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Binax now home users guide by hafsa wadood
- 1. https://biotechcommerce.com/ presents you Covid-19 antigen card home test kit
- 2. COVID-19Ag CARDHOMETEST KIT BinaxNOWTM PROCEDURE CARD DO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SO
- 3. TheBinaxNOWTM COVID-19AgCardHomeTest isfor FDAEmergencyUseAuthorization(EUA)Only For Prescription Use Only ForIn Vitro Diagnostic (IVD)Use ••ThisproducthasnotbeenFD Aclearedorapproved;buthasbeenauthorizedbyFD A underanEU A; •Thisproducthasbeenauthorizedonlyforthedetectionof proteinsfromSARS- CoV-2,notfor anyotherviruses or pathogens;and, •Thisproductisonlyauthorizedforthedurationofthedeclarationthatcircumstancesexist justifyingtheauthorizationofemergencyuseofIVDsfordetectionand/ordiagnosis of COVID-19underSection564(b)(1)oftheFederalFood,DrugandCosmeticAct,21 U.S.C.§360bbb-3(b)(1),unlessthedeclarationisterminatedor authorizationi s revokedsooner. •FormoreinformationonEU Asgohere:https://www .fda.gov/emergency-preparedness- and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization •ForthemostuptodateinformationonCO VID-19,pleasevisit: www .cdc.go v/CO VID19 BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 4. •For detailed instructions, please visit : BinaxNOWhometest.abbott.com BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 5. Frequently AskedQuestions Will this testhurt? No,thenasals wabisnotsharpanditshouldnothurt.S o m e t i m e sthes w a bc a nfeelslightly uncomfortableortickly.If youfeelpain,pleasestopthetestandseekadvicefroma healthcareprovider. Whataretheknownandpotentialrisks andbenefitsof this test? Potential risks include: • P ossiblediscomf ortduringsampl ecollection. • P ossibleincorrecttestresults(seeR esultssection). Potential benefits include: • Th e re su lts, a lo n g w ith o th e r inform a tio n , c a n h e lp y o u r h e a lth c a re p ro vid e r m a k e info rm ed recommendationsaboutyourcare. • TheresultsofthistestmayhelplimitthespreadofCOVID-19toyourfamilyandothersinyour community. You have the option to refuse this test. However, your doctor has prescribed this test because they believe it could help with your care. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 6. What is the difference between an antigen and molecular test? BinaxNOWCOVID-19AgCARDHOMETESTKIT There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation.
- 7. HowAccurate is this Test? Basedontheinterimresultsofaclinicalstudyw h e retheBin a x NOWTM COVID-1 9AgCa rdH ome T estwascomparedtoanFD AauthorizedhighsensitivitySARS-CoV-2test,BinaxNOWCO VID-19 AgCardH o m eT estcorrectlyidentified91.7%ofpositivespecimensand100%ofnegative specimens. BinaxNOW COVID-19 Ag Card Home Test Study* In the graph above, BLUE bars represent samples where the both the BinaxNOW COVID-19 Ag Card Home Test and molecular test result were positive. The ORANGE bars represent samples where the BinaxNOW COVID-19 Ag Card Home Test results that were negative and the molecular test was positive. All of the ORANGE bars occurred in samples where there were very low levels of virus detected by the molecular test. In a separate larger study, the BinaxNOW COVID-19 Ag Card clinical study where tests were performed by healthcare providers, BinaxNOW COVID-19 Ag Card correctly identified 90.6% (116/128) positive specimens with high amounts of virus. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 8. Due to the relatively small sample size for the home use clinical study, the BinaxNOW™ COVID-19 Ag Card Home Test is estimated to correctly identify between 73.0% and 98.9% of positive specimens as reflected in the 95% Confidence Interval. This is consistent with the performance established in a separate multi-site clinical study in the US, where the BinaxNOW COVID-19 Ag Card test was performed and results interpreted by test operators with no laboratory experience. In that study, BinaxNOW™ COVID-19 Ag Card test correctly identified 84.6% of positive specimens and 98.5% of negative specimens. Based on this information, negative results may require additional testing to confirm your result. Please talk to your healthcare provider to determine if you need additional testing. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 13. Open Card TopHole BottomHole ResultsWindow TestStrip DO NOT touch any parts on insideofcard. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 14. Apply Fluid to Top Hole A. Remo vedropper bottlecap. B. Hold dropper bottle straightoverTOPHOLE, notatanangle. C. Put6DROPSinto TOPHOLE.Donot touchcardwithtip. 6 drops Note:Falsenegativeresults mayoccuriflessthan6drops BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 15. of fluid is used. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 16. Open Swab Keepfingersawayfromswabend. A. O p e ns w a bp a c k ag ea t stickend. B. T ak es wabout. ! BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 18. Swab LeftNostril A. Inserttheentireabsorbenttip of the s wab (usually 1/2 to 3/4 of aninch)intoleftnostril. B.Firmlybrushagainstinsidesof nostrilinacircularmotion5times ormoreforatleast15 seconds. Upto3/4of aninch. x5 BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 19. Swab RightNostril A. R e m o v es w a ba n dinsertit intorightnostril. B.Firmlybrushagainstinsidesof nostrilinacircularmotion5times ormoreforatleast15 seconds. x5 Note:Falsenegativeresults may occurifthenasalswabis not properlycollected. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 21. Turn Swab 3Times Turnswabtoright3timesincardandleaveitinplace. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 24. Wait 15Minutes Note: False results can occur if the card is disturbed/moved or test results are read before 15 minutes. 15:00 BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 27. Steps ToCheckYourResults Therearethreetypesofresultspossible.Y o uwillb einstructedh o wto readeachtypeinaspecificorder .Followthisorderwithyourproctor: 1.Check for a PositiveResult 2. Check for a Negative Result 3. Check for an Invalid Result BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 28. CheckforPositiveCOVID-19Result Findresultwindowandlookcarefullyfortwopink/purplelinesinwindow. • PositiveResult:T w opink/purplelineswillappear.Oneonthetop halfandoneonthebottomhalf.COVID-19wasdetected. Positive Positive CONTROL OR SAMPLE Look veryclosely! Thebottomlinecanbeveryfaint. Anypink/purplelinevisiblehereindicates apositive result. SolidLine FaintLine Herearephotosof actual positivetests. Onthe right, notehowfaint the bottomline canget. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 29. Positive COVID-19Result ApositivetestresultmeansitisverylikelyyouhaveCOVID-19 anditisimportanttobeunderthecareofyourhealthcareprovider . Thetelehealthproctorisnotahealthcareprovider .Itisalso likelythaty oum a yb eplacedinisolationtoav oidspreadingthe virus toothers.Thereisaverysmallchancethatthistestcangive a positiveresultthatiswrong(afalsepositiveresult).Y our healthcareproviderwillworkwithyoutodetermineho wbestto careforyoubasedonyourtestresult(s)alongwithyourmedical history,and yoursymptoms. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 30. CheckforNegativeCOVID-19Result Findresultwindowandlookforasinglepink/purplelineinwindow . • NegativeResult:Asinglepink/purplelineon thetophalf whereitsays“Control.”COVID-19was notdetected. Negative CONTROL SAMPLE No Line BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 31. Negative COVID-19Result Anegativetestresultmeansthatproteinsfromthevirusthat causesCOVID-19werenotfoundinyoursample. Negativeresultsmayrequireadditionalmolecular testingtoconfirmthat youdonothaveCOVID-19. Itispossibleforthistesttogiveanegativeresultthatisincorrect (falsenegative)insomepeoplewithCO VID-19.Thismeansthat youcouldpossiblystillhaveCO VID-19eventhoughthetestis negative.Ifyourtestresultisnegative,pleaseconsultyour healthcareprovider .Thetelehealthproctorisnota healthcareprovider .Y o u rhealthcareproviderwillconsiderthe testresulttogetherwithallotheraspectsofyourmedical history(suc hassymp t o m s ,possiblee xposures,a n dgeographical locationofplacesyouhaverecentlytraveled)in deciding howtocareforyou. If you or the healthcare proctor disagree on the presence of a faint line and/or the presence of a line is uncertain, additional BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 32. confirmatory testing should be conducted. Itisimportantthatyouworkwithyourhealthcareprovidertohelp youunderstandthenextstepsyoushouldtake. BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 33. Bluecontrol lineonly Check for InvalidResult Ifyouseeanyofthese,thetestisinvalid. CONTROL SAMPLE Nolinesseen Pink/purple sampleline only Blue control line AND pink/purplesample line BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 35. Reporting Patient Results Using NAVICA Uponcompletionofthetestandresultinterpretation,thetelehealthproctorwillsendyourtest resultsviatheNAVICAapp.Y o uwillbenotifiedbyemailandonyourmobiledevicethatyour resultsareready.Y o uwillgototheresultsscreeninNAVICAtoobtainyourtestresults. IfyourBinaxNOWCOVID-19AgCardHomeTest resultisNegative,youwillreceivethefollowing: IfyourBinaxNOWCOVID-19AgCardHomeTest resultisPositive,youwillreceivethefollowing: BinaxNOWCOVID-19AgCARDHOMETESTKIT
- 36. Reporting Patient Results Using NAVICA Uponcompletionofthetestandresultinterpretation,thetelehealthproctorwillsendyourtest resultsviatheNAVICAapp.Y o uwillbenotifiedbyemailandonyourmobiledevicethatyour resultsareready.Y o uwillgototheresultsscreeninNAVICAtoobtainyourtestresults. IftheBinaxNOWCOVID-19AgCardHomeTest resultisInvalid,youwillreceivethefollowing: ©2020Abbott.All rights reserved. Alltrademarksreferencedaretrademarksofeitherthe Abbottgroupofc o m p a n i e sortheirrespectiv eo wners. IN195101Rev12020/12 BinaxNOW COVID-19 Ag CARD HOME TEST KIT
- 37. Abbott BinaxNOW COVID-19AgCardHomeTest Procedure Card Size: 16.35in.x12.21in. Colors PN: IN195101 Rev:1 Date of Last Revision: 1.7 2020/12/14 RGB For Reference Only PMS2995C PrimaryBlue PMS 303 C DarkBlue PMS 224 C Magenta-Pink --