FAQ COVID-19isarespiratorydiseasecausedbyinfectionwithanew form ofcoronavirus(sars-cov-2)thathasnow beendetectedinmultiple locationsaroundtheworld,includingtheunitedstates. BelowareanswerstoquestionsaboutMAKO stestforcovid-19,includingtestmethodology, appropriatespecimentypes,specimenpackagingandshipping,andtestresultreporting. 1)DoesMAKO offeratesttodetectthepresenceofthe2019novelcoronavirus? Answer:Yes.TheMAKO COVID-19{TaqPathRT-PCR}{720100}isavailablefororderingby physiciansandotherauthorizedmedicalproviders.thetestdetectsthepresenceofthe underlyingvirus(sars-cov-2)thatcausescovid-19andisforusewithpatientswhomeet curentguidanceforevaluationofinfectionwithcovid-19. 2)WhatinstrumentationdoesMAKO utilizeforcovid-19testing? Answer: MAKO utilizeslifetechnologiesquantstudio12kflexsystemstoperform TaqPath COVID-19assays.ThisinstrumentationisRealTime PolymeraseChainReaction. 3)WhatassaydoesMAKO utilizeforcovid-19testing? Answer:MAKO utilizesthethermofishertaqpathassayforcovid-19.thetaqpathassay hasatargetedspecificityis100%ofcurentlyavailablecompletegenomesforsars-cov-2. 4)Whattypesofspecimensarerequiredfortesting? Answer:COVID-19testingrequiresspecimenscolectedfrom thenoseorthroat. Thepreferedsampletypesarenasopharyngeal(NP)ororopharyngeal(OP)swabs. 5)WhattypesofcolectionkitsdoesMAKO accept? Answer:MAKO validatedmultiplecolectionmedia,includinguniversaltransportmedia, saline,andliquidamies.mako utilizescolectionkitsfrom HardyDiagnostics,Puritan,Copan, Purflock,BDViralTransport,andStarplex. (FAQ scontinued»)
6)How shouldsamplesbeshipped? Answer:Samples/specimensshouldbeshippedrefrigeratedifreceivedfortestingwithin 72hoursofcolection,room temperatureifreceivedwithin24hoursofcolection,orfrozen ifsamplesareolderthan72hoursandhavebeenfrozenprior. 7)How shouldspecimensbecolected? Answer:DetailedilustrationsandinstructionsforNPandOPspecimencolectioncanbe foundonpagefourandfiveofthisdocument. 8)Whatarecriteriaforsamplerejection? Answer:Unacceptablespecimensincludethosethatare: Room temperatureswabsgreaterthan24hoursold; Refrigeratedswabsgreaterthan72hoursold; Calcium alginatetipswabsorswabswithwoodenshafts Glasstubes Improperlylabeled,contaminated,broken,orleakingtransportdevice 9)How longwilittakemako toreportresultsback? Answer:MAKO wilreportresultswithin48hoursofreceiptwithinthelaboratory. 10)How wiltestresultsbereported? Answer:Testresultswilbereportedas positive or notdetected. 11)How wilorderingphysiciansbenotifiedofpositiveresults? Answer:Positiveresultsaretreatedasacriticalresultandcaledtotheorderingphysicianor healthcareprovider.negativeresultswilnotbecaledintotheorderprovider. 12)WhataretheclinicalfeaturesofCOVID-19? Answer:Theclinicalspectrum ofcovid-19rangesfrom milddiseasewithnon-specificsigns andsymptomsofacuterespiratoryilness,toseverepneumoniawithrespiratoryfailureand septicshock.therehavealsobeenreportsofasymptomaticinfectionwithcovid-19. (FAQ scontinued»)
13)WilMAKO senddetectedresultsforconfirmation,andifso,wherewil resultsbesent? Answer:Makodoesnotplantoperform additionalonsiteconfirmatorytestingonpositive ornegativeresultsunlessthefdaorthecdcchangescurentrecommendations.makowil complywithapplicablepublichealthrequirementsorrequestsforspecimensfrom state publichealthdepartments(seebelow). 14)IsthistestapprovedbytheFDA? Answer:ThetesthasbeenvalidatedbyFDA sindependentreviewthroughthe EmergencyUseAuthorization(EUA)process We reworkingaroundtheclocktoprovidesolutionsforyou,builtexclusively tohelpyoucontinueseeingpatientsandprovideworldclasscare.