Isivivinyo se-Aehealth 2019- nCov antigen sithole imvume ekhethekile evela e-German Federal Institute for Drugs and Medical Devices (BfArM) ngokusho §11 isigaba 1 somthetho i-German Medical Devices Act (MPG) wokuhlolwa kwe-antigen ukuze kutholwe i-coronavirus.
Ihambisana nefilosofi ethi “Ukunakekelwa Kwezempilo Okungcono Kwesintu”, i-Aehealth ibilokhu isebenza ngokuqhubekayo ukuze yanelise isidingo somhlaba wonke sokuhlolwa okusheshayo ekuvimbeleni nasekulawuleni izifo eziwubhadane emhlabeni wonke.I-Aehealth 2019- nCoV Antigen Test (igolide eliyi-colloidal) eyenziwa ngesampula ye-swab evela emgodini wamakhala iletha imiphumela ngemizuzu engu-15, ifinyeza kakhulu isikhathi sokubona, uma kuqhathaniswa nendlela ye-PCR.Ukuhlolwa kunganikeza abasebenzisi ukuguquguquka okuphezulu ngemiphumela emihle kakhulu yekhwalithi.
UNgqongqoshe Wezempilo waseJalimane uJens Spahn uthe ukuvunywa kokuhlolwa kwe-COVID-19 antigen kuvumela abantu abaningi ukuthi bahlolwe.Ukuhlonzwa kusenesikhathi kwabantu abangenazimpawu kungagqashula ngempumelelo iketango lokutheleleka, kumise ukusabalala kokutheleleka.
I-Rapid COVID-19 Antigen Test iyi-colloidal gold immunochromatography ehloselwe ukutholwa kwekhwalithi yama-nucleocapsid antigens avela ku-COVID-19 emakhaleni omuntu, ama-swabs omphimbo noma amathe kubantu okusolwa ukuthi bane-COVID-19 ngumhlinzeki wabo wezempilo.
Ama-coronavirus anoveli awohlobo lwe-β.I-COVID-19 yisifo esithathelwanayo sokuphefumula esinamandla.
Imiphumela ingeyokuhlonza i-COVID-19 nucleocapsid antigen.I-antigen ngokuvamile itholakala kumasampula aphezulu okuphefumula noma amasampula aphansi okuphefumula phakathi nesigaba esibucayi sokutheleleka.
Imiphumela emihle ibonisa ukuba khona kwama-antigen amagciwane, kodwa ukuhlobana komtholampilo nomlando wesiguli kanye nolunye ulwazi lokuxilonga kuyadingeka ukuze kunqunywe isimo sokutheleleka.
Imiphumela emihle ayikukhiphi ukutheleleka ngebhaktheriya noma ukutheleleka ngokuhlanganyela namanye amagciwane.I-antigen etholakele ingase ingabi imbangela eqondile yesifo.
Imiphumela engemihle ayikhiphi i-COVID-19 futhi akufanele isetshenziswe njengesisekelo sodwa sokwelashwa noma izinqumo zokuphatha isiguli, okuhlanganisa nezinqumo zokulawula ukutheleleka.
Imiphumela engemihle kufanele icatshangelwe kumongo wokuchayeka kwesiguli kwakamuva, umlando kanye nokuba khona kwezimpawu zomtholampilo kanye nezimpawu ezihambisana ne-COVID-19 futhi kuqinisekiswe ngokuhlolwa kwe-molecular, uma kudingekile ekuphathweni kwesiguli.
Njengenkampani ephethe izitifiketi zokuhlolwa kwe-antigen ka-2019-nCoV, i-Aehealth izibophezele ekwenzeni igalelo empini yomhlaba wonke yokulwa nezifo eziwubhadane.Ukuhlolwa okuningi kwe-Aehealth kwe-COVID-19 kuzuze ukugunyazwa kwamamaki e-CE futhi kwaqinisekiswa yizwe lomthengi ongaphandle ngokwezindinganiso nemithetho yendawo.I-Aehealth manje isihlinzeka ngesixazululo esihlanganisiwe se-“PCR+ Antigen+Neutralization Antibody” esihlangabezana nezimo ezihlukahlukene zezicelo zokuxilonga manjalo ukutheleleka nge-COVID-19.
Isikhathi sokuthumela: Dec-12-2021