Tijaabadii ugu horeysay ee caafimaad ee dalka Mareykanka ayaa xaqiijisay in 15-daqiiqo baaritaan degdeg ah oo Clungene® SARS-CoV-2 fayraska IgG/IgM uu si sax ah u aqoonsaday unugyada difaaca jirka 100% bukaannada qaba COVID-positive 13 maalmood ka dib.

Tijaabadii ugu horeysay ee caafimaad ee dalka Mareykanka ayaa xaqiijisay in 15-daqiiqo baaritaan degdeg ah oo Clungene® SARS-CoV-2 fayraska IgG/IgM uu si sax ah u aqoonsaday unugyada difaaca jirka 100% bukaannada qaba COVID-positive 13 maalmood ka dib.
Plymouth, Pennsylvania Shir, Juun 15, 2021/PRNewswire/- Tijaabo caafimaad oo Mareykan ah oo loogu talagalay baaritaanka degdega ah ee COVID-19 ee ay ansixiyeen Guddiga Dib-u-eegista Hay'adaha ayaa lagu ogaaday in gaar ahaanshaha bukaannada Covid-19-negative ee uu xaqiijiyay RT-PCR ay ahayd 100% (95) % inta u dhaxaysa kalsoonida, 88.4% -100.0%);tani waxay ka dhigan tahay 100% heshiis u dhexeeya RT-PCR taban iyo natiijooyinka baaritaanka serological Clungene® diidmo ah.Bukaannada laga helay fayraska 13 maalmood ka dib, heshiiska u dhexeeya Clungene® SARS-CoV-2 fayraska IgG/IgM 15-daqiiqo baaritaan degdeg ah iyo baaritaanka silsiladda polymerase (PCR) ayaa ka badan 90%.Natiijadu waxay tilmaamaysaa in baadhitaanadani ay noqon karaan qalab wax ku ool ah oo lagu ogaado joogitaanka unugyada difaaca jirka ee dadka qaba fayraska.Tijaabada waxaa sameeyay Sharp Healthcare ee San Diego, California, waxaana ku jiray bukaanada bukaan jiifka iyo xarumaha bukaan socodka.Tijaabada ayaa la sameeyay ka hor inta aan tallaalka si ballaaran loo helin.Natiijooyinka cilmi-baadhiseed ee asliga ahaa ayaa lagu daabacay majaladda LymphoSign (https://lymphosign.com/journal/lpsn).
Natiijooyinkani waa kuwo si cajiib ah u dhiirigelinaya sababtoo ah waxay muujinayaan in CLUNGENE® SARS-COV-2 fayraska (COVID-19) IgG/IgM xirmada tijaabada degdega ah ay aad waxtar ugu leedahay aqoonsashada shakhsiyaadka leh jawaab-celinta difaaca la-qabsiga, taasoo muujineysa in dhawaan ama kii hore uu cudurku yahay. si waafaqsan siyaasadda oggolaanshaha isticmaalka degdegga ah ee Maamulka Cuntada iyo Dawooyinka ee Maraykanka ee la filayo," ayuu yidhi Dr. Fadi Haddad, khabiir ku takhasusay cudurrada faafa oo ka socda Kooxda Bulshada Caafimaadka ee Sharp oo gacan ka geysatay samaynta cilmi-baaristan."Tani aad bay muhiim u tahay xilli malaayiin qof aan la tallaalin suurtagalnimada infekshinkuna waa arrin dhab ah."
"Aad ayaan ugu hanweynahay natiijada tijaabada," ayuu yiri madaxa fulinta Scott Wise.Tijaabadani waxay xaqiijinaysaa faa'iidada imtixaanada sida Clungene® SARS-CoV-2 fayraska IgG/IgM 15-daqiiqo baaritaan degdeg ah oo lagu caawinayo xirfadlayaasha daryeelka caafimaadka.Fududnaanteeda iyo fududaynteeda adeegsigeeda ayaa ka dhigaya qalab ogaanshaha faa'iido leh."
Xirmada tijaabada degdega ah ee Clungene SARS-CoV-2 (COVID-19) IgG/IgM waxay soo saari kartaa natiijooyin 15 daqiiqo gudahood.Tijaabadani uma baahna qalab shaybaar oo adag si loo habeeyo akhrinta.
Ku saabsan PROVEN PHARMA La aasaasay 2012, Proven Pharma waa bixiye adeeg oo ku jira daryeelka caafimaadka iyo warshadaha sayniska nolosha.Shirkaddu waxay bixisaa xalal ballaadhan oo kala duwan, oo ay ku jiraan qaybinta xirfadlayaasha, soo iibinta isbarbardhigga tijaabada caafimaadka, kooxda iibka gudaha ee u go'an, taageerada suuqgeynta, isbeddelka dhijitaalka ah iyo la-talinta farsamada.Waxay leeyihiin in ka badan labaatan sano oo waayo-aragnimo qani ah meelo badan oo ka mid ah goobaha daryeelka caafimaadka oo ay siiyaan xalal.
Warshadaha ay ka buuxaan hubanti la'aan, Proven Pharma waxay siisaa macaamiisheeda kalsooni.Shirkaddu waxay ku soo bandhigtaa waqtigeeda wakhti kasta iyadoo la isticmaalayo hababka iyo hababka ugu wanaagsan ee la aqoonsan yahay si loo hubiyo badbaadada iyo u hoggaansanaanta tallaabo kasta.Proven Pharma waxaa ka go'an in ay si joogto ah u wanaajiso khibrada macmiilka si macaamiishani ay u horumariyaan nolosha bukaanada.Guusha shirkadu waxay ka timid daacadnimada, daacadnimada iyo isku halaynta kooxdeeda.
Ku saabsan Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. waa tignoolajiyada sare, hormuudna u ah soo saaraha agabka bayoolojiga iyo alaabada ogaanshaha vitro in vitro.Shirkaddu waxay sumcad ku leedahay bixinta adeegyo kala duwan iyo dabacsanaan sare oo loogu talagalay qaybiyeyaasha xirfadlayaasha ah iyo la-hawlgalayaasha suuqa caalamiga ah.
Hangzhou Kelon Biotechnology Co., Ltd. waxaa la aasaasay sanadkii 2004. Waxay leedahay ISO 13485 ugu horumarsan: 2016 R&D shahaado iyo tas-hiilaadka wax soo saarka ee Hangzhou, Shiinaha, line la Shiinaha ee GMP, oo daboolaya aag of 19,000 mitir oo laba jibbaaran.Alaabooyinkeeda waxay heleen shahaadooyin CE, shahaadooyin FSC iyo oggolaanshaha US FDA 510 (k) (lambarka diiwaangelinta FDA: 3009414546).
CLUNGENE® SARS-COV-2 fayraska (COVID-19) IgG/IgM xirmada tijaabada degdega ah waxaa la heli karaa iyadoo la raacayo tilmaamaha FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Oggolaanshaha isticmaalka degdega ah-qalabka caafimaadka/in vitro diagnostic-euas-serology-iyo-kale-la qabsiga-immune-jawaab-jawaab-tijaabooyinka-sars-cov-2
Marka laga reebo waxa ku qoran Tilmaamaha Isticmaalka (IFU), isticmaal kasta ama bayaan kasta waa mamnuuc.Fadlan booqo www.proven.com ama wac 1-855-678-7768 wixii macluumaad dheeraad ah.