Uvavanyo lwe-Ag ye-2019-nCoV (I-Latex Chromatography Assay) / Uvavanyo lobuNgcali / amathe
Iinkcukacha zeMveliso:
Uvavanyo lwe-Innovita® 2019-nCoV Ag lwenzelwe ukufunyaniswa ngokuthe ngqo kunye nomgangatho we-SARS-CoV-2 nucleocapsid protein antigen kumathe kubantu abarhanelwa ukuba bane-COVID-19 ngumboneleli wabo wezempilo kwiintsuku ezisixhenxe zokuqala zeempawu okanye ukuhlola abantu ngaphandle kweempawu okanye ezinye izizathu zokukrokrela usulelo lwe-COVID-19.
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.Indawo yomzekelo iqulethe i-antibody ye-monoclonal ngokuchasene neprotheyini ye-SARS-CoV-2 N kunye nenkukhu ye-IgY ebhalwe zombini nge-latex microspheres.Umgca wovavanyo uqulethe enye i-antibody ye-monoclonal ngokuchasene neprotheni ye-SARS-CoV-2 N.Umgca wolawulo une-antibody ye-IgY yomvundla-anti-inkukhu.
Emva kokuba i-specimen isetyenziswe kwi-specimen well yesixhobo, i-antigen kwi-specimen yenza i-immune complex kunye ne-reagent ebophelelayo kwindawo ye-specimen.Emva koko i-complex ifudukela kwindawo yokuvavanya.Umgca wovavanyo kwindawo yovavanyo uqulethe i-antibody esuka kwi-pathogen ethile.Ukuba i-concentration ye-antigen ethile kwi-specimen iphezulu kune-LoD, iya kubanjwa kumgca wokuvavanya (T) kwaye wenze umgca obomvu.Ngokwahlukileyo, ukuba i-concentration ye-antigen ethile iphantsi kune-LoD, ayiyi kwenza umgca obomvu.Uvavanyo lukwanalo nenkqubo yolawulo lwangaphakathi.Umgca wokulawula obomvu (C) kufuneka uhlale uvela emva kokuba uvavanyo lugqityiwe.Ukungabikho komgca wolawulo obomvu kubonisa umphumo ongasebenziyo.
Ukuqulunqwa:
| Ukuqamba | Isixa |
| IFU | 1 |
| Ikhasethi yovavanyo | 1/20 |
| Ukukhutshwa kwe-diluent | 1/20 |
| Umqokeleli amathe | 1/20 |
Inkqubo yoVavanyo:
1.Ukuqokelelwa komzekelo kunye nokuPhathwa
● Khipha umnqwazi we-diluent yokutsalwa kwaye ubeke umqokeleli wamathe kuwo.
● Hlamba umlomo ngamanzi.Khohlela kakhulu kathathu.Shica amathe ukusuka kwi-oropharynx yangasemva ukuya kwifunnel evulekileyo.Qokelela amathe ngomqokeleli wamathe ukuya kumgca wokuzalisa.Musa ukudlula umgca wokuzalisa.
● Susa umqokeleli wamathe kwaye ujije isiciko setyhubhu yesampuli kwakhona.
● Vuthulula ityhubhu yokuvavanya amaxesha ali-10 ukuze amathe adibanise kakuhle kunye ne-extraction diluent.Emva koko makhe ume umzuzu we-1 kwaye ugubungele kakuhle kwakhona.
• Ukuba isampulu yamathe ibonakala ilifu, yiyeke ukuze izinze phambi kovavanyo.Umzekelo
2.Inkqubo yoVavanyo
● Vumela isixhobo sovavanyo, umzekelo kunye ne-diluent zilingane kwiqondo lobushushu begumbi 15~30℃ phambi kokuvula isingxobo.Susa isixhobo sovavanyo kwisingxobo sefoil etywiniweyo yealuminiyam.
● Galela amathontsi angama-4-5 omzekelo wovavanyo kumthombo wequla.
● Lindela ukuba umgca obomvu ubonakale kwiqondo lobushushu begumbi.Funda iziphumo phakathi kwe-15 ~ 30 imizuzu.Musa ukufunda umphumo emva kwemizuzu engama-30.
Iziphumo Utoliko:
