Iindaba ezimnandi!Ikhithi ye-PCR yaseShanghai Chuangkun ye-Biotech 15 ye-HPV ifumene isatifikethi sobhaliso saseThailand FDA!

Kutshanje, iShanghai Chuangkun Biotechnology Co., Ltd. ifumene isatifikethi sobhaliso saseThailand FDA kuhlobo lwe-15 lwekhithi yokuchwetheza ye-HPV yokubona i-PCR, ebonisa ukuba iimveliso ze-Chuangkun Biotech ziye zamkelwa yi-Thailand FDA, inika inkxaso eyomeleleyo kwi-Chuangkun Biotech ukukhulisa ngakumbi imarike yamazwe ngamazwe.

Ngokwezibalo zoMbutho wezeMpilo weHlabathi, izehlo zomhlaza womlomo wesibeleko kumathumba amabi abasetyhini kwihlabathi liphela.kuphela okwesibini kumhlaza wemiphunga kunye nomhlaza wamabele, kwindawo yesithathu.Rhoqo ngonyaka, malunga ne-500000 yabasetyhini kwihlabathi liphela baphathwa ngumhlaza womlomo wesibeleko, kwaye malunga ne-200000 yabasetyhini ababulawa sesi sifo.Umhlaza womlomo wesibeleko ngowokuphela konobangela owaziwayo wamathumba ayingozi ebantwini.Uphononongo lubonise ukuba usulelo lwe-human papilloma virus (HPV) ngoyena nobangela womhlaza womlomo wesibeleko kunye nezilonda zawo ezingaphambi komhlaza (i-cervical intraepithelial neoplasia (CIN)).Ngomhla we-17 kaNovemba ka-2020, uMbutho wezeMpilo weHlabathi (i-WHO) wasungula isicwangciso-qhinga sehlabathi sokukhawulezisa ukupheliswa komhlaza womlomo wesibeleko, ugxininisa ukubaluleka kovavanyo lwe-HPV kunye nokuhlolwa.NgoJulayi 6, 2021, i-WHO yahlaziya kwaye yakhupha izikhokelo zovavanyo kunye nonyango lwezilonda zomlomo wesibeleko kuthintelo lomhlaza womlomo wesibeleko,icebisa uvavanyo lwe-DNA lwe-human papillomavirus (HPV) njengendlela yokuqala yokuhlola umhlaza womlomo wesibeleko.

Ikhithi yovavanyo yokuchwetheza ye-HPV ye-nucleic acid yeChuangkun ye-HPV isekwe kubuchwepheshe be-PCR fluorescence probe kwaye iyasebenza kwisixhobo se-PCR esiqhelekileyo se-fluorescence quantitative.Imveliso ithatha inkqubo yemveliso yecandelo elipheleleyo lokumisa umkhenkce.Ikiti inokuthuthwa kwaye igcinwe kwiqondo lokushisa, elisombulula indawo yeentlungu zokuthuthwa kwekhonkco elibandayo kwi-reagents yolwelo oluqhelekileyo, kwaye inokunciphisa kakhulu iindleko zokuhamba kunye nokuthutha ukuthengiswa kwamanye amazwe.Le mveliso isetyenziselwa ikakhulu ukufumanisa i-in vitro ye-papillomavirus yabantu kwiiseli ezikhutshiweyo zomlomo wesibeleko, ezigubungela iintlobo ze-15 ezinobungozi obuphezulu, kunye nokuchonga ngokukodwa i-16 kunye ne-18 yeentlobo ezinobungozi obuphezulu.Imveliso ineempawu zobuntu obuphezulu (ukubona ukuva ukuya kwiikopi ze-500 / ml), ukuchaneka okuphezulu kunye nokuphuma okuphezulu.Ukusebenzisa iteknoloji yokukhulisa ngokuthe ngqo i-extraction kunye nokusebenzisana nochungechunge lwe-Thunder olukhawulezayo lwe-PCR isixhobo sokubona isixhobo se-Chuangkun Bio, imveliso inokugqiba ukufunyanwa ngokukhawuleza kweesampuli ze-16 ~ 96 kwimizuzu engama-40, kunye neziphumo ezichanekileyo nezithembekileyo.

Ukufumana isatifikethi sokubhaliswa kwe-FDA yaseThailand ngeli xesha kukuqondwa ngokupheleleyo kunye nokuqinisekiswa kweemveliso zebhayoloji zaseChuangkun.Iyakwandisa ngakumbi ukuthandwa kweemveliso zikaChuangkun kwimarike yehlabathi.Kwixesha elizayo, iChuangkun iya kuqhubeka nokunamathela kuqhelaniso lwemarike, ithatha inzululwazi neteknoloji njengenkxaso, iphucule ngokuqhubekayo ukhuphiswano olungundoqo lweshishini, idale uphawu olubalaseleyo olunombono wehlabathi, kwaye izabalazele ukukhuthaza uphuhliso olukhulu. ishishini lezempilo kwaye uqonde iphupha lempilo yoluntu ngemizamo engapheliyo kunye nokuzingisa!