Read more about m2000: https://abbo.tt/2U1WMiU 0000007821 00000 n 0 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. 5qy_MkmBVBv.e:aIQn O/f%Sok^kVs>pbZrP}`J{bO]^WS|*wKcaC i+d*>e/NiW. 0000008006 00000 n D 0000005785 00000 n agr. For our rapid antigen tests, BinaxNOW is available in the U.S. and Panbio is available in many countries outside of the U.S. $E;n7$%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 The expiration date is set at the end of the shelf-life. 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. 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. It is used on our ID NOW platform. A single at-home COVID-19 test by Quidel sits on a drugstore shelf on Sept. 14, 2021, in Chicago. This test has been authorized by FDA under an EUA for use by authorized laboratories. 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{` Healthcare professionals using ID NOW should be trained on how to use the instrument. 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. HOW LONG HAS THE ID NOW INSTRUMENT BEEN IN USE? 0000001341 00000 n 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. 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. endstream endobj 162 0 obj <>stream Many of these instruments are already located in hospital and academic medical center labs where patients go for care. Read more about Alinity i: https://abbo.tt/2SWCvtU It can also be performed at home using a virtually guided service in partnership with eMed. Make sure youre looking at the expiration date. 109 0 obj <> endobj pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht 'hR00U8s5Bc9U+R+XhFo.AZB`08'tH 0000015920 00000 n 159 0 obj <>stream Your purchase was successful, and you are now logged in. %PDF-1.7 startxref We continue to work closely with our customers around the world to bring testing to where its needed most. !.ObGl]q MnK#Xp;E,Z,HM\VYw|:aP+: endstream endobj 161 0 obj <>stream Low 33F. Hs"`S*2rT0 Lost in the summer news cycle was the fact that the U.S. Food and Drug Administration approved an. The ID NOW COVID-19 test is a rapid, molecular point-of-care test that detects COVID-19 in 13 minutes or less. The FDA advises against using at-home Covid tests past their expiration date, because tests and their parts can break down over time. Data transmitted in the app is encrypted and users only share name, birthdate, phone number, zip code and email address which is used for creating your personal profile in the app. ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu gs&m0V\;IfM @`hn21.B@,`|7 MEXlq9@8X/a9 -+S@ %9 If you forget it, you'll be able to recover it using your email address. 0000006548 00000 n Most of our tests may be available through your healthcare provider or at retail pharmacies. h2T0Pw/+Q0L)67 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This is the name that will be displayed next to your photo for comments, blog posts, and more. Read more about BinaxNOW COVID-19 Ag Card:https://abbo.tt/3hZPfNx. If you are an individual, please reach out to your healthcare provider. H\j@}l/4 `t 3077 0 obj <> endobj If you're with a hospital, lab or healthcare provider, please see the contact details below. kdv1_2x/ 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 Afterward, they dont work as well.. The website you have requested also may not be optimized for your specific screen size. 0000020325 00000 n This letter is to notify you the BinaxNOW COVID-19 Ag Card, part number 195- :yt8t$6;-lFh -/WG]w;Z]uN BinaxNOW COVID-19 Self Tests are available at major U.S. food, drug and mass merchandiser retailers across the country. Submitting this form below will send a message to your email with a link to change your password. endstream endobj startxref Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. :C1lr"wiUog-+Wu4W_*_EVqX~/,Lgj>Am=1-ij [)l+vr}H\b5&k?~s?YJgX?9n/t(8,?zzIc^|vxH>_{$HH>X{F)"y$sDmA=Jd:"'Vvu;;iX[g Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. The expiration date to reference is the one on the outside of the box by the hourglass icon. Our ID NOW molecular point-of-care test met all testing criteria in the FDA's emergency use authorization (EUA) and were continuing to collect more clinical data in the field. An email message containing instructions on how to reset your password has been sent to the e-mail address listed on your account. The test does not need any additional equipment. Most of these antigen tests have a pretty good shelf life, he said. h2T0Pw/+Q0L)67 The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. Abbott received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the ID NOW COVID-19 test in March 2020. 0000003892 00000 n 0000004095 00000 n hlj@E.3AF,lKS(a2/IuwsOC"A"(H>C)DBsHshJbmBLX+XpEOr ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu Winds light and variable.. A clear sky. 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. They are still fine, according to WHEC, the NBC affiliate in chilly Rochester, New York, which posed that question to manufacturers. An extended expiration date means the manufacturer provided. 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. a Cqv1Xpl%3,QC~:?[>27C 8Bc u6{Wn7:gZk"W8'4 xdtN=$cM0.zuFTu%@"($O~p_7MeLq'{(0KdkJ1PQ? Results may be delivered in 13 minutes or less. 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. 0000000016 00000 n 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. 0000004068 00000 n 0000004942 00000 n #cQR Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. 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. In some cases, the companies have inserted notices into the packages with the updated info. But be aware that with the COVID antigen tests, the expiration date may be a moving target. T$ T 0000126767 00000 n 0000015990 00000 n All three versions of the test pair with our optional mobile app foriPhoneandAndroiddevices, NAVICATM. %%EOF 0000009168 00000 n 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. Invalid password or account does not exist. f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. 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. >>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 The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The shelf lives for tests from some other manufacturers have been extended as well. Click on the bell icon to manage your notifications at any time. 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. 0000152529 00000 n 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 U 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) 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. [!1~t8Cwvl3Skjn~4'r)eT_7Wq=*pd uzLa?H3yz|s. That guidance is based on how the products were tested. 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. 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. <<6E9C363DB97F0F4FA676E3E40C7FF57B>]/Prev 190041/XRefStm 1630>> 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. Testing has been completed to support a shelf-life (expiration date) of up to 9 months from Date of Manufacture. 0000151822 00000 n %PDF-1.4 % Antibody testing is an important step to tell if someone has been previously infected. A clear sky. 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. Read more about ARCHITECT: https://abbo.tt/3abd0eq 869 0 obj <>stream hXnF}L @[ X"@)]JiZB R, The direct swab method is the best way to ensure the test performs as expected. IS THERE ANY RISK OF CONTAMINATION FOR LAB WORKERS WHO ARE OPERATING ID NOW? 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. 0000126497 00000 n %PDF-1.5 % endstream endobj 160 0 obj <>stream o Abbott Panbio COVID -19 AG Rapid Test Device (nasal) (December 31, 2020) . The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. An antibody is a protein that the body produces in the late stages of infection. o This . For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension. 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. 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. 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. Antigen testing: For more information on how antigen testing works, check out this article. Generally, the expiration dates are stamped on the back of the package. 3130 0 obj <>stream 109 51 endstream endobj 123 0 obj <> endobj 124 0 obj <>stream There are a variety of different tests being deployed and a whole ecosystem is needed to support testing in different healthcare settings. 0000019899 00000 n endstream endobj 121 0 obj <> endobj 122 0 obj <>stream HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY? It may seem obvious, but read the instructions. But stick to the recommended temperatures as much as possible. 0 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. 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 . 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. 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. Rapid antigen tests offer several important benefits. 0000010349 00000 n ecri.org/covid-at-home-testing. 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. {]Tuvpnl/'|PZge~MDlegn{O:>'S9kDI#LqGTj?#]aT?!8y+vX4[{cWLh7qqrR_~ibzcDjbkU The test does not need any . wK8 |vX@:) Learn more. You can find more information on BinaxNOW COVID-19 Ag Card and NAVICA here. To be on the safe side, use a test that has not expired. 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. 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$C\*6eM! To optimize results, do not use viral transport media (VTM), which could reduce the sensitivity of the test through dilution. The ID NOW instrument uses molecular technology and molecular tests in general are valued for their high level of accuracy in similar settings such as flu testing. 2021, Health Canada authorized an amendment for a shelf life extension from 12 to 24 months. This follows a request by the company to provide a longer shelf life for its test, after it reported stability studies that showed the tests remained . % 0000001933 00000 n Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Antigen tests detect proteins of the SARS-CoV-2 virus that form during the infection cycle and indicate that a person has an active infection. If there is any doubt, stick with the date on the package. %%EOF Fx J+-'[^(0V*JCIZ$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 Choosing a selection results in a full page refresh. https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. The website you have requested also may not be optimized for your specific screen size. Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. They are not all the same, and they can be confusing. o H\n@E^& 0000038489 00000 n hlj@E.3AF,lKS(a2/IuwsOC"A"(H>C)DBsHshJbmBLX+XpEOr HOW DOES EMERGENCY USE AUTHORIZATION (EUA) SUBMISSION PROCESS WORK? BinaxNOW is also a rapid test. 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. 0000126794 00000 n The agency typically authorizes at-home tests for four to. But the manufacturer, Abbott, obtained a three-month extension on the expiration date after supplying additional data to the FDA. 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. 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 . agr. endstream endobj 160 0 obj <>stream Ourm2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. All BinaxNOW COVID-19 Ag Card Kits currently have a fifteen-month expiry date. We are producing 50,000 COVID-19 tests a day for our ID NOW system. 0000011516 00000 n 0000152083 00000 n 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 It will provide a better understanding of the virus, including how long antibodies stay in the body. 0000004396 00000 n In August 2021, the 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. 0000006042 00000 n This article helps explain how the ID NOW molecular point-of-care test for COVID-19 works. 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. 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. The Philadelphia Inquirer (TNS), Subscriber Verification(Must be Logged In Using Free Account). With the number of cases still high, youll likely be using the test long before that date anyway. ID NOW is an FDA approved CLIA-waived instrument, which means that the technology can be used in settings outside the traditional hospital setting. endstream endobj 119 0 obj <> endobj 120 0 obj <>stream This test is used on our ID NOW instrument. 1899 0 obj <>stream We have developed twelve tests for COVID-19 globally. The U.S. Food and Drug Administration has increased the shelf life for one of the most popular at-home COVID-19 test kits. 864 0 obj <>/Filter/FlateDecode/ID[<5A9A7A95AE6AEC49AE3B8C30CF6206D9><39572FB4FEF03A449DD694F8FBD6E0F4>]/Index[848 22]/Info 847 0 R/Length 81/Prev 115121/Root 849 0 R/Size 870/Type/XRef/W[1 2 1]>>stream HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS? :x$eh 0000166391 00000 n 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. HOW LONG DOES IT TAKE TO GET RESULTS FOR THE ID NOW TEST? 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. 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. So here's how to know if your at-home test kits are still. hbbd```b``Vu dso|&-|&D H2 I~ #yfoxe`o| Our first molecular test is used on our lab-based molecular instrument, m2000. Theyre pretty stable for over a year.. When the seller offers the pricing below market rates; When the seller claims that they can import iHealth tests directly from China. Facilities should keep a copy of the referenced document for any Sign up for our newsletter to get up-to-date information on healthcare! 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. 0000004645 00000 n endstream endobj 161 0 obj <>stream 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. HOW ACCURATE ARE THE ID NOW COVID-19 TESTS? 0000014860 00000 n In others, new expiration dates are posted on company websites, organized by lot number, but finding them can be a challenge. Press the space key then arrow keys to make a selection. 0000012590 00000 n 0000105378 00000 n For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19? 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. We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. Your e-mail address will be used to confirm your account. hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;? Select CVS and Walgreens are using ID NOW in drive-thru settings in the U.S. You can find ID NOW in your local areahere, and BinaxNOW COVID-19 Self Tests in retailers near youhere. Please disable your ad blocker, whitelist our site, or purchase a subscription. 0000013781 00000 n 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. Our rapid antigen test, BinaxNOW COVID-19 Ag Card, Home Test and Self Test all provide results in 15 minutes. LOOKING FOR MORE INFO? Sign up to receive news and updates from this site directly to your desktop. Another test, called the QuickVue SARS Antigen Test, is designed to be stored at 59 to 86 degrees. Create a password that only you will remember. But the exact date in each case is an open question, in part because some of the manufacturers are new at this game. 0 H\j0~ ? They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19.
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