LimingBio enwetala ndebanye aha ANVISA na Brazil yana asambodo ndebanye aha na Singapore na Indonesia

LimingBio has obtained the ANVISA registration in Brazil

Abstract
N'oge na-adịbeghị anya, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit ka ụlọ ọrụ nlekọta ahụike mba Brazil nwetagoro asambodo ANVISA.N'otu oge ahụ, SARS-CoV-2 RT-PCR na ngwa ule ngwa ngwa IgM/IgG ka edepụtara na ndepụta ịzụ ahịa ndị gọọmentị akwadoro nke Indonesia.Ka ọ dị ugbu a, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, nke ndị Singapore Health Sciences Authority (HSA) kwadoro, wee nweta asambodo HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Foto 1 Asambodo ANVISA Brazil

Asambodo Brazil (ANVISA).
ANVISA, nke a maara dị ka Agência Nacional de Vigilância Sanitária, bụ onye na-ahụ maka ngwaọrụ ahụike Brazil.Ọ dị mkpa ka ụlọ ọrụ debanye aha na ANVISA, National Health Supervision Agency, iji ree ngwaọrụ ahụike n'ụzọ iwu kwadoro na Brazil.Iji nweta asambodo, ngwaọrụ ahụike ndị na-abanye Brazil ga-enwerịrị ihe GMP nke Brazil chọrọ yana ụkpụrụ akọwapụtara nke ndị ọchịchị Brazil setịpụrụ.Na Brazil, a na-ekewa ngwaọrụ ahụike IVD n'ime Klas I, II, III, na IV dịka ọkwa dị ize ndụ si dị ala ruo elu.Maka ngwaahịa Klas I na II, a na-anabata usoro Cadastro, ebe maka ngwaahịa Klas III na IV, a na-eji usoro Registro.Mgbe ndebanye aha nke ọma gasịrị, ANVISA ga-enye nọmba ndebanye aha, a ga-ebugo data ahụ na nchekwa data ngwaọrụ ahụike Brazil, nọmba a na ozi ndebanye aha kwekọrọ ga-apụta na DOU (Diário Oficial da União).

LimingBio has obtained the ANVISA registration in Brazil2
LimingBio has obtained the ANVISA registration in Brazil3

Foto nke 2 asambodo ikike sayensị ahụike Singapore (HSA).

LimingBio has obtained the ANVISA registration in Brazil4
LimingBio has obtained the ANVISA registration in Brazil6

Foto 3 Ndị ọrụ gọọmentị tụrụ aro ndepụta ịzụ ahịa nke Indonesia

LimingBio has obtained the ANVISA registration certificate in Brazil and entered the official procurement list in Indonesia6

Foto 4 Nzọụkwụ siri ike®Nnwale ngwa ngwa SARS-CoV-2 IgM/IgG Antibody

LimingBio has obtained the ANVISA registration in Brazil7

Foto 5 Novel Coronavirus (SARS-CoV-2) Ngwa PCR Real-Time Multiplex

Mara:
Ngwa PCR a dị njikere nke ukwuu dị n'ụdị lyophilized (usoro ịsa oyi) maka nchekwa ogologo oge.Enwere ike ibufe ngwa ahụ ma chekwaa ya na ụlọ okpomọkụ ma kwụsie ike maka otu afọ.Ọkpụkpọ premix ọ bụla nwere reagents niile achọrọ maka nkwalite PCR, gụnyere Reverse-transcriptase, Taq polymerase, primers, probes na dNTPs substrates.Ọ chọrọ ịgbakwunye 13ul distilled mmiri na 5ul amịpụtara RNA template, mgbe ahụ enwere ike ịgba ya ma gbasaa na ngwa PCR.

Ihe isi ike nke ụgbọ njem yinye oyi nke Novel Coronavirus nucleic acid reagent nchọpụta

Mgbe a na-ebufe reagents nchọpụta nucleic acid a na-ahụkarị n'ebe dị anya, a chọrọ nchekwa (-20 ± 5) ℃ oyiri yinye nchekwa na njem iji hụ na bioactive nke enzyme na reagents ka na-arụ ọrụ.Iji jide n'aka na okpomọkụ ahụ ruru ọkọlọtọ, a chọrọ ọtụtụ kilogram nke ice akọrọ maka igbe ọ bụla nke nucleic acid test reagent ọbụna ihe na-erughị 50g, ma ọ nwere ike ịdịru naanị ụbọchị abụọ ma ọ bụ atọ.N'echiche nke omume ụlọ ọrụ, n'ezie arọ nke reagents nyere site emepụta bụ ihe na-erughị 10% (ma ọ bụ nnọọ ihe na-erughị nke a uru) nke akpa.Ọtụtụ n'ime ibu dị arọ na-abịa site na ice akọrọ, ngwugwu ice na igbe ụfụfụ, ya mere ọnụ ahịa njem dị oke elu.

Na Machị 2020, COVID-19 malitere itolite n'ọtụtụ mba ofesi, na ọchịchọ maka nchọpụta Nucleic acid Novel Coronavirus reagent mụbara nke ukwuu.N'agbanyeghị ọnụ ahịa dị elu nke mbupụ reagents na agbụ oyi, ọtụtụ ndị na-emepụta ihe ka nwere ike ịnakwere ya n'ihi nnukwu ego na nnukwu uru.

Otú ọ dị, na mmelite nke mba mbupụ atumatu maka mgbochi ọrịa na ngwaahịa, nakwa dị ka upgrading nke mba akara n'elu eruba nke ndị mmadụ na lọjistik, e nwere ndọtị na ejighị n'aka na njem oge nke reagents, nke mere ka a ma ama ngwaahịa nsogbu kpatara. site na njem njem.Ogologo oge njem (oge mbufe ihe dị ka ọkara ọnwa na-adịkarị) na-eduga na ọdịda ngwaahịa mgbe niile mgbe ngwaahịa ahụ ruru onye ahịa ahụ.Nke a akpatala nsogbu ọtụtụ ụlọ ọrụ nucleic acid reagents na-ebupụ.

Teknụzụ Lyophilized maka PCR reagent nyeere aka mbugharị nke ihe nchọpụta ihe nchọpụta novel Coronavirus nucleic acid n'ụwa niile

Enwere ike iburu PCR reagents lyophilized ma chekwaa ya n'ime ụlọ okpomọkụ, nke nwere ike ọ bụghị naanị ibelata ọnụ ahịa njem, kamakwa zere nsogbu dị mma nke usoro njem na-akpata.Ya mere, lyophilizing reagent bụ ụzọ kachasị mma isi dozie nsogbu nke njem mbupụ.

Lyophilization gụnyere ịsacha ihe ngwọta n'ime ọnọdụ siri ike, wee sublimate ma kewaa vapo mmiri n'okpuru ọnọdụ agụụ.Solute a mịrị amị na-anọgide n'ime akpa ahụ nwere otu ihe mejupụtara na ọrụ.N'iji ya na reagents mmiri mmiri a na-ahụkarị, ihe mejupụtara lyophilized Novel Coronavirus nucleic acid reagent nke Liming Bio mepụtara nwere njirimara ndị a:

Oke ike okpomọkụ kwụsie ike: ọ nwere ike na-eguzobe ọgwụgwọ na 56 ℃ maka 60 ụbọchị, na morphology na arụmọrụ nke reagent nọgidere na-agbanweghi agbanwe.
Nkịtị okpomọkụ nchekwa na njem: ọ dịghị mkpa oyi na-atụ yinye, ọ dịghị mkpa na-echekwa na obere okpomọkụ tupu unsealing, n'ụzọ zuru ezu hapụ oyi nchekwa ohere.
Njikere iji: lyophilizing nke ihe niile, ọ dịghị mkpa maka nhazi usoro, na-ezere mfu nke ihe ndị nwere nnukwu viscosity dị ka enzyme.
Ebumnuche Multiplex n'otu tube: ebumnuche nchọpụta ahụ na-ekpuchi mkpụrụ ndụ coronavirus ORF1ab gene, N gene, S gene iji zere nje virus.Iji belata adịghị mma ụgha, a na-eji mkpụrụ ndụ RNase P mmadụ mee ihe dị ka njikwa ime, iji gboo mkpa ụlọ ọgwụ maka njikwa mma nlele.

SARS-CoV-2 IgM/IgG Antibody Rapid Test na Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (nchọpụta maka mkpụrụ ndụ ihe nketa atọ) ejirila akara CE na UK na UK ugbu a nabata ma na-ahazi ya site na EUA. FDA na America.

Nanjing Liming Bio-Products Co., Ltd na-etinyekarị àgwà nke ngwa ule na mbụ, ma na-elekwasị anya na mgbasawanye nke ikike.Ụlọ ọrụ ahụ ga-enye ụlọ ọrụ ahụike gburugburu ụwa ngwaahịa na ọrụ nyocha COVID-19 dị elu, ma tinye aka na mgbochi na njikwa ọrịa zuru ụwa ọnụ, iji wuo obodo zuru ụwa ọnụ nke ọdịnihu.

Ogologo Pịa ~ Nyochaa wee soro anyị
Email:sales@limingbio.com
Weebụsaịtị: https://limingbio.com

LimingBio has obtained the ANVISA registration certificate in Brazil and entered the official procurement list in Indonesia9

Oge nzipu: Jul-06-2020