I-LimingBio ifumene ukubhaliswa kwe-ANVISA eBrazil kunye nesatifikethi sokubhalisa eSingapore nase-Indonesia

LimingBio has obtained the ANVISA registration in Brazil

Abstract
Kutshanje, iNanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit iye yaqinisekiswa yiBrazilian National Health Supervision Bureau yaze yafumana isatifikethi se-ANVISA.Kwangaxeshanye, i-SARS-CoV-2 RT-PCR kunye ne-IgM/IgG antibody ikiti yovavanyo olukhawulezayo nazo zidweliswe kuluhlu olusemthethweni olucetyiswayo lokuthengwa kwempahla yase-Indonesia.Ngeli xesha, iLiming Bio StrongStep®INovel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, yamkelwa liGunya leSayensi yezeMpilo yaseSingapore (HSA) , kwaye yafumana isatifikethi se-HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Umfanekiso woku-1 wesatifikethi seBrazil ANVISA

Isiqinisekiso saseBrazil (ANVISA).
I-ANVISA, eyaziwa ngokuba yi-Agência Nacional de Vigilância Sanitária, ngumlawuli wesixhobo sonyango saseBrazil.Kuyimfuneko ukuba inkampani ibhaliswe kunye ne-ANVISA, i-Arhente yoLawulo lwezeMpilo yeSizwe, ukuthengisa izixhobo zonyango ngokusemthethweni eBrazil.Ukuze uqinisekiswe, ezo zixhobo zonyango zingena eBrazil kufuneka zihlangabezane neemfuno zeBrazilian GMP kunye nemigangatho ethile ebekwe ngabasemagunyeni baseBrazil.EBrazil, izixhobo zonyango ze-IVD zihlelwa kwiKlasi I, II, III, kunye ne-IV ngokwezinga lomngcipheko ukusuka phantsi ukuya phezulu.Kwiimveliso zeKlasi I kunye ne-II, indlela yeCadastro iyamkelwa, ngelixa i-Class III kunye ne-IV yeemveliso, indlela yeRegistro isetyenziswa.Emva kokubhaliswa okuyimpumelelo, inombolo yobhaliso iya kukhutshwa ngu-ANVISA, kwaye idatha iya kufakwa kwi-database yesixhobo sezonyango saseBrazil, le nombolo kunye nolwazi oluhambelanayo lokubhalisa luya kubonakala kwi-DOU (Diário Oficial da União).

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

Umfanekiso wesi-2 iSiqinisekiso seSayensi sezeMpilo saseSingapore (HSA).

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

Umfanekiso wesi-3 Uluhlu lokuthengwa kwempahla olusemthethweni lwase-Indonesia

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

Umfanekiso we-4 Inyathelo eliqinileyo®Uvavanyo oluKhawulezayo lwe-SARS-CoV-2 IgM/IgG Antibody

LimingBio has obtained the ANVISA registration in Brazil7

Umfanekiso wesi-5 weNoveli yeCoronavirus (SARS-CoV-2) yeMultiplex yeXesha lokwenyani PCR kit

Phawula:
Le khithi yePCR enovakalelo kakhulu, elungele ukusetyenziswa iyafumaneka kwifomati ye-lyophilized (inkqubo yokumisa umkhenkce) yokugcina ixesha elide.Ikiti inokuthuthwa kwaye igcinwe kwiqondo lokushisa kwaye izinzile unyaka omnye.Ityhubhu nganye ye-premix iqulethe zonke ii-reagents ezifunekayo kwi-PCR amplification, kubandakanywa i-Reverse-transcriptase, i-Taq polymerase, i-primers, i-probes, kunye ne-dNTPs substrates.Ifuna kuphela ukongeza i-13ul yamanzi e-distilled kunye ne-5ul ekhutshwe i-template ye-RNA, ngoko inokuqhuba kwaye ikhuliswe kwizixhobo ze-PCR.

Ubunzima bokuhamba ngekhonkco elibandayo leNoveli yeCoronavirus nucleic acid yokufumanisa ireagent

Xa ii-reagents zokubona i-nucleic acid eqhelekileyo zithuthwa kumgama omde, i-(-20±5) ℃ ukugcinwa kwekhonkco elibandayo kunye nokuthuthwa kuyafuneka ukuze kuqinisekiswe i-bioactive ye-enzyme kwii-reagents zihlala zisebenza.Ukuqinisekisa ukuba izinga lokushisa lifikelela kumgangatho, iikhilogram eziliqela zomkhenkce owomileyo ziyafuneka kwibhokisi nganye ye-nucleic acid test reagent nangaphantsi kwe-50g, kodwa inokuhlala iintsuku ezimbini okanye ezintathu kuphela.Ngokombono wokuziqhelanisa noshishino, obona bunzima beerejenti ezikhutshwe ngabavelisi bungaphantsi kwe-10% (okanye ngaphantsi kakhulu kweli xabiso) lwesikhongozeli.Uninzi lobunzima buvela kumkhenkce owomileyo, iipakethe zomkhenkce kunye neebhokisi zegwebu, ngoko ke iindleko zothutho ziphezulu kakhulu.

Ngo-Matshi ka-2020, i-COVID-19 yaqala ukuqhambuka kwinqanaba elikhulu phesheya, kwaye imfuno yeNoveli yeCoronavirus i-nucleic acid yokubona i-reagent inyuke kakhulu.Ngaphandle kweendleko eziphezulu zokuthumela ii-reagents kwikhonkco elibandayo, abaninzi abavelisi basenakho ukuyamkela ngenxa yobuninzi kunye nenzuzo ephezulu.

Nangona kunjalo, ngokuphuculwa kwemigaqo-nkqubo yesizwe yokuthumela ngaphandle kwiimveliso ezichasene nobhubhane, kunye nokuphuculwa kolawulo lwesizwe lokuhamba kwabantu kunye nokuhanjiswa, kukho ukongezwa kunye nokungaqiniseki kwixesha lothutho lwe-reagents, okubangele iingxaki ezibalaseleyo zemveliso ezibangelwayo. ngezothutho.Ixesha elongeziweyo lokuthutha (ixesha lezothutho malunga nesiqingatha senyanga lixhaphake kakhulu) likhokelela ekungaphumeleli kwemveliso rhoqo xa imveliso ifikelela kumxhasi.Oku kuye kwawakhathaza kakhulu amashishini athumela ngaphandle kwe-nucleic acid.

Itekhnoloji ye-Lyophilized ye-PCR reagent incede ukuthuthwa kweNoveli yeCoronavirus i-nucleic acid efunyenwe kwihlabathi liphela.

I-PCR reagents ye-lyophilized inokuthuthwa kwaye igcinwe kwiqondo lokushisa, elingenako ukunciphisa iindleko zokuthutha kuphela, kodwa liphinde ligweme iingxaki ezisemgangathweni ezibangelwa yinkqubo yokuthutha.Ngoko ke, i-lyophilizing i-reagent yindlela efanelekileyo yokusombulula ingxaki yokuthutha ngaphandle.

I-Lyophilization ibandakanya ukukhenkceza isisombululo kwisimo esiqinileyo, kwaye emva koko i-sublimate kwaye ihlukanise umphunga wamanzi phantsi kwemeko ye-vacuum.I-solute eyomileyo ihlala kwisitya kunye nokubunjwa okufanayo kunye nomsebenzi.Xa kuthelekiswa neereagents zolwelo eziqhelekileyo, icandelo elipheleleyo le-lyophilized Novel Coronavirus nucleic acid yokufumanisa ireagent eveliswe yiLiming Bio inezi mpawu zilandelayo:

Uzinzo lobushushu obunamandla kakhulu: lunokuba nonyango lokuma kwi-56 ℃ iintsuku ezingama-60, kwaye i-morphology kunye nokusebenza kwe-reagent kuhlala kungatshintshi.
Ukugcinwa kweqondo lokushisa eliqhelekileyo kunye nokuhamba: akukho mfuneko yekhonkco elibandayo, akukho mfuneko yokugcina kwiqondo lokushisa eliphantsi ngaphambi kokungatywinwa, khulula ngokupheleleyo indawo yokugcina ebandayo.
Ukulungele ukusetyenziswa: i-lyophilizing yawo onke amacandelo, akukho mfuneko yokulungiswa kwenkqubo, ukuphepha ukulahlekelwa kwamacandelo kunye ne-viscosity ephezulu njenge-enzyme.
Iithagethi ezininzi kwityhubhu enye: i-target target igubungela inoveli ye-coronavirus ORF1ab gene, i-N gene, i-S gene ukuphepha i-virus genovariation.Ukuze kuncitshiswe ubuxoki obungalunganga, ijini ye-RNase P yomntu isetyenziswa njengolawulo lwangaphakathi, ukuze kuhlangatyezwane nemfuno yekliniki yolawulo lomgangatho wesampulu.

I-SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ukuchongwa kweegenes ezintathu) ibikhe yaphawulwa e-UK, kwaye ngoku yamkelwe kwaye isenziwa yi-EUA. ye-FDA eMelika.

I-Nanjing Liming Bio-Products Co., Ltd. isoloko ibeka umgangatho wekiti yokuvavanya kwindawo yokuqala, kwaye igxininise ekwandiseni umthamo.Inkampani iya kubonelela ngeemveliso zovavanyo olukumgangatho ophezulu we-COVID-19 kunye neenkonzo kumaziko ezonyango kwihlabathi liphela, kwaye ifake isandla kuthintelo nolawulo lobhubhane wehlabathi, ukuze kwakhiwe uluntu lwehlabathi lwekamva ekwabelwana ngalo.

Cinezela ixesha elide ~ Skena kwaye Usilandele
I-imeyile:sales@limingbio.com
Iwebhusayithi: https://limingbio.com

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

Ixesha lokuposa: Jul-06-2020