Muva nje, i-Nanjing Limingbio's Novel Coronavirus (SARS-Cov-2) I-Antigen Detection Repegent "ConfStep® SARS Test" ithole ukuqinisekiswa kokusebenza kwePaul-Ehrlich-Institut (Pei *) eJalimane, lo mkhiqizo ubelokhu Kuqinisekiswe yi-German Federal Agency ngemithi kanye ne-Medical Device Administration (BFARM). I-Limingbio isiphenduke ingenye abakhiqizi abambalwa eChina ethole isitifiketi esimbaxambili se-Bfarm + Pei eJalimane. Ukuhlolwa okusheshayo kwe-antigen antigen okusheshayo kudlule isitifiketi esigunyaziwe soMnyango Wezempilo wamazwe amaningi, okubonisa ngokuphelele ukusebenza okuhle kwekhithi.
Ukuhlolwa kwe-antigen kwe-antigen ngokushesha kwe-antigen kudlule ngempumelelo ukuqinisekiswa kokusebenza kokusebenza kweGerman Pei
I-PSE: UPaul Ehrlich Institute (IsiJalimane: UPaul-Ehrlich-Institut), owaziwa nangokuthi iJamerali Federal Institute of Imijovo yokugoma kanye ne-biomedicine, iyisikhungo sokulawula sezokwelapha kanye ne-Federal Ministry of Health (BMG ), inokusebenza okuzimele kokuhlolwa komkhiqizo wemvelo, ukuvunywa kwecala lomtholampilo, ukuvunyelwa komkhiqizo nokumaketha, nokukhishwa kwe-batch. Ngasikhathi sinye, futhi yenza nokwakha ukubhala, ukubuyekeza izimiso ezifanele, futhihlinzekaushikukaziIseluleko sesayensi ezinhlanganweni ezahlukahlukene, ikakhulukazi amazwe athile ase-European Union, amakomidi e-European Union nama-International. Also, ithlinzekaushikukaziIseluleko sochwepheshe kuHulumeni waseJalimane, ama-ejensi endawo nasePhalamende, futhi ahlinzekeushikukaziImininingwane efanele ezigulini nakwabathengi.
Ukuhlolwa kwe-antigen kwe-antigen ngokushesha kwe-antigen kudlule isitifiketi se-bfarm yaseJalimane
I-ConfStep® SARS-Cov-2 Antigen Rapid Test ethuthukiswe yi-Nanjing Liming Bio isitholile ngempumelelo isitifiketi sokuhlola i-European CE, i-China National Institute yokubhalisa kokudla okunconyiwe, i-Guatemala Isitifiketi, uMnyango Wezempilo wase-Italy, isitifiketi saseJalimane, isitifiketi se-Ecuador, isitifiketi seChile, isitifiketi se-Argentica, isitifiketi se-Minasica, isitifiketi se-MinaySOre, isitifiketi se-Indonesia, isitifiketi sase-Indonesia, iThailand isitifiketi. Ithole indumiso ekuhlolweni okuzimele koMnyango Wezempilo kanye Nezinsizakalo Zabantu baseBrithani (DHSC) kanye (nesitifiketi saseBrithani AAA).
IMalaysia MDA Inoveli Coronavirus Antigen Ukuzihlola Isitifiketi Sokuzihlola
Izici nezinzuzo
I-01 Sampling elula: Iqoqo lesampula elingahlaseli, amathe noma i-nasopharyngeeal swab.
Ukutholwa okusheshayo: yonke inqubo yokutholwa ithatha kuphela imizuzu eyi-15, futhi imiphumela ibonwa ngqo ngamehlo.
Ukusebenza okulula okulula: Kungasebenza ngaphandle kwemishini yokusiza futhi ngaphandle kokuhlangenwe nakho.
Ukusebenza okuhle kakhulu: Ukucaciswa ngu-99.26%, ukuzwela kungu-96.2%, futhi ukunemba okuphelele kungama-95%.
I-05 ifuna ngokwezifiso
Le divayisi yesistimu ye-SARS-Cov-2 Antigen Rapid Test (Uhlobo lwe-Antigen (Type) ifakwe ngempumelelo i-virus yokuphepha, engavimba ngempumelelo leli gciwane kusisombululo sokulungisa isixazululo kusuka ekuzithobeni emoyeni, ingcolise imvelo, ukuvikela ngempumelelo opharetha ngesikhathi sokutholwa kwe-SARS-Cov-2 Antigen Rapid Test.
Isimo samanje se-World Bilomic sisenzima. Ngokuvela nokusakazeka kwegciwane lenoveli coronavirus virus, isimo se-epidemic emazweni amaningi nasezifundeni sekwenziwe kabusha, futhi imizamo yokulawula kanye nemizamo yokulawula ibhekene nezinselelo ezinkulu. I-SARS-Cov-2 Antigen Rapid Test iyashesha, inembile, ilula ukusebenza, futhi idinga imishini ephansi nabasebenzi. Ilungele kakhulu ukuphenywa okusheshayo kwamacala asolwayo atheleleke ngegciwane eliphakeme le-Crown Virus, futhi aphumelela kakhulu ekutholweni okusheshayo kokuqubuka okugxilwe ngokushesha. Ingasetshenziswa njengomugqa wokuqala wokuvikela ukulawula ubhubhane, usetshenziselwe ukutholwa kwezifo zakuqala, ukusiza ukuvikela nokulawula ubhubhane, futhi kulawule ukusakazeka kwaleli gciwane.
I-Nanjing Liming Bio-Products Co, Ltd yasungulwa ngonyaka ka-2001. Kuyinkampani yokuxilonga yemvelo egxile ocwaningweni nasekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwama-microbical microbic Discobial reagents. Ineminyaka engama-20 yekhwalithi enhle kakhulu futhi iqoqe uhlelo oluphelele lwekhwalithi, futhi ithole isitifiketi se-IS013485. Ukuphathwa kokukhiqizwa kuqhuba ngokuqinile ngokuya ngohlelo lokuphathwa kwekhwalithi yamazwe omhlaba, ukuqinisekisa ukuthi imikhiqizo esezingeni eliphakeme isebenza amakhasimende emhlabeni wonke. Ithuthukiswe kancane kancane ebhizinisini elidume kakhulu eliphakeme futhi eliphakathi nobuchwepheshe obuphakeme obukhethekile e-R & D, ukukhiqizwa, ukuthengisa kanye nenkonzo ye-vitro ukuxilonga okusheshayo.
Isikhathi Sokuthumela: Oct-28-2021
