I-San Diego (KGTV)-Inkampani eseSan Diego isanda kuthola ukugunyazwa okuphuthumayo kwa-US Food and Drug Administration (FDA) ukuthi ithengise uhlelo lokuzihlola lwe-COVID-19, olungabuyela ekhaya ngokuphelele phakathi nemizuzu eyi-10.
Ekuqaleni, ukuhlolwa kwe-Quidel-Home COVID-19 okuhlinzekwe yi-Quidel Corporation kungasetshenziswa kuphela ngaphansi kwencwadi kadokotela, kodwa isikhulu senkampani uDouglas Bryant uthe inkampani izoba ezinyangeni ezimbalwa ezizayo.I-China ifuna ukugunyazwa kwesibili ukuthengisa izidakamizwa ezithengwayo.
Engxoxweni uthe: “Uma singakwazi ukwenza izivivinyo njalo ekhaya, singavikela umphakathi futhi senze ukuthi sonke sikwazi ukuya ezindaweni zokudlela nasezikoleni ngokuphepha.
Abaphathi beBiden bathi ukuhlolwa okuphelele ekhaya njengeQuidel kuyingxenye evelayo yenkambu yokuxilonga, futhi abaphathi beBiden bathi lokhu kubalulekile ukwenza impilo ibejwayelekile.
Ezinyangeni ezimbalwa ezedlule, abathengi bakwazile ukusebenzisa inqwaba "yokuhlola iqoqo lasekhaya", futhi abasebenzisi bangakwazi ukusula futhi bathumele amasampula emuva ezindaweni zokucwaninga zangaphandle ukuze zicutshungulwe.Nokho, ukuhlolwa kokuhlolwa okusheshayo (njengokuhlolwa kokukhulelwa) okwenziwa ekhaya akuzange kusetshenziswe kabanzi.
Ukuhlolwa kuka-Quidel kuwukuhlolwa kwesine okugunyazwe yi-FDA emasontweni asanda kwedlula.Okunye ukuhlola kufaka phakathi ikhithi yokuhlola ye-Lucira COVID-19 all-in-one, ukuhlolwa kwasekhaya kwe-Ellume COVID-19 kanye nokuhlolwa kwasekhaya kwekhadi le-BinaxNOW COVID-19 Ag.
Uma kuqhathaniswa nokuthuthukiswa kwemithi yokugoma, ukuthuthukiswa kokuhlolwa kuhamba kancane.Abagxeki bakhombe inani lezimali zikahulumeni ezabiwe ngesikhathi sokuphatha kukaTrump.Kusukela ngo-Agasti nyakenye, iNational Institutes of Health yabele izinkampani zokuhlola amaRandi ayizigidi ezingu-374, futhi yathembisa u-US$9 billion kubakhiqizi bemithi yokugoma.
UTim Manning, oyilungu le-White House COVID Response Team, uthe: “Izwe lisemuva kakhulu lapho kudingeka senze khona izivivinyo, ikakhulukazi ukuhlolwa kwasekhaya okushesha, okusivumela ukuthi sonke sibuyele emsebenzini ojwayelekile, njengokuthi Hamba uye esikoleni uye esikoleni. esikoleni.”, kusho ngenyanga edlule.
Abaphathi beBiden basebenza kanzima ukukhulisa umkhiqizo.Uhulumeni waseMelika umemezele isivumelwano ngenyanga edlule sokuthenga izivivinyo zasekhaya eziyizigidi eziyi-8.5 enkampanini yase-Australia, i-Ellume, ngamaRandi ayizigidi ezingama-231.Ukuhlolwa kwe-Ellume okwamanje kuwukuphela kokuhlola okungasetshenziswa ngaphandle kwencwadi kadokotela.
Uhulumeni waseMelika uthe usezingxoxweni nezinye izinkampani eziyisithupha ezingadalulwanga ukuthi zenze izivivinyo eziyizigidi ezingama-61 ngaphambi kokuphela kwehlobo.
UBryant uthe akakwazanga ukuqinisekisa ukuthi u-Kidd ubengomunye wabayisithupha abangene kowamanqamu, kodwa wathi inkampani ibixoxisana nohulumeni wobumbano ukuze ithenge isivivinyo sasekhaya esisheshayo futhi inikeze nesithembiso.I-Quidel ayizange imemezele esidlangalaleni intengo yokuhlolwa kwe-Quidel.
Njengokuhlola okuningi okusheshayo, i-Quidel's QuickVue iwukuhlolwa kwe-antigen ekwazi ukubona izici ezingaphezulu zegciwane.
Uma kuqhathaniswa nokuhlolwa kwe-polymerase chain reaction (PCR) ehamba kancane, ebhekwa njengezinga legolide, ukuhlolwa kwe-antigen kuza ngezindleko zokunemba.Ukuhlolwa kwe-PCR kungakhulisa izingcezu ezincane zezinto zofuzo.Le nqubo ingandisa ukuzwela, kodwa idinga amalabhorethri futhi yandise isikhathi.
U-Quidel uthe kubantu abanezimpawu, ukuhlolwa okusheshayo kufana nemiphumela ye-PCR ngaphezu kuka-96% wesikhathi.Kodwa-ke, kubantu abane-asymptomatic, ucwaningo lwathola ukuthi isivivinyo sathola amacala angama-41.2% kuphela wesikhathi.
UBryant uthe: “Umphakathi wezokwelapha uyazi ukuthi ukunemba kungase kungabi okuphelele, kodwa uma sinekhono lokuhlola njalo, khona-ke imvamisa yokuhlolwa okunjalo kunganqoba ukuntula ukuphelela.”
NgoMsombuluko, ukugunyazwa kwe-FDA kuvumele i-Quidel ukuthi inikeze odokotela ukuhlolwa kwencwadi kadokotela zingakapheli izinsuku eziyisithupha zezimpawu zokuqala.UBryant uthe ukugunyazwa kuzokwenza inkampani ibambe iqhaza ezivivinyweni eziningi zemitholampilo ukuze isekele ukusetshenziswa komuthi othengwayo, okuhlanganisa nesivivinyo sisebenzisa uhlelo lwefoni oluwumngane ukusiza abasebenzisi ukuchaza imiphumela.
Ngaso leso sikhathi, uthe odokotela bangakwazi ukunikeza imiyalelo “engenalutho” yokuhlolwa ukuze abantu abangenazo izimpawu bangenele ukuhlolwa.
Uthe: “Ngokwencwadi kadokotela ebanzi, odokotela bangagunyaza ukusetshenziswa kokuhlolwa abakubona kufanele.”
I-Quidel ikhulise umphumela walezi zivivinyo ngosizo lwesikhungo sayo esisha sokukhiqiza eCarlsbad.Ngekota yesine yalo nyaka, bahlele ukwenza izivivinyo ezisheshayo ze-QuickVue ezingaphezu kwezigidi ezingu-50 njalo ngenyanga.
Isikhathi sokuthumela: Mar-05-2021