Nyob rau 2022.10.05, Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab tau suav nrog hauv EU Cov Npe!
HSC Mutual Recognition List yog daim ntawv tso cai ntawm cov tshuaj tiv thaiv antigen reagents hauv European Union.
Nyob rau 2021.01.21, European Commission tau tshaj tawm Pawg Neeg Saib Xyuas Kev Pom Zoo ntawm ib lub hauv paus rau kev siv thiab kev siv tau ntawm cov tshuaj tiv thaiv sai sai thiab kev sib koom ua ke ntawm COVID-19 cov txiaj ntsig ntawm EU 2021/C 24/0 (xws li "Common List").
Daim ntawv teev npe tau tshaj tawm los ua qhov kev sim tshuaj tiv thaiv sai sai hauv EU cov tswvcuab lub tebchaws kom tau txais kev pom zoo.HSC qhia meej tias kev sim tshuaj tiv thaiv kab mob sai los ntawm cov npe yuav tsum tau lees paub thiab siv hauv kev xyaum los ntawm tsawg kawg 3 lub teb chaws cov tswv cuab rau cov txiaj ntsig tau lees paub.
Raws li cov ntaub ntawv, cov xwm txheej ntawm kev suav nrog hauv cov npe nrov yog hauv qab no:
1, Tau txais ntawv pov thawj los ntawm CE
2, Meet the minimum performance requirements: sensitivity >90%, specificity >97 feem pua
3, Muab cov ntsiab lus ntawm cov txheej txheem thiab cov txiaj ntsig ntawm cov kev tshawb fawb txog kev lees paub uas tau lees paub los ntawm tsawg kawg yog ib Lub Xeev Cov Tswv Cuab raws li muaj feem xyuam rau COVID-19, xws li hom qauv siv rau kev siv tau, ib puag ncig hauv kev ntsuas kev ntsuas tau siv, thiab seb lawv puas tuaj yeem ua tau raws li qhov xav tau ntawm cov txheej txheem rhiab heev lossis lwm yam ntsuas kev ua tau zoo.
Raws li cov ntaub ntawv kho mob ntawm Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab qhia hauv qab no, Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab yog qhov tseeb ntawm cov npe ntawm cov npe:
1. Cov kab mob kuaj pom:
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617. 1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
2. Cov yam ntxwv ua haujlwm:
Qhov tseeb 98.63 feem pua
Clinical Sensitivity 97.22 feem pua
Clinical Specificity 99 feem pua
Lub url hauv qab no qhia txog daim ntawv pov thawj ntau:
https://covid{{0}}diagnostics.jrc.ec.europa.eu/devices/detail/1446?fbclid=IwAR14lEozPdnVc0lQI7By0F- Zr0Ud8i-fQ6sVqxGzqfgU4f920XnQFiF8l40
Singclean COVID-19 Cov Khoom Siv Xeem (Colloidal Gold Method) yog cov txheej txheem immunochromatographic tshuaj ntsuam xyuas kom sai, muaj txiaj ntsig zoo ntawm antigen rau 2019 Novel Coronavirus hauv tib neeg lub qhov ntswg. Qhov kev sim no tsuas yog muab qhov tshwm sim ua ntej. Yog li ntawd, ib qho kev kuaj mob nrog rau COVID-19 Cov Khoom Siv Xeem (Colloidal Gold Method) yuav tsum tau lees paub nrog lwm txoj kev kuaj thiab kev tshawb pom.
Singclean COVID-19 Antigen Test
Txij li thaum muaj tus kab mob COVID-19, Singclean COVID-19 Antigen Test Kit tau muag zoo hauv lub teb chaws Yelemees, Greek, Czech, Latvia thiab ntau lub teb chaws Europe.
