Izindaba ezinhle!Ikhithi ye-PCR ye-Shanghai Chuangkun Biotech 15 HPV ithole isitifiketi sokubhalisa sase-Thailand FDA!

Muva nje, i-Shanghai Chuangkun Biotechnology Co., Ltd. ithole isitifiketi sokubhalisa se-Thailand FDA sekhithi ye-PCR yohlobo lwe-HPV yohlobo oluyi-15, ebonisa ukuthi imikhiqizo ye-Chuangkun Biotech yaqashelwa yi-Thailand FDA, inikeza ukwesekwa okuqinile kwe-Chuangkun Biotech ukuze iqhubeke nokwandisa imakethe yamazwe ngamazwe.

Ngokwezibalo zeWorld Health Organisation, izigameko zomdlavuza womlomo wesibeletho kubantu besifazane emhlabeni jikeleleisibili kuphela kumdlavuza wamaphaphu nomdlavuza webele, okleliswe endaweni yesithathu.Minyaka yonke, babalelwa ku-500000 abesifazane emhlabeni jikelele abaphethwe umdlavuza womlomo wesibeletho, futhi babalelwa ku-200000 abesifazane ababulawa yilesi sifo.Umdlavuza womlomo wesibeletho ukuphela kwembangela eyaziwayo yezimila eziyingozi kubantu.Ucwaningo selukhombisile ukuthi ukutheleleka ngegciwane le-human papilloma virus (HPV) kuyimbangela enkulu yomdlavuza womlomo wesibeletho kanye nezilonda zawo ezingaphambi komdlavuza (i-cervical intraepithelial neoplasia (CIN)).NgoNovemba 17, 2020, Inhlangano Yezempilo Yomhlaba (i-WHO) yethula isu lomhlaba wonke lokusheshisa ukuqedwa komdlavuza womlomo wesibeletho, igcizelela ukubaluleka kokuhlolwa nokuhlolwa kwe-HPV.Ngomhla ziyisi-6 kuJulayi 2021, i-WHO yabuyekeza futhi yakhipha imihlahlandlela yokuhlolwa nokwelashwa kwezilonda zomlomo wesibeletho ekuvimbeleni umdlavuza womlomo wesibeletho,incoma ukuhlolwa kwe-DNA ye-human papillomavirus (HPV) njengendlela yokuqala yokuhlola ukuhlolwa komdlavuza womlomo wesibeletho.

Ikhithi yokuhlola yokuthayipha ye-HPV ye-nucleic acid ye-Chuangkun Biotech isekelwe kubuchwepheshe be-PCR fluorescence probe eminingi futhi iyasebenza ensimbini evamile ye-PCR yamashaneli amane e-fluorescence quantitative.Umkhiqizo wamukela inqubo yokukhiqiza yengxenye egcwele yokumisa iqhwa.Ikhithi ingathuthwa futhi igcinwe endaweni yokushisa yasekamelweni, exazulula indawo yobuhlungu bokuthuthwa kweketango elibandayo lama-reagents ajwayelekile e-liquid, futhi inganciphisa kakhulu izindleko zokuhamba nezokuthutha zokuthengisa phesheya.Lo mkhiqizo usetshenziselwa kakhulu ukutholwa kwe-in vitro ye-human papillomavirus kumaseli akhishwe ngomlomo wesibeletho, ohlanganisa izinhlobo ezingu-15 ezinobungozi obukhulu, futhi ukhomba ngokukhethekile izinhlobo ezinobungozi obukhulu obuyi-16 kanye ne-18.Umkhiqizo unezici zokuzwela okuphezulu (ukubona ukuzwela kufika kumakhophi angu-500/ml), ukucaciswa okuphezulu kanye nokuphuma okuphezulu.Usebenzisa isizinda samahhala sokukhulisa amandla okuqondile ubuchwepheshe kanye nokusebenzisana nochungechunge lwe-Thunder olusheshayo lwe-PCR yokutholwa kwensimbi ye-Chuangkun Bio, umkhiqizo ungaqedela ukutholwa ngokushesha kwamasampula ayi-16~96 ngemizuzu engama-40, ngemiphumela enembile nethembekile.

Ukuthola isitifiketi sokubhaliswa kwe-FDA yaseThailand kulokhu kuwukuqashelwa okugcwele nokuqinisekiswa kwemikhiqizo yebhayoloji ye-Chuangkun.Izophinde ithuthukise ukuthandwa kwemikhiqizo kaChuangkun emakethe yamazwe ngamazwe.Ngokuzayo, i-Chuangkun izoqhubeka nokunamathela emakethe, ithathe uguquko lwesayensi nezobuchwepheshe njengokwesekwa, ithuthukise ngokuqhubekayo ukuncintisana okuyinhloko kwebhizinisi, idale uhlobo oluvelele olunombono wembulunga yonke, futhi ilwele ukukhuthaza ukuthuthukiswa kwenkampani enkulu. imboni yezempilo futhi ufeze iphupho lezempilo lesintu ngemizamo engapheli nokuphikelela!