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2019 Ubushinwa Igishushanyo gishya Ubushinwa Igiciro Cyiza Kumenya Antigen Byihuta Ikizamini hamwe na CE

Ibisobanuro:

Iki gikoresho gikoresha tekinoroji nyayo ya RT PCR (rRT-PCR) kugirango hamenyekane neza SARS-CoV-2 hamwe nimirongo itandukanye nucleic acidein nasofaryngeal cyangwa oropharyngeal swab urugero nka SARS-CoV-2 B.1.1.7 umurongo (UK), umurongo wa B.1.351 (ZA) na P.1 (BR).

Iki gikoresho ni combo yo gutunganya aside nucleic hamwe nibikoresho bya RT-qPCR byerekana ibikoresho bya SARS-CoV-2 Acide nucleic aside.Ntabwo rero hakenewe kwezwa aside nucleic, ni ubukungu.Irashobora kurangiza ikizamini mumasaha 1, cyane cyane ikwiranye nubunini bunini bwihuse.


Ibicuruzwa birambuye

Ibicuruzwa

Hamwe niyi ntego, twahindutse rwose kuba umwe mubakora udushya mu ikoranabuhanga, gukoresha amafaranga menshi, no guhatanira ibiciro mu mwaka wa 2019 Ubushinwa Bwashushanyije Ubushinwa Ibiciro Byihuta Byihuta Antigen Rapid Test Kit hamwe na CE, Hamwe n’ubuyobozi bw’inganda, isosiyete yamye yiyemeje gutera inkunga abakiriya kugira ngo babe umuyobozi w’isoko mu nganda zabo.
Hamwe niyi ntego, twahindutse rwose kuba umwe mubakora udushya mu ikoranabuhanga, dukoresha amafaranga menshi, kandi duhatanira ibiciro kuriIkizamini cya Antigen, Ubushinwa Antigen Byihuta, Muguhuza inganda ninzego zubucuruzi n’ububanyi n’amahanga, dushobora gutanga ibisubizo byuzuye byabakiriya twizeza itangwa ryibicuruzwa byiza nibisubizo ahantu heza mugihe gikwiye, ibyo bikaba bishyigikirwa nubunararibonye bwacu bwinshi, ubushobozi bukomeye bwo gukora, ubuziranenge buhoraho, ibicuruzwa bitandukanye bitandukanye hamwe no kugenzura imigendekere yinganda kimwe na serivise zacu zikuze mbere na nyuma yo kugurisha.Turashaka gusangira nawe ibitekerezo byacu kandi twishimiye ibitekerezo byanyu nibibazo.
Ikizamini cya SARS-CoV-2 Antigen igamije kumenya neza antigen nucleacapsid proteine ​​antigen ikomoka kuri SARS-CoV-2 muri nasopharyngeal (NP) na nasab (NS) swab, hamwe n'amacandwe y'amacandwe aturuka kubantu ku giti cyabo kandi ni ubufasha mu gusuzuma byihuse abarwayi bakekwaho kwandura SARS-CoV-2.

Ibisobanuro

1T / Kit, 20T / Kit

Ibiranga ibyiza

Hitamo neza antibody idasanzwe ya monoclonal kuri nucleocapsid protein antigen ya SARS-CoV-2;

Ingero zitandukanye zikoreshwa;Nasopharyngeal (NP) swab, Nasal (NS) swab na Amacandwe;

Run Kwiruka byoroshye, byoroshye gusobanurwa n'amaso yambaye ubusa;

Result Ibisubizo by'ibizamini bizaboneka mu minota 15.

Imikorere

-GUKURIKIRA: 1.5 × 102TClD50kuri virusi lysate, 10pg / mL ya recombinant Nucleocapsid protein antigen.

-Gereranije nuburyo bwa NAT, ingero hamwe na Ct intera iri hagati ya 30-35 izamenyekana.

-Nta reaction zifatika hamwe na bagiteri zitandukanye, virusi nibihumyo mubisanzwe biboneka mumyanya y'ubuhumekero.

-Amasezerano meza (95% Cl): 30/31 96.8% (83.3% -99.9%)

-Amasezerano gakondo (95% Cl): 80/80 100.0% (95.5% -100%).

Ububiko

1. Igikoresho cyo kwipimisha cyumva ubushuhe kimwe nubushyuhe.

2. Bika ibikoresho bigize ibikoresho kuri 2-30 ° C, biturutse ku zuba ryinshi.Ibigize ibikoresho birahagaze kugeza igihe cyo kurangiriraho cyacapwe kumasanduku yo hanze.

3. Nyuma yo gufungura umufuka wa aluminiyumu, cassette yikizamini igomba gukoreshwa vuba bishoboka mumasaha abiri.

4. Ntugahagarike. Hamwe niyi ntego, twahindutse rwose kuba umwe mubakora udushya twinshi mu ikoranabuhanga, gukoresha neza, no guhatanira ibiciro muri 2019 Ubushinwa Bwashushanyije Ubushinwa Ibiciro Byihuse Byihuta Byihuta Antigen Rapid Test Kit hamwe na CE, Hamwe n’ubuyobozi bw’inganda, isosiyete yamye yiyemeje gutera inkunga abakiriya kugira ngo babe umuyobozi w’isoko mu nganda zabo.
2019 Ubushinwa Igishushanyo gishyaUbushinwa Antigen Byihuta, Ikizamini cya Antigen, Muguhuza inganda ninzego zubucuruzi n’ububanyi n’amahanga, dushobora gutanga ibisubizo byuzuye byabakiriya twizeza itangwa ryibicuruzwa byiza nibisubizo ahantu heza mugihe gikwiye, ibyo bikaba bishyigikirwa nubunararibonye bwacu bwinshi, ubushobozi bukomeye bwo gukora, ubuziranenge buhoraho, ibicuruzwa bitandukanye bitandukanye hamwe no kugenzura imigendekere yinganda kimwe na serivise zacu zikuze mbere na nyuma yo kugurisha.Turashaka gusangira nawe ibitekerezo byacu kandi twishimiye ibitekerezo byanyu nibibazo.


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