Na nso nso a, Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) antigen nchọpụta reagent "StrongStep® SARS-CoV-2 Antigen Rapid Test" enwetala nkwenye arụmọrụ nke Paul-Ehrlich-Institut (PEI *) na Germany, ngwaahịa a bụ nke German Federal Agency for Medicines and Medical Device Administration (BfArM) kwadoro.LimingBio abụrụla otu n'ime ndị nrụpụta ole na ole na China nwetara asambodo abụọ nke BfArM+PEI na Germany.Nnwale ngwa ngwa Liming Bio's antigen agafeela asambodo ikike nke Ministri Ahụike nke ọtụtụ mba, nke gosipụtara n'ụzọ zuru oke arụmọrụ kacha mma nke ngwa ahụ.
Nnwale ngwa ngwa Liming Bio nke antigen gafere nkwenye arụmọrụ German PEI nke ọma
PS PEI: Paul Ehrlich Institute (German: Paul-Ehrlich-Institut), nke a makwaara dị ka German Federal Institute of Vaccines and Biomedicine, bụ ụlọ ọrụ nyocha na ụlọ ọrụ nlekọta ahụike nke German Federation, ugbu a n'okpuru Federal Ministry of Health (BMG). ), nwere arụmọrụ kwụụrụ onwe ya nke nyocha ngwaahịa ndu, nnabata nnwale ụlọ ọgwụ, nnabata ngwaahịa na ịre ahịa, na ntinye ogbe.N'otu oge ahụ, ọ na-arụkwa ọrụ ịdepụta, ngbanwe nke ụkpụrụ dị mkpa, nanyesndụmọdụ sayensị maka òtù dị iche iche, karịsịa ụfọdụ mba European Union, European Union na kọmitii mba ụwa.Al, ọnyesndụmọdụ ọkachamara na gọọmentị German, ụlọ ọrụ mpaghara na nzuko omeiwu, ma nyesozi dị mkpa nye ndị ọrịa na ndị na-azụ ahịa.
Nnwale ngwa ngwa Liming Bio's antigen gafere asambodo German BfArM nke ọma
StrongStep® SARS-CoV-2 Antigen Rapid Test nke Nanjing Liming Bio mebere enwetala asambodo European Union CE nke ọma, nyocha nyocha ndebanye aha nke China National Institute for Food and Drug Control (NIFDC), banye na Rockefeller Foundation akwadoro na Guatemala. asambodo , Italian Ministry of Health asambodo, German asambodo, Ecuador asambodo, Brazil (ANVISA) asambodo, Chile asambodo, Argentina asambodo, Dominica asambodo, Guatemala asambodo, Singapore HSA asambodo, Malaysia (MDA) asambodo, Philippines FDA asambodo, Indonesia asambodo, Thailand asambodo.O nwetala otuto na ntule onwe onye nke British Department of Health and Human Services (DHSC) na (asambodo AAA nke Britain).
Asambodo MDA Novel Coronavirus Antigen Nyocha onwe
Atụmatụ na uru
01 Nlere anya dị mma: nchịkọta ihe nlele na-adịghị emerụ ahụ, mmiri ma ọ bụ swab nasopharyngeal.
02 Nchọpụta ngwa ngwa: Usoro nchọpụta niile na-ewe naanị nkeji iri na ise, anya na-ahụkwa nsonaazụ ya ozugbo.
03 Ọrụ dị mfe: Enwere ike ịrụ ọrụ na-enweghị ihe enyemaka ọ bụla na-enweghị ahụmahụ ọ bụla.
04 Ọmarịcha arụmọrụ: nkọwapụta bụ 99.26%, uche bụ 96.2%, yana izizi zuru oke bụ 95%.
05 Achọ customization: Ka ọ dị ugbu a, ụlọ ọrụ ahụ nwere ụdị ahụike ọkachamara ọkachamara, ule onwe onye nke ụlọ (saliva + nasopharyngeal swab) na ụdị ule nyocha nke Obere, wdg. Enwere ike ịhazi igbe nkwakọ ngwaahịa na ntụziaka dịka mkpa ndị ahịa si dị.
Ngwa sistemu a maka SARS-CoV-2 Antigen Rapid Test (ụdị pen) nwere ngwaọrụ nchekwa nchekwa ndụ, nke nwere ike igbochi nje na-eme ihe n'ụdị nhazi ka ọ ghara ịbanye n'ikuku, na-emetọ gburugburu ebe obibi ma chebe ya nke ọma. onye ọrụ n'oge nchọpụta nke SARS-CoV-2 antigen ngwa ngwa ule.
Ọnọdụ ọrịa na-efe efe zuru ụwa ọnụ ugbu a ka dị njọ.Site na nputa na mgbasa nke ụdị dị iche iche nke nje novel Coronavirus, ọnọdụ ọrịa na-efe efe n'ọtụtụ mba na mpaghara agbakeghachila, mbọ mgbochi na njikwa na-eche ihe ịma aka ka ukwuu ihu.Nnwale ngwa ngwa SARS-CoV-2 Antigen dị ngwa ngwa, ziri ezi, dị mfe iji rụọ ọrụ ma chọọ akụrụngwa na ndị ọrụ dị ala.Ọ dabara nke ọma maka nyocha ngwa ngwa nke ndị a na-enyo enyo na ọrịa nje virus okpueze ọhụrụ buru ibu, ma dị irè karịsịa maka nyocha ngwa ngwa nke ntiwapụ nke mgbakasị ahụ.Enwere ike iji ya dị ka ụzọ nchebe mbụ maka ịchịkwa ọrịa na-efe efe, na-etinye aka na nchọpụta nke ọrịa mbụ, iji nyere aka igbochi na ịchịkwa ọrịa, na ịchịkwa mgbasa nke nje.
Nanjing Liming Bio-products Co., Ltd. e tọrọ ntọala na 2001. Ọ bụ a ndu diagnostic ụlọ ọrụ pụrụ iche na nnyocha na mmepe, mmepụta na ahịa nke clinical microbial in vitro diagnostic reagents.Ọ nwere afọ 20 nke ezigbo mma ma chịkọtala usoro dị mma zuru oke, wee nweta asambodo IS013485.Njikwa mmepụta na-arụ ọrụ nke ọma dabere na usoro njikwa ogo mba ụwa, na-ahụ na ngwaahịa dị elu na-ejere ndị ahịa ozi n'ụwa niile.Ọ ji nwayọọ nwayọọ na-etolite ghọọ mba ama nnukwu na ọkara-sized elu-tech enterprise ọkachamara na R&D, mmepụta, ahịa na ọrụ nke in vitro ngwa ngwa diagnostic reagents.
Oge nzipu: Ọktoba 28-2021
