FDA ta amince da gwajin rigakafin cutar COVID-19 na farko

FDA ta amince da gwajin rigakafinta na farko, wanda baya amfani da samfuran jini don bincika shaidar kamuwa da cutar COVID-19, amma a maimakon haka ta dogara da swabs na baka mai sauƙi, mara zafi.
Gaggawar gano saurin kwarara ta gefe wanda Diabetomics ya haɓaka ya sami izini na gaggawa daga hukumar, yana ba da damar yin amfani da shi a wuraren kulawa ga manya da yara.An tsara gwajin CovAb don samar da sakamako a cikin mintuna 15 kuma baya buƙatar ƙarin kayan aiki ko kayan aiki.
A cewar kamfanin, lokacin da maganin rigakafi na jiki ya kai matsayi mafi girma bayan akalla kwanaki 15 bayan bayyanar cututtuka, ƙimar gwajin karya ba ta kai kashi 3% ba, kuma adadin karya yana kusa da 1% .
Wannan reagent na bincike na iya gano ƙwayoyin rigakafi na IgA, IgG da IgM, kuma a baya ya sami alamar CE a Turai.A Amurka, reshen kamfanin na COVYDx ne ke siyar da gwajin.
Bayan yin aiki don haɓaka gwajin tushen yau da kullun don ƙididdige matakan sukari na jini na mako-mako na masu ciwon sukari na 2, Diabetomics ya juya ƙoƙarinsa zuwa cutar ta COVID-19.Hakanan yana aiki akan gwajin tushen jini don gano farkon nau'in ciwon sukari na 1 a cikin yara da manya;kuma har yanzu FDA ba ta amince da su ba.
A baya kamfanin ya ƙaddamar da gwajin kulawa don gano pre-eclampsia a farkon watanni uku na ciki.Wannan rikitarwa mai yuwuwar haɗari yana da alaƙa da cutar hawan jini da lalacewar gabobin jiki, amma ƙila ba za a sami wasu alamu ba.
Kwanan nan, gwaje-gwajen rigakafin mutum sun fara bayyana karara a cikin 'yan watannin farko na cutar ta COVID-19, suna ba da shaida cewa coronavirus ya isa gabar tekun Amurka tun kafin a dauki shi a matsayin gaggawa na kasa, kuma yana da miliyoyin zuwa dubun dubatar. miliyoyin.Ba a gano abubuwan da za su iya asymptomatic ba.
Binciken da Cibiyar Kiwon Lafiya ta Kasa ta gudanar ya dogara ne da busassun samfuran tabo na jini da aka tattara daga dubun dubatar mahalarta.
Wani bincike da aka yi amfani da samfurori da aka tattara asali don shirin binciken yawan jama'a na NIH na "Dukkanmu" a cikin 'yan watannin farko na 2020 ya gano cewa ƙwayoyin rigakafin COVID suna nuna kamuwa da cuta a duk faɗin Amurka a farkon Disamba 2019 (idan ba a baya ba).Wadannan binciken sun samo asali ne daga rahoton Red Cross na Amurka, wanda ya gano kwayoyin rigakafi a cikin gudummawar jini a lokacin.
Wani binciken da ya dauki mahalarta sama da 240,000 ya nuna cewa adadin shari'o'in hukuma ya ragu da kusan miliyan 20 a lokacin bazarar da ta gabata.Masu bincike sun kiyasta cewa dangane da adadin mutanen da suka gwada ingancin kwayoyin cutar, ga kowane kamuwa da cutar COVID da aka tabbatar, kusan mutane 5 ba a gano su ba.


Lokacin aikawa: Yuli-14-2021