I-IMMUNOBIO 2019-NCOVIkhithi yovavanyo lwe-Antigenisetyenziselwa kuphela ukufumanisa umgangatho we-in vitro we-2019-ncov antigen ukusuka kwi-nasopharyngeal swabs okanye i-oropharyngeal swabs specimens.

The IMMUNOBIO 2019-NCOV Antigen test kit is applicable for the auxiliary diagnosis of 2019 2019 novel coronavirus, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision.

Iziphumo zovavanyo oluhle zifuna ukuqinisekiswa ngakumbi, iziphumo ezingalunganga aziluthinteli usulelo lwe-Ivd ka-2019.

I-IMMUNOBIO 2019-NCOV ikiti yovavanyo ye-Antigen yenzelwe ukusetyenziswa ngabasebenzi belabhoratri yezonyango abaqeqeshiweyo nabaqeqeshiweyo abayalelwe ngokukodwa kwaye baqeqeshwe kubuchule beenkqubo zokuxilonga kwi-vitro.

Iimbonakalo

A. Uvavanyo olukhawulezayo kakhulu, iziphumo ziya kuboniswa imizuzu eyi-10-15

B. Uvakalelo lwe-Immuno 2019 coronavirus kit yovavanyo olukhawulezayo: 95.6%

C. Ukucaciswa kwe-Immuno 2019 COVID Antigen yovavanyo lwekhithi yovavanyo olukhawulezayo: 100%.

D. Isebenza kwimpumlo kunye neSwab yoMqala

E.Funa iiSampulu ezincinci, iimpumlo ezimbalwa okanye i-swabs yomqala

Igunyazisiwe iziqinisekiso

1. Nge-CE Mark, i-DOC kunye ne-ISO 13485

2. VumanguMphathiswa wezeMpilo waseJamani

3. Uluhlu olumhlophe lwaseTshayina uMboneleli oQinisekisiweyo

UvavanyoPumqhubi 

1. Thatha uvavanyo luka-2019 lwe-COVID Antigen uvavanyo olukhawulezayo lwekhithi yovavanyo, isithinteli, kunye/okanye ulawulo ukuze lulingane nobushushu begumbi (15-30°C) phambi kovavanyo.

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

3. Beka isixhobo sovavanyo olukhawulezayo lwe-Antigen kwindawo ecocekileyo nethe tye.Buyisa umva ityhubhu yokuqokelela i-specimen, khupha amathontsi ama-3 omfanekiso olungisiweyo kwiqula le-specimen (S) lekhasethi yovavanyo kwaye uqalise isibali-xesha.Jonga umfanekiso ongezantsi.

4. Lindela ukuba kuvele umgca onemibala.Funda iziphumo ngemizuzu eyi-10.Musa ukutolika umphumo emva kwemizuzu eli-15.

UKUTOLIKWA KWEZIPHUMO

- Okuhle (+): Kuvela imigca emibini enemibala.Umgca omnye onemibala kufuneka uhlale uvela kummandla wolawulo (C) kwaye omnye umgca kufuneka ube kwindawo ye-T.*QAPHELA: Ubunzulu bombala kwiindawo zovavanyo bunokwahluka ngokuxhomekeke kuxinzelelo lwe-SARS-CoV-2 ekhoyo kumzekelo.Ke ngoko, nawuphi na umthunzi wombala kwingingqi yovavanyo kufuneka ithathwe njengelungileyo kwaye irekhodwe ngolo hlobo.– Engalunganga (-): Umgca omnye onemibala ubonakala kwingingqi yolawulo (C).Akukho mgca uvelayo kwindawo yomgca we-T.-Ayisebenzi: Umgca wolawulo uyasilela ukubonakala.Umthamo wesampulu engonelanga okanye ubuchule benkqubo obungachanekanga zezona zizathu ezinokuthi zibe kho zokungaphumeleli komgca wolawulo.Hlaziya inkqubo kwaye uluphinde uvavanyo ngovavanyo olutsha.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikiti yovavanyo ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo