Muyedzo wekutanga wekiriniki muUnited States wakasimbisa kuti kuyedza kwemaminetsi gumi nemashanu nekukurumidza kweClungene® SARS-CoV-2 hutachiona IgG/IgM yakanyatsoona masoja ekudzivirira chirwere che100% yevarwere vane COVID-positive mushure memazuva gumi nematatu.
Plymouth, Pennsylvania Musangano, Chikumi 15, 2021/PRNewswire/-Kuyedzwa kwekiriniki yekuUS yekukurumidza kuongororwa kweCCIDID-19 yakabvumidzwa neInstitutional Review Board yakawana kuti hunyanzvi hwevarwere veCovid-19-negative hwakasimbiswa neRT-PCR hwaive zana (95). % nguva yekuvimba, 88.4% -100.0%);izvi zvinoreva chibvumirano che100% pakati peyakaipa RT-PCR uye isina kunaka Clungene® serological test results.Muvarwere vakaongororwa hutachiona mushure memazuva gumi nematatu, chibvumirano pakati peClungene® SARS-CoV-2 hutachiona IgG/IgM maminetsi gumi nemashanu bvunzo nekukurumidza uye polymerase chain reaction (PCR) bvunzo yaipfuura makumi mapfumbamwe muzana muzana.Zvabuda zvinoratidza kuti bvunzo idzi dzinogona kunge dziri chishandiso chinoshanda chekuona kuvepo kwemasoja ekudzivirira chirwere muvanhu vane hutachiona.Muedzo uyu wakaitwa neSharp Healthcare yeSan Diego, California, uye waisanganisira varwere munzvimbo dzevarwere nevanorarisa.Muedzo wakaitwa jekiseni risati ravapo zvakanyanya.Mhedzisiro yetsvakiridzo yakaongororwa nevezera inoburitswa mumagazini yeLymphoSign (https://lymphosign.com/journal/lpsn).
"Izvi zvabuda zvinokurudzira zvikuru nekuti zvinoratidza kuti CLUNGENE® SARS-COV-2 hutachiona (COVID-19) IgG/IgM yekukurumidza test kit inoshanda zvakanyanya mukuziva vanhu vane inoshanduka immune immune mhinduro, zvichiratidza kuti hutachiona hwazvino kana hwapfuura. zvichifambirana nemutemo weUS Food and Drug Administration wazvino uno wemvumo yemvumo yekushandiswa kwechimbichimbi,” vakadaro Dr. Fadi Haddad, nyanzvi yezvirwere zvinotapukira kubva kuSharp Medical Community Group yakabatsira kuita tsvakiridzo iyi."Izvi zvakakosha panguva iyo mamirioni avanhu asati abaiwa uye mukana wekutapukirwa ichiri nyaya chaiyo."
"Tinodada nemhedzisiro yekutongwa," akadaro Proven CEO Scott Wise.“Muedzo uyu unosimbisa kubatsira kwebvunzo dzakaita seClungene® SARS-CoV-2 hutachiona IgG/IgM maminitsi gumi nemashanu bvunzo yekukurumidza mukubatsira vashandi vehutano.Kureruka kwayo uye nyore kushandisa kunoita kuti ive chishandiso chinobatsira chekuongorora. "
Iyo Clungeneâ SARS-CoV-2 hutachiona (COVID-19) IgG/IgM yekukurumidza bvunzo kit inogona kuburitsa mhedzisiro mukati memaminitsi gumi nemashanu.Muedzo uyu haudi michina yemurabhoritari yakaoma kuti igadzirise kuverenga.
Nezve PROVEN PHARMA Yakavambwa muna 2012, Proven Pharma mupi webasa muindasitiri yehutano nesainzi yehupenyu.Iyo kambani inopa huwandu hwakasiyana hwemhinduro, kusanganisira kugovera kwehunyanzvi, kiriniki yekuedza comparator kutenga, yakatsaurirwa timu yekutengesa yemukati, rutsigiro rwekushambadzira, shanduko yedhijitari uye kubvunzana kwehunyanzvi.Vane anopfuura makumi maviri emakore eruzivo rwakapfuma munzvimbo dzakawanda dzemunda wehutano uye vanovapa mhinduro.
Mune indasitiri izere nekusava nechokwadi, Proven Pharma inopa vatengi vayo chivimbo.Iyo kambani inopa nenguva yega yega-inoshandisa inozivikanwa akanakisa maitiro uye maitiro ekuona chengetedzo uye kutevedzera padanho rega rega.Proven Pharma yakazvipira kuramba ichivandudza ruzivo rwevatengi kuitira kuti vatengi ava vavandudze hupenyu hwevarwere.Kubudirira kwekambani kunobva mukutendeseka, kuvimbika uye kuvimbika kwechikwata chayo.
Nezve Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. ndeyepamusoro-tekinoroji, inotungamira mugadziri wezvinhu zvipenyu uye in vitro diagnostic zvigadzirwa.Iyo kambani ine mukurumbira wekupa akasiyana masevhisi uye kuchinjika kwepamusoro kune nyanzvi dzekugovera uye vanodyidzana mumusika wepasi rose.
Hangzhou Kelon Biotechnology Co., Ltd. yakavambwa muna 2004. Iine yakanyanya kusimira ISO 13485:2016 yakasimbiswa R&D uye zvivakwa zvekugadzira muHangzhou, China, inoenderana neChina yeGMP, inofukidza 19,000 square metres.Zvigadzirwa zvayo zvakawana CE zvitupa, FSC zvitupa uye US FDA 510 (k) mvumo (FDA kunyoresa nhamba: 3009414546).
CLUNGENE® SARS-COV-2 hutachiona (COVID-19) IgG/IgM yekukurumidza test kit inogona kuwanikwa zvinoenderana neFDA EUA nhungamiro: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Emergency use mvumo-medical device/in vitro diagnostic-euas-serology-uye-zvimwe-adaptive-immune-response-tests-sars-cov-2
Kunze kwezviri kutaurwa muMirairo Yekushandisa (IFU), chero kushandisa kana kutaura kunorambidzwa zvachose.Ndokumbira ushanyire www.proven.com kana kufonera 1-855-678-7768 kuti uwane rumwe ruzivo.
Nguva yekutumira: Jun-18-2021