Thawj qhov kev sim tshuaj hauv Tebchaws Meskas tau lees paub tias 15-feeb kev sim sai ntawm Clungene® SARS-CoV-2 tus kab mob IgG/IgM raug txheeb xyuas cov tshuaj tiv thaiv ntawm 100% ntawm cov neeg mob zoo tom qab 13 hnub.
Plymouth, Pennsylvania Lub Rooj Sib Tham, Lub Rau Hli 15, 2021 / PRNewswire / -A US kev sim tshuaj rau kev kuaj mob sai sai ntawm COVID-19 tau pom zoo los ntawm Pawg Saib Xyuas Kev Tshawb Fawb pom tias qhov tshwj xeeb ntawm Covid-19-tsis zoo cov neeg mob tau lees paub los ntawm RT-PCR yog 100% (95 % kev ntseeg siab ib ntus, 88.4% -100.0%);Qhov no txhais tau tias 100% kev pom zoo ntawm qhov tsis zoo RT-PCR thiab Clungene® serological xeem tau zoo.Hauv cov neeg mob uas kuaj pom tus kab mob zoo tom qab 13 hnub, qhov kev pom zoo ntawm Clungene® SARS-CoV-2 tus kab mob IgG/IgM 15-feeb sai sai thiab cov tshuaj tiv thaiv polymerase chain reaction (PCR) ntau dua 90%.Cov txiaj ntsig tau qhia tias cov kev sim no yuav yog ib qho cuab yeej siv tau zoo los kuaj pom muaj cov tshuaj tiv thaiv kab mob hauv cov neeg kis tus kab mob.Qhov kev sim no tau ua los ntawm Sharp Healthcare ntawm San Diego, California, thiab suav nrog cov neeg mob hauv cov tsev kho mob thiab cov neeg mob sab nraud.Qhov kev sim tau ua ua ntej qhov tshuaj tiv thaiv tau dav dav.Thawj cov kev tshawb fawb soj ntsuam tau luam tawm hauv LymphoSign magazine (https://lymphosign.com/journal/lpsn).
"Cov txiaj ntsig no tau txhawb nqa tsis txaus ntseeg vim tias lawv pom tias CLUNGENE® SARS-COV-2 tus kab mob (COVID-19) IgG/IgM cov khoom siv kuaj sai sai tau zoo heev hauv kev txheeb xyuas cov tib neeg uas muaj kev tiv thaiv kab mob, qhia tau tias tsis ntev los no lossis yav dhau los tus kab mob no. raws li qhov xav tau US Food and Drug Administration txoj cai tso cai siv thaum muaj xwm txheej ceev, "hais tias Dr. Fadi Haddad, tus kws tshaj lij kis kab mob los ntawm Sharp Medical Community Group uas tau pab ua qhov kev tshawb fawb no."Qhov no tseem ceeb heev nyob rau lub sijhawm uas ntau lab tus tib neeg tsis tau txhaj tshuaj tiv thaiv thiab qhov muaj feem kis tau yog qhov teeb meem tiag tiag."
"Peb zoo siab heev rau cov txiaj ntsig ntawm kev sim," said Proven CEO Scott Wise."Qhov kev sim no lees paub qhov muaj txiaj ntsig ntawm kev sim zoo li Clungene® SARS-CoV-2 tus kab mob IgG/IgM 15-feeb kev sim sai hauv kev pab cov kws kho mob.Nws qhov yooj yim thiab yooj yim ntawm kev siv ua rau nws muaj txiaj ntsig zoo rau kev kuaj mob. "
Tus kab mob Clungeneâ SARS-CoV-2 (COVID-19) IgG/IgM cov khoom kuaj sai sai tuaj yeem tsim cov txiaj ntsig hauv 15 feeb.Qhov kev ntsuam xyuas no tsis tas yuav muaj cov cuab yeej kuaj sim nyuaj los ua cov ntawv nyeem.
Txog PROVEN PHARMA Founded hauv 2012, Proven Pharma yog ib lub chaw muab kev pabcuam hauv kev kho mob thiab kev tshawb fawb txog kev ua neej.Lub tuam txhab muab ntau yam kev daws teeb meem, suav nrog kev tshaj tawm kev tshaj lij, kev sim tshuaj ntsuam xyuas kev sib piv kev yuav khoom, pab pawg muag khoom sab hauv, kev txhawb nqa kev lag luam, kev hloov pauv digital thiab kev pab tswv yim.Lawv muaj ntau tshaj li ob xyoo caum ntawm kev nplua nuj nyob hauv ntau qhov chaw ntawm kev kho mob thiab muab cov kev daws teeb meem rau lawv.
Hauv kev lag luam uas muaj qhov tsis paub meej, Proven Pharma muab nws cov neeg siv khoom muaj kev ntseeg siab.Lub tuam txhab xa tawm raws sijhawm txhua lub sijhawm-siv lees paub cov kev coj ua zoo tshaj plaws thiab cov txheej txheem los xyuas kom muaj kev nyab xeeb thiab ua raws txhua kauj ruam.Proven Pharma tau cog lus los txhim kho cov neeg siv khoom tsis tu ncua kom cov neeg siv khoom tuaj yeem txhim kho lub neej ntawm cov neeg mob.Lub tuam txhab txoj kev vam meej yog los ntawm kev ncaj ncees, kev ncaj ncees thiab kev ntseeg siab ntawm nws pab neeg.
Hais txog Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd.Lub tuam txhab muaj lub koob npe nrov rau kev muab ntau yam kev pabcuam thiab kev ua haujlwm zoo tshaj plaws rau cov kws tshaj lij thiab cov neeg koom tes hauv kev lag luam thoob ntiaj teb.
Hangzhou Kelon Biotechnology Co., Ltd. tau tsim nyob rau hauv 2004. Nws muaj qhov zoo tshaj plaws ISO 13485: 2016 certified R & D thiab chaw tsim khoom nyob rau hauv Hangzhou, Tuam Tshoj, raws li Tuam Tshoj tus GMP, npog thaj tsam ntawm 19,000 square meters.Nws cov khoom tau txais daim ntawv pov thawj CE, FSC daim ntawv pov thawj thiab US FDA 510 (k) kev pom zoo (FDA tus lej sau npe: 3009414546).
CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM cov khoom kuaj sai sai tuaj yeem tau txais raws li FDA EUA cov lus qhia: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Emergency use authorization-medical device/in vitro diagnostic-euas-serology-and-lwm-adaptive-immune-response-tests-sars-cov-2
Tsuas yog cov ntsiab lus tau teev tseg hauv Cov Lus Qhia rau Kev Siv (IFU), kev siv lossis nqe lus raug txwv nruj heev.Thov mus saib hauv www.proven.com lossis hu rau 1-855-678-7768 yog xav paub ntxiv.
Post lub sij hawm: Jun-18-2021