LimingBio ya sami rajistar ANVISA a Brazil da takardar shaidar rajista a Singapore da Indonesiya

LimingBio has obtained the ANVISA registration in Brazil

Abtract
Kwanan nan, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit an ba da takardar shedar daga Ofishin Kula da Lafiya ta Ƙasa ta Brazil kuma ya sami takardar shedar ANVISA.A lokaci guda, SARS-CoV-2 RT-PCR da IgM/IgG antibody kayan gwaji mai sauri suma an jera su a cikin jerin abubuwan da aka ba da shawarar siyan Indonesiya.A halin yanzu, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, Hukumar Kimiyyar Kiwon Lafiya ta Singapore (HSA) ta amince da ita, kuma ta sami takardar shaidar HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Hoto na 1 takardar shedar ANVISA ta Brazil

Brazil (ANVISA) takardar shaida
ANVISA, wanda aka sani da Agência Nacional de Vigilância Sanitária, shine mai kula da na'urar likitancin Brazil.Wajibi ne kamfani ya yi rajista da ANVISA, Hukumar Kula da Lafiya ta Ƙasa, don sayar da na'urorin likitanci bisa doka a Brazil.Don samun takaddun shaida, waɗancan na'urorin likitancin da ke shiga Brazil dole ne su cika buƙatun GMP na Brazil tare da takamaiman ƙa'idodin da hukumomin Brazil suka tsara.A Brazil, ana rarraba na'urorin likitancin IVD zuwa Class I, II, III, da IV bisa ga matakin haɗari daga ƙasa zuwa babba.Don samfuran Class I da II, ana ɗaukar tsarin Cadastro, yayin da samfuran Class III da IV, ana amfani da tsarin Registro.Bayan yin nasarar yin rajista, ANVISA za ta ba da lambar rajista, kuma za a loda bayanan zuwa ma'aunin bayanan na'urar likitancin Brazil, wannan lamba da bayanan rajistar da suka dace za su bayyana akan DOU (Diário Oficial da União).

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

Hoto 2 Takaddun shaida Hukumar Kimiyyar Kiwon Lafiya ta Singapore (HSA).

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

Hoto na 3 Jami'in da ya ba da shawarar jerin sayayya na Indonesiya

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

Hoto 4 Mataki mai ƙarfi®Gwajin gaggawa na SARS-CoV-2 IgM/IgG Antibody

LimingBio has obtained the ANVISA registration in Brazil7

Hoto na 5 Novel Coronavirus (SARS-CoV-2) Kayan PCR na Real-Time Multiplex

Lura:
Wannan kayan aikin PCR mai mahimmanci, shirye-shiryen amfani yana samuwa a cikin tsarin lyophilized (tsarin bushewa daskarewa) don adana dogon lokaci.Ana iya jigilar kayan kuma a adana shi a zazzabi na ɗaki kuma ya tsaya tsayin daka har tsawon shekara guda.Kowane bututu na premix ya ƙunshi duk na'urorin da ake buƙata don haɓakawa na PCR, gami da Reverse-transcriptase, Taq polymerase, primers, probes, da kuma dNTPs substrates.Yana buƙatar ƙara 13ul distilled ruwa da 5ul fitar da samfurin RNA, sannan ana iya gudu da haɓaka akan kayan PCR.

Wahalar safarar sarkar sanyi na Novel Coronavirus nucleic acid reagent ganowa

Lokacin da na al'ada nucleic acid gano reagents ana hawa a cikin dogon nesa, da (-20± 5) ℃ sanyi sarkar ajiya da kuma harkokin sufuri ake bukata don tabbatar da bioactive na enzyme a cikin reagents ci gaba da aiki.Don tabbatar da cewa zafin jiki ya kai ga ma'auni, ana buƙatar kilogiram da yawa na busassun ƙanƙara don kowane akwati na reagent na gwajin nucleic acid ko da ƙasa da 50g, amma zai iya wucewa na kwanaki biyu ko uku kawai.Dangane da aikin masana'antu, ainihin nauyin reagents da masana'antun ke bayarwa bai wuce 10% (ko ƙasa da wannan ƙimar) na akwati ba.Yawancin nauyin ya fito ne daga busassun kankara, fakitin kankara da akwatunan kumfa, don haka farashin sufuri yana da yawa.

A cikin Maris 2020, COVID-19 ya fara bazuwa a cikin babban sikeli a ƙasashen waje, kuma buƙatun novel Coronavirus gano nucleic acid reagent ya karu sosai.Duk da babban farashin fitarwa da reagents a cikin sanyi sarkar, mafi masana'antun iya har yanzu yarda da shi saboda da babban yawa da babban riba.

Koyaya, tare da haɓaka manufofin fitarwa na ƙasa don samfuran rigakafin cutar, gami da haɓaka ikon ƙasa kan kwararar mutane da dabaru, akwai tsawaitawa da rashin tabbas a lokacin jigilar kayayyaki na reagents, wanda ya haifar da manyan matsalolin samfuran da suka haifar. ta hanyar sufuri.Tsawaita lokacin sufuri (lokacin jigilar kayayyaki na kusan rabin wata ya zama gama gari) yana haifar da gazawar samfur akai-akai lokacin da samfurin ya isa ga abokin ciniki.Wannan ya dami mafi yawan masana'antun nucleic acid reagents na fitar da kayayyaki.

Fasahar Lyophilized don PCR reagent ta taimaka jigilar Novel Coronavirus nucleic acid gano reagent a duk duniya

Za'a iya ɗaukar reagents na PCR na lyophilized da adana su a cikin zafin jiki, wanda ba zai iya rage farashin sufuri kawai ba, har ma da guje wa matsalolin ingancin da tsarin sufuri ya haifar.Saboda haka, lyophilizing da reagent ita ce hanya mafi kyau don magance matsalar sufurin fitarwa.

Lyophilization ya ƙunshi daskarewa bayani a cikin wani m yanayi, sa'an nan kuma sublimate da kuma raba ruwa tururi a karkashin injin yanayi.Busassun solute ya kasance a cikin akwati tare da abun da ke ciki da aiki iri ɗaya.Idan aka kwatanta da reagents na ruwa na al'ada, cikakken nau'in lyophilized Novel Coronavirus nucleic acid reagent wanda Liming Bio ya samar yana da halaye masu zuwa:

Matsanancin ƙarfi zafi kwanciyar hankali: yana iya tare da tsayawa magani a 56 ℃ for 60 days, da ilimin halittar jiki da kuma yi na reagent kasance canzawa.
Ma'ajiyar zafin jiki na al'ada da sufuri: babu buƙatar sarkar sanyi, babu buƙatar adanawa a ƙananan zafin jiki kafin buɗewa, cikakken sakin sararin ajiyar sanyi.
Shirye-shirye don amfani: lyophilizing na duk abubuwan da aka gyara, babu buƙatar tsarin tsarin, guje wa asarar abubuwan da aka gyara tare da babban danko kamar enzyme.
Maƙasudin Multiplex a cikin bututu guda ɗaya: manufar ganowa ta ƙunshi sabon coronavirus ORF1ab gene, N gene, S gene don guje wa ƙwayar cuta.Don rage rashin kuskuren ƙarya, ana amfani da kwayar halittar ɗan adam RNase P azaman kulawa ta ciki, don saduwa da buƙatun asibiti don sarrafa ingancin samfurin.

SARS-CoV-2 IgM/IgG Antibody Rapid Test da Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (gano ga kwayoyin halitta uku) a baya an yi alama CE a Burtaniya, kuma yanzu EUA ta karɓi kuma ana sarrafa ta. FDA a Amurka.

Nanjing Liming Bio-Products Co., Ltd. koyaushe yana sanya ingancin kayan gwajin a farkon wuri, kuma yana mai da hankali kan haɓaka ƙarfin.Kamfanin zai samar da samfurori da sabis na gwaji na COVID-19 masu inganci ga cibiyoyin kiwon lafiya a duk faɗin duniya, kuma za su ba da gudummawa ga rigakafin kamuwa da cutar ta duniya, ta yadda za a gina al'ummar duniya na gaba ɗaya.

Dogon Latsa ~ Duba kuma ku Bi Mu
Imel:sales@limingbio.com
Yanar Gizo: https://limingbio.com

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

Lokacin aikawa: Yuli-06-2020