Inkuru nziza!Shanghai Chuangkun Biotech 15 ibikoresho byinshi byo gupima aside HPV nucleic (uburyo bwa lyophilized, PCR fluorescence probe uburyo), yabonye icyemezo cyo kwiyandikisha muri Indoneziya FDA!

Vuba aha, Shanghai Chuangkun Biotech HPV (15 subtype ifite ibyago byinshi) ADN PCR yerekana ibikoresho (lyophilized) yabonye icyemezo cyo kwiyandikisha muri FDA yo muri Indoneziya, ibyo bikaba byerekana ko ibicuruzwa bya Chuangkun Biotech byamenyekanye na FDA yo muri Indoneziya, bikomeza gutanga inkunga ikomeye kuri Chuangkun Biotech iteza imbere iterambere isoko mpuzamahanga.

Dukurikije imibare y’umuryango w’ubuzima ku isi ， mu mwaka wa 2020, kanseri y’inkondo y'umura ku isi, ubwandu bwa kanseri y'inkondo y'umura mu bibyimba bibi by’abagore biza ku mwanya wa kane nyuma ya kanseri y'ibihaha, kanseri y'ibere na kanseri y'urura runini.Ku isi hose, buri mwaka abagore bagera ku 500.000 barwara kanseri y'inkondo y'umura kandi abagera ku 200.000 bapfa bazize iyo ndwara.Kanseri y'inkondo y'umura niyo malariya yonyine ya etiologiya izwi cyane mungaruka mbi zabantu.Indwara ya papillomavirus (HPV) yagaragaye ko ari yo nyirabayazana ya kanseri y'inkondo y'umura ndetse n'ibikomere byayo mbere (cervical intraepithelial neoplasia (CIN), hamwe na HPV16 n'ubwoko 18 bitanga 50% bya kanseri y'inkondo y'umura ibisebe byanduye. Ku ya 17 Ugushyingo 2020 Ishami ry'Umuryango w'Abibumbye ryita ku Buzima (OMS) ryatangije ingamba mpuzamahanga zo kwihutisha kurandura kanseri y'inkondo y'umura, ishimangira akamaro ko kwipimisha HPV. Ku ya 6 Nyakanga 2021, OMS yavuguruye kandi isohora umurongo ngenderwaho wo gusuzuma no kuvura ibikomere by’inkondo y'umura mu nkondo y'umura kwirinda kanseri, gusaba abantu ibyago byinshi byo gupima papillomavirus (HPV ifite ibyago byinshi) kwipimisha ADN nkuburyo bwatoranijwe bwo gusuzuma kanseri y'inkondo y'umura.

Chuangkun Biotech HPV (12 + 3) ibikoresho byo kumenya ADN PCR (lyophilized) bishingiye kuri tekinoroji ya multiplex PCR-fluorescent kandi ikwiranye nibikoresho bisanzwe bine bya PCR.Igicuruzwa gikoresha uburyo bwo gukora ibintu byose byitwa lyophilisation, kandi ibikoresho birashobora gutwarwa no kubikwa mubushyuhe bwicyumba, ibyo bikaba bikemura ikibazo cyububabare bwo gutwara iminyururu ikonje itwara ibintu bisanzwe, kandi birashobora kugabanya cyane ibikoresho byo gutwara no kugurisha ibicuruzwa byo hanze.Iki gicuruzwa gikoreshwa cyane cyane muri vitro gutahura papillomavirus yumuntu muri selile cervical exfoliated selile, ikubiyemo ubwoko 15 bwibyago byinshi, kandi irashobora kumenya ubwoko butatu bwa 16, 18 na 52. Igicuruzwa gifite ibiranga sensibilité nyinshi (LOD ni kopi 500 / ml ). ibisubizo ni ukuri kandi byizewe.

Kugura icyemezo cya FDA cyo kwiyandikisha muri Indoneziya ni ukumenyekanisha byimazeyo no kwemeza ibicuruzwa bya Chuangkun Biotech.Mu bihe biri imbere, tuzakomeza gukurikiza isoko rishingiye ku isoko, ubumenyi bwa tekinoloji n’ikoranabuhanga nk’inkunga, duhora tuzamura irushanwa ry’ibanze ry’imishinga, hamwe n’icyerekezo cy’isi yose cyo kubaka ibicuruzwa byiza, binyuze mu mbaraga zidatezuka no gutsimbarara, kugira ngo duteze imbere iterambere yinganda zubuzima, kugirango tugere ku nzozi zubuzima bwabantu kandi duharanire cyane!