Nsuku zonke, inkampani esePasadena, eCalifornia ithumela abagibeli abayisishiyagalombili abathwele izivivinyo ze-coronavirus e-UK.
Isikhulu esiphezulu se-Innova Medical Group sithemba ukusebenzisa izivivinyo ezisheshayo ukunciphisa ukutheleleka eduze nasekhaya.Esigabeni esibi kakhulu salolu bhubhane kulobu busika, izibhedlela eziseLos Angeles County bezigcwele iziguli, kanti isibalo sokufa sifinyelele irekhodi eliphezulu.
Kodwa-ke, u-Innova akagunyaziwe yi-US Food and Drug Administration ukuthi athengise le mikhiqizo yokuhlola e-United States.Esikhundleni salokho, amajethi afakwe izivivinyo andiza phesheya ukuze ayokhonza “iNyanga” lapho uNdunankulu waseBrithani u-Boris Johnson enza khona isivivinyo esikhulu.
UDaniel Elliott, uMongameli kanye ne-CEO ye-Innova Medical Group, uthe: "Ngikhungathekile kancane."“Ngicabanga ukuthi sesiwenzile wonke umsebenzi ongase wenziwe, umsebenzi okufanele wenziwe, nomsebenzi odingekayo ukuze uhlolwe ngokugunyazwa.”
Ucwaningo olwengeziwe luyaqhubeka ukufakazela ukunemba kokuhlolwa kwe-Innova, okubiza ngaphansi kuka-$5 futhi kungaletha imiphumela phakathi nemizuzu engama-30.U-Elliott uthe abacwaningi baseHarvard University, University of California, San Francisco naseColby College bakuhlolile ukuhlolwa, kanti amanye amaqembu ocwaningo azimele enza izivivinyo kubantu abanezimpawu ze-COVID-19 noma abangenazo.
Ochwepheshe bathi i-United States inganweba ngokushesha ukunikezwa okulinganiselwe kwemikhiqizo yokuhlola e-United States futhi ikhulise isivinini ngokugunyaza ukuhlolwa kwe-antigen yephepha ngokushesha (njengokuxilongwa kwe-Innova).Abameli bathi lezi zivivinyo zishibhile futhi kulula ukuzenzela, futhi zingasetshenziswa kabili noma kathathu ngesonto ukuthola ukuthi umuntu uthelele nini futhi angase asakaze igciwane kwabanye.
Ukubi: Uma kuqhathaniswa nokuhlolwa kwaselabhorethri, ukunemba kokuhlolwa okusheshayo akulungile, futhi ukuhlolwa kwaselabhorethri kuthatha isikhathi eside ukuqedwa, futhi izindleko zingama-dollar ayi-100 noma ngaphezulu.
Kusukela ngentwasahlobo edlule, abaphathi bakaMongameli uJoe Biden baye basekela zombili izindlela - ukutshala imali ekuhlolweni kwe-antigen okusheshayo, okungabizi kanye nokusabela kwe-polymerase chain okusekelwe elabhorethri noma ukuhlolwa kwe-PCR.
Ngasekuqaleni kwale nyanga, izikhulu zikahulumeni zimemezele ukuthi abahlinzeki abayisithupha abangaziwa bazoletha izivivinyo ezisheshayo eziyizigidi ezingama-61 ngasekupheleni kwehlobo.UMnyango Wezokuvikela uphinde wafinyelela esivumelwaneni samaRandi ayizigidi ezingama-230 ne-Ellume ese-Australia sokuvula ifektri e-United States ukuze yenze izivivinyo ze-antigen eziyizigidi eziyi-19 ngenyanga, kuzonikezwa izigidi eziyi-8.5 kuhulumeni wobumbano.
Abaphathi beBiden bamemezele uhlelo lwama-dollar ayizigidi eziyizinkulungwane eziyi-1.6 ngoLwesithathu lokuqinisa ukuhlolwa ezikoleni nakwezinye izindawo, ukuhlinzeka ngezinto ezidingekayo, nokutshala imali ngokulandelana kwe-genome ukuhlonza okuhlukile kwe-coronavirus.
Cishe ingxenye yemali izosetshenziselwa ukusekela ukukhiqizwa kwasekhaya kwezinto ezibalulekile zokuhlola, njengama-plastic pen nibs kanye neziqukathi.Amalabhorethri awakwazi njalo ukuqinisekisa ukuphepha - lapho amasampula ethunyelwa kumalabhorethri ahlome kahle, izikhala ze-supply chain zingabambezela imiphumela.Uhlelo lwephakheji ye-Biden luhlanganisa nokusebenzisa imali ezintweni zokusetshenziswa ezidingekayo ukuze kuhlolwe i-antigen ngokushesha.
Izikhulu zikahulumeni zithi lezi zindleko zanele ukuhlangabezana nezidingo zalolu hlelo lokusebenza ukuze kuhlangatshezwane nezidingo eziphuthumayo.Umxhumanisi wezimpendulo ze-COVID-19 uJeffrey Zients uthe iCongress idinga ukwedlula uhlelo lokuhlenga lwe-Biden ukuze kuqinisekiswe ukuthi uxhaso luphindwe kabili ukuthuthukisa amakhono okuhlola nokunciphisa izindleko.
Izifunda zesikole eSeattle, Nashville, Tennessee, naseMaine sezivele zisebenzisa izivivinyo ezisheshayo ukuthola leli gciwane phakathi kothisha, abafundi nabazali.Inhloso yokuhlolwa okusheshayo wukwehlisa izinkathazo zokuvula kabusha isikole.
UCarole Johnson, umxhumanisi wokuhlola wethimba lokuphendula le-COVID-19 labaphathi beBiden, uthe: "Sidinga izinketho eziningi lapha.""Lokhu kufaka phakathi izinketho okulula ukuzisebenzisa, ezilula futhi ezithengekayo."
Abameli bathi uma abalawuli benhlangano begunyaza izinkampani esezikwazi ukwenza izivivinyo eziningi, kusho ukuthi i-United States ingenza izivivinyo ezengeziwe.
UDkt. Michael Mina, udokotela wezifo eziwumshayabhuqe eNyuvesi yaseHarvard, ubelokhu enza lezi zivivinyo.Uthe ukuhlola okusheshayo “kungelinye lamathuluzi angcono kakhulu futhi anamandla eMelika” ekulweni ne-COVID-19.
UMina uthe: “Kufanele silinde kuze kufike ihlobo ukuze sihlole abantu…kuyahlekisa lokhu.”
Ngaphansi kokuhlolwa okubanzi okuhlanganiswe nezinyathelo eziqinile zokuvalelwa yedwa, izwe laseYurophu iSlovakia lehlise izinga lokutheleleka cishe ngama-60% lingakapheli isonto.
I-UK isiqale uhlelo lokuhlola izinga elikhulu.Yethule uhlelo lokuhlola ukuhlola i-Innova e-Liverpool, kodwa yandise uhlelo ezweni lonke.I-UK yethule uhlelo lokuhlola olunolaka, yayala izivivinyo ezingaphezu kwezigidi eziyinkulungwane zamaRandi.
Ukuhlola kuka-Innova sekuvele kusetshenziswe emazweni angu-20, futhi inkampani ihlanganisa ukukhiqizwa ukuze kuhlangatshezwane nesidingo.U-Elliott uthe izivivinyo eziningi zale nkampani zenziwa efekthri eChina, kodwa i-Innova ivule imboni eBrea, eCalifornia, futhi maduze izovula engu-350,000 eRancho Santa Margarita, eCalifornia.Imboni yezinyawo zesikwele.
Manje u-Innova usengakwazi ukukhiqiza amakhithi okuhlola ayizigidi eziyi-15 ngosuku.Le nkampani ihlela ukunweba ukupakishwa kwayo kube ngamasethi ayizigidi ezingama-50 ngosuku ehlobo.
U-Elliott uthe: "Kuzwakala kakhulu, kodwa akunjalo."Abantu badinga ukuhlola kathathu ngeviki ukuze banqamule ngempumelelo uchungechunge lokudlulisela.Kunabantu abayizigidi eziyizinkulungwane eziyisi-7 emhlabeni.”
Uhulumeni waseBiden uthenge izivivinyo ezingaphezu kwezigidi ezingama-60, ezingeke zikwazi ukweseka izinhlelo ezinkulu zokuhlola esikhathini eside, ikakhulukazi uma izikole nezinkampani zivivinya abantu kabili kuya kathathu ngesonto.
Amanye amaDemocrats acele ukukhuthazwa okusebenzayo kokuhlolwa kwabantu abaningi ngokuhlolwa okusheshayo.Abamele ezentengiso baseMelika uKim Schrier, uBill Foster kanye noSuzan DelBene banxuse Ibamba likaKhomishana we-FDA uJanet Woodcock ukuthi enze ucwaningo oluzimele lokuhlolwa okusheshayo ukuze "avule indlela yokuhlolwa kwasekhaya okubanzi nokungabizi."
'Hlola umongameli ngokufanele nangokucophelela': Yize egonyiwe, uMongameli uJoe Biden uyaqhubeka nokuhlolwa njalo i-COVID-19
I-FDA inikeze ukugunyazwa okuphuthumayo kwezivivinyo eziningi kusetshenziswa ubuchwepheshe obuhlukahlukene, obusetshenziswa ezindaweni zokucwaninga, izikhungo zezokwelapha ngezinsizakalo zezokwelapha ezisheshayo, kanye nokuhlolwa kwasekhaya.
Ukuhlolwa kwe-Ellume ka-$30 ukuphela kokuhlola okungasetshenziswa ekhaya ngaphandle kwencwadi kadokotela, akudingi ilabhorethri, futhi kunganikeza imiphumela phakathi nemizuzu engu-15.Ukuhlolwa kwekhaya kwe-Abbott's BinaxNow kudinga isincomo esivela kumhlinzeki we-telemedicine.Okunye ukuhlolwa kwasekhaya kudinga ukuthi abantu bathumele amasampula amathe noma ama-nasal swab elabhorethri yangaphandle.
U-Innova uthumele idatha ku-FDA kabili, kodwa ayikagunyazwa.Izikhulu zenkampani zithe njengoba isivivinyo somtholampilo siqhubeka, sizothumela imininingwane eminingi emasontweni ambalwa ezayo.
NgoJulayi, i-FDA yakhipha idokhumenti edinga ukuhlolwa kwasekhaya ukuze kuhlonzwe kahle igciwane elibangela i-COVID-19 okungenani u-90% wesikhathi.Kodwa-ke, isikhulu esiphezulu se-FDA esibhekele ukwengamela ukuhlolwa sitshele i-USA Today ukuthi i-ejensi izocubungula ukuhlola ngokuzwela okuphansi - ukulinganisa imvamisa ukuhlolwa okuhlonza ngayo igciwane ngendlela efanele.
UJeffrey Shuren, umqondisi we-FDA's Center for Equipment and Radiological Health, uthe le nhlangano igunyaze izivivinyo eziningi ze-antigen futhi ilindele ukuthi izinkampani eziningi zizofuna ukugunyazwa ukuhlolwa kwasekhaya.
UShuren utshele i-USA Today: “Kusukela ekuqaleni, lesi yisikhundla sethu, futhi sisebenza kanzima ukukhuthaza ukufinyelela ezivivinyweni ezisebenzayo.”"Izivivinyo ezinembile nezithembekile zenza abantu baseMelika bazizwe beqiniseka ngakho."
UDkt. Patrick Godbey, uDean we-American College of Pathologists, wathi: “Uhlobo ngalunye lokuhlola lunenjongo yalo, kodwa ludinga ukusetshenziswa ngendlela efanele.”
"Abantu baseMelika kumele bayiqonde ngokugcwele le nqubo": Umbusi utshele uMongameli uJoe Biden ukuthi bafuna ukuqinisa ukuhlangana komgomo we-COVID futhi babike ngokucacile.
U-Godbey uthi ukuhlolwa kwe-antigen okusheshayo kusebenza kahle uma kusetshenziswa kumuntu phakathi kwezinsuku ezinhlanu kuya kweziyisikhombisa kuqale izimpawu.Kodwa-ke, uma kusetshenziselwa ukuhlola abantu abangenazimpawu, ukuhlolwa kwe-antigen kungenzeka kuphuthelwe ukutheleleka.
Ukuhlola okushibhile kungase kube lula ukukuthola, kodwa wayekhathazekile ngokuthi amacala aphuthelwe angasetshenziswa njengethuluzi lokuhlola elisabalele.Uma behlola imiphumela engemihle ngokungeyikho, kungase kunikeze abantu umuzwa ongamanga wokulondeka.
UGoldby, umqondisi welabhorethri yeSoutheast Georgia Regional Medical Center eBrunswick, eGeorgia, wathi: “Kumelwe ulinganisele izindleko (zokuhlola) nezindleko zokulahlekelwa umuntu omatasa nokuvumela lowo muntu ukuba axhumane nabanye.”“Lokhu kuyakhathaza ngempela.Ihambisana nokuzwela kokuhlolwa.”
Ithimba elivela eNyuvesi yase-Oxford kanye nelabhorethri kahulumeni yase-Porton Down lenze ucwaningo olunzulu ngokuhlolwa okusheshayo kuka-Innova e-UK.
Ocwaningweni olungabuyekeziwe kontanga lokuhlola okusheshayo oluhlolwe u-Innova nabanye abakhiqizi, ithimba labacwaningi liphethe ngokuthi ukuhlola “kuyinketho ekhangayo yokuhlolwa kwesilinganiso esikhulu.”Kepha abacwaningi bathi izivivinyo ezisheshayo kufanele zisetshenziswe njalo ukuze kuhlolwe ukunemba kanye nezinzuzo ezingaba khona.
Ucwaningo luhlole ukuhlolwa kwe-Innova okungu-8,951 okwenziwa ezigulini zasemtholampilo, abasebenzi bezokwelapha, abasebenzi bezempi, kanye nezingane zesikole.Ucwaningo luthole ukuthi ukuhlola kuka-Innova kukhombe kahle u-78.8% wamacala eqenjini lesampula le-198 uma kuqhathaniswa nokuhlolwa kwe-PCR okusekelwe elabhorethri.Kodwa-ke, kumasampula anamazinga aphezulu egciwane, ukuzwela kwendlela yokuthola kukhushulwa kube ngaphezu kwama-90%.Lolu cwaningo luveze “ubufakazi obandayo” bokuthi abantu abanenani legciwane egazini bayatheleleka kakhulu.
Abanye ochwepheshe bathi i-United States kufanele iguqule isu layo lokutholwa isu eligcizelela ukuhlolwa ngokuhlolwa okusheshayo ukuhlonza ukuqubuka ngokushesha okukhulu.
Izikhulu zezempilo zithi i-coronavirus kungenzeka ibe ubhubhane eminyakeni embalwa ezayo: kusho ukuthini?
Emazwaneni ashicilelwe ngoLwesithathu yiThe Lancet, uMina kanye nabacwaningi baseNyuvesi yaseLiverpool nase-Oxford bathi ucwaningo lwakamuva aluqondanga ukuzwela kokuhlolwa kwe-antigen okusheshayo.
Bakholelwa ukuthi lapho abantu mancane amathuba okuthi basakaze leli gciwane kwabanye, ukuhlolwa kwe-PCR okusekelwe elabhorethri kungathola izingcezu zaleli gciwane.Ngenxa yalokho, ngemuva kokuhlolwa ukuthi bane-HIV elabhorethri, abantu bahlala bodwa isikhathi eside kunalokho abakudingayo.
UMina uthe indlela abalawuli e-United States nakwamanye amazwe abahumusha ngayo idatha yohlelo lokuhlola olusheshayo lwase-UK “inokubaluleka okukhulu emhlabeni jikelele.”
UMina uthe: "Siyazi ukuthi abantu baseMelika bafuna lezi zivivinyo."“Asikho isizathu sokucabanga ukuthi lokhu kuhlolwa akukho emthethweni.Kuyahlanya lokho.”
Isikhathi sokuthumela: Mar-15-2021