Izindaba ezinhle!I-Shanghai Chuangkun Biotech 15 yemishini yokuhlola i-HPV nucleic acid enobungozi obukhulu (i-lyophilized, indlela ye-PCR fluorescence probe), ithole isitifiketi sokubhaliswa kwe-FDA yase-Indonesia!

Muva nje, i-Shanghai Chuangkun Biotech HPV(15 High-isk subtype) i-DNA PCR yokuthola isitifiketi (lyophilized) ithole isitifiketi sokubhaliswa kwe-FDA yase-Indonesia, esiphawula ukuthi imikhiqizo ye-Chuangkun Biotech yaqashelwa yi-FDA yase-Indonesia, futhi inikeza ukwesekwa okuqinile kwe-Chuangkun Biotech imakethe yamazwe ngamazwe.

Ngokwezibalo zeWorld Health Organisation, ngonyaka wezi-2020, umdlavuza womlomo wesibeletho emhlabeni, izehlakalo zomdlavuza womlomo wesibeletho phakathi kwezimila eziyingozi zabesifazane zikleliswe endaweni yesine ngemuva komdlavuza wamaphaphu, umdlavuza webele kanye nomdlavuza wekoloni.Emhlabeni jikelele, abesifazane ababalelwa ku-500,000 baba nomdlavuza womlomo wesibeletho unyaka ngamunye futhi babalelwa ku-200,000 ababulawa yilesi sifo.Umdlavuza womlomo wesibeletho ukuphela kwesifo esibulalayo se-etiology eyaziwayo phakathi kwezifo ezibulalayo zabantu.Ukutheleleka kwe-Human papillomavirus (HPV) kukhonjiswe njengembangela enkulu yomdlavuza womlomo wesibeletho kanye nezilonda zawo ezingaphambi komdlavuza (i-cervical intraepithelial neoplasia (CIN), enezinhlobo ze-HPV16 kanye ne-18 ezinomthelela ngaphezu kwama-50% wezilonda ezinomdlavuza womlomo wesibeletho. NgoNovemba 17, 2020 , Inhlangano Yezempilo Yomhlaba (i-WHO) yethule i-Global Strategy to Accelerate Elimination of Cervical Cancer, igcizelela ukubaluleka kokuhlolwa kwe-HPV Ngomhla ziyisi-6 kuJulayi 2021, i-WHO yabuyekeza futhi yakhipha imihlahlandlela yokuhlolwa nokwelashwa kwezilonda ezidala umdlavuza emlonyeni wesibeletho. ekuvimbeleni umdlavuza, incoma ukuhlolwa kwe-DNA ye-human papillomavirus (ingozi ephezulu ye-HPV) njengendlela ekhethwayo yokuhlola umdlavuza womlomo wesibeletho.

I-Chuangkun Biotech HPV (12+3) Ikhithi yokuthola i-DNA PCR (lyophilized) isekelwe kubuchwepheshe be-multiplex PCR-fluorescent probe futhi ifanele ithuluzi elivamile le-PCR lamashaneli amane.Umkhiqizo wamukela inqubo yokukhiqiza yazo zonke izingxenye ze-lyophilization, futhi ikhithi ingathuthwa futhi igcinwe ekamelweni lokushisa, elixazulula iphuzu lobuhlungu bokuthuthwa kweketanga elibandayo lama-reagents ajwayelekile e-liquid, futhi linganciphisa kakhulu izindleko zokuthutha kanye nezindleko zokuthengisa phesheya kwezilwandle.Lo mkhiqizo usetshenziselwa ikakhulukazi ukutholwa kwe-in vitro ye-human papillomavirus kumaseli akhishwe ngomlomo wesibeletho, ahlanganisa izinhlobo eziyi-15 ezinobungozi obukhulu, futhi uyakwazi ukubona izinhlobo ezintathu ezingaphansi 16, 18 kanye no-52. Umkhiqizo unezici zokuzwela okuphezulu (i-LOD ingamakhophi angu-500/ml ), ukucaciswa okuphezulu, ukusebenza okuphezulu nokulawulwa kwekhwalithi yereferensi yangaphakathi, futhi isebenzisa ubuchwepheshe bokunweba obuqondile obungakhiqizi futhi isebenzisane nochungechunge lwe-Chuangkun Biotech Thunder uchungechunge lwemishini yokutholwa kwensimbi esheshayo ye-PCR ukuqedela ukutholwa ngokushesha kwamasampula ayi-16~96 ngemizuzu engama-40, kanye imiphumela inembile futhi ithembekile.

Ukutholwa kwesitifiketi sokubhaliswa kwe-FDA yase-Indonesia ukuqashelwa okugcwele kanye nokuqinisekiswa kwemikhiqizo ye-Chuangkun Biotech.Ngokuzayo, sizoqhubeka nokubambelela ekusungulweni okugxile emakethe, kwezesayensi nezobuchwepheshe njengokusekela, sithuthukisa njalo ukuncintisana okuyinhloko kwamabhizinisi, ngombono womhlaba wonke wokwakha imikhiqizo enenzuzo, ngemizamo engapheli kanye nokuphikelela, ukukhuthaza intuthuko. wemboni yezempilo, ukufeza iphupho lempilo yabantu futhi ulwele kanzima!