Ukuhlolwa kwe-2019-nCoV Ag (I-Latex Chromatography Assay) / Ukuhlolwa Kochwepheshe / I-Nasopharyngeal Swab
Imininingwane Yomkhiqizo:
I-Innovita® 2019-nCoV Ag Test ihloselwe ukutholwa okuqondile nokusezingeni eliphezulu kwe-SARS-CoV-2 nucleocapsid protein antigen kuma-nasopharyngeal swabs avela kubantu okusolwa ukuthi bane-COVID-19 ngumhlinzeki wabo wezempilo phakathi kwezinsuku eziyisikhombisa zokuqala kwezimpawu. noma ukuhlola abantu ngaphandle kwezimpawu noma ezinye izizathu zokusola ukutheleleka nge-COVID-19.
Imiphumela yokuhlolwa yale khithi ingeyenkomba yomtholampilo kuphela.Kunconywa ukwenza ukuhlaziywa okuphelele kwesimo ngokusekelwe ekubonakalisweni komtholampilo kwesiguli kanye nezinye izivivinyo zaselabhorethri.
Isimiso:
Ikhithi iyisivivinyo esisekelwe ku-double antibody sandwich immunoassay.Idivayisi yokuhlola iqukethe indawo yesifanekiso kanye nendawo yokuhlola.I-specimen zone iqukethe i-monoclonal antibody ngokumelene ne-SARS-CoV-2 N amaprotheni kanye ne-chicken IgY zombili ezibhalwe ngama-latex microspheres.Ulayini wokuhlola uqukethe elinye i-monoclonal antibody ngokumelene namaprotheni e-SARS-CoV-2 N.Ulayini wokulawula uqukethe amasosha omzimba we-Rabbit-anti-chicken IgY.
Ngemva kokuba isifanekiso sisetshenziswe esibonelweni somthombo wedivayisi, i-antigen kusifanekiso yakha i-immune complex ene-reagent ebophayo endaweni yesifanekiso.Bese i-complex ithuthela endaweni yokuhlola.Umugqa wokuhlola endaweni yokuhlola uqukethe amasosha omzimba asuka ku-pathogen ethile.Uma ukugxila kwe-antigen ethile kusifanekiso kungaphezu kwe-LoD, izoshuthwa kulayini wokuhlola (T) bese yakhe umugqa obomvu.Ngokuphambene, uma ukugxiliswa kwe-antigen ethile kuphansi kune-LoD, ngeke yakhe umugqa obomvu.Ukuhlola futhi kuqukethe isistimu yokulawula yangaphakathi.Ulayini wokulawula obomvu (C) kufanele uvele njalo ngemva kokuqedwa kokuhlolwa.Ukungabi bikho komugqa wokulawula obomvu kubonisa umphumela ongavumelekile.
Ukwakhiwa:
| Ukwakheka | Inani |
| IFU | 1 |
| Hlola ikhasethi | 1/25 |
| I-diluent yokukhishwa | 1/25 |
| Ithiphu ye-Dropper | 1/25 |
| Uswazi | 1/25 |
Inqubo Yokuhlola:
1.Iqoqo le-Specimen
Faka i-swab kwelinye lekhala lesiguli kuze kube yilapho ifinyelela ku-nasopharynx yangemuva;qhubeka ufaka kuze kube yilapho uhlangabezana nokuphikiswa noma ibanga lilingana nalelo ukusuka endlebeni kuya ekhaleni lesiguli.I-swab kufanele ijikelezwe ku-mucosa ye-nasopharyngeal izikhathi ezingu-5 noma ngaphezulu, bese ikhishwa.
2.Ukuphathwa Kwesampula
3.Inqubo Yokuhlola
● Vumela idivayisi yokuhlola, isifanekiso ne-diluent ukuthi ilingane nezinga lokushisa legumbi elingu-15~30℃ ngaphambi kokuvula isikhwama.Khipha idivayisi yokuhlola esikhwameni se-aluminium evaliwe ye-foil.
● Faka amaconsi ama-3 esampula emthonjeni.
● Linda ukuthi ulayini obomvu uvele kuzinga lokushisa legumbi.Funda imiphumela phakathi kwemizuzu eyi-15–30.Ungawufundi umphumela ngemuva kwemizuzu engama-30.
Ukuhunyushwa Kwemiphumela:
