Uvakalelo kunye neNgcaciso: Isixhobo sika-2019-nCOV/COVID-19 IgG/IgM Rapid Test Device sithelekiswe neRT-PCR ehamba phambili yovavanyo kusetyenziswa imizekelo yezonyango. Iziphumo zibonisa ukuba i-2019-nCoV/COVID-19 IgG/IgM Rapid Test Isixhobo sinovakalelo oluphezulu kunye nokukodwa.

Kuvavanyo lwe-IgG:

Uvakalelo olunxulumeneyo:233/268=86.94%(95%CI*:82.35%-90.49%)

Iinkcukacha Ngokuhambelanayo:287/289=99.31% (95%CI*:97.52%-99.92%)

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

*Ithuba lokuzithemba

Kuvavanyo lwe-IgM

Uvakalelo olunxulumeneyo:223/268=83.21% (95%CI*:78.19%-87.48%)

Iinkcukacha Ngokuhambelana:282/289=97.58% (95%CI*: 95.07%-99.02%)

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

*Ithuba lokuzithemba

I-2019-nCOV/COVID-19 IgG/IgM Rapid Test Device luvavanyo olukhawulezayo lwechromatographic immunoassay ekubhaqweni komgangatho we-IgG&IgM antibody ye-Coronavirus Disease 2019 egazini lomntu lonke, serum, okanye iplasma njengoncedo ekufumaniseni usulelo lwe-COVID-19.

UKUSETYENZISWA OKUNJWEYO: I-2019-nCOV/COVID-19 IgG/IgM Rapid Test Device luvavanyo olukhawulezayo lwechromatographic immunoassay ekubhaqweni okusemgangathweni kwe-IgG&IgM antibody ye-Coronavirus Disease ka-2019 kwigazi elipheleleyo lomntu, iserum, okanye iplasma njengoncedo ekufumaniseni usulelo lwe-COVID19.

USHWANKATHELO: I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla. Ngokuqhelekileyo abantu basengozini. Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo; abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo. Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7. Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo. Ukuxinana kweempumlo, impumlo evuzayo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.

IZIKHOKELO ZOKUSETYENZISWA: Vumela isixhobo sovavanyo, isampuli, isithinteli, kunye/okanye ulawulo ukufikelela kubushushu begumbi (15-30°C) phambi kovavanyo. 1. Zisa isingxobo kwiqondo lobushushu begumbi phambi kokuvula. Susa isixhobo sovavanyo kwisingxobo esivaliweyo kwaye usisebenzise ngokukhawuleza. 2. Beka isixhobo sokuvavanya kwindawo ecocekileyo kunye nenqanaba. ? KwiSerum okanye iSampulu sePlasma: Usebenzisa i-10μL yepipette elahlayo enikiweyo, zoba isampuli ukuya kumgca wokuZalisa, kwaye udlulisele i-10μL serum/plasma kumzekelo wequla lesixhobo sovavanyo, emva koko wongeze amathontsi ama-2 e-buffer kwaye uqalise isibali-xesha. ? NgeGazi Elipheleleyo (I-Venipuncture/Fingerstick) Iisampulu: Ukusebenzisa i-10μL enikiweyo yepipette elahlayo, kwaye udlulisele ithontsi legazi eli-1 (malunga ne-20μL) kumzekelo wequla lesixhobo sovavanyo, emva koko wongeze amathontsi ama-2 e-buffer kwaye uqalise isibali-xesha. Qaphela: Imizekelo ingasetyenziswa kusetyenziswa i-micropipette. 3. Lindela umgca onemibala ukuba uvele.Funda iziphumo ngemizuzu eyi-10.Sukutolika iziphumo emva kwemizuzu eli-15.

UMGAQO: Le khithi isebenzisa i-immunochromatography.Ikhadi lovavanyo liqulethe:1) igolide ye-colloidal-ibhalwe i-recombinant novel coronavirus antigen kunye nolawulo lomgangatho wokumakisha igolide ye-antibody;2) imigca emibini yokufumanisa (imigca ye-IgG kunye ne-IgM) kunye nomgca omnye wokulawula umgangatho (umgca we-C) we-nitrocellulose membrane. Umgca we-M awushukumi kunye ne-antibody ye-IgM yomntu ye-monoclonal yokubona i-antibody ye-IgM yenoveli; Umgca we-IgG awushukumi kunye ne-reagent yokukhangela inoveli ye-coronavirus ye-IgG antibody; kwaye umgca we-C awushukumi kunye ne-antibody yokulawula umgangatho. Xa isixa esifanelekileyo sesampulu yovavanyo yongezwa kumngxuma wesampulu yekhadi lovavanyo, isampuli iya phambili ecaleni kwekhadi lovavanyo phantsi kwesenzo se-capillary.Ukuba isampulu iqulethe i-antibody ye-IgM, i-antibody iya kubophelela kwigolide ye-colloidal-ebhalwe inoveli coronavirus antigen. I-immune complex iya kubanjwa yi-anti-IgM ye-antibody yomntu engashukumiyo kwi-membrane ukuze yenze umgca omfusa-obomvu we-M, ebonisa ukuba inoveli ye-coronavirus ye-IgM antibody ilungile. Ukuba isampuli iqulethe i-antibody ye-IgG, i-antibody iya kuzibophelela kwi-colloidal yegolide - ebhalwe inoveli coronavirus antigen, kwaye i-immune complex iya kubanjwa yi-reagent immobilized kwi-membrane ukuze yenze umgca omfusa - obomvu we-IgG, ebonisa ukuba inoveli ye-coronavirus ye-IgG i-antibody ilungile. Ukuba uvavanyo lwe-IgG kunye nemigca ye-IgM ayinambala, umphumo ongathandekiyo uboniswa.Ikhadi lokuvavanya kwakhona liqulethe umgca wokulawula umgangatho we-C. Umgca wokulawula umgangatho we-fuchsia kufuneka ubonakale kungakhathaliseki ukuba umgca wokuvavanya ubonakala. Ukuba umgca wokulawula umgangatho we-C awubonakali, umphumo wokuvavanya awusebenzi, kwaye isampuli kufuneka ihlolwe kwakhona kunye nelinye ikhadi lokuvavanya.