Muva nje, i-Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) i-antigen regent ye-"StrongStep® SARS-CoV-2 Antigen Rapid Test" ithole ukuqinisekiswa kokusebenza kwe-Paul-Ehrlich-Institut (PEI*) eJalimane, lo mkhiqizo uqinisekisiwe. kuqinisekiswe i-German Federal Agency for Medicines and Medical Device Administration (BfArM).I-LimingBio isibe ngomunye wabakhiqizi abambalwa e-China abathole isitifiketi esikabili se-BfArM+PEI eJalimane.Ukuhlolwa okusheshayo kwe-antigen ye-Liming Bio kuphumelele isitifiketi esigunyaziwe soMnyango Wezempilo wamazwe amaningi, okufakazela ngokugcwele ukusebenza okuhle kakhulu kwekhithi.
Ukuhlolwa okusheshayo kwe-antigen ye-Liming Bio kuphumelele ngempumelelo ukuqinisekiswa kokusebenza kwe-PEI yaseJalimane
I-PS PEI: I-Paul Ehrlich Institute (isiJalimane: i-Paul-Ehrlich-Institut), eyaziwa nangokuthi i-German Federal Institute of Vaccines and Biomedicine, iyisikhungo socwaningo kanye ne-ejensi elawulayo yezokwelapha ye-German Federation, okwamanje engaphansi koMnyango Wezempilo Wenhlangano (BMG). ), inokusebenza okuzimele kokuhlolwa komkhiqizo webhayoloji, ukugunyazwa kwesilingo somtholampilo, ukugunyazwa komkhiqizo nokumakethwa, kanye nokukhishwa kwenqwaba.Ngaso leso sikhathi, yenza futhi uhlaka, ukubuyekezwa kwemithethonqubo efanele, kanyehlinzekasizeluleko zesayensi zezinhlangano ezahlukahlukene, ikakhulukazi amazwe athile e-European Union, i-European Union kanye namakomiti aphesheya.Alnjalo,hlinzekasizeluleko zobungcweti kuhulumeni waseJalimane, izinhlaka zendawo kanye nephalamende, futhi unikezesulwazi olubalulekile ezigulini nakubathengi.
Ukuhlolwa okusheshayo kwe-antigen ye-Liming Bio kuphumelele ngempumelelo isitifiketi se-BfArM yaseJalimane
I-StrongStep® SARS-CoV-2 Antigen Rapid Test eyakhiwe yi-Nanjing Liming Bio ithole ngokulandelana isitifiketi se-European Union CE, i-China National Institute for Food and Drug Control (NIFDC) yokuqinisekisa ukubhaliswa kokubhaliswa, ingene ohlwini olunconyiwe lwe-Rockefeller Foundation, kanye neGuatemala. isitifiketi , Isitifiketi soMnyango Wezempilo wase-Italy, Isitifiketi saseJalimane, Isitifiketi se-Ecuador, Isitifiketi saseBrazil (ANVISA), Isitifiketi saseChile, Isitifiketi sase-Argentina, Isitifiketi se-Dominica, Isitifiketi saseGuatemala, Isitifiketi se-Singapore HSA, Isitifiketi saseMalaysia (MDA), Philippines Isitifiketi se-FDA, Thailand isitifiketi.Izuze udumo ekuhloleni okuzimele koMnyango Wezempilo WaseBrithani kanye Nezinsizakalo Zabantu (DHSC) kanye (nesitifiketi se-AAA saseBrithani).
I-Malaysia MDA Novel Coronavirus Antigen Self-Test Certificate
Izici nezinzuzo
01 Isampula elilula: iqoqo lesampula elingahlaseli, amathe noma i-nasopharyngeal swab.
02 Ukutholwa ngokushesha: Yonke inqubo yokuthola ithatha imizuzu eyi-15 kuphela, futhi imiphumela ibonwa ngqo ngamehlo.
03 Ukusebenza okulula: Kungenziwa ngaphandle kwanoma iyiphi into eyinsimbi futhi ngaphandle kokuhlangenwe nakho.
04 Ukusebenza okuhle kakhulu: ukucaciswa okungu-99.26%, ukuzwela kungu-96.2%, nokunemba kukonke kungu-95%.
05 Ukwenziwa ngendlela oyifisayo: Njengamanje, inkampani inenguqulo yezokwelapha yochwepheshe, inguqulo yokuzihlola ekhaya (amathe + nasopharyngeal swab) kanye nenguqulo encane yokuzihlola, njll. Ibhokisi lokupakisha nemiyalo kungenziwa ngendlela oyifisayo kuye ngokwezidingo zamakhasimende.
Le divayisi Yesistimu ye-SARS-CoV-2 Antigen Rapid Test (uhlobo lwepeni) ifakwe idivayisi yokuvikela ukuphepha kwebhayoloji, engavimba ngempumelelo igciwane elisesixazululweni sokucutshungulwa kwesifanekiso ukuthi lingashisi emoyeni, lingcolise imvelo, futhi livikele ngempumelelo opharetha ngesikhathi kutholwa isivivinyo esisheshayo se-SARS-CoV-2 antigen.
Isimo samanje sobhubhane lomhlaba wonke sisanzima.Ngokuvela nokusabalala kwezinhlobonhlobo zegciwane le-Novel Coronavirus, isimo esiwumqedazwe emazweni amaningi nasezifundeni sesiphinde savela, futhi imizamo yokuvimbela nokulawula ibhekene nezinselele ezinkulu.I-SARS-CoV-2 Antigen Rapid Test iyashesha, inembile, kulula ukuyisebenzisa, futhi idinga amathuluzi nezisebenzi eziphansi.Ifaneleka kakhulu uphenyo olusheshayo lwamacala asolwayo okutheleleka ngegciwane le-crown enkulu, futhi iphumelela kakhulu ekuxilongeni ngokushesha ukuqubuka okugxilile.Ingasetshenziswa njengendlela yokuqala yokuzivikela ekulawuleni ubhubhane, isetshenziswe ekutholeni izifo kusenesikhathi, ukusiza ukuvimbela nokulawula ubhubhane, nokulawula ukusabalala kwegciwane.
I-Nanjing Liming Bio-products Co., Ltd. yasungulwa ngo-2001. Kuyinkampani yokuxilongwa kwebhayoloji egxile ocwaningweni nasekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwama-microbial in vitro diagnostic reagents.Ineminyaka engu-20 yekhwalithi enhle kakhulu futhi iqoqe uhlelo oluphelele lwekhwalithi, futhi ithole isitifiketi se-IS013485.Ukuphathwa kokukhiqiza kusebenza ngokuhambisana nesistimu yokuphatha ikhwalithi yamazwe ngamazwe, iqinisekisa ukuthi imikhiqizo yekhwalithi ephezulu isiza amakhasimende emhlabeni wonke.Ithuthuke kancane kancane yaba yibhizinisi lobuchwepheshe elidume umhlaba wonke elikhulu neliphakathi nendawo elisebenza nge-R&D, ukukhiqiza, ukuthengisa kanye nensizakalo yama-in vitro asebenza ngokuxilonga ngokushesha.
Isikhathi sokuthumela: Oct-28-2021
