0 R/Length 104/Prev 631165/Root 3078 0 R/Size 3131/Type/XRef/W[1 3 1]>>stream 0000001341 00000 n The website that you have requested also may not be optimized for your screen size. Ourm2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. 0000126232 00000 n The tests are available on our ARCHITECT and Alinityi systems. 0 endstream endobj 162 0 obj <>stream %%EOF Sign up to receive news and updates from this site directly to your desktop. In others, new expiration dates are posted on company websites, organized by lot number, but finding them can be a challenge. In August 2021, the WHAT'S THE TURN-AROUND TIME FOR YOUR TESTS? ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu Posted on 11/05/2021 You can access the most information related to Abbott of BinaxNOW tests that have been authorized to have their expiration dates extended by accessing information directly from Abbott's website. You can find more information on BinaxNOW COVID-19 Ag Card and NAVICA here. 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): . Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Re: EUA210264/5003 Trade/Device Name: BinaxNOW COVID-19 Antigen SelfTest Dated: December 27, 2021 Received: December 27, 202 1 Dear Ms. Drysdale: This is to notify you that your request to; (1) update the shelf-life expiration date of the BinaxNOW COVID-19 Ag Has your COVID rapid test expired? The agency typically authorizes at-home tests for four to. Hs"`S*2rT0 0000126794 00000 n Our rapid antigen test, BinaxNOW COVID-19 Ag Card, Home Test and Self Test all provide results in 15 minutes. An antibody is a protein that the body produces in the late stages of infection. Most of these antigen tests have a pretty good shelf life, he said. And when its time to use the test, read the instructions carefully then, too. Read more about m2000: https://abbo.tt/2U1WMiU $E;n7$%YJ{^,Y7ofx->XB7oOOB+.N#EIE(.2t-Vgcv)~&(f;#X{L21R+Mk.U eM,+D]q/K&KwDA6=WWOBNP|:SX!\GUEaaw)eJQBS8o9;[&}EZ$,,58@7$2v AU$pRB8SYzt)^S 2*g5 Submitting this form below will send a message to your email with a link to change your password. Such tests which work by detecting antigens (pieces of viral proteins) on the patients swab sample will eventually expire.