A yau, Hukumar Abinci da Magunguna ta Amurka ta ba da izinin amfani da gaggawa (EUA) don gwajin gwaji na farko na COVID-19 wanda ke gano mahaษan sinadarai a cikin samfuran numfashi masu alaฦa da kamuwa da cuta ta SARS-CoV-2. Za a iya yin gwajin a wuraren da ake tattara samfuran marasa lafiya tare da bincikar su, kamar ofisoshin likitoci, asibitoci da wuraren gwajin wayar hannu, ta amfani da kayan aiki mai girman girman kayan da aka ษauka. ฦwararren ma'aikaci mai horarwa ne yayi gwajin a ฦarฦashin kulawar ma'aikacin kiwon lafiya mai lasisi ko izini daga dokar jiha don tsara gwaje-gwaje kuma yana iya ba da sakamako cikin ฦasa da mintuna uku.
"Izinin yau wani misali ne na saurin ฦirฦira da ke faruwa tare da gwaje-gwaje na gwaji don COVID-19," in ji Jeff Shuren, MD, JD, darektan Cibiyar na'urori na FDA da Lafiyar Radiyo. "FDA ta ci gaba da tallafawa haษaka sabbin gwaje-gwajen COVID-19 tare da manufar haษaka fasahar da za su iya taimakawa magance cutar ta yanzu da kuma mafi kyawun matsayi na Amurka don gaggawar lafiyar jama'a ta gaba."
An inganta aikin InspectIR COVID-19 Breathalyzer a cikin babban binciken mutane 2,409, gami da waษanda ke da kuma ba tare da alamun cutar ba. A cikin binciken, an nuna gwajin yana da 91.2% hankali (kashi na samfurori masu inganci da aka gano daidai) da ฦayyadaddun 99.3% (kashi na samfuran mara kyau da gwajin ya gano daidai). Har ila yau binciken ya nuna cewa, a cikin yawan mutanen da ke da kashi 4.2% na mutanen da ke dauke da kwayar cutar, gwajin yana da mummunan kimar 99.6%, ma'ana cewa mutanen da suka sami mummunan sakamakon gwajin na iya zama mara kyau a yankunan da ke fama da ฦananan cututtuka. . Gwajin da aka yi tare da irin wannan azanci a cikin binciken asibiti mai zuwa wanda aka mayar da hankali kan bambance-bambancen Omicron.
InspectIR COVID-19 Breathalyzer yana amfani da wata dabara da ake kira gas chromatography gas mass-spectrometry (GC-MS) don rarrabewa da gano gaurayawan sinadarai da sauri gano Haษaษษen Magungunan Halittu (VOCs) guda biyar waษanda ke da alaฦa da kamuwa da cutar SARS-CoV-2 a cikin numfashin numfashi. Lokacin da InspectIR COVID-19 Breathalyzer ya gano kasancewar alamun VOC na SARS-CoV-2, an dawo da sakamakon gwajin da ake tsammani (ba a tabbatar ba) kuma yakamata a tabbatar da shi tare da gwajin ฦwayoyin cuta. Ya kamata a yi la'akari da sakamako mara kyau a cikin mahallin bayyanar majiyyata kwanan nan, tarihi da kasancewar alamun asibiti da alamomin da suka dace da COVID-19, saboda ba sa kawar da kamuwa da cutar ta SARS-CoV-2 kuma bai kamata a yi amfani da su azaman tushen tushen kawai ba. don magani ko yanke shawara na kulawa da haฦuri, gami da yanke shawarar sarrafa kamuwa da cuta.
InspectIR yana tsammanin zai iya samar da kayan aiki kusan 100 a mako guda, waษanda kowane ษayan za a iya amfani dashi don kimanta samfuran kusan 160 kowace rana. A wannan matakin na samarwa, ana tsammanin ฦarfin gwaji ta amfani da InspectIR COVID-19 Breathalyzer zai ฦaru da kusan samfuran 64,000 a kowane wata.
