1. Ibura ryibikoresho byo kumenya aside nucleic bizaba ikibazo cyisi yose.

2. Ibigo bya IVD byabashinwa bifite ubushobozi bwo kujya mumahanga no guhangana nisi - imishinga yo murwego rwo hejuru.

3, kubizamini byo kwisoko reagent akajagari, igikorwa cyo kugenzura ibiyobyabwenge!

Ibigo byinshi bya IVD byabonye icyiciro cya mbere cyemezo cyamahanga kubicuruzwa byabo bishya bya corona

Kugeza ubu, Ikigo cya Leta gishinzwe ibiryo n’ibiyobyabwenge cyemeje 20 kuri - bya - ibikoresho byo gusuzuma umubiri mu gihe cyihutirwa, harimo reagent 12 za nucleic aside na reagent 8 za antibody.
Raporo y’ubushakashatsi bw’iburengerazuba bw’Ubushinwa ivuga ko buri munsi isi ikoresha ibikoresho byo gupima aside nucleic 500.000 kugeza 700.000 buri munsi. Ibura ryibikoresho byo gupima aside nucleic bizahinduka ikibazo cyisi yose, mugihe icyifuzo cyo hejuru - ibikoresho byiza bikozwe mubushinwa biteganijwe ko kizakomeza kuba kinini.

Raporo y’ubushakashatsi yerekana ko nibura ibihugu 26 byatanze ibicuruzwa mu Bushinwa, hamwe n’ibikoresho birenga miliyoni 15. Ku wa kabiri, AMA yagize ati: "Ibura rikomeye ry'ibikoresho byo gutahura Coronavirus n'ibikoresho byo gukingira abantu biracyakemuka."

Vuba aha, umubare wibigo byinshi bya IVD ibicuruzwa bishya byambitswe ikamba ryambere ryamahanga ku isoko. Mu masosiyete yashyizwe ku rutonde, byibuze ibigo 9 byashyizwe ku rutonde, birimo Meikang Biotechnology, Peoson Biotechnology, Cape Biotechnology, Anke Biotechnology, Daan Genomics, Wanfu Biotechnology, Mike Biotechnology na Hangzhou Realytech, bavuga ko ibicuruzwa byabo babonye icyemezo cya EU CE.

AusDiagnostics inc., Roche Diagnostics Inc., Vivacheck Inc., Zhijiang Group LTD., CTK Itsinda LTD. Ku wa gatandatu, tariki ya 22 Werurwe, (TGA) na Hollogier Group Inc (TGA), nk'uko bitangazwa n’ubuyobozi bushinzwe ibiyobyabwenge muri Ositaraliya (TGA). Hangzhou Otai, Vivacheck na Shanghai Zhijiang ni imishinga ya IVD yo mu gihugu.

Muri Amerika, nk'uko urubuga rwemewe rwa FDA rubitangaza, ibikoresho nyabyo - igihe fluorescent RT - PCR PCR yakozwe na BGI kugirango hamenyekane SARS - 2019 - NCOV yemejwe na FDA kandi irashobora gushyirwa kumugaragaro mu gukumira no kurwanya icyorezo muri Amerika. Nibicuruzwa byambere byabashinwa byatsinze FDA byihutirwa.
Mubyukuri, abashoramari IVD bo mubushinwa bafite ubushobozi bwo kujya mumahanga no guhangana nisi - imishinga yo murwego rwo hejuru.

Hangzhou Realytech yatsinze icyemezo cya FDA. Igitabo cya Coronavirus cyo kumenya ni kinini. Nyamuneka nyamuneka twandikire niba ubikeneyegura coronavirus byihuse gutahura reagent kubwinshi.