Sensitivity and Specificity: The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device tau raug muab piv rau ib qho kev ua lag luam RT-PCR kev sim siv cov qauv kuaj mob.Cov txiaj ntsig tau pom tias 2019-nCoV/COVID-19 IgG/IgM Rapid Tests Devices muaj qhov tshwj xeeb thiab muaj peev xwm.

Rau kev kuaj IgG:

Cov txheeb ze rhiab heev: 233/268 = 86.94% (95% CI *: 82.35% - 90.49%)

Tus txheeb ze Specificity: 287/289 = 99.31% (95% CI *: 97.52% - 99.92%)

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

* Kev ntseeg siab luv

Rau kev kuaj IgM

Tus txheeb ze rhiab heev: 223/268 = 83.21% (95% CI *: 78.19% - 87.48%)

Tus txheeb ze Specificity: 282/289 = 97.58% (95% CI *: 95.07% - 99.02%)

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

* Kev ntseeg siab luv

2019-nCOV/COVID-19 IgG/IgM Rapid Test Device yog cov tshuaj tiv thaiv kab mob sai sai rau kev kuaj pom zoo ntawm IgG&IgM cov tshuaj tiv thaiv kab mob Coronavirus 2019 hauv tib neeg cov ntshav, ntshav, lossis ntshav raws li kev pabcuam hauv kev kuaj mob.

TSEEM CEEB SIV: 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device yog cov tshuaj tiv thaiv kab mob sai sai rau kev kuaj pom zoo ntawm IgG&IgM tshuaj tiv thaiv kab mob Coronavirus 2019 hauv tib neeg cov ntshav, ntshav, lossis ntshav raws li kev pab cuam ntawm tus kab mob COVID1.

TSEEM CEEB: KEVID-19 yog tus kab mob ua pa hnyav heev. Tib neeg feem ntau raug mob. Tam sim no, cov neeg mob kis los ntawm tus kabmob tshiab no yog qhov tseem ceeb ntawm kev kis tus kabmob; Cov neeg mob asymptomatic kuj tuaj yeem yog qhov kis tau. Raws li kev tshawb nrhiav kev kis kabmob tam sim no, lub sijhawm incubation yog 1 txog 14 hnub, feem ntau yog 3 txog 7 hnub. Cov tsos mob tseem ceeb muaj xws li kub taub hau, qaug zog thiab hnoos qhuav. Qhov ntswg congestion, los ntswg qhov ntswg, mob caj pas, myalgia thiab raws plab yog pom nyob rau hauv ob peb kis.

LUS CEEB TOOM: Tso cai rau cov cuab yeej kuaj, cov qauv, tsis, thiab / lossis kev tswj kom ncav cuag chav sov (15 - 30 ° C) ua ntej kuaj. 1. Nqa lub hnab rau hauv chav sov ua ntej qhib. Tshem tawm cov cuab yeej kuaj ntawm lub hnab ntim thiab siv nws sai li sai tau. 2. Muab cov cuab yeej xeem tso rau ntawm qhov chaw huv thiab theem. ? Rau Cov Ntshav lossis Plasma Specimens: Siv cov khoom siv 10μL pov tseg, kos cov qauv mus rau Fill Line, thiab hloov 10μL cov ntshav / ntshav mus rau cov qauv zoo ntawm cov khoom kuaj, tom qab ntawd ntxiv 2 tee ntawm qhov tsis thiab pib lub sijhawm. ? Rau Cov Ntshav Tag Nrho (Venipuncture / Fingerstick) Cov Qauv: Siv 10μL pov tseg pipette, thiab hloov 1 poob ntawm cov ntshav tag nrho (kwv yees li 20μL) mus rau cov qauv zoo ntawm cov cuab yeej kuaj, tom qab ntawd ntxiv 2 tee ntawm qhov tsis thiab pib lub sijhawm. Lus Cim: Cov qauv kuj tuaj yeem siv tau siv lub micropipette. 3. Tos kom cov kab xim tshwm sim.Nyeem tau ntawm 10 feeb.Tsis txhob txhais cov ntsiab lus tom qab 15 feeb.

TSEEM CEEB: Cov khoom siv no siv immunochromatography.Daim ntawv xeem muaj: 1) colloidal kub - daim ntawv lo recombinant tshiab coronavirus antigen thiab zoo tswj antibody kub cim; 2) ob kab kuaj (IgG thiab IgM kab) thiab ib tug zoo Tswj kab (C kab) ntawm nitrocellulose membrane. M kab yog immobilized nrog monoclonal anti-tib neeg IgM tshuaj tiv thaiv rau kev kuaj pom tus kabmob tshiab IgM antibody; IgG kab yog immobilized nrog reagent txhawm rau kuaj pom tus kabmob tshiab IgG antibody; thiab C kab yog immobilized nrog cov tshuaj tiv thaiv zoo. Thaum tus nqi tsim nyog ntawm cov qauv kuaj tau ntxiv rau qhov piv txwv ntawm daim npav xeem, tus qauv yuav txav mus tom ntej nrog daim npav xeem nyob rau hauv qhov kev txiav txim ntawm cov hlab ntsha. Lub cev tiv thaiv kab mob yuav raug ntes los ntawm cov tshuaj tiv thaiv - tib neeg IgM cov tshuaj tiv thaiv kab mob immobilized ntawm daim nyias nyias los tsim cov ntshav - liab M kab, qhia tias tus tshiab coronavirus IgM tshuaj tiv thaiv zoo. Yog tias tus qauv muaj cov tshuaj tiv thaiv IgG, cov tshuaj tiv thaiv kab mob yuav khi rau cov kub colloidal - sau npe tshiab coronavirus antigen, thiab lub cev tiv thaiv kab mob yuav raug ntes los ntawm cov tshuaj tiv thaiv immobilized rau ntawm daim nyias nyias los ua cov ntshav - liab IgG kab, qhia tias tus tshiab coronavirus IgG tshuaj tiv thaiv zoo. Yog hais tias qhov kev xeem IgG thiab IgM kab tsis muaj xim, cov txiaj ntsig tsis zoo yuav tshwm sim. Daim npav xeem kuj muaj cov kab tswj kev ua tau zoo C.Cov fuchsia zoo tswj kab C yuav tsum tshwm sim txawm tias cov kab xeem zoo li tshwm. Yog tias cov kab tswj kev ua tau zoo C tsis tshwm sim, cov txiaj ntsig kev xeem tsis raug, thiab cov qauv yuav tsum tau sim dua nrog lwm daim ntawv xeem.