Ulingo lokuqala lwezonyango e-United States luqinisekisile ukuba uvavanyo olukhawulezileyo lwemizuzu eli-15 lwe-Clungene® SARS-CoV-2 intsholongwane ye-IgG/IgM ichonge ngokuchanekileyo amajoni omzimba we-100% yezigulana ezine-COVID emva kweentsuku ezili-13.
I-Plymouth, iNkomfa yasePennsylvania, nge-15 kaJuni, ngo-2021/PRNewswire/-Ulingo lwezonyango lwase-US lovavanyo olukhawulezayo lwe-COVID-19 oluvunywe yiBhodi yoHlolo yeZiko lufumanise ukuba ubunyani bezigulana ezingenayo i-Covid-19 eziqinisekiswe yi-RT-PCR zaziyi-100% (95). I-% yexesha lokuzithemba, i-88.4% -100.0%);oku kuthetha isivumelwano se-100% phakathi kwe-RT-PCR engalunganga kunye neziphumo ze-Clungene® ze-serological negative.Kwizigulana ezafunyaniswa zinentsholongwane emva kweentsuku ezili-13, isivumelwano phakathi kwe-Clungene® SARS-CoV-2 intsholongwane ye-IgG/IgM imizuzu eli-15 yovavanyo olukhawulezayo kunye novavanyo lwe-polymerase chain reaction (PCR) lwalungaphezulu kwe-90%.Iziphumo zibonisa ukuba olu vavanyo lunokuba sisixhobo esisebenzayo sokubona ubukho be-antibodies kubantu abosulelwe yile ntsholongwane.Ulingo lwenziwe yiSharp Healthcare yaseSan Diego, eCalifornia, kwaye ibandakanya izigulana ezikwindawo ezilaliswayo nezingaphandle.Ulingo lwenziwa phambi kokuba isitofu sokugonya sifumaneke ngokubanzi.Iziphumo zophando eziphononongwe ngoontanga zipapashwa kwimagazini yeLymphoSign (https://lymphosign.com/journal/lpsn).
Ezi ziphumo zikhuthaza kakhulu kuba zibonisa ukuba i-CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM yekhithi yovavanyo olukhawulezayo iyasebenza kakhulu ekuchongeni abantu abaneempendulo eziguqukayo zokhuselo lomzimba, nto leyo ebonisa ukuba usulelo lwamva nje okanye lwangaphambili. ngokuhambelana nomgaqo-nkqubo wogunyaziso wosetyenziso olungxamisekileyo lwase-US olulindelekileyo,” utshilo uGqr. Fadi Haddad, ingcali yezifo ezosulelayo kwiQela loLuntu lwezoNyango lweSharp oye wanceda ekuqhubeni olu phando."Oku kubaluleke kakhulu ngexesha apho izigidi zabantu zingakhange zigonywe kwaye ukuba nokwenzeka kosulelo kusengumcimbi wokwenyani."
“Siyazingca kakhulu ngeziphumo zetyala,” utshilo umphathi weProven uScott Wise.“Olu vavanyo luqinisekisa ukuba luncedo kovavanyo olufana ne-Clungene® SARS-CoV-2 virus ye-IgG/IgM yemizuzu eli-15 yovavanyo olukhawulezayo ekuncedeni iingcali zempilo.Ukulula kwayo kunye nokusebenziseka ngokulula kuyenza ibe sisixhobo esiluncedo sokuxilongwa. ”
I-Clungeneâ SARS-CoV-2 virus (COVID-19) IgG/IgM kit yovavanyo olukhawulezayo inokuvelisa iziphumo kwimizuzu eli-15.Olu vavanyo alufuni zixhobo zaselabhoratri ezintsonkothileyo ukuze kuqhutywe ufundo.
Malunga ne-PROVEN PHARMA Eyasungulwa kwi-2012, i-Proven Pharma ngumboneleli wenkonzo kwishishini lezempilo kunye nesayensi yobomi.Inkampani inikeza uluhlu olubanzi lwezisombululo, kubandakanywa ukuhanjiswa kobuchwephesha, ukuthengwa komlinganiso wovavanyo lwekliniki, iqela elizinikeleyo lokuthengisa langaphakathi, inkxaso yokuthengisa, ukuguqulwa kwedijithali kunye nokubonisana nobugcisa.Baneminyaka engaphezu kwamashumi amabini amava atyebileyo kwiindawo ezininzi zecandelo lezempilo kwaye babanike izisombululo.
Kwishishini eligcwele ukungaqiniseki, iProven Pharma ibonelela abathengi bayo ngokuzithemba.Inkampani inikezela ngexesha lonke ixesha-isebenzisa ezona ndlela zibalaseleyo kunye neenkqubo zokuqinisekisa ukhuseleko kunye nokuthotyelwa kwinqanaba ngalinye.I-Pharma eqinisekisiweyo izinikele ekuphuculeni ngokuqhubekayo amava abathengi ukuze aba bathengi banokuphucula ubomi bezigulane.Impumelelo yenkampani isukela kukunyaniseka, imfezeko kunye nokuthembeka kweqela layo.
Malunga ne-Hangzhou Kelon Biotechnology I-Hangzhou Kelon Biotechnology Co., Ltd. yiteknoloji ephezulu, ekhokela umenzi wezinto zebhayoloji kunye neemveliso zokuxilonga kwi-vitro.Inkampani inegama lokubonelela ngeenkonzo ezahlukeneyo kunye nokuguquguquka okuphezulu kubasasazi abachwephesha kunye namaqabane kwimarike yehlabathi.
I-Hangzhou Kelon Biotechnology Co., Ltd. yasekwa ngo-2004. Ineyona ISO 13485:2016 eqinisekisiweyo ye-R & D kunye neendawo zokuvelisa e-Hangzhou, e-China, ngokuhambelana ne-GMP yase-China, equka indawo ye-19,000 square metres.Iimveliso zayo zifumene izatifikethi ze-CE, izatifikethi ze-FSC kunye ne-US FDA 510 (k) imvume (inombolo yobhaliso ye-FDA: 3009414546).
CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM ikhithi yovavanyo olukhawulezayo inokufunyanwa ngokwemigaqo ye-FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Ukusetyenziswa okungxamisekileyo ugunyaziso-isixhobo zonyango/in vitro diagnostic-euas-serology-kunye-enye-adaptive-immune-response-tests-sars-cov-2
Ngaphandle komxholo ochazwe kwiMiyalelo yokuSetyenziswa (IFU), nakuphi na ukusetyenziswa okanye ingxelo kuthintelwe ngokungqongqo.Nceda undwendwele www.proven.com okanye ufowunele 1-855-678-7768 ngolwazi olungakumbi.
Ixesha lokuposa: Jun-18-2021