San Diego (KGTV)-Ib lub tuam txhab hauv San Diego nyuam qhuav tau txais kev tso cai xwm txheej ceev los ntawm US Food and Drug Administration (FDA) kom muag ib qho kev tshuaj xyuas tus kheej rau COVID-19, uas tuaj yeem rov qab los tsev hauv 10 feeb.
Thaum pib, QuickVue At-Home COVID-19 kev sim muab los ntawm Quidel Corporation tsuas yog siv tau raws li kws kho mob cov tshuaj, tab sis lub tuam txhab CEO Douglas Bryant tau hais tias lub tuam txhab yuav nyob rau ob peb lub hlis tom ntej no.Tuam Tshoj nrhiav kev tso cai thib ob los muag cov tshuaj hauv khw muag khoom.
Nws tau hais hauv kev xam phaj: "Yog tias peb tuaj yeem ua qhov kev sim ntau zaus hauv tsev, peb tuaj yeem tiv thaiv cov zej zog thiab ua kom peb txhua tus mus rau hauv khw noj mov thiab tsev kawm ntawv yam xyuam xim."
Biden tus thawj coj tau hais tias ua tiav kev sim hauv tsev zoo li Quidel yog ib feem ntawm kev kuaj mob, thiab Biden tus thawj coj tau hais tias qhov no yog qhov tseem ceeb rau kev ua neej zoo li qub.
Ob peb lub hlis dhau los, cov neeg tau txais kev pab tau siv ntau ntau ntawm "kev sim sau hauv tsev", thiab cov neeg siv tuaj yeem so lawv thiab xa cov qauv rov qab mus rau cov chaw sim sab nraud rau kev ua haujlwm.Txawm li cas los xij, kev sim rau kev sim sai (xws li kev kuaj cev xeeb tub) ua hauv tsev tsis tau siv dav.
Quidel qhov kev sim yog qhov kev sim thib plaub uas tau pom zoo los ntawm FDA hauv lub lis piam tsis ntev los no.Lwm yam kev sim suav nrog Lucira COVID-19 cov khoom siv kuaj txhua-hauv-ib, Ellume COVID-19 kuaj hauv tsev thiab BinaxNOW COVID-19 Ag daim npav kuaj hauv tsev.
Piv nrog rau kev tsim cov tshuaj tiv thaiv, kev txhim kho ntawm kev sim yog qeeb dua.Cov neeg thuam tau taw qhia txog qhov nyiaj ntawm tsoomfwv cov nyiaj tau faib thaum lub sijhawm Trump cov thawj coj.Raws li lub Yim Hli xyoo tas los, Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv Hauv Tebchaws tau faib nyiaj US $ 374 lab rau cov tuam txhab kuaj, thiab tau cog lus $ 9 nphom rau cov tuam txhab tshuaj tiv thaiv.
Tim Manning, tus tswvcuab ntawm Pawg Pabcuam Tiv Thaiv Kab Mob Dawb hauv Tsev Dawb tau hais tias: “Lub tebchaws nyob deb dhau qhov uas peb yuav tsum tau ua cov kev xeem, tshwj xeeb tshaj yog kev sim hauv tsev sai, uas tso cai rau peb txhua tus rov qab mus ua haujlwm li qub, xws li Mus kawm ntawv thiab mus. mus kawm ntawv.", hais lub hli tas los.
Thawj Tswj Hwm Biden tab tom ua haujlwm hnyav txhawm rau txhawm rau nce kev tsim khoom.Tsoomfwv Meskas tau tshaj tawm tsab ntawv pom zoo rau lub hli dhau los los yuav 8.5 lab qhov kev sim hauv tsev los ntawm Australian tuam txhab, Ellume, rau $ 231 lab.Qhov kev xeem Ellume tam sim no tsuas yog qhov kev sim uas tuaj yeem siv yam tsis muaj tshuaj.
Tsoomfwv Meskas tau hais tias nws tab tom tham nrog rau lwm lub tuam txhab tsis muaj npe los ua 61 lab qhov kev sim ua ntej lub caij ntuj sov xaus.
Bryant tau hais tias nws tsis tuaj yeem lees paub tias Kidd yog ib tus ntawm rau qhov kawg, tab sis nws tau hais tias lub tuam txhab tau sib tham nrog tsoomfwv kom yuav qhov kev sim hauv tsev sai thiab muab qhov kev thov.Quidel tsis tau tshaj tawm cov nqi ntawm QuickVue xeem.
Zoo li feem ntau cov kev sim ceev, Quidel's QuickVue yog ib qho kev kuaj antigen uas tuaj yeem kuaj pom tus yam ntxwv ntawm tus kab mob.
Piv nrog rau qhov qeeb qeeb polymerase saw cov tshuaj tiv thaiv kab mob (PCR), uas yog suav tias yog tus qauv kub, qhov kev kuaj antigen tuaj ntawm qhov raug nqi.Kev ntsuam xyuas PCR tuaj yeem nthuav dav me me ntawm cov khoom siv caj ces.Cov txheej txheem no tuaj yeem ua rau kom muaj kev nkag siab zoo, tab sis yuav tsum muaj cov chaw sim thiab ua kom lub sijhawm.
Quidel tau hais tias nyob rau hauv cov neeg muaj cov tsos mob, qhov kev sim nrawm nrawm ua rau PCR tau txais ntau dua 96% ntawm lub sijhawm.Txawm li cas los xij, hauv cov neeg asymptomatic, ib txoj kev tshawb nrhiav pom tias qhov kev sim pom muaj qhov zoo tsuas yog 41.2% ntawm lub sijhawm.
Bryant tau hais tias: "Lub zej zog kev kho mob paub tias qhov tseeb yuav tsis zoo tag nrho, tab sis yog tias peb muaj peev xwm ua qhov kev sim ntau zaus, qhov zaus ntawm cov kev sim no tuaj yeem kov yeej qhov tsis muaj qhov zoo tag nrho."
Hnub Monday, FDA qhov kev tso cai tau tso cai rau Quidel muab cov kws kho mob nrog kws kho mob cov ntawv xaj tsis pub dhau rau hnub ntawm thawj cov tsos mob.Bryant tau hais tias qhov kev tso cai yuav ua rau lub tuam txhab tuaj yeem koom nrog ntau qhov kev sim tshuaj los txhawb nqa daim ntawv thov ntawm cov tshuaj tom khw, suav nrog kev sim siv daim ntawv thov xov tooj los pab cov neeg siv txhais cov txiaj ntsig.
Nyob rau tib lub sijhawm, nws hais tias, cov kws kho mob tuaj yeem sau ntawv "dawb" rau kev kuaj xyuas kom cov neeg uas tsis muaj tsos mob tuaj yeem nkag mus kuaj.
Nws tau hais tias: "Raws li cov ntawv sau dav dav, cov kws kho mob tuaj yeem tso cai siv qhov kev sim lawv pom tias tsim nyog."
Quidel tau nce cov txiaj ntsig ntawm cov kev sim no nrog kev pab los ntawm nws qhov chaw tsim khoom tshiab hauv Carlsbad.Los ntawm lub quarter thib plaub ntawm lub xyoo no, lawv npaj yuav ua ntau tshaj 50 lab QuickVue kev xeem ceev txhua lub hlis.
Post lub sij hawm: Mar-05-2021