Isivivinyo sokuqala somtholampilo e-United States sikuqinisekisile ukuthi ukuhlolwa okusheshayo kwemizuzu eyi-15 kwegciwane le-Clungene® SARS-CoV-2 i-IgG/IgM kukhombe ngokunembile amasosha omzimba angama-100% eziguli ezine-COVID ngemuva kwezinsuku eziyi-13.
I-Plymouth, Pennsylvania Conference, June 15, 2021/PRNewswire/-Isivivinyo sase-US somtholampilo sokuhlolwa okusheshayo kwe-COVID-19 esigunyazwe Ibhodi Lokubuyekeza Isikhungo sithole ukuthi ukucaciswa kweziguli ezingenayo i-Covid-19 okuqinisekiswe yi-RT-PCR bekungu-100% (95). % isikhawu sokuzithemba, 88.4% -100.0%);lokhu kusho ukuvumelana okungu-100% phakathi kwe-RT-PCR enegethivu kanye nemiphumela yokuhlolwa kwe-serological negative ye-Clungene®.Ezigulini ezahlolelwa ukuthi zinegciwane ngemva kwezinsuku eziyi-13, isivumelwano phakathi kwe-Clungene® SARS-CoV-2 virus IgG/IgM imizuzu engu-15 yokuhlolwa okusheshayo kanye nokuhlolwa kwe-polymerase chain reaction (PCR) sasingaphezu kwama-90%.Imiphumela ikhomba ukuthi lokhu kuhlola kungase kube ithuluzi elisebenzayo lokuthola ukuba khona kwamasosha omzimba kubantu abangenwe yileli gciwane.Ukuqulwa kwecala kwenziwa yi-Sharp Healthcare yase-San Diego, e-California, futhi kwahlanganisa iziguli ezikhungweni ezilaliswayo nezilaliswayo.Uhlolo lwenziwa ngaphambi kokuba umgomo utholakale kabanzi.Imiphumela yasekuqaleni yocwaningo olubuyekezwe ontanga ishicilelwe kumagazini we-LymphoSign (https://lymphosign.com/journal/lpsn).
“Le miphumela ikhuthaza ngendlela emangalisayo ngoba ikhombisa ukuthi ikhithi yokuhlola ngokushesha i-CLUNGENE® SARS-COV-2 (COVID-19) IgG/IgM isebenza kahle kakhulu ekuhlonzeni abantu abanezimpendulo eziguquguqukayo zokuzivikela komzimba, okubonisa ukuthi ukutheleleka kwakamuva noma okwedlule. ngokuhambisana nenqubomgomo elindelekile ye-US Food and Drug Administration yamanje yokugunyaza ukusetshenziswa kwezimo eziphuthumayo,” kusho uDkt. Fadi Haddad, uchwepheshe wezifo ezithathelwanayo we-Sharp Medical Community Group osize ekwenzeni lolu cwaningo."Lokhu kubaluleke kakhulu esikhathini lapho izigidi zabantu zingagonyiwe futhi ukuthi kungenzeka ukutheleleka kuseyinkinga yangempela."
"Siyaziqhenya kakhulu ngemiphumela yecala," kusho isikhulu esiphezulu seProven, uScott Wise.“Lokhu kuhlolwa kuqinisekisa ukuba wusizo kokuhlolwa okufana nokuhlolwa okusheshayo kwe-Clungene® SARS-CoV-2 IgG/IgM yemizuzu engu-15 ekusizeni ochwepheshe bezempilo.Ubulula bayo nokusebenziseka kalula kuyenza ibe ithuluzi lokuhlola eliwusizo.”
Ikhithi yokuhlola ngokushesha i-Clungeneâ SARS-CoV-2 (COVID-19) IgG/IgM ingaveza imiphumela phakathi nemizuzu eyi-15.Lokhu kuhlola akudingi okokusebenza kwaselabhorethri okuyinkimbinkimbi ukucubungula ukufundwa.
Mayelana ne-PROVEN PHARMA Yasungulwa ngo-2012, iProven Pharma ingumhlinzeki wesevisi embonini yezempilo nesayensi yezempilo.Le nkampani inikeza izixazululo eziningi, okuhlanganisa ukusatshalaliswa kochwepheshe, ukuthengwa kwesiqhathanisi sesivivinyo somtholampilo, ithimba elizinikele langaphakathi lokuthengisa, ukusekelwa kokumaketha, ukuguqulwa kwedijithali kanye nokubonisana kwezobuchwepheshe.Baneminyaka engaphezu kwamashumi amabili yokuhlangenwe nakho okucebile ezindaweni eziningi zenkundla yokunakekelwa kwezempilo futhi babanikeze izixazululo.
Embonini egcwele ukungaqiniseki, i-Proven Pharma inikeza amakhasimende ayo ngokuzethemba.Inkampani iletha ngesikhathi ngaso sonke isikhathi kusetshenziswa imikhuba nezinqubo ezihamba phambili ezibonwayo ukuze kuqinisekiswe ukuphepha nokuhambisana kuzo zonke izinyathelo.I-Proven Pharma izibophezele ekuthuthukiseni ngokuqhubekayo ulwazi lwamakhasimende ukuze la makhasimende akwazi ukuthuthukisa izimpilo zeziguli.Impumelelo yenkampani isukela ekuthembekeni, ekuthembekeni nasekuthembekeni kwethimba layo.
Mayelana ne-Hangzhou Kelon Biotechnology I-Hangzhou Kelon Biotechnology Co., Ltd. ingumkhiqizi osezingeni eliphezulu, oholayo wezinto zebhayoloji kanye nemikhiqizo yokuxilonga ye-in vitro.Le nkampani inedumela lokuhlinzeka ngezinsizakalo ezahlukahlukene kanye nokuvumelana nezimo okuphezulu kubasabalalisi abangochwepheshe kanye nozakwethu emakethe yomhlaba.
I-Hangzhou Kelon Biotechnology Co., Ltd. yasungulwa ngo-2004. Ine-ISO 13485:2016 eqinisekisiwe ye-R&D nezindawo zokukhiqiza ezithuthuke kakhulu e-Hangzhou, e-China, ngokuhambisana ne-GMP yase-China, ehlanganisa indawo engamamitha-skwele ayi-19,000.Imikhiqizo yayo ithole izitifiketi ze-CE, izitifiketi ze-FSC kanye nokugunyazwa kwe-US FDA 510(k) (inombolo yokubhalisa ye-FDA: 3009414546).
Ikhithi yokuhlola ngokushesha ye-CLUNGENE® SARS-COV-2 (COVID-19) IgG/IgM ingatholwa ngokuvumelana neziqondiso ze-FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Ukusetshenziswa kwesimo esiphuthumayo-idivayisi yezokwelapha/in vitro diagnostic-euas-serology-kanye-nokunye-adaptive-immune-response-tests-sars-cov-2
Ngaphandle kokuqukethwe okucaciswe emiyalweni yokusebenzisa (i-IFU), noma yikuphi ukusebenzisa noma isitatimende sinqatshelwe ngokuphelele.Sicela uvakashele ku-www.proven.com noma ushayele ku-1-855-678-7768 ukuze uthole ulwazi olwengeziwe.
Isikhathi sokuthumela: Jun-18-2021