I-IMMUNOBIO 2019-NCOV Ikhithi yovavanyo lwe-Antigen isetyenziselwa kuphela ukufumanisa i-vitro esemgangathweni ye-2019-ncov antigen evela kwi-nasopharyngeal swabs yabantu okanye kwi-oropharyngeal swabs specimens.

I-IMMUNOBIO 2019-NCOV Antigen yokuvavanya ikhithi iyasebenza kuxilongo oluncedisayo lwenoveli ye-coronavirus ka-2019, iziphumo zereferensi yeklinikhi kuphela kwaye ayinakusetyenziswa njengesiseko sodwa sokufumanisa isifo kunye nesigqibo sokukhetha.

Iziphumo zovavanyo ezifanelekileyo kufuneka ziphinde ziqinisekiswe, iziphumo ezingalunganga aziluthinteli usulelo lwe-2019 Ivd.

I-IMMUNOBIO 2019-NCOV Antigen yokuvavanya ikhithi yenzelwe ukuba isetyenziswe ngabasebenzi abaqeqeshiweyo nabaqeqeshiweyo bezonyango zaselabhoratri abafundiswe ngokukodwa baqeqeshwa kubuchule beenkqubo ze-vitro diagnostic.

Iimbonakalo

A. Uvavanyo olukhawulezileyo, isiphumo siya kuboniswa imizuzu eli-10-15

Ubuntununtunu be-Immuno 2019 coronavirus yovavanyo olukhawulezileyo lwekhithi: 95.6%

Ukucaciswa kwe-Immuno 2019 COVID Antigen yovavanyo olukhawulezileyo lwekit: 100%.

D. Iyasebenza kwimpumlo nangomqala

E. Funa ii-specimens ezincinci, zimbalwa iimpumlo zempumlo okanye zomqala

Ugunyazisiwe Izatifikethi

1. Kunye CE Mark, DOC Kwaye ISO 13485

2. Vuma nguMphathiswa Wezempilo waseJamani

3. Uluhlu olumhlophe lwase China Umthengisi oqinisekisiweyo

Uvavanyo Pumvelisi 

1. Thatha uvavanyo lwe-2019 COVID Antigen yovavanyo olukhawulezileyo lwe-specimen, i-buffer, kunye / okanye ulawulo lokulinganisa kubushushu begumbi (15-30 ° C) ngaphambi kovavanyo.

2. Susa ikhithi yovavanyo lwe-Antigen kwisingxobo esitywiniweyo kwaye uyisebenzise ngokukhawuleza.

3. Beka isixhobo sovavanyo esikhawulezayo se-Antigen kwindawo ecocekileyo ethe tyaba. Guqula ityhubhu yokuqokelela isampuli, ukhuphe amathontsi ama-3 e-specimen elungisiweyo kwi-specimen kakuhle (S) yekhasethi yovavanyo kwaye uqalise isibali-xesha. Jonga umzekeliso ongezantsi.

4. Lindela imigca enemibala ukuba ivele. Funda iziphumo kwimizuzu eli-10. Musa ukutolika iziphumo emva kwemizuzu eli-15.

UTSHINTSHO LWEZIPHUMO

- Efanelekileyo (+): Imigca emibini enemibala iyavela. Umgca omnye wemibala kufuneka uhlale uvela kummandla wolawulo lwendawo (C) kwaye omnye umgca kufuneka ubengummandla we-T. * QAPHELA: Ukuqina kombala kwimimandla yovavanyo yovavanyo kuyahluka ngokuxhomekeka kwi-SARS-CoV-2 ekhoyo kwisampuli. Ke ngoko, nawuphi na umthunzi wombala kumda wovavanyo kufuneka uthathwe ngokuba ulungile kwaye urekhodwe ngolo hlobo. - Okubi (-): Umgca omnye wemibala uvela kummandla wolawulo (C). Akukho mgca uvela kwingingqi yomgca we-T. -Ayisebenzi: Umgca wolawulo uyasilela ukuvela. Umthamo weesampuli ongonelanga okanye ubuchwephesha benkqubo engachanekanga zezona zizathu zokuba usilele kumgca wokulawula. Ukuphonononga inkqubo kwaye uphinde uvavanyo ngovavanyo olutsha. Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikiti yovavanyo kwangoko kwaye unxibelelane nomhambisi wakho wobulali