Abstract
Muva nje, i-Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit iqinisekiswe yi-Brazilian National Health Supervision Bureau futhi yathola isitifiketi se-ANVISA.Ngasikhathi sinye, i-SARS-CoV-2 RT-PCR kanye nekhithi yokuhlola esheshayo ye-IgM/IgG antibody nazo zifakwe ohlwini lokuthenga olunconyiwe olusemthethweni lwase-Indonesia.Ngaleso sikhathi, i-Liming Bio StrongStep®I-Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, yagunyazwa yi-Singapore Health Sciences Authority (HSA) , futhi yathola isitifiketi se-HSA.
Isithombe 1 isitifiketi se-Brazil ANVISA
Isitifiketi saseBrazil (ANVISA).
I-ANVISA, eyaziwa nge-Agência Nacional de Vigilância Sanitária, isilawuli semishini yezokwelapha yase-Brazil.Kudingeka ukuthi inkampani ibhaliswe ne-ANVISA, I-National Health Supervision Agency, ukuze ithengise imishini yezokwelapha ngokusemthethweni e-Brazil.Ukuze zigunyazwe, lezo zisetshenziswa zezokwelapha ezingena e-Brazil kufanele zihlangabezane nezimfuneko ze-Brazilian GMP kanye namazinga athile abekwe iziphathimandla zase-Brazilian.E-Brazil, izinsiza zezokwelapha ze-IVD zihlukaniswa zibe Ikilasi I, II, III, kanye ne-IV ngokwezinga lengozi ukusuka kokuphansi ukuya phezulu.Emikhiqizweni ye-Class I kanye ne-II, indlela ye-Cadastro iyamukelwa, kuyilapho emikhiqizweni ye-Class III ne-IV, indlela ye-Registro isetshenziswa.Ngemva kokubhaliswa ngempumelelo, inombolo yokubhalisa izokhishwa i-ANVISA, futhi idatha izolayishwa kusizindalwazi sedivayisi yezokwelapha yaseBrazil, le nombolo kanye nolwazi oluhambisanayo lokubhalisa kuzovela ku-DOU (Diário Oficial da União).
Isithombe 2 Isitifiketi Seziphathimandla Zesayensi Yezempilo SaseSingapore (HSA).
Isithombe 3 Uhlu olusemthethweni olunconyiwe lokuthenga lwase-Indonesia
Isithombe 4 Isinyathelo Esiqinile®Ukuhlolwa Okusheshayo kwe-SARS-CoV-2 IgM/IgG Antibody
Ikhithi ye-PCR ye-Picture 5 Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR
Qaphela:
Le kit ye-PCR ezwela kakhulu, elungele ukusetshenziswa itholakala ngefomethi ye-lyophilized (inqubo yokumisa iqhwa) ukuze igcinwe isikhathi eside.Ikhithi ingathuthwa futhi igcinwe ekamelweni lokushisa futhi izinzile unyaka owodwa.Ishubhu ngayinye ye-premix iqukethe wonke ama-reagents adingekayo ukuze kukhuliswe i-PCR, okuhlanganisa i-Reverse-transcriptase, i-Taq polymerase, ama-primers, ama-probe, nama-dNTPs substrates.Idinga kuphela ukungeza amanzi acwecwe angu-13ul kanye nesifanekiso se-RNA esikhishwe ngu-5ul, bese singasetshenziswa futhi sikhuliswe kumathuluzi e-PCR.
Ubunzima bokuhamba ngeketango elibandayo leNovel Coronavirus nucleic acid discovery reagent
Lapho ama-reagents ajwayelekile okuthola i-nucleic acid ethuthwa ebangeni elide, isitoreji (-20±5) ℃ seketango elibandayo kanye nokuhamba kuyadingeka ukuze kuqinisekiswe ukuthi i-bioactive ye-enzyme kuma-reagents ihlala isebenza.Ukuze uqiniseke ukuthi izinga lokushisa lifinyelela izinga, amakhilogremu amaningana eqhwa elomile ayadingeka ebhokisini ngalinye le-nucleic acid test reagent ngisho nangaphansi kuka-50g, kodwa lingahlala izinsuku ezimbili noma ezintathu kuphela.Ngokombono wokusebenza kwemboni, isisindo sangempela sama-reagents akhishwe abakhiqizi singaphansi kuka-10% (noma ngaphansi kakhulu kunaleli xabiso) lesiqukathi.Isisindo esiningi sivela eqhweni elomile, amaphakethe eqhwa namabhokisi egwebu, ngakho-ke izindleko zokuhamba ziphezulu kakhulu.
NgoMashi 2020, i-COVID-19 yaqala ukuqubuka ngezinga elikhulu phesheya, futhi isidingo se-Novel Coronavirus nucleic acid discovery reagent sakhula kakhulu.Naphezu kwezindleko eziphakeme zokuthumela ama-reagents ochungechungeni olubandayo, abakhiqizi abaningi basengayamukela ngenxa yobuningi kanye nenzuzo ephezulu.
Kodwa-ke, ngokuthuthukiswa kwezinqubomgomo zikazwelonke zokuthumela ngaphandle kwemikhiqizo elwa nobhubhane, kanye nokuthuthukiswa kokulawula kukazwelonke phezu kokuhamba kwabantu kanye nempahla, kukhona ukunwetshwa nokungaqiniseki ngesikhathi sokuthuthwa kwama-reagents, okuholele ezinkingeni zemikhiqizo ezivelele ezidalwe. ngezokuthutha.Isikhathi sokuthutha esandisiwe (isikhathi sokuthutha cishe isigamu senyanga sivame kakhulu) siholela ekuhlulekeni komkhiqizo njalo lapho umkhiqizo ufinyelela iklayenti.Lokhu kukhathaze amabhizinisi amaningi okuthekelisa ama-nucleic acid.
Ubuchwepheshe be-Lyophilized be-PCR reagent busize ukuthuthwa kwe-Novel Coronavirus nucleic acid yokuthola i-reagent emhlabeni jikelele.
Ama-reagents e-PCR e-lyophilized angathuthwa futhi agcinwe ekamelweni lokushisa, elingakwazi ukunciphisa izindleko zokuthutha kuphela, kodwa futhi ligweme izinkinga zekhwalithi ezibangelwa inqubo yokuthutha.Ngakho-ke, i-lyophilizing the reagent iyindlela engcono kakhulu yokuxazulula inkinga yokuthutha ngaphandle.
I-Lyophilization ihilela ukuqhwaza isixazululo esimweni esiqinile, bese i-sublimate futhi ihlukanise umhwamuko wamanzi ngaphansi kwesimo se-vacuum.I-solute eyomile isala esitsheni esinokwakheka okufanayo nomsebenzi.Uma kuqhathaniswa nama-reagents avamile oketshezi, isakhi esigcwele se-Lyophilized Novel Coronavirus nucleic acid esitholwa yi-Liming Bio sinezici ezilandelayo:
Ukuzinza kokushisa okuqine ngokwedlulele: kungaba ngokwelashwa kokuma ku-56℃ izinsuku ezingu-60, futhi ukumila nokusebenza kwe-reagent kuhlala kungashintshile.
Ukugcinwa kwezinga lokushisa okujwayelekile kanye nezinto zokuhamba:asikho isidingo seketango elibandayo, asikho isidingo sokugcina ezingeni lokushisa eliphansi ngaphambi kokuvula, khulula ngokuphelele indawo yokugcina ebandayo.
Ukulungele ukusetshenziswa: i-lyophilizing yazo zonke izingxenye, asikho isidingo sokucushwa kwesistimu, ukugwema ukulahlekelwa kwezingxenye ezine-viscosity ephezulu njenge-enzyme.
Okuqondiwe ku-Multiplex kushubhu eyodwa: okuhlosiwe okuhlosiwe kuhlanganisa inoveli yofuzo lwe-coronavirus ORF1ab, isakhi sofuzo esingu-N, isakhi sofuzo sika-S ukugwema ukuguquguquka kwegciwane.Ukuze kwehliswe okungalungile okungamanga, isakhi sofuzo se-RNase P yomuntu sisetshenziswa njengokulawula kwangaphakathi, ukuze kuhlangatshezwane nesidingo somtholampilo sokulawulwa kwekhwalithi okuyisampula.
I-SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ukutholwa kwezakhi zofuzo ezintathu) ibikade imakwe njenge-CE e-UK, futhi manje yamukelwa futhi yenziwa yi-EUA. we-FDA eMelika.
I-Nanjing Liming Bio-Products Co., Ltd. ibilokhu ibeka ikhwalithi yekhithi yokuhlola kuqala, futhi igxile ekwandiseni umthamo.Inkampani izohlinzeka ngemikhiqizo namasevisi okuhlola i-COVID-19 ekhwalithi ephezulu ezikhungweni zezokwelapha emhlabeni wonke, futhi ifake isandla ekunqandeni nasekulawuleni ubhubhane lomhlaba wonke, ukuze kwakhiwe umphakathi womhlaba wonke wekusasa okwabelwana ngalo.
Cindezela Okude~Skena futhi Usilandele
I-imeyili:sales@limingbio.com
Iwebhusayithi: https://limingbio.com
Isikhathi sokuthumela: Jul-06-2020