I-FDA Igunyaza Ukuhlolwa Kokuqala Kokuxilongwa kwe-COVID-19 Isebenzisa Amasampula Okuphefumula

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Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

Namuhla, i-US Food and Drug Administration ikhiphe isigunyazo sokusetshenziswa kwezimo eziphuthumayo (i-EUA) sokuhlolwa kokuqala kokuhlonza i-COVID-19 okuthola inhlanganisela yamakhemikhali kumasampula okuphefumula ahlobene nokutheleleka kwe-SARS-CoV-2. Ukuhlolwa kungenziwa ezindaweni lapho isifanekiso sesiguli siqoqwa futhi sihlaziywe, njengamahhovisi odokotela, izibhedlela nezindawo zokuhlola amaselula, kusetshenziswa ithuluzi elilingana nocezu lomthwalo othwalayo. Ukuhlolwa kwenziwa u-opharetha oqeqeshiwe, oqeqeshiwe ngaphansi kokuqondisa komhlinzeki wezempilo onelayisensi noma ogunyazwe umthetho wezwe ukuthi anqume ukuhlolwa futhi anganikeza imiphumela ngaphansi kwemizuzu emithathu.

"Ukugunyazwa kwanamuhla kungesinye isibonelo sokuqanjwa okusha okwenzekayo ngokuhlolwa kokuxilonga kwe-COVID-19," kusho uJeff Shuren, MD, JD, umqondisi we-FDA's Center for Devices and Radiological Health. "I-FDA iyaqhubeka nokweseka ukuthuthukiswa kokuhlolwa kwe-COVID-19 ngenhloso yokuthuthukisa ubuchwepheshe obungasiza ukubhekana nalolu bhubhane olukhona kanye nokubeka kangcono i-US esimweni esiphuthumayo esilandelayo sezempilo yomphakathi."

Ukusebenza kwe-InspectIR COVID-19 Breathalyzer kwaqinisekiswa ocwaningweni olukhulu lwabantu abangu-2,409, okuhlanganisa nalabo abanezimpawu nabangenazo. Ocwaningweni, ukuhlolwa kuboniswe kunokuzwela okungama-91.2% (iphesenti lamasampula amahle ukuhlolwa okuhlonzwe kahle) kanye nokucaciswa okungu-99.3% (iphesenti lamasampuli anegethivu ukuhlolwa okuhlonzwe kahle). Lolu cwaningo luphinde lwakhombisa ukuthi, esibalweni sabantu esinamaphesenti angama-4.2 kuphela abantu abanaleli gciwane, ukuhlolwa kube nenani elibikezelayo elibi lika-99.6%, okusho ukuthi abantu abathola imiphumela yokuhlolwa okungemihle kungenzeka babi ngokweqiniso ezindaweni zokusabalala kwezifo eziphansi. . Ukuhlolwa okwenziwe ngokuzwela okufanayo ocwaningweni lomtholampilo olulandelanayo olugxile kokuhlukile kwe-Omicron.

I-InspectIR COVID-19 Breathalyzer isebenzisa indlela ebizwa nge-gas chromatography gas mass-spectrometry (GC-MS) ukuze ihlukanise futhi ikhombe izingxube zamakhemikhali futhi ithole ngokushesha ama-Volatile Organic Compounds (VOC) amahlanu ahlotshaniswa nokutheleleka kwe-SARS-CoV-2 ekuphefumuleni okukhishwe umoya. Lapho i-InspectIR COVID-19 Breathalyzer ithola ukuba khona komaka be-VOC be-SARS-CoV-2, umphumela wokuhlola wokucabangela (ongaqinisekisiwe) uyabuya futhi kufanele uqinisekiswe ngokuhlolwa kwamangqamuzana. Imiphumela engemihle kufanele icatshangelwe esimweni sokuchayeka kwesiguli kwakamuva, umlando kanye nokuba khona kwezimpawu zomtholampilo kanye nezimpawu ezihambisana ne-COVID-19, njengoba zingakhiphi ukutheleleka kwe-SARS-CoV-2 futhi akufanele kusetshenziswe njengesisekelo sodwa. ngezinqumo zokwelashwa noma zokuphatha isiguli, okuhlanganisa nezinqumo zokulawula ukutheleleka.

I-InspectIR ilindele ukuthi ikwazi ukukhiqiza amathuluzi acishe abe yi-100 ngeviki, angasetshenziswa ngalinye ukuhlola amasampula angaba ngu-160 ngosuku. Kuleli zinga lokukhiqiza, amandla okuhlola kusetshenziswa i-InspectIR COVID-19 Breathalyzer kulindeleke ukuthi enyuke cishe ngamasampula angama-64,000 ngenyanga.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

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