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I-2019 yaseChina iYilo eNtsha yaseTshayina iXabiso eliLungileyo lokuFumana i-Antigen eKhawulezayo yoVavanyo lweKhiti kunye ne-CE

Inkcazelo yeKit:

Le khithi isebenzisa ubuchwepheshe be-Real-time RT PCR (rRT-PCR) ekubhaqweni komgangatho we-SARS-CoV-2 kunye nemigca eyohlukileyo ye-nucleic acidsin iisampulu zeswab zabantu ze-nasopharyngeal okanye i-oropharyngeal ezifana ne-SARS-CoV-2 B.1.1.7 umnombo (UK), B.1.351 umgca1 (ZA) kunye ne-P.

Le khithi yikhithi yokucoca i-nucleic acid kunye nekhithi yokufumanisa i-RT-qPCR ye-SARS-CoV-2 Variant nucleic acid.Ngaloo ndlela akukho mfuneko yokuhlanjululwa kwe-nucleic acid, kuqoqosho.inokugqiba uvavanyo kwiyure e-1, ngakumbi ilungele ukubonwa ngokukhawuleza okukhulu.


Iinkcukacha zeMveliso

Iithegi zeMveliso

Sinale motto engqondweni, ngokuqinisekileyo siye saba ngomnye wabavelisi abavelisa izinto ezintsha, abaxabisa kakhulu, kunye nabakhuphisana ngamaxabiso ngo-2019 China Uyilo olutsha lwaseTshayina ngeXabiso eliLungileyo lokuFumana i-Antigen eRapid Test Kit nge-CE, ngenzuzo yolawulo lweshishini, inkampani ibisoloko izibophelele ekuxhaseni abathengi ukuba babe yinkokeli yemarike kumashishini abo.
Sinale motto engqondweni, ngokuqinisekileyo siye saba ngomnye wabona benzi bobuchwepheshe buvelisa izinto ezintsha, bonga iindleko, nabakhuphisana ngamaxabiso ezinto.I-Antigen Test Kit, China Antigen Rapid Test Kit, Ngokudibanisa imveliso kunye namacandelo orhwebo angaphandle, sinokubonelela ngezisombululo zabathengi zizonke ngokuqinisekisa ukuhanjiswa kweemveliso ezifanelekileyo kunye nezisombululo kwindawo efanelekileyo ngexesha elifanelekileyo, elixhaswa ngamava ethu amaninzi, amandla okuvelisa amandla, umgangatho ongaguqukiyo, iipotfoliyo zeemveliso ezahlukeneyo kunye nolawulo lwendlela yoshishino kunye neenkonzo zethu ezivuthiweyo ngaphambi nasemva kokuthengisa.Singathanda ukwabelana nawe ngezimvo zethu kwaye samkele izimvo kunye nemibuzo yakho.
Uvavanyo lwe-SARS-CoV-2 Antigen lwenzelwe ukufunyaniswa okusemgangathweni kwe-nucleacapsid protein antigen evela kwa-SARS-CoV-2 kwi-nasopharyngeal (NP) kunye ne-nasal (NS) swab, kunye nesampulu zamathe ngqo kubantu kwaye inceda ekuxilongeni ngokukhawuleza kwezigulana ezinosulelo lwe-SARS-CoV-2.

Inkcazo

1T/Kit,20T/Kit

Iimpawu&izinto eziluncedo

∎ Ukukhetha ngononophelo i-antibody eyodwa ye-monoclonal kwi-nucleocapsid protein antigen evela kwa-SARS-CoV-2;

■ imizekelo eyahlukeneyo esetyenzisiweyo;I-Nasopharyngeal (NP) i-swab, i-Nasal (NS) i-swab kunye ne-Saliva;

■ Ukubaleka ngokulula, kulula ukutolika ngamehlo;

■ Iziphumo zovavanyo ziya kubakho kwimizuzu eli-15.

Imiboniso

-LoD:1.5×102I-TClD50kwi-virus lysate, i-10pg/mL ye-recombinant Nucleocapsid protein antigen.

-Xa kuthelekiswa nendlela ye-NAT, iisampuli ezinoluhlu lwe-Ct phakathi kwe-30-35 ziya kubonakala.

-Akukho zimpendulo ezinqamlezayo kunye neebhaktheriya ezahlukeneyo, iintsholongwane kunye nomngundo oqhelekileyo ofumaneka kumzila wokuphefumla.

-IsiVumelwano esiPositive(95% Cl):30/31 96.8% (83.3%-99.9%)

-Negative Agreement(95% Cl):80/80 100.0%(95.5%-100%).

Ugcino

1. Isixhobo sovavanyo sinovakalelo kukufuma kunye nobushushu.

2. Gcina izixhobo zekhithi kwi-2-30 ° C, ngaphandle kwelanga elithe ngqo.Amacandelo ekhithi azinzile de kube ngumhla wokuphelelwa kwawo oprintwe kwibhokisi yangaphandle.

3. Emva kokuvula isikhwama se-aluminium foil, i-cassette yovavanyo kufuneka isetyenziswe ngokukhawuleza kwiiyure ezimbini.

4. Ungakhe ube ngumkhenkce. Unale motto engqondweni, ngokuqinisekileyo siye saba yenye yezona zinto zintsha kwezobuchwepheshe, iindleko-zoneleyo, kunye nabavelisi abakhuphisana nexabiso ngo-2019 China Uyilo olutsha lwaseTshayina ngeXabiso eliLungileyo lokuFumana i-Antigen eKhawulezayo yoVavanyo lweKit nge-CE, Ngenzuzo yolawulo lweshishini, inkampani ibisoloko izibophelele ekuxhaseni abathengi babo ukuba babe yinkokeli yemarike.
2019 Uyilo olutsha lwaseTshayinaChina Antigen Rapid Test Kit, I-Antigen Test Kit, Ngokudibanisa imveliso kunye namacandelo orhwebo angaphandle, sinokubonelela ngezisombululo zabathengi zizonke ngokuqinisekisa ukuhanjiswa kweemveliso ezifanelekileyo kunye nezisombululo kwindawo efanelekileyo ngexesha elifanelekileyo, elixhaswa ngamava ethu amaninzi, amandla okuvelisa amandla, umgangatho ongaguqukiyo, iipotfoliyo zeemveliso ezahlukeneyo kunye nolawulo lwendlela yoshishino kunye neenkonzo zethu ezivuthiweyo ngaphambi nasemva kokuthengisa.Singathanda ukwabelana nawe ngezimvo zethu kwaye samkele izimvo kunye nemibuzo yakho.


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