FDA Ivomereza Mayeso Oyamba a COVID-19 Pogwiritsa Ntchito Zitsanzo za Mpweya

Lero, US Food and Drug Administration yapereka chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) pa mayeso oyamba a matenda a COVID-19 omwe amapeza mankhwala omwe ali m'masampuli a mpweya okhudzana ndi matenda a SARS-CoV-2. Kuyezetsa kungathe kuchitidwa m'madera omwe chitsanzo cha wodwalayo chimasonkhanitsidwa ndikuwunikidwa, monga maofesi a dokotala, zipatala ndi malo oyesera mafoni, pogwiritsa ntchito chida cha kukula kwa katundu wonyamula katundu. Mayesowa amachitidwa ndi munthu woyenerera, wophunzitsidwa bwino yemwe akuyang'aniridwa ndi wothandizira zaumoyo yemwe ali ndi chilolezo kapena wololedwa ndi malamulo a boma kuti apereke mayesero ndipo akhoza kupereka zotsatira pasanathe mphindi zitatu.

"Chilolezo chamasiku ano ndi chitsanzo china chaukadaulo womwe umachitika mwachangu poyesa matenda a COVID-19," atero a Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "FDA ikupitilizabe kuthandizira kupititsa patsogolo mayeso a COVID-19 ndi cholinga chopititsa patsogolo matekinoloje omwe angathandize kuthana ndi mliri womwe ulipo komanso kuyika bwino US pazadzidzi wazachipatala."

Kuchita kwa InspectIR COVID-19 Breathalyzer kudatsimikizika pakufufuza kwakukulu kwa anthu 2,409, kuphatikiza omwe ali ndi zizindikiro komanso opanda. Mu kafukufukuyu, mayesowo adawonetsedwa kuti ali ndi chidwi ndi 91.2% (peresenti ya zitsanzo zabwino zomwe mayesowo adadziwika bwino) ndi 99.3% yeniyeni (peresenti ya zitsanzo zoyipa zomwe mayesowo adadziwika bwino). Kafukufukuyu adawonetsanso kuti, mwa anthu omwe ali ndi 4.2% yokha ya anthu omwe ali ndi kachilomboka, mayesowo anali ndi 99.6% yolosera, kutanthauza kuti anthu omwe alandila zotsatira zoyipa amakhala opanda chiyembekezo m'malo omwe amadwala matendawa. . Kuyesedwa kochitidwa ndi chidwi chofananira mu kafukufuku wotsatira wazachipatala woganizira za mtundu wa Omicron.

InspectIR COVID-19 Breathalyzer imagwiritsa ntchito njira yotchedwa gas chromatography gas mass-spectrometry (GC-MS) kuti ilekanitse ndikuzindikira zosakaniza zamankhwala ndikuzindikira mwachangu ma Volatile Organic Compounds (VOCs) asanu okhudzana ndi matenda a SARS-CoV-2 mu mpweya wotuluka. InspectIR COVID-19 Breathalyzer ikazindikira kukhalapo kwa zolembera za VOC za SARS-CoV-2, zotsatira zongoyerekeza (zosatsimikiziridwa) zabwino zimabwezedwa ndipo ziyenera kutsimikiziridwa ndi mayeso a molekyulu. Zotsatira zoyipa ziyenera kuganiziridwa potengera zomwe wodwalayo adakumana nazo posachedwa, mbiri yakale komanso kupezeka kwazizindikiro zakuchipatala zomwe zimagwirizana ndi COVID-19, popeza sizikuletsa matenda a SARS-CoV-2 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okha. posankha chithandizo chamankhwala kapena kasamalidwe ka odwala, kuphatikiza zisankho zolimbana ndi matenda.

InspectIR ikuyembekeza kutulutsa zida pafupifupi 100 pa sabata, zomwe zitha kugwiritsidwa ntchito kuyesa pafupifupi zitsanzo 160 patsiku. Pa mlingo uwu wa kupanga, kuyesa pogwiritsa ntchito InspectIR COVID-19 Breathalyzer ikuyembekezeka kukwera ndi zitsanzo pafupifupi 64,000 pamwezi.