Yonke imihla, iPasadena, inkampani esekwe eCalifornia ithumela abakhweli abasibhozo bethwele iimvavanyo ze-coronavirus e-UK.
Umphathi ophezulu we-Innova Medical Group unethemba lokusebenzisa uvavanyo olukhawulezileyo ukucothisa usulelo kufutshane nasekhaya.Kwelona nqanaba libi lobhubhani kobu busika, izibhedlele zaseLos Angeles County bezigcwele izigulana, kwaye inani lokufa lifike phezulu.
Nangona kunjalo, u-Innova akagunyaziswanga yi-US Food and Drug Administration ukuba athengise ezi mveliso zovavanyo eUnited States.Endaweni yoko, iijethi ezixhotyiswe ngovavanyo zathunyelwa phesheya ukuya kukhonza "iNyanga" apho iNkulumbuso yase-Bhritane u-Boris Johnson wenza uvavanyo olukhulu.
UDaniel Elliott, uMongameli kunye ne-CEO ye-Innova Medical Group, uthe: "Ndikhathazekile kancinci."“Ndicinga ukuba siwenze wonke umsebenzi onokuthi wenziwe, umsebenzi ekufuneka wenziwe, kunye nomsebenzi ofunekayo ukuze uvavanywe ngenkqubo yokuvunywa.”
Uphando oluninzi luyaqhubeka ukubonisa ukuchaneka kovavanyo lwe-Innova, oluxabisa ngaphantsi kwe-5 yeedola kwaye lunokuzisa iziphumo kwimizuzu engama-30.U-Elliott uthe abaphandi kwiYunivesithi yaseHarvard, kwiYunivesithi yaseCalifornia, eSan Francisco naseColby College baye baluvavanya uvavanyo, kwaye amanye amaqela ophando abucala aqhuba ulingo kubantu abaneempawu ze-COVID-19 okanye abangenazo.
Iingcali zithi iUnited States inokwandisa ngokukhawuleza unikezelo olulinganiselweyo lweemveliso zovavanyo eUnited States kwaye yandise isantya ngokugunyazisa uvavanyo lwe-antigen olukhawulezayo lwephepha (njenge-Innova diagnosis).Abameli bathi olu vavanyo luxabiso eliphantsi kwaye kulula ukulwenza, kwaye lunokusetyenziswa kabini ukuya kathathu ngeveki ukukhangela xa umntu esulelekile kwaye anokuyisasaza intsholongwane kwabanye.
Ukungalungi: Xa kuthelekiswa novavanyo lwaselabhoratri, ukuchaneka kovavanyo olukhawulezileyo akulunganga, kwaye uvavanyo lwaselabhoratri luthatha ixesha elide ukugqitywa, kwaye ixabiso li-100 leedola zaseMelika nangaphezulu.
Ukususela entwasahlobo yokugqibela, ulawulo lukaMongameli uJoe Biden luxhase iindlela zombini - utyalo-mali ngokukhawuleza, ukuvavanya i-antigen engabizi kakhulu kunye ne-laboratory-based based polymerase chain reaction okanye uvavanyo lwe-PCR.
Kwangoko kule nyanga, amagosa karhulumente abhengeze ukuba ababoneleli abathandathu abangaziwayo bazakwenza uvavanyo olukhawulezileyo oluzizigidi ezingama-61 ekupheleni kwehlobo.UMphathiswa wezoKhuselo ufikelele kwisivumelwano se-230 yezigidi zeerandi kunye ne-Ellume esekwe e-Australia yokuvula umzi-mveliso e-United States ukuze enze uvavanyo lwe-antigen ezizigidi ezili-19 ngenyanga, apho izigidi ezisi-8.5 ziya kunikwa urhulumente wobumbano.
Ulawulo lwe-Biden lubhengeze isicwangciso se-1.6 yeebhiliyoni zeedola ngoLwesithathu ukomeleza uvavanyo ezikolweni nakwezinye iindawo, ukubonelela ngezinto eziyimfuneko, kunye nokutyala imali kulandelelwano lwe-genome ukuchonga ukwahluka kwe-coronavirus.
Malunga nesiqingatha semali siya kusetyenziselwa ukuxhasa imveliso yasekhaya yezinto ezibalulekileyo zovavanyo, ezifana neentsimbi zosiba zeplastiki kunye nezikhongozeli.Iilabhoratri azinakusoloko ziqinisekisa ukhuseleko - xa iisampulu zithunyelwa kwiilabhoratri ezixhotyiswe kakuhle, izikhewu zekhonkco lobonelelo zinokulibazisa iziphumo.Isicwangciso sephakheji yeBiden sikwabandakanya ukuchitha imali kwizinto eziyimfuneko kuvavanyo olukhawulezayo lwe-antigen.
Amagosa karhulumente athi le nkcitho yanele ukuhlangabezana neemfuno zeprojekthi yokulinga ukuhlangabezana neemfuno ezingxamisekileyo.Umququzeleli wempendulo ye-COVID-19 uJeffrey Zients uthe iCongress kufuneka ipasise isicwangciso sokuhlangula se-Biden ukuqinisekisa ukuba inkxaso-mali iphindwe kabini ukuphucula amandla ovavanyo kunye nokunciphisa iindleko.
Izithili zesikolo eSeattle, eNashville, eTennessee, naseMaine sele zisebenzisa iimvavanyo ezikhawulezayo ukufumanisa intsholongwane phakathi kootitshala, abafundi kunye nabazali.Injongo yolu vavanyo lukhawulezayo kukunciphisa amaxhala okuvulwa kwesikolo kwakhona.
UCarole Johnson, umnxibelelanisi wovavanyo weqela lokuphendula le-Biden kwi-COVID-19, uthe: "Sifuna uluhlu lwezinto onokukhetha kuzo apha.""Oku kubandakanya iinketho ekulula ukuzisebenzisa, ezilula nezifikelelekayo."
Abameli bathi ukuba abalawuli be-federal bagunyazisa iinkampani ezikwaziyo ukuqhuba iimvavanyo ezininzi, ke i-United States inokwenza iimvavanyo ezininzi.
UGqr. Michael Mina, isazi ngezifo zezifo kwiYunivesithi yaseHarvard, ebesenza olo vavanyo.Uthe uvavanyo olukhawulezileyo "sesinye sezona zixhobo zibalaseleyo nezinamandla eMelika" kumlo ochasene ne-COVID-19.
UMina uthe: "Kufuneka silinde kude kube yihlobo ukuze sivavanye abantu ... kuyahlekisa oku."
Ngaphantsi kovavanyo olubanzi oludityaniswe namanyathelo angqongqo okuvalelwa yedwa, ilizwe laseYurophu iSlovakia lehlise izinga losulelo phantse ngama-60% kwisithuba seveki.
I-UK iqalise inkqubo yokuhlola ibhongo elikhulu.Iqalise inkqubo yokulinga yokuvavanya uvavanyo lwe-Innova eLiverpool, kodwa iye yandisa inkqubo kwilizwe lonke.I-UK isungule inkqubo yokuhlola ebukhali, iyalela ngaphezulu kwe-1 yeebhiliyoni zeerandi zovavanyo.
Iimvavanyo zika-Innova sele zisetyenziswa kumazwe angama-20, kwaye inkampani inyusa imveliso ukuhlangabezana nemfuno.U-Elliott uthe uninzi lovavanyo lwenkampani lwenziwa kumzi-mveliso waseTshayina, kodwa u-Innova uvule umzi-mveliso eBrea, eCalifornia, kwaye kungekudala uza kuvula i-350,000 eRancho Santa Margarita, eCalifornia.Umzi-mveliso weenyawo zesikwere.
U-Innova ngoku unokuvelisa izixhobo zovavanyo ezizizigidi ezili-15 ngosuku.Inkampani iceba ukwandisa ukupakishwa kwayo kwi-50 yezigidi zeesethi ngosuku ehlotyeni.
U-Elliott uthe: "Kuvakala kakhulu, kodwa akunjalo."Abantu kufuneka bavavanye kathathu ngeveki ukuze baqhawule ngokufanelekileyo ikhonkco losulelo.Kukho abantu abazibhiliyoni ezisi-7 ehlabathini.”
Urhulumente wase-Biden uthenge iimvavanyo ezingaphezulu kwezigidi ezingama-60, ezingazukwazi ukuxhasa iinkqubo zovavanyo olukhulu kwixesha elide, ngakumbi ukuba izikolo kunye neenkampani zivavanya abantu kabini ukuya kathathu ngeveki.
Ezinye iidemokhrasi zafuna ukukhuthazwa okusebenzayo ngakumbi kovavanyo ngovavanyo olukhawulezayo.Abameli bezentengiso baseMelika uKim Schrier, uBill Foster, kunye noSuzan DelBene babongoze uMkomishinala obambeleyo we-FDA uJanet Woodcock ukuba enze uphononongo oluzimeleyo lovavanyo olukhawulezayo ukuze "avule indlela yovavanyo olubanzi nolungabizi kakhulu ekhaya."
'Ngengqiqo kwaye ngononophelo jonga umongameli ngokungakhethiyo': Ngaphandle kokugonywa, uMongameli uJoe Biden uyaqhubeka nokuvavanywa rhoqo kwi-COVID-19
I-FDA ibonelele ngogunyaziso olungxamisekileyo kuvavanyo oluninzi kusetyenziswa itekhnoloji eyahlukeneyo, esetyenziswa kwiilebhu, kumaziko ezonyango kwiinkonzo zonyango ezikhawulezileyo, kunye novavanyo lwasekhaya.
Uvavanyo lwe-Ellume yeedola ezingama-30 luvavanyo kuphela olunokusetyenziswa ekhaya ngaphandle kwencwadi kagqirha, ayifuni ilabhoratri, kwaye inokubonelela ngeziphumo kwimizuzu eyi-15.Uvavanyo lwasekhaya lwe-Abbott lweBinaxNow lufuna isincomo esivela kumboneleli we-telemedicine.Olunye uvavanyo lwasekhaya lufuna ukuba abantu bathumele amathe okanye iisampulu zempumlo kwilabhoratri yangaphandle.
U-Innova ungenise idatha kwi-FDA kabini, kodwa ayikavunywa.Amagosa enkampani athi njengoko ulingo lweklinikhi luqhubela phambili, luya kungenisa idatha eninzi kwiiveki ezimbalwa ezizayo.
NgoJulayi, i-FDA ikhuphe uxwebhu olufuna uvavanyo lwasekhaya ukuchonga ngokuchanekileyo intsholongwane ebangela i-COVID-19 ubuncinci i-90% yexesha.Nangona kunjalo, igosa eliphezulu le-FDA elinoxanduva lokongamela uvavanyo lixelele i-USA Namhlanje ukuba i-arhente iya kuthathela ingqalelo uvavanyo ngovakalelo olusezantsi-ukulinganisa amaxesha apho uvavanyo luyichonga ngokuchanekileyo intsholongwane.
UJeffrey Shuren, umlawuli weZiko le-FDA leZixhobo kunye neRadiological Health, uthe i-arhente ivume iimvavanyo ezininzi ze-antigen kwaye ilindele ukuba iinkampani ezininzi ziya kufuna ugunyaziso lovavanyo lwasekhaya.
UShuren uxelele i-USA Today: "Kwasekuqaleni, esi sisikhundla, kwaye sisebenza nzima ukukhuthaza ukufikelela kuvavanyo olusebenzayo.""Uvavanyo oluchanekileyo noluthembekileyo lwenza abantu baseMelika bazithembe ngalo."
UGqr. Patrick Godbey, iDean yeAmerican College of Pathologists, wathi: “Uvavanyo ngalunye lunenjongo yalo, kodwa lufanele lusetyenziswe ngokuchanileyo.”
"Abantu baseMelika kufuneka bayiqonde ngokupheleleyo le nkqubo": Irhuluneli ixelele uMongameli uJoe Biden ukuba bafuna ukomeleza ulungelelwaniso logonyo lwe-COVID kunye nengxelo ecacileyo.
UGodbey uthi uvavanyo lwe-antigen olukhawulezayo lusebenza kakuhle xa lusetyenziswa emntwini phakathi kweentsuku ezintlanu ukuya kwezisixhenxe zokuqala kweempawu.Nangona kunjalo, xa isetyenziselwa ukuvavanya abantu abangenazimpawu, uvavanyo lwe-antigen lunokuthi luphose usulelo.
Uvavanyo olungabizi kakhulu lunokuba lula ukulufumana, kodwa wayenexhala lokuba iimeko eziphosiweyo zingasetyenziswa njengesixhobo sokuhlola esixhaphakileyo.Ukuba bavavanya iziphumo ezibi ngendlela engachanekanga, oko kunokwenza abantu bazive bekhuselekile.
Goldby, umalathisi welebhu yeZiko Lezonyango Lommandla wakuMzantsi-mpuma weGeorgia eBrunswick, eGeorgia, wathi: “Kufuneka ulungelelanise iindleko (zokuvavanya) neendleko zokuphoswa ngumntu osebenzayo nokuvumela loo mntu ukuba asebenzisane nabanye.”“Le yinkxalabo yokwenene.Ixhomekeke kubuntununtunu bovavanyo. ”
Iqela leYunivesithi yaseOxford kunye nelebhu karhulumente yasePorton Down lenze uphando olubanzi ngovavanyo olukhawulezayo luka-Innova e-UK.
Kuphononongo olungaphononongwa ngontanga yovavanyo olukhawulezayo oluvandlakanywe ngu-Innova kunye nabanye abavelisi, iqela lophando ligqibe kwelokuba uvavanyo "lukhetho olunomtsalane kuvavanyo olukhulu."Kodwa abaphandi bathi iimvavanyo ezikhawulezayo kufuneka zisetyenziswe rhoqo ukuvavanya ukuchaneka kunye neenzuzo ezinokubakho.
Uphononongo luvavanye iimvavanyo ze-Innova ezingama-8,951 ezenziwe kwizigulana zeklinikhi, abasebenzi bezonyango, abasebenzi basemkhosini, kunye nabantwana besikolo.Uphononongo lufumanise ukuba uvavanyo luka-Innova luchonge ngokuchanekileyo ama-78.8% eemeko kwiqela lesampulu eli-198 xa kuthelekiswa novavanyo lwePCR olusekwe kwilabhoratri.Nangona kunjalo, kwiisampulu ezinamazinga aphezulu entsholongwane, uvakalelo lwendlela yokubona lunyuswa ngaphezu kwe-90%.Uphononongo lukhankanye “ubungqina obonyukayo” bokuba abantu abanomthamo wentsholongwane egazini bosulela ngakumbi.
Ezinye iingcali zathi i-United States kufuneka itshintshe isicwangciso sayo sokufumanisa isicwangciso esigxininisa uvavanyo ngovavanyo olukhawulezileyo ukuchonga uqhambuko ngokukhawuleza.
Amagosa ezempilo athi i-coronavirus kungenzeka ukuba ibe sisifo kule minyaka imbalwa izayo: ithetha ukuthini?
Kwingxelo epapashwe ngoLwesithathu nguThe Lancet, uMina kunye nabaphandi kwiYunivesithi yaseLiverpool naseOxford bathi uphando lwakutsha nje aluqondanga uvakalelo lovavanyo olukhawulezayo lwe-antigen.
Bakholelwa ukuba xa abantu bengafane basasaze intsholongwane kwabanye, iimvavanyo zePCR ezisekwe elebhu zinokufumanisa amaqhekeza ale ntsholongwane.Ngenxa yoko, emva kovavanyo lwalebhu, abantu bahlala bodwa ixesha elide kunokuba belifuna.
UMina uthe indlela abalawuli e-United States nakwamanye amazwe abatolika ngayo idatha evela kwinkqubo yovavanyo olukhawulezayo yase-UK "ibaluleke kakhulu kwihlabathi."
UMina uthe: “Siyazi ukuba abantu baseMelika bayalufuna olu vavanyo.“Akukho sizathu sokucinga ukuba olu vavanyo alukho mthethweni.Yimpambano leyo.”
Ixesha lokuposa: Mar-15-2021