Amakuru

1. Ibura ry'ibikoresho byo kumenya aside nucleic bizahinduka ikibazo cyisi yose.

2. Ibigo bya IVD byabashinwa bifite ubushobozi bwo kujya mumahanga no guhangana ninganda zo ku isi.

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

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

Kugeza ubu, Ikigo cya Leta gishinzwe ibiryo n’ibiyobyabwenge cyemeje ibikoresho 20 byo kwisuzumisha hanze y’umubiri mu bihe byihutirwa, birimo 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 ry'ibikoresho byo gupima aside nucleique bizaba ikibazo ku isi yose, mu gihe biteganijwe ko ibikoresho bikenerwa cyane bikozwe mu Bushinwa bizakomeza kuba byinshi.

Raporo y’ubushakashatsi yerekana ko byibuze ibihugu 26 byohereje 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 UMUNTU biracyakemuka."

Vuba aha, umubare wibigo byinshi bya IVD ibicuruzwa byambitswe ikamba nicyemezo cya mbere cyamahanga 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 bya fluorescent RT-PCR byakozwe na BGI kugira ngo hamenyekane SARS-2019-NCOV byemejwe na FDA kandi birashobora gushyirwa ku mugaragaro mu gukumira icyorezo no kugenzura muri Amerika. Nibicuruzwa byambere byabashinwa byatsinze FDA byihutirwa.
Mubyukuri, imishinga yubushinwa IVD ifite ubushobozi bwo kujya mumahanga no guhangana ninganda zo ku isi.

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


Igihe cyo kohereza: Nyakanga-15-2020