Talu ai nei, na maua ai e le Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) antigen detection reagent "StrongStep® SARS-CoV-2 Antigen Rapid Test" le faʻamaoniga faʻatinoga a Paul-Ehrlich-Institut (PEI*) i Siamani, o lenei oloa ua maua. fa'amaonia e le German Federal Agency for Medicines and Medical Device Administration (BfArM).LimingBio ua avea ma se tasi o nai tagata gaosi oloa i Saina ua maua le lua tusipasi a BfArM + PEI i Siamani.O le su'ega vave o le antigen a le Liming Bio ua pasia le fa'amaoniaga fa'amaonia a le Matagaluega o le Soifua Maloloina a le tele o atunu'u, lea e fa'amaonia atoatoa ai le lelei o le fa'atinoga o le pusa.
Ole su'ega vave ole antigen a Liming Bio na fa'amanuiaina le fa'amaoniga o fa'atinoga a Siamani PEI
PS PEI: Paul Ehrlich Institute (Siamani: Paul-Ehrlich-Institut), e lauiloa foi o le German Federal Institute of Vaccines and Biomedicine, o se faʻalapotopotoga suʻesuʻe ma faʻalapotopotoga faʻapitoa faʻafomaʻi a le German Federation, o loʻo i lalo o le Federal Ministry of Health (BMG). ), o lo'o iai le fa'atinoga tuto'atasi o su'esu'ega o oloa fa'aolaola, fa'amaoniaga fa'ata'ita'i falema'i, fa'atagaga o oloa ma maketi, ma le tu'uina atu o vaega.I le taimi lava e tasi, na te faia foi le tusiaina, toe iloiloga o tulafono faatonutonu talafeagai, masauniasfautuaga fa'asaienisi mo fa'alapotopotoga 'ese'ese, aemaise o nisi o atunu'u o le Iuni a Europa, Iuni a Europa ma komiti fa'avaomalo.Also, esauniasfautuaga faʻapolofesa i le malo Siamani, ofisa faʻapitonuʻu ma le palemene, ma tuʻuina atusfa'amatalaga talafeagai i gasegase ma tagata fa'atau.
Ole su'ega vave ole antigen a Liming Bio na pasi manuia ile fa'ailoga Siamani BfArM
O le StrongStep® SARS-CoV-2 Antigen Rapid Test na atiina ae e Nanjing Liming Bio ua maua faasolosolo le European Union CE certification, le China National Institute for Food and Drug Control (NIFDC) siaki siaki siaki, ulufale i le Rockefeller Foundation lisi fautuaina, ma Kuatemala tusipasi , Italia Matagaluega o le Soifua Maloloina tusi faamaonia, Siamani tusi faamaonia, Ekuatoa tusi faamaonia, Pasila (ANVISA) tusi faamaonia, Chile tusi faamaonia, Argentina tusi faamaonia, Dominica tusi faamaonia, Guatemala tusi faamaonia, Singapore HSA tusipasi, Malaysia (MDA) tusi faamaonia, Filipaina FDA tusipasi, Initonesia tusipasi, Thailand tusipasi.Ua manumalo le viia i le iloiloga tutoatasi a le Matagaluega a Peretania o le Soifua Maloloina ma Auaunaga Tagata (DHSC) ma le (British AAA certification).
Meleisia MDA Novel Coronavirus Antigen Self-Su'ega Tusi Faamaonia
Fa'ailoga ma mea lelei
01 Fa'ata'ita'iga fa'afaigofie: aoina fa'ata'ita'iga e le fa'aoso, faua po'o le su'ega o le nasopharyngeal.
02 Su'esu'ega vave: O le fa'agasologa o le su'esu'ega atoa e na'o le 15 minute, ma o taunu'uga e va'aia sa'o e mata.
03 Faiga faigofie: E mafai ona faʻaogaina e aunoa ma ni meafaigaluega fesoasoani ma e aunoa ma se poto masani.
04 Fa'atinoga lelei: fa'apitoa o le 99.26%, fa'alogona o le 96.2%, ma le sa'o atoatoa o le 95%.
05 Faʻatonuga faʻapitoa: I le taimi nei, o loʻo i ai i le kamupani faʻamatalaga faafomaʻi faʻapitoa, suʻega a le fale (saliva + nasopharyngeal swab) version ma Mini suʻega faʻataʻitaʻiga, ma isi.
O lenei Mea Faʻatonu mo le SARS-CoV-2 Antigen Rapid Test (tulaga peni) ua faʻapipiʻiina i se masini puipuia o le saogalemu o meaola, lea e mafai ona poloka lelei le siama i le faʻataʻitaʻiga fofo fofo mai le faʻafefe i le ea, faʻaleagaina le siosiomaga, ma puipuia lelei le fa'atonu i le taimi na maua ai le su'ega vave o le antigen SARS-CoV-2.
O le tulaga o le faʻamaʻi o le lalolagi o loʻo i ai nei o loʻo ogaoga pea.Faatasi ai ma le tulaʻi mai ma le salalau o fesuiaiga o le Novel Coronavirus virus, o le faʻamaʻi tulaga i le tele o atunuʻu ma itulagi ua toe faʻaleleia, ma o loʻo feagai ma le puipuiga ma le faʻatonutonuina o faʻafitauli sili atu.Ole su'ega ole SARS-CoV-2 Antigen Rapid Test e vave, sa'o, faigofie ona fa'agaioi, ma e mana'omia mea faigaluega ma tagata faigaluega maualalo.E fetaui lelei mo le suʻesuʻeina vave o mataupu masalomia o faʻamaʻi pipisi o le korona fou, ma e sili ona aoga mo faʻamaʻi vave o faʻamaʻi pipisi.E mafai ona faʻaaogaina e avea ma laina muamua o le puipuiga mo faʻamaʻi faʻamaʻi, faʻaogaina i le suʻesuʻeina o faʻamaʻi vave, e fesoasoani ai i le puipuia ma le puleaina o faʻamaʻi, ma pulea le sosolo o le siama.
Nanjing Liming Bio-products Co., Ltd. na faavaeina i le 2001. O se kamupani faʻapitoa faʻapitoa faʻapitoa i suʻesuʻega ma atinaʻe, gaosiga ma le faʻatau atu o microbial in vitro diagnostic reagents.E 20 tausaga o le tulaga sili ona lelei ma ua faʻaputuina se faiga lelei atoatoa, ma ua maua le IS013485 tusipasi.O le fa'atonuga o gaosiga e fa'atautaia e tusa ai ma faiga fa'ava-o-malo fa'atonuga lelei, fa'amautinoaina o oloa maualuga e tautuaina tagata fa'atau i le lalolagi atoa.Ua faasolosolo malie ona atiina ae i se tulaga faava o malo lauiloa tele ma feololo-tele-tele pisinisi maualuga-tekinolosi faapitoa i le R&D, gaosiga, faatau atu ma le auaunaga o in vitro vave diagnostic reagents.
Taimi meli: Oke-28-2021
