Igeragezwa rya mbere ry’amavuriro muri Amerika ryemeje ko isuzuma ry’iminota 15 ryihuse rya virusi ya Clungene® SARS-CoV-2 IgG / IgM ryagaragaje neza antibodi z’abarwayi 100% banduye COVID nyuma yiminsi 13

Igeragezwa rya mbere ry’amavuriro muri Amerika ryemeje ko isuzuma ry’iminota 15 ryihuse rya virusi ya Clungene® SARS-CoV-2 IgG / IgM ryagaragaje neza antibodi z’abarwayi 100% banduye COVID nyuma yiminsi 13
Ihuriro rya Plymouth, muri Pennsylvania, ku ya 15 Kamena 2021 / PRNewswire / -Ikigereranyo cy’amavuriro yo muri Amerika cyo kwipimisha vuba COVID-19 cyemejwe n’ikigo gishinzwe gusuzuma isuzuma cyerekanye ko umwihariko w’abarwayi ba Covid-19-babi bemejwe na RT-PCR ari 100% (95 % intera y'icyizere, 88.4% -100.0%);ibi bivuze amasezerano 100% hagati ya RT-PCR itari nziza nibisubizo bibi bya Clungene®.Mu barwayi bapimishije virusi nyuma yiminsi 13, amasezerano hagati ya virusi ya Clungene® SARS-CoV-2 IgG / IgM yipimishije iminota 15 n’ikizamini cya polymerase (PCR) yarenze 90%.Ibisubizo byerekana ko ibi bizamini bishobora kuba igikoresho cyiza cyo kumenya ko antibodiyite zanduye abantu banduye virusi.Urubanza rwakozwe na Sharp Healthcare ya San Diego, muri Californiya, rushyiramo abarwayi mu bitaro by’indwara n’ubuvuzi.Ikigeragezo cyakozwe mbere yuko urukingo ruboneka henshi.Ibisubizo byubushakashatsi bwambere byasuzumwe byasohotse mu kinyamakuru LymphoSign (https://lymphosign.com/journal/lpsn).
Ati: "Ibi bisubizo birashimishije bidasanzwe kuko byerekana ko virusi ya CLUNGENE® SARS-COV-2 (COVID-19) IgG / IgM ibikoresho byipimisha byihuse bigira uruhare runini mu kumenya abantu bafite ubudahangarwa bw'umubiri, byerekana ko ubwandu bwa vuba cyangwa bwabanje bijyanye na politiki ishinzwe uburenganzira bwo gukoresha ibyihutirwa muri Amerika muri iki gihe, ”ibi bikaba byavuzwe na Dr. Fadi Haddad, impuguke mu ndwara zandura zo mu itsinda rya Sharp Medical Community Group wafashije gukora ubu bushakashatsi.Ati: "Ibi ni ingenzi cyane mu gihe abantu babarirwa muri za miriyoni batakingiwe kandi amahirwe yo kwandura aracyari ikibazo gikomeye."
Umuyobozi mukuru wa Proven, Scott Wise yagize ati: "Twishimiye cyane ibyavuye mu rubanza."Ati: “Iki kizamini cyemeza akamaro k'ibizamini nka virusi ya Clungene® SARS-CoV-2 IgG / IgM ikizamini cy'iminota 15 cyihuse mu gufasha inzobere mu buzima.Kuba yoroshye no kuyikoresha bituma iba igikoresho cyifashishwa mu gusuzuma. ”
Virusi ya Clungeneâ SARS-CoV-2 (COVID-19) IgG / IgM ibikoresho byipimisha byihuse birashobora gutanga ibisubizo muminota 15.Iki kizamini ntigisaba ibikoresho bya laboratoire bigoye gutunganya ibyasomwe.
Ibyerekeranye na PHARMA YATANZWE Yashinzwe mu 2012, Proven Pharma ni serivisi itanga serivisi mubikorwa byubuzima nubumenyi bwubuzima.Isosiyete itanga ibisubizo byinshi, harimo gukwirakwiza umwuga, gutanga amasoko yo kugereranya ivuriro, kugura itsinda ryagurishijwe imbere, inkunga yo kwamamaza, guhindura imibare no kugisha inama tekinike.Bafite uburambe bwimyaka irenga makumyabiri mubice byinshi byubuvuzi kandi bibaha ibisubizo.
Mu nganda zuzuye gushidikanya, Proven Pharma iha abakiriya bayo ikizere.Isosiyete itanga ku gihe buri gihe-ikoresheje ibikorwa byiza bizwi neza kugirango ibungabunge umutekano no kubahiriza kuri buri ntambwe.Pharma Proven yiyemeje gukomeza kunoza uburambe bwabakiriya kugirango aba bakiriya bashobore kuzamura imibereho yabarwayi.Intsinzi yisosiyete ituruka ku kuba inyangamugayo, ubunyangamugayo no kwizerwa kwitsinda ryayo.
Kubijyanye na Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. ni tekinoroji yo mu rwego rwo hejuru, ikora ibicuruzwa bikomoka ku binyabuzima ndetse n’ibicuruzwa bisuzumwa na vitro.Isosiyete izwiho gutanga serivisi zinyuranye no guhuza neza n'abacuruzi babigize umwuga n'abafatanyabikorwa ku isoko mpuzamahanga.
Hangzhou Kelon Biotechnology Co., Ltd yashinzwe mu 2004. Ifite ibikoresho bya ISO 13485: 2016 byemewe na R&D n’ibikorwa by’inganda i Hangzhou, mu Bushinwa, bijyanye na GMP y’Ubushinwa, ifite ubuso bwa metero kare 19.000.Ibicuruzwa byayo byabonye ibyemezo bya CE, ibyemezo bya FSC hamwe na US FDA 510 (k) byemewe (nomero ya FDA: 3009414546).
CLUNGENE® SARS-COV-2 virusi (COVID-19) IgG / IgM ibikoresho byipimisha byihuse birashobora kuboneka ukurikije amabwiriza ya FDA EUA: https://www.fda.gov/medical-devices/coronavirus-indwara-2019-covid- 19- Koresha byihutirwa uruhushya-ibikoresho byubuvuzi / muri vitro kwisuzumisha-euas-serologiya-n-ibindi-bihuza-n’ubudahangarwa-bwo-gusubiza-ibizamini-sars-cov-2
Usibye ibikubiye mu mabwiriza yo gukoresha (IFU), gukoresha cyangwa imvugo birabujijwe rwose.Nyamuneka sura kuri www.proven.com cyangwa uhamagare 1-855-678-7768 kugira ngo umenye amakuru.