Iimveliso

Iinkcukacha zeMveliso:

I-Innovita®Umkhuhlane A/Umkhuhlane B/ 2019-nCoV Ag 3 kuVavanyo lweCombo olu-1 lwenzelwe ukufunyaniswa komgangatho kunye nokwahlulwa kwe-nucleocapsid antigen ukusuka kuhlobo lweNtsholongwane yoMkhuhlane A, uhlobo lweNtsholongwane yoMkhuhlane B kunye ne-2019-nCoV ngokuthe ngqo kwisampulu ze-nasopharyngeal swab ezifunyenwe kubantu.
Ingasetyenziswa kuphela kumaziko aqeqeshiweyo.
Iziphumo zovavanyo oluqinisekileyo zifuna uqinisekiso olongezelelweyo.Iziphumo zovavanyo olubi alukhupheli phandle ukuba kungenzeka usulelo.
Iziphumo zovavanyo zale khithi zezereferensi yezonyango kuphela.Kunconywa ukuba kuqhutywe uhlalutyo olubanzi lwemeko esekelwe kwimibonakaliso yekliniki yesigulane kunye nezinye iimvavanyo zebhubhoratri.

Umgaqo:

Ikhithi luvavanyo olusekwe kwisangweji ye-antibody ephindwe kabini.Isixhobo sovavanyo siquka indawo yomboniso kunye nendawo yovavanyo.
1) Umkhuhlane A/Umkhuhlane BAg: Indawo yomzekelo iqulethe i-antibody ye-monoclonal ngokuchasene nomkhuhlane A/Umkhuhlane BN protein.Umgca wovavanyo uqulethe enye i-antibody ye-monoclonal ngokuchasene neprotheni ye-Flu A/Flu B.Umgca wolawulo unebhokhwe-anti-mouse IgG antibody.
2) 2019-nCoV Ag: Indawo yomzekelo iqulethe i-monoclonal antibody ngokuchasene neprotein ye-2019-nCoV N kunye nenkukhu ye-IgY.Umgca wovavanyo uqulethe enye i-antibody ye-monoclonal ngokuchasene neprotheni ye-2019-nCoV N.Umgca wolawulo une-antibody ye-IgY yomvundla-anti-inkukhu.
Emva kokuba umzekeliso usetyenziswe kumzekelo wequla lesixhobo, i-antigen kwisampulu yenza i-immune complex kunye ne-antibody ebophayo kwindawo yomzekelo.Emva koko i-complex ifudukela kwindawo yokuvavanya.Umgca wovavanyo kwindawo yovavanyo uqulethe i-antibody esuka kwi-pathogen ethile.Ukuba ukuxinwa kwe-antigen ethile kwi-specimen iphezulu kune-LOD, iya kwenza umgca omfusa-obomvu kumgca wokuvavanya (T).Ngokwahlukileyo, ukuba i-concentration ye-antigen ethile iphantsi kune-LOD, ayiyi kwenza umgca omfusa-obomvu.Uvavanyo lukwanalo nenkqubo yolawulo lwangaphakathi.Umgca wokulawula obomvu-obomvu (C) kufuneka uhlale uvela emva kokuba uvavanyo lugqityiwe.Ukungabikho komgca wolawulo omfusa-bomvu kubonisa isiphumo esingasebenziyo.

Ukuqulunqwa:

Inkqubo yoVavanyo:

1. Iimfuno zokuqokelelwa kwemizekelo:
1.Beka i-swab kwelinye leempumlo zesigulane de ifike kwi-nasopharynx yangasemva;qhubeka ufaka de kufike ukuchasana okanye umgama ulingana naloo nto ukusuka endlebeni ukuya kwimpumlo yesigulane.I-swab kufuneka ijikelezwe kwi-nasopharyngeal mucosa ngamaxesha angama-5 okanye ngaphezulu, kwaye emva koko ikhutshwe.
I-2.I-swabs eyomileyo eqokelelwe ngokutsha kufuneka iqhutywe ngokukhawuleza, kodwa ingadlulanga iyure eli-1 emva kokuqokelela i-specimen.

2. Ukuphatha isampuli:

3.Iziphumo zokutolikwa