Ukuzwela nokucacisa: Idivayisi ka-2019-nCOV/COVID-19 IgG/IgM Rapid Test iqhathaniswe nokuhlola okuhamba phambili kwe-RT-PCR yezentengiselwano kusetshenziswa amasampula omtholampilo. Imiphumela ibonisa ukuthi i-2019-nCoV/COVID-19 IgG/IgM Rapid Test Device inokuzwela okuphezulu nokucacile.

Ngokuhlolwa kwe-IgG:

Ukuzwela Okuhlobene:233/268=86.94%(95%CI*:82.35%-90.49%)

Ukucaciswa Okuhlobene:287/289=99.31% (95%CI*:97.52%-99.92%)

Ukunemba:520/557=93.36% (95%CI*: 90.96%-95.16%)

*Isikhawu Sokuzethemba

Okokuhlolwa kwe-IgM

Ukuzwela Okuhlobene:223/268=83.21% (95%CI*:78.19%-87.48%)

Ukucaciswa okuhlobene:282/289=97.58% (95%CI*: 95.07%-99.02%)

Ukunemba: 505/557=90.66% (95%CI*: 87.94%-92.95%)

*Isikhawu Sokuzethemba

I-2019-nCOV/COVID-19 IgG/IgM Rapid Test Device iyi-chromatographic immunoassay esheshayo yokutholwa kwekhwalithi ye-IgG&IgM antibody ye-Coronavirus Disease 2019 egazini lomuntu lonke, i-serum, noma i-plasma njengosizo ekuxilongweni kwezifo ze-COVID-19.

UKUSETSHENZISWA OKUHLOSIWE: The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device iyi-chromatographic immunoassay esheshayo yokutholwa kwekhwalithi ye-IgG&IgM antibody ye-Coronavirus Disease 2019 egazini lomuntu lonke, i-serum, noma i-plasma njengosizo ekuxilongweni kwe-COVID19.

ISIFINYEZO: I-COVID-19 yisifo esithathelwanayo sokuphefumula esiyingozi. Ngokuvamile abantu bayathinteka. Njengamanje, iziguli ezingenwe yi-coronavirus yenoveli ziwumthombo oyinhloko wokutheleleka; abantu abane-asymptomatic abangenwe yileli gciwane bangaba umthombo othathelwanayo. Ngokusekelwe ophenyweni lwamanje lwe-epidemiological, isikhathi sokufukamela siyizinsuku ezi-1 kuya kweziyi-14, izikhathi eziningi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile. Ukucinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.

IZIKHOKELO ZOKUSETSHENZISWA: Vumela idivayisi yokuhlola, i-specimen, ibhafa, kanye/noma izilawuli ukuthi zifinyelele izinga lokushisa legumbi (15-30°C) ngaphambi kokuhlolwa. 1. Letha isikhwama ekamelweni lokushisa ngaphambi kokusivula. Susa idivayisi yokuhlola esikhwameni esivaliwe futhi uyisebenzise ngokushesha. 2. Beka idivayisi yokuhlola endaweni ehlanzekile neleveli. ? Ngezifanekiso zeSerum noma zePlasma: Usebenzisa ipayipi elahlwayo elingu-10μL enikeziwe, dweba isifanekiso siye phezulu Kulayini Wokugcwalisa, bese udlulisela i-serum/plasma engu-10μL esibonelweni somthombo wedivayisi yokuhlola, bese wengeza amaconsi angu-2 ebhafa bese uqala isibali sikhathi. ? Ngegazi Eliphelele (I-Venipuncture/Fingerstick) Izifanekiso: Ukusebenzisa ipayipi elahlwayo elingu-10μL enikeziwe, futhi udlulisele iconsi eli-1 legazi eliphelele (cishe u-20μL) esibonelweni somthombo wedivayisi yokuhlola, bese wengeza amaconsi angu-2 ebhafa bese uqala isibali sikhathi. Qaphela: Izifanekiso zingasetshenziswa kusetshenziswa i-micropipette. 3. Lindela ukuthi kuvele ulayini onemibala.Funda imiphumela ngemizuzu eyi-10.Ungahumushi umphumela ngemuva kwemizuzu eyi-15.

ISIMISO: Le kit isebenzisa i-immunochromatography.Ikhadi lokuhlola liqukethe:1) igolide le-colloidal-elilebulwe kabusha ukuthi i-coronavirus antigen kanye nezimpawu zegolide zokulawula umzimba womuntu;2) imigqa emibili yokuthola (imigqa ye-IgG ne-IgM) kanye nomugqa owodwa Wokulawula wekhwalithi (umugqa C) we-nitrocellulose membrane. Ulayini we-M awunyakazi nge-anti-human IgM antibody ye-monoclonal ukuze kutholwe i-antibody ye-IgM ye-coronavirus yenoveli; ulayini we-IgG awunyakazi nge-reagent yokuthola i-antibody ye-IgG yenoveli; futhi umugqa u-C awunyakazi nge-antibody yokulawula ikhwalithi. Uma inani elifanele lesampula lokuhlola lengezwa embotsheni yesampula yekhadi lokuhlola, isampula izoqhubekela phambili eduze nekhadi lokuhlola ngaphansi kwesenzo se-capillary.Uma isampula iqukethe i-antibody ye-IgM, i-antibody izobophezela ku-colloidal gold-ebhalwe inoveli coronavirus antigen. I-immune complex complex izobanjwa i-anti-human IgM antibody enganyakazi kulwelwesi ukuze yakhe umugqa ongu-M onsomi-obomvu, okubonisa ukuthi i-antibody ye-coronavirus ye-IgM yenoveli ilungile. Uma isampula iqukethe i-antibody ye-IgG, i-antibody izobophezela ku-colloidal gold antigen-ebhalwe inoveli coronavirus antigen, futhi ukuzivikela komzimba kuzothathwa yi-reagent enganyakazi kulwelwesi ukwenza ulayini we-IgG onsomi-obomvu, okubonisa ukuthi inoveli ye-coronavirus IgG antibody ilungile. Uma imigqa yokuhlola ye-IgG ne-IgM ingenambala, kuvela umphumela ongemuhle.Ikhadi lokuhlola liqukethe nolayini wokulawula ikhwalithi C. Umugqa wokulawula ikhwalithi we-fuchsia kufanele uvele kungakhathaliseki ukuthi umugqa wokuhlola uyavela.Umugqa wokulawula ikhwalithi uyibhande lombala lokulawula ikhwalithi i-antibody immune complex. Uma ulayini wokulawula ikhwalithi C ungaveli, umphumela wokuhlolwa awuvumelekile, futhi isampula idinga ukuhlolwa futhi ngelinye ikhadi lokuhlola.