Kutshanje, i-Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) i-antigen yokufumanisa i-reagent "StrongStep® SARS-CoV-2 Antigen Rapid Test" ifumene ukuqinisekiswa kokusebenza kwe-Paul-Ehrlich-Institut (PEI*) eJamani, le mveliso iye yafunyanwa. iqinisekiswe yi-Arhente yaseJamani ye-Federal for Medicines and Medical Device Administration (BfArM).ILimingBio iye yaba ngomnye wabavelisi abambalwa eTshayina abafumene isatifikethi esiphindwe kabini se-BfArM+PEI eJamani.Uvavanyo olukhawulezayo lwe-antigen ye-Liming Bio luphumelele isiqinisekiso esigunyazisiweyo soMphathiswa wezeMpilo wamazwe amaninzi, engqina ngokupheleleyo ukusebenza kakuhle kwekhithi.
Uvavanyo olukhawulezayo lwe-antigen ye-Liming Bio luphumelele ngempumelelo ukuqinisekiswa kokusebenza kwe-PEI yaseJamani
I-PS PEI: I-Paul Ehrlich Institute (isiJamani: i-Paul-Ehrlich-Institut), eyaziwa ngokuba yi-German Federal Institute of Vaccines kunye ne-Biomedicine, iziko lophando kunye ne-arhente yolawulo lwezonyango ye-German Federation, okwangoku iphantsi kwe-Federal Ministry of Health (BMG). ), inomsebenzi ozimeleyo wokuhlolwa kwemveliso yebhayoloji, ukuvunywa kovavanyo lweklinikhi, ukuvunywa kwemveliso kunye nokuthengisa, kunye nokukhutshwa kwebhetshi.Kwangaxeshanye, yenza ukuyila, uhlaziyo lwemigaqo efanelekileyo, kunyebonelelasiingcebiso zenzululwazi kwimibutho eyahlukeneyo, ngakumbi amanye amazwe aseYurophu Union, European Union kunye neekomiti zamazwe ngamazwe.Akwakhona, yonabonelelasiingcebiso zobungcali kurhulumente waseJamani, ii-arhente zasekhaya kunye nepalamente, kwaye unikesulwazi olufanelekileyo kwizigulane kunye nabathengi.
Uvavanyo olukhawulezayo lwe-antigen ye-Liming Bio lupasise ngempumelelo isatifikethi se-BfArM yaseJamani
I-StrongStep® SARS-CoV-2 Antigen Rapid Test ephuhliswe nguNanjing Liming Bio ifumene isiqinisekiso se-CE seManyano yaseYurophu, iZiko leSizwe leSizwe loLawulo lokuTya kunye noLawulo lweziyobisi (NIFDC) lokuqinisekisa ubhaliso lobhaliso, lingene kuluhlu olucetyiswayo lweRockefeller Foundation, kunye neGuatemala. isatifikethi , isatifikethi se-Italian Ministry of Health, isatifikethi saseJamani, isatifikethi se-Ecuador, isatifikethi saseBrazil (ANVISA), isatifikethi saseChile, isatifikethi saseArgentina, isatifikethi seDominica, isatifikethi saseGuatemala, isatifikethi seSingapore HSA, iMalaysia (MDA) isatifikethi, iPhilippines Isiqinisekiso se-FDA, iThailand isiqinisekiso.Iphumelele indumiso kuvavanyo oluzimeleyo lweSebe laseBrithani lezeMpilo kunye neeNkonzo zoLuntu (DHSC) kunye (i-British AAA certification).
Isatifikethi sokuZivavanya se-MDA yaseMalaysia i-Antigen ye-Antigen
Iimpawu kunye neenzuzo
I-01 isampuli esilungeleyo: i-sampulu yokuqokelela i-non-invasive, i-saliva okanye i-nasopharyngeal swab.
I-02 Ukufumanisa ngokukhawuleza: Yonke inkqubo yokufumanisa ithatha imizuzu eyi-15 kuphela, kwaye iziphumo zijongwa ngokuthe ngqo ngamehlo.
03 Ukusebenza okulula: Inokusebenza ngaphandle kwezixhobo ezincedisayo kwaye ngaphandle kwamava.
04 Ukusebenza okugqwesileyo: ukuchaneka kwe-99.26%, uvakalelo yi-96.2%, kunye nokuchaneka okupheleleyo yi-95%.
I-05 Imfuno yokwenza ngokwezifiso: Okwangoku, inkampani inenguqulo yezokwelapha yobuchwephesha, ukuzivavanya kwekhaya (i-saliva + nasopharyngeal swab) version kunye ne-Mini self-test version, njl.
Esi sixhobo seNkqubo ye-SARS-CoV-2 ye-Antigen Rapid Test (uhlobo losiba) luxhotyiswe ngesixhobo sokhuseleko lwebhayoloji, esinokuyithintela ngokufanelekileyo intsholongwane kwisisombululo somzobo ukuba singaguquguquki emoyeni, singcolise indalo, kwaye sikhusele ngokufanelekileyo intsholongwane. Umsebenzisi ngexesha lokufunyanwa kwe-SARS-CoV-2 ye-antigen yovavanyo olukhawulezayo.
Imeko yangoku yobhubhani wehlabathi isembi kakhulu.Ngokuvela kunye nokusasazeka kweentlobo ngeentlobo zeNtsholongwane yeCoronavirus, imeko yobhubhani kumazwe amaninzi nakwimimandla iye yaphinda yavela, kwaye iinzame zokuthintela nokulawula zijongene nemingeni emikhulu.UVavanyo oluKhawulezayo lwe-SARS-CoV-2 Antigen Rapid luyakhawuleza, luchanekile, kulula ukulusebenza, kwaye lufuna izixhobo eziphantsi kunye nabasebenzi.Ilunge kakhulu kuphando olukhawulezileyo lwamatyala akrokrelekayo osulelo olukhulu lwentsholongwane yesithsaba esitsha, kwaye lusebenza ngakumbi ukuxilongwa ngokukhawuleza koqhambuko olugxile.Ingasetyenziswa njengomgca wokuqala wokukhusela ubhubhane, isetyenziswe ekubhaqweni kosulelo kwangethuba, ukuncedisa ekuthinteleni nasekulawuleni ubhubhane, nokulawula ukusasazeka kwentsholongwane.
I-Nanjing Liming Bio-products Co., Ltd. yasekwa ngo-2001. Yinkampani yokuxilongwa kwebhayoloji ekhethekileyo kuphando kunye nophuhliso, ukuveliswa kunye nokuthengiswa kwee-reagents zeklinikhi ze-microbial in vitro diagnostic.Ineminyaka engama-20 yomgangatho obalaseleyo kwaye iqokelele inkqubo epheleleyo yomgangatho, kwaye ifumene isiqinisekiso se-IS013485.Ulawulo lwemveliso luqhuba ngokungqongqo ngokuhambelana nenkqubo yolawulo lomgangatho wamazwe ngamazwe, ukuqinisekisa ukuba iimveliso ezikumgangatho ophezulu zinceda abathengi kwihlabathi liphela.Ithe chu yaphuhliswa yaba lishishini elaziwayo kwihlabathi elikhulu neliphakathi ngobukhulu obuphezulu eligxile kwi-R&D, imveliso, ukuthengisa kunye nenkonzo ye-in vitro yokuxilonga ngokukhawuleza.
Ixesha lokuposa: Oct-28-2021
