I-Limingbio ithole ukubhaliswa kwe-anvisa esitifiketini saseBrazil naseSitifiketi sokubhaliswa eSingapore nase-Indonesia

I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil

-Catshangwa
Muva nje, i-Nanjing Liming Bio-Products Co, Ltd. (www.limingbio.com) I-SARS-Cov-2 Antibody Rapid Test Kit iye yaqinisekiswa yi-Brazil National Health Health Team Bureau futhi yathola isitifiketi se-Anvisa. Ngasikhathi sinye, abakwaSARS-CoV-2 RT-PCR ne-IGM / IGG Antibody Rapid Vitar Kit futhi bafakwa ohlwini olwangeni olusemthethweni lokuthengwa kwempahla ye-Indonesia. Ngaleso sikhathi, ukunciphisa i-bio strongstep®Inoveli coronavirus (SARS-Cov-2) I-Multiplex real-time PCR KIT, ivunyelwe yi-Singapore Health Sciences Authority (HSA), futhi yathola isitifiketi se-HSA.

I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil1

ISITHOMBE 1 ISIQINISEKISO SEBRAZIL ANVISA

Isitifiketi seBrazil (Anviesa)
I-AnviSA, eyaziwa ngokuthi i-Agência Nacional de Vigilântia Sanitária, ungumlawuli wedivayisi waseBrazil. Kuyadingeka ukuthi inkampani ibhaliswe ne-Anviesa, i-National Health Superving Agency, ukuthengisa amadivaysi ezokwelapha ngokusemthethweni eBrazil. Ukuqinisekiswa, lawo madivaysi ezokwelapha angena eBrazil kumele ahlangabezane nezidingo ze-GMP yaseBrazil kanye namazinga athile abekwe yiziphathimandla zaseBrazil. EBrazil, amadivaysi ezokwelapha we-IVD ahlukaniswa ekilasini I, II, iii, kanye ne-IV ngokuya ngezinga lobungozi kusuka phezulu kuya phezulu. Ngemikhiqizo ye-Class I kanye ne-II, indlela yeCadastro yamukelwa, ngenkathi i-Class III kanye nemikhiqizo ye-IV, i-Registro Indlela iyasetshenziswa. Ngemuva kokubhaliswa ngempumelelo, kuzonikezwa inombolo yokubhalisa nge-Anviesa, futhi imininingwane izolayishwa database ye-Medical ye-Medical yezokwelapha yaseBrazil, le nombolo nemininingwane yayo yokubhalisa ehambisanayo izovela ku-DO (Diário Oficial DA União).

I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil2
I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil3

Isithombe 2 2 Singapore Health Sciences (HSA) isitifiketi

I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil4
I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil6

ISITHOMBE 3 Uhlu Lokuthengwa Kwempahla olusemthethweni lwe-Indonesia

I-Limingbio ithole isitifiketi sokubhaliswa kwe-Anvisa eBrazil futhi yangena ohlwini olusemthethweni lokuthengwa kwempahla e-Indonesia6

ISITHOMBE 4 STROSTEP®I-SARS-Cov-2 IGM / IGG Antibody Rapid Test

I-Limingbio ithole ukubhaliswa kwe-anvisa eBrazil7

Isithombe 5 i-coronavirus coronavirus (SARS-Cov-2) Multiplex real-time PCR KCR KCR

Qaphela:
Le kit ebucayi kakhulu, elungele ukusetshenziswa kwe-PCR KIT iyatholakala ngefomethi ye-Lyophilesed (i-Freeze-yomiswa inqubo) ukuze isitoreji isikhathi eside. Ikhithi ingathuthwa futhi igcinwe emazingeni okushisa asekamelweni futhi iqinile unyaka owodwa. I-tube ngayinye ye-Premix iqukethe yonke i-reagents edingekayo ye-PCR Amplication, kufaka phakathi i-Reverse-Transcriptase, iTaq Polymerase, ama-PROMSTS, ama-DNTPS, kanye nama-DNTPS, nezindawo zokuphumula ze-DNTPS. Idinga kuphela ukwengeza amanzi ancishisiwe we-13Ul kanye ne-run ekhishwe i-rna template, khona-ke ingaqhutshwa futhi yandiswa kuzinsimbi ze-PCR.

Ubunzima bokuhanjiswa kwamaketanga okubandayo kwenoveli coronavirus nucleic acid detection reagent

Lapho ama-reagents ajwayelekile we-nucleic acid athuthelwa ebangeni elide, okungu-(-20 Ukuqinisekisa ukuthi izinga lokushisa lifinyelela ezingeni, amakhilogremu ambalwa eqhwa elomile ayadingeka ebhokisini ngalinye le-realent yokuhlola i-nucleic acid ngisho nangaphansi kuka-50g, kepha ingahlala izinsuku ezimbili noma ezintathu kuphela. Ngombono wokuzijwayeza kwezimboni, isisindo sangempela se-reagents esikhishwe ngabakhiqizi singaphansi kwe-10% (noma ngaphansi kwaleli nani) lesitsha. Iningi lesisindo livela eqhweni elomile, amaphakethe eqhwa namabhokisi egwebu, ngakho-ke izindleko zokuhamba ziphezulu kakhulu.

Ngo-Mashi 2020, iCovilit-19 yaqala ukugqashuka ngezinga elikhulu, futhi isidingo senoveli coronavirus reagent reagent yokutholwa kwe-coronavirus inyuke kakhulu. Ngaphandle kwezindleko eziphakeme zokuthumela ama-reagents ku-chain ebandayo, iningi labakhiqizi lingakwamukela ngenxa yenani elikhulu nenzuzo ephezulu.

Kodwa-ke, ngokuthuthuka kwezinqubomgomo zikazwelonke zokuthekelisa zemikhiqizo yokulwa nobhubhane, kanye nokwenziwa ngcono kokulawulwa kwezwe ngokugeleza kwabantu kanye nezinto, kukhona ukungaqiniseki ngesikhathi sokuhamba se-reagents, okuholele ekutheni kube nezinkinga zomkhiqizo ezivelele ezibangelwa ngokuhamba. Isikhathi sokuhamba esandisiwe (isikhathi sokuhamba esingesigamu senyanga sivame kakhulu) siholela ukwehluleka komkhiqizo njalo lapho umkhiqizo ufinyelela kwiklayenti. Lokhu kukhathazeke kakhulu amabhizinisi athumela ama-reagents we-nucleic acid.

Ubuchwepheshe be-Lyophilesed for PCR Repent basize ukuthutha kwenoveli coronavirus nucleic acid detection reagent emhlabeni jikelele

Ama-reachents we-ppcro alolophilized angahanjiswa futhi agcinwe emazingeni okushisa asekamelweni, angakwazi ukunciphisa izindleko zokuhamba kuphela, kepha futhi agweme izinkinga zekhwalithi ezibangelwa inqubo yokuhamba. Ngakho-ke, ukujoyina i-reagent kuyindlela engcono kakhulu yokuxazulula inkinga yokuhamba kwamanye amazwe.

I-Lyophilization ifaka ukuqalisa isixazululo esimweni esiqinile, bese ifaka futhi ihlukanise umphunga wamanzi ngaphansi kwesimo se-vacuum. Isizungu omisiwe sihlala esitsheni esinokwakheka kanye nomsebenzi ofanayo. Uma kuqhathaniswa ne-reagents evamile ye-liquid, i-coronavirus ephelele ye-coronavirus nucleic acid dection reaglent ekhiqizwa nge-ling bio inezici ezilandelayo:

Ukuqina okuqinile kokushisa okunamandla
Isitoreji sokushisa esijwayelekile nokuhamba: asikho isidingo sokhuni olubandayo, asikho isidingo sokugcina emazingeni okushisa aphansi ngaphambi kokungasho lutho, ukhulule ngokugcwele isikhala sokugcina esibandayo.
Ukulungele ukusetshenziswa: i-lophiling yazo zonke izinto, asikho isidingo sokucushwa kwesistimu, ukugwema ukulahlekelwa kwezakhi nge-viscosity ephezulu enjenge-enzyme.
Amathagethi we-Multiplex ku-tube eyodwa: Ithango lokutholwa lihlanganisa uhlobo lwe-novel coronavirus orf1ab gene, uhlobo lwe-n gene ukuze ugweme i-virus genevariation. Ukuze unciphise ukungahambi kahle kwamanga, i-rnase p gene isetshenziswa njengokulawulwa kwangaphakathi, ukuze ihlangabezane nesidingo somtholampilo sokulawulwa kwekhwalithi yesampula.

I-SARS-COV-2 IGM / IGG Antibody Rapid Test ne-Novel Couravirus (SARS-Cov-2) I-Multiplex Real-Time Pccr KIT (ukutholwa kwezinhlobo ezintathu ye-FDA eMelika.

I-Nanjing Liming Bio-Products Co, Ltd ihlala ibeka ikhwalithi yekhithi yokuhlola kwasekuqaleni, futhi igxile ekunwebisweni kwekhono. Le nkampani izohlinzeka ngemikhiqizo nezinsizakalo ezisezingeni eliphakeme ze-Covil-19 ezikhungweni zezokwelapha emhlabeni wonke emhlabeni jikelele, futhi zinikele ekuvinjelweni nasekulawuleni komhlaba wonke, ukuze kwakhiwe umphakathi wembulunga yonke yekusasa elihlanganyelwe.

Cindezela isikhathi eside ~ scan bese usilandela
I-imeyili:sales@limingbio.com
Iwebhusayithi: https://limingbio.com

I-Limingbio ithole isitifiketi sokubhaliswa kwe-Anvisa eBrazil futhi yangena ohlwini olusemthethweni lokuthengwa kwempahla e-Indonesia9

Isikhathi sePosi: Jul-06-2020