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FDA ta ba da izinin gwajin gwajin COVID-19 na farko ta amfani da samfuran numfashi

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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 mahaɗan sinadarai a cikin samfuran numfashi masu alaƙa 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 ɗauka. ƙwararren ma'aikaci mai horarwa ne yayi gwajin a ƙarƙashin kulawar ma'aikacin kiwon lafiya mai lasisi ko izini daga dokar jiha don tsara gwaje-gwaje kuma yana iya ba da sakamako cikin ƙasa da mintuna uku.

"Izinin yau wani misali ne na saurin ƙirƙira 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 haɓaka sabbin gwaje-gwajen COVID-19 tare da manufar haɓaka 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 waɗanda 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 ƙayyadaddun 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 ƙananan 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 Haɗaɗɗen Magungunan Halittu (VOCs) guda biyar waɗanda ke da alaƙa 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 ƙwayoyin 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 haƙuri, gami da yanke shawarar sarrafa kamuwa da cuta.

InspectIR yana tsammanin zai iya samar da kayan aiki kusan 100 a mako guda, waɗanda kowane ɗayan za a iya amfani dashi don kimanta samfuran kusan 160 kowace rana. A wannan matakin na samarwa, ana tsammanin ƙarfin gwaji ta amfani da InspectIR COVID-19 Breathalyzer zai ƙaru da kusan samfuran 64,000 a kowane wata.

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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