Ukuchazwa okuphezulu kwe-Coronavirus Ag Test - 2019-nCOV IgGIgM Rapid Test Idivayisi(ukukhonza okukodwa) - Realy
Ukuchazwa okuphezulu kwe-Coronavirus Ag Test - 2019-nCOV IgGIgM Rapid Test Idivayisi(ukukhonza okukodwa) - RealyDetail:
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:
| Indlela | RT-PCR | Isamba Semiphumela | ||
| 2019-nCOV IgG/IgM Rapid Test Device | Imiphumela | Okuhle | Okubi | |
| Okuhle | 233 | 2 | 235 | |
| Okubi | 35 | 287 | 322 | |
| Isamba Semiphumela | 268 | 289 | 557 | |
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
| Indlela | RT-PCR | Isamba Semiphumela | ||
| 2019-nCOV IgG/IgM Rapid Test Device | Imiphumela | Okuhle | Okubi | |
| Okuhle | 223 | 7 | 230 | |
| Okubi | 45 | 282 | 327 | |
| Isamba Semiphumela | 268 | 289 | 557 | |
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.
Izithombe zemininingwane yomkhiqizo:
Umhlahlandlela Womkhiqizo Ohlobene:
Imiklomelo yethu izindleko eziphansi,iqembu lenzuzo eguqukayo,i-QC ekhethekile,izimboni ezinamandla,izinsizakalo ezisezingeni eliphezulu zokuchazwa okuphezulu kwe-Coronavirus Ag Test - 2019-nCOV IgGIgM Idivayisi Yokuhlola Esheshayo(ukunikezwa okukodwa) – Ngempela, Umkhiqizo uzohlinzeka kuwo wonke umhlaba, njengalokhu: Malawi, Romania, India, Njengendlela yokusebenzisa insiza olwazini olukhulayo ekuhwebeni kwamazwe ngamazwe, siyawamukela amathemba avela yonke indawo kuwebhu nokungaxhunyiwe ku-inthanethi. Naphezu kwezinto ezisezingeni eliphezulu esikunikeza zona, insizakalo yokubonisana ephumelelayo nenelisayo ihlinzekwa yiqembu lethu lesevisi eliqeqeshiwe ngemva-lokudayiswa. Uhlu lwezinto kanye nemingcele ejulile kanye nanoma yimiphi eminye imininingwane etholakalayo ithunyelwa kuwe ngesikhathi ukuze uthole imibuzo. Ngakho kufanele uxhumane nathi ngokusithumela ama-imeyili noma usishayele uma unemibuzo mayelana nenhlangano yethu. futhi ungathola imininingwane yethu yekheli kusayithi lethu futhi uze ebhizinisini lethu. Sithola inhlolovo yenkambu yokuthengiswayo kwethu. Siyaqiniseka ukuthi sizokwabelana ngokufeziwe futhi sakhe ubudlelwano obuqinile bokusebenzisana nabalingani bethu kule ndawo yemakethe. Sibheke phambili ngemibuzo yakho.
