LimingBio waxay ka heshay diiwaangelinta ANVISA ee Brazil iyo shahaadada diiwaangelinta ee Singapore iyo Indonesia

LimingBio has obtained the ANVISA registration in Brazil

Abstract
Dhawaan, Nanjing Liming Bio-Products Co., Ltd.Isla mar ahaantaana, SARS-CoV-2 RT-PCR iyo qalabka tijaabada degdega ah ee IgM/IgG ayaa sidoo kale ku taxan liiska rasmiga ah ee soo iibsiga ee Indonesia.Dhanka kale, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Qalabka PCR ee-waqtiga-dhabta ah ee Multiplex, waxaa ansixiyay Maamulka Sayniska Caafimaadka ee Singapore (HSA) , wuxuuna helay shahaadada HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Sawirka 1 shahaadada Brazil ANVISA

Brazil (ANVISA) shahaado
ANVISA, oo loo yaqaan Agência Nacional de Vigilância Sanitária, waa maamulaha aaladaha caafimaadka Brazil.Waa lagama maarmaan in shirkad laga diiwaan geliyo ANVISA, Wakaaladda Kormeerka Caafimaadka Qaranka, si ay si sharci ah ugu iibiso qalabka caafimaadka Brazil.Si loo caddeeyo, aaladaha caafimaadka ee soo galaya Brazil waa inay buuxiyaan shuruudaha GMP-ga Brazil oo ay la socdaan heerarka gaarka ah ee ay dejiyeen mas'uuliyiinta Brazil.Brazil gudaheeda, aaladaha caafimaadka ee IVD waxaa loo kala saaray Fasalka I, II, III, iyo IV iyadoo loo eegayo heerka khatarta hoose ilaa sare.Alaabta I iyo II, habka Cadastro waa la qaatay, halka alaabta Class III iyo IV, habka Registro la isticmaalo.Isdiiwaan gelinta guusha leh ka dib, nambarka diiwaangelinta waxaa bixin doonta ANVISA, xogtana waxaa lagu shubi doonaa kaydka xogta qalabka caafimaadka Brazil, lambarkan iyo macluumaadka diiwaangelinta u dhigma waxay ka soo bixi doontaa DOU (Diário Oficial da União).

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

Sawirka 2 Shahaadada Maamulka Sayniska Caafimaadka ee Singapore (HSA).

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

Sawirka 3 Rasmiga ah ee lagu taliyay liiska wax iibsiga ee Indonesia

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

Sawirka 4 Talaabo Xoogan®SARS-CoV-2 IgM/IgG Antibody Test Degdeg ah

LimingBio has obtained the ANVISA registration in Brazil7

Sawirka 5 Novel Coronavirus (SARS-CoV-2) Qalabka PCR-waqtiga-dhabta ah ee Multiplex

Fiiro gaar ah:
Xirmadan aadka u xasaasiga ah, ee diyaar u ah in la isticmaalo PCR waxa lagu heli karaa qaab lyophilized ah (habka qalajinta qaboojinta) kaydinta muddada dheer.Qalabka waxa lagu rari karaa oo lagu kaydin karaa heerkulka qolka waana mid deggan muddo hal sano ah.Tuubo kasta oo premix ah waxa ay ka kooban tahay dhammaan reage-yaasha looga baahan yahay kor u qaadida PCR, oo ay ku jiraan Reverse-transcriptase, Taq polymerase, primers, probes, iyo dNTPs substrates.Kaliya waxay u baahan tahay in lagu daro 13ul biyo nadiif ah iyo 5ul oo la soo saaray RNA template, ka dib waa la ordi karaa oo lagu kordhin karaa qalabka PCR.

Dhibaatada gaadiidka silsilad qabow ee Novel Coronavirus nucleic acid reagent ogaanshaha

Marka reagents-ka ogaanshaha aashitada nukliyeerka ee caadiga ah lagu qaado masaafo dheer, (-20± 5) ℃ kaydinta silsiladda qabow iyo gaadiidka ayaa loo baahan yahay si loo hubiyo bioactive-ka enzyme ee reagents-ku inay firfircoon yihiin.Si loo hubiyo in heerkulku gaadho heerka, dhawr kiilogaram oo baraf qalalan ayaa loo baahan yahay sanduuq kasta oo ah reagent tijaabinta aashitada nukliyeerka xitaa wax ka yar 50g , laakiin waxay socon kartaa oo keliya laba ama saddex maalmood.Marka la eego dhaqanka warshadaha, miisaanka dhabta ah ee reagents ee ay soo saareen warshadeeyayaasha ayaa ka yar 10% (ama aad uga yar qiimahan) weelka.Miisaanka intiisa badan wuxuu ka yimaadaa baraf qallalan, baraf baraf ah iyo sanduuqyada xumbo, markaa qiimaha gaadiidku aad buu u sarreeyaa.

Bishii Maarso 2020, COVID-19 wuxuu bilaabay inuu si baaxad leh ugu dillaaco dibadda, iyo baahida loo qabo in la ogaado Novel Coronavirus nucleic acid reagent ayaa si aad ah u kordhay.Inkasta oo qiimaha sare ee dhoofinta reagents ee silsiladda qabow, inta badan soo saarayaasha ayaa weli aqbali kara sababtoo ah tirada badan iyo faa'iidada sare.

Si kastaba ha ahaatee, iyada oo la hagaajinayo siyaasadaha dhoofinta qaranka ee alaabada ka hortagga faafa, iyo sidoo kale cusboonaysiinta xakamaynta qaranka ee socodka dadka iyo saadka, waxaa jira kordhin iyo hubin la'aan wakhtiga gaadiidka ee reagents, taas oo keentay dhibaatooyin caan ah oo badeecado ah oo sababay gaadiidka.Waqtiga gaadiidka ee la dheereeyey (waqtiga gaadiidka ee ku dhow nus bilood waa mid aad u badan) waxay keentaa cillado soo noqnoqda marka alaabtu gaarto macmiilka.Tani waxa ay dhibsatay inta badan reagen-yaasha aashitada nukliyeerka ah ee dhoofiya.

Farsamaynta Lyophilized ee PCR reagent waxay caawisay gaadiidka Novel Coronavirus nucleic acid reagent ogaanshaha adduunka oo dhan

Dib-u-hagaajinta PCR-ka lyophilized waa la rari karaa laguna kaydin karaa heerkulka qolka, taas oo aan yarayn karin oo keliya kharashka gaadiidka, laakiin sidoo kale ka fogow dhibaatooyinka tayada ee ay keento habka gaadiidka.Sidaa darteed, lyophilizing reagent waa habka ugu wanaagsan ee lagu xallin karo dhibaatada gaadiidka dhoofinta.

Lyophilization waxay ku lug leedahay qaboojinta xalka xaalad adag, ka dibna hoos u dhig oo kala saar uumiga biyaha ee xaalad faaruq ah.Solubka qallalan wuxuu ku sii jiraa weelka oo leh isku halabuur iyo hawl isku mid ah.Marka la barbar dhigo reageniyeyaasha dareeraha caadiga ah, qayb ka kooban lyophilized Novel Coronavirus nucleic acid reagent oo ay soo saartay Liming Bio waxay leedahay sifooyinka soo socda:

Xasilooni kulayl aad u xoog badan: waxay la socon kartaa daawaynta 56 ℃ 60 maalmood, iyo qaab-dhismeedka iyo waxqabadka reagent-ka waxba iskama beddelin.
Kaydinta heerkulka caadiga ah iyo gaadiidka: looma baahna silsilad qabow, looma baahna in lagu kaydiyo heerkul hoose ka hor inta aan la furin, si buuxda u sii daa booska kaydinta qabow.
Diyaar u ah in la isticmaalo: lyophilizing ee dhammaan qaybaha, looma baahna qaabeynta nidaamka, iska ilaalinta lumitaanka qaybaha leh viscosity sare sida enzyme.
Bartilmaameedyada Multiplex ee hal tube: bartilmaameedka ogaanshaha wuxuu daboolayaa coronavirus-ga cusub ee ORF1ab, hidda-wadaha N, S hidda-wadaha si looga fogaado genovariation-ka fayraska.Si loo yareeyo diidmada beenta ah, hiddo-wadaha RNase P ee bini'aadamka waxaa loo isticmaalaa xakameyn gudaha ah, si loo daboolo baahida bukaan-socodka ee ilaalinta tayada muunadda.

SARS-CoV-2 IgM/IgG Antibody Test degdeg ah iyo Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ogaanshaha saddexda hidde-side) ayaa hore loogu calaamadeeyay CE gudaha Boqortooyada Midowday, oo hadda la aqbalay oo ay farsamaysay EUA FDA ee Ameerika.

Nanjing Liming Bio-Products Co., Ltd. waxay had iyo jeer gelisaa tayada qalabka tijaabada meesha ugu horeysa, waxayna xoogga saartaa ballaarinta awoodda.Shirkaddu waxay siin doontaa agab iyo adeegyo shaybaadh oo tayo sare leh oo COVID-19 ah hay'adaha caafimaadka adduunka oo dhan, waxayna gacan ka geysan doontaa ka-hortagga iyo xakamaynta cudurka faafa ee caalamiga ah, si loo dhiso bulsho caalami ah oo mustaqbal wadaag ah.

Riix dheer~Saami oo nalasoco
Iimayl:sales@limingbio.com
Website: https://limingbio.com

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

Waqtiga boostada: Jul-06-2020