Uvavanyo lwe-Ag ye-2019-nCoV (I-Latex Chromatography Assay) / Uvavanyo lobuNgcali / i-Nasopharyngeal Swab
Iinkcukacha zeMveliso:
Uvavanyo lwe-Innovita® 2019-nCoV Ag lwenzelwe ukuchongwa ngokuthe ngqo kunye nomgangatho we-SARS-CoV-2 nucleocapsid protein antigen kwi-nasopharyngeal swabs evela kubantu ekurhanelwa ukuba bane-COVID-19 ngumboneleli wabo wezempilo kwiintsuku ezisixhenxe zokuqala kweempawu. 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 | 1/25 |
| Ukukhutshwa kwe-diluent | 1/25 |
| Ingcebiso yedropha | 1/25 |
| Swab | 1/25 |
Inkqubo yoVavanyo:
1.Ingqokelela yoMfanekiso
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.
2.Ukuphathwa koMfanekiso
3.Inkqubo yoVavanyo
● Vumela isixhobo sovavanyo, umzekelo kunye nediluyinti ilingane neqondo lobushushu begumbi 15~30℃ phambi kokuvula isingxobo.Susa isixhobo sovavanyo kwisingxobo sefoil etywiniweyo yealuminiyam.
● Galela amathontsi ama-3 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:
