Kuyesa koyamba kwachipatala ku United States kunatsimikizira kuti kuyesa kwachangu kwa mphindi 15 kwa kachilombo ka Clungene® SARS-CoV-2 IgG/IgM kudazindikira molondola ma antibodies a 100% a odwala omwe ali ndi COVID patatha masiku 13.

Kuyesa koyamba kwachipatala ku United States kunatsimikizira kuti kuyesa kwachangu kwa mphindi 15 kwa kachilombo ka Clungene® SARS-CoV-2 IgG/IgM kudazindikira molondola ma antibodies a 100% a odwala omwe ali ndi COVID patatha masiku 13.
Plymouth, Pennsylvania Conference, June 15, 2021/PRNewswire/-A mayeso azachipatala aku US pakuyezetsa mwachangu kwa COVID-19 ovomerezedwa ndi Institutional Review Board adapeza kuti kutsimikizika kwa odwala omwe alibe Covid-19 omwe adatsimikiziridwa ndi RT-PCR anali 100% (95). % nthawi yodalirika, 88.4% -100.0%);izi zikutanthauza mgwirizano wa 100% pakati pa RT-PCR yoyipa ndi zotsatira za mayeso a Clungene® serological.Odwala omwe adayezetsa kuti ali ndi kachilomboka patatha masiku 13, mgwirizano pakati pa Clungene® SARS-CoV-2 kachilombo ka IgG/IgM mphindi 15 ndi mayeso a polymerase chain reaction (PCR) anali opitilira 90%.Zotsatira zikuwonetsa kuti kuyezetsaku kungakhale chida chothandiza kudziwa ngati pali ma antibodies mwa anthu omwe ali ndi kachilomboka.Mlanduwu udachitidwa ndi Sharp Healthcare ya ku San Diego, California, ndipo idaphatikizapo odwala omwe ali m'malo ogona komanso odwala kunja.Kuyesa kunachitika katemera asanapezeke kwambiri.Zotsatira zoyambilira zowunikiridwa ndi anzawo zidasindikizidwa mu magazini ya LymphoSign (https://lymphosign.com/journal/lpsn).
"Zotsatirazi ndi zolimbikitsa kwambiri chifukwa zikuwonetsa kuti kachilombo ka CLUNGENE® SARS-COV-2 (COVID-19) IgG/IgM ndiyothandiza kwambiri pozindikiritsa anthu omwe ali ndi mphamvu zolimbana ndi chitetezo chamthupi, zomwe zikuwonetsa kuti kachilombo ka HIV kaposachedwa kapena m'mbuyomu. mogwirizana ndi ndondomeko ya US Food and Drug Administration yomwe ikuyembekezeredwa kuti igwiritsidwe ntchito mwadzidzidzi, "anatero Dr. Fadi Haddad, katswiri wa matenda opatsirana kuchokera ku Sharp Medical Community Group yemwe anathandizira kuchita kafukufukuyu."Izi ndizofunikira kwambiri panthawi yomwe anthu mamiliyoni ambiri sanalandire katemera ndipo kuthekera kotenga matenda kukadali nkhani yeniyeni."
"Ndife onyadira kwambiri zotsatira za mayesero," adatero CEO wa Proven Scott Wise."Mayesowa akutsimikizira kufunika kwa mayeso ngati Clungene® SARS-CoV-2 kachilombo ka IgG/IgM mphindi 15 pothandiza akatswiri azaumoyo.Kuphweka kwake komanso kugwiritsa ntchito kwake kumapangitsa kukhala chida chothandiza pozindikira matenda. ”
Kachilombo ka Clungeneâ SARS-CoV-2 (COVID-19) IgG/IgM yoyeserera mwachangu imatha kutulutsa zotsatira mkati mwa mphindi 15.Mayesowa safuna zida za labotale zovuta kuti awerenge.
About PROVEN PHARMA Yakhazikitsidwa mu 2012, Proven Pharma ndi wopereka chithandizo m'makampani azaumoyo ndi sayansi ya moyo.Kampaniyo imapereka mayankho osiyanasiyana, kuphatikiza kugawa kwa akatswiri, kugula kofananira ndi mayeso azachipatala, gulu lodzipatulira lamalonda lamkati, chithandizo chamalonda, kusintha kwa digito ndi kufunsira kwaukadaulo.Ali ndi zaka zopitilira makumi awiri zokumana nazo zambiri m'malo ambiri azachipatala ndikuwapatsa mayankho.
Mumakampani odzaza kusatsimikizika, Proven Pharma imapatsa makasitomala ake chidaliro.Kampaniyo imapereka nthawi ndi nthawi yogwiritsira ntchito njira zabwino zodziwikiratu kuti zitsimikizire chitetezo ndi kutsata pagawo lililonse.Proven Pharma yadzipereka kupititsa patsogolo luso lamakasitomala kuti makasitomala awa athe kusintha miyoyo ya odwala.Kupambana kwa kampaniyi kumachokera kuwona mtima, kukhulupirika komanso kudalirika kwa gulu lake.
About Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. ndiukadaulo wapamwamba kwambiri, wotsogola wopanga zida zazachilengedwe komanso zinthu zoyezera matenda m'galasi.Kampaniyo ili ndi mbiri yopereka ntchito zosiyanasiyana komanso kusinthasintha kwapamwamba kwa akatswiri ogawa ndi othandizana nawo pamsika wapadziko lonse lapansi.
Hangzhou Kelon Biotechnology Co., Ltd. idakhazikitsidwa mu 2004. Ili ndi ISO 13485:2016 yotsimikizika ya R&D komanso malo opangira zinthu ku Hangzhou, China, mogwirizana ndi GMP yaku China, yomwe ili ndi malo okwana 19,000 masikweya mita.Zogulitsa zake zapeza ziphaso za CE, ziphaso za FSC ndi chivomerezo cha US FDA 510(k) (nambala yolembetsa ya FDA: 3009414546).
CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM yoyeserera mwachangu imatha kupezeka molingana ndi malangizo a FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Chilolezo chogwiritsa ntchito mwadzidzidzi-chida chachipatala/in vitro diagnostic-euas-serology-ndi-zina-adaptive-immune-response-mayeso-sars-cov-2
Kupatula zomwe zafotokozedwa mu Malangizo Ogwiritsa Ntchito (IFU), kugwiritsa ntchito kulikonse kapena mawu ndikoletsedwa.Chonde pitani www.proven.com kapena imbani 1-855-678-7768 kuti mudziwe zambiri.