Imikhiqizo

Imininingwane Yomkhiqizo:

I-Innovata®Umkhuhlane A/Umkhuhlane 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 kumasampula e-nasopharyngeal swab atholwe kubantu ngabanye.
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 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.
1) Umkhuhlane A/Umkhuhlane BAg: Indawo yesifanekiso iqukethe i-monoclonal antibody ngokumelene nomkhuhlane A/Umkhuhlane BN amaprotheni.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 neprotein ye-2019-nCoV N kanye nenkukhu ye-IgY.Ulayini 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 kungaphansi kune-LOD, ngeke kwenze 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:

Inqubo Yokuhlola:

1. Izidingo zokuqoqwa kwesifanekiso:
1.Faka i-swab emakhaleni esiguli 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.Ama-swabs omisiwe aqoqwe kabusha kufanele acutshungulwe ngokushesha ngangokunokwenzeka, kodwa kungakapheli ihora elingu-1 ngemva kokuqoqwa kwesifanekiso.

2. Ukuphatha isifanekiso:

3.Ukuhunyushwa kwemiphumela