umbhalo
Imininingwane Yomkhiqizo:
I-Innovita® Flu A/Flu B/2019-nCoV Ag 3 ku-1 Combo Test ihloselwe ukutholwa kwekhwalithi nokuhlukaniswa kwe-nucleocapsid antigen ohlotsheni lwe-Influenza Virus A, i-Influenza Virus uhlobo B kanye no-2019-nCoV ngokuqondile kuma-specimens we-nasopharyngeal swab .
Ingasetshenziswa kuphela ezikhungweni zobuchwepheshe.
Umphumela wokuhlolwa othi unayo idinga ukuqinisekiswa okwengeziwe. Umphumela wokuhlolwa onegethivu awukhiphi amathuba okutheleleka.
Imiphumela yokuhlolwa yale khithi ingeyenkomba yomtholampilo kuphela. Kunconywa ukwenza ukuhlaziya okuphelele kwesimo ngokusekelwe ekubonakalisweni komtholampilo kwesiguli kanye nezinye izivivinyo zaselabhorethri.
Isimiso:
Ikhithi iwukuhlola okusekelwe ku-double antibody sandwich immunoassay. Idivayisi yokuhlola iqukethe indawo yesifanekiso kanye nendawo yokuhlola.
1) Umkhuhlane A/Umkhuhlane B Ag: Indawo yesifanekiso iqukethe i-monoclonal antibody ngokumelene nephrotheni ye-Flu A/Flu BN. Umugqa wokuhlola uqukethe elinye i-monoclonal antibody ngokumelene nephrotheni ye-Flu A/Flu B. Ulayini wokulawula uqukethe amasosha omzimba we-IgG wembuzi-anti-mouse.
2) 2019-nCoV Ag: Indawo yesifanekiso iqukethe i-monoclonal antibody ngokumelene nephrotheni ye-2019-nCoV N kanye nenkukhu ye-IgY. Umugqa wokuhlola uqukethe enye i-monoclonal antibody ngokumelene nephrotheni ye-2019-nCoV N. Ulayini wokulawula uqukethe amasosha omzimba we-Rabbit-anti-chicken IgY.
Ngemva kokuba isifanekiso sisetshenziswe esibonelweni somthombo wedivayisi, i-antigen esifanekisweni yenza i-immune complex ene-antibody 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, izokwakha umugqa onsomi-obomvu kulayini wokuhlola (T). Ngokuphambene, uma ukugxila kwe-antigen ethile kuphansi kune-LOD, ngeke kwakhe umugqa onsomi-obomvu. Ukuhlola futhi kuqukethe isistimu yokulawula yangaphakathi. Ulayini wokulawula onsomi-obomvu (C) kufanele uvele njalo ngemva kokuqedwa kokuhlolwa. Ukungabikho komugqa wokulawula onsomi-bomvu kubonisa umphumela ongavumelekile.
Ukwakhiwa:
| Ukwakheka | Inani | Ukucaciswa |
| IFU | 1 | / |
| Hlola ikhasethi | 25 | Isikhwama ngasinye se-foil esivaliwe esiqukethe idivayisi eyodwa yokuhlola kanye ne-desiccant eyodwa |
| I-diluent yokukhishwa | 500μL*1 Ishubhu *25 | Ibhafa ye-Tris-Cl, NaCl, NP 40, ProClin 300 |
| Ithiphu ye-Dropper | 25 | / |
| I-Swab | 25 | / |
Inqubo Yokuhlola:
1.Iqoqo le-Specimen
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| 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. |
2.Ukuphathwa Kwesampula
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| 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. |
3.Inqubo Yokuhlola
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| 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. | 1. Khipha i-swab ephaketheni ngaphandle kokuthinta i-padding. |
Ukuhunyushwa Kwemiphumela:
