Ortho Clinical Diagnostics, imwe yemakambani makuru epasi rose akachena in vitro diagnostic, yakazivisa kutangwa kweyekutanga yehuwandu hweCOVID-19 IgG antibody bvunzo uye yakazara COVID-19 nucleocapsid antibody bvunzo.
Ortho ndiyo yega kambani muUnited States inopa musanganiswa wekuyedzwa kwehuwandu uye nucleocapsid kuyedzwa kwemarabhoritari.Ose ari maviri bvunzo aya anobatsira timu yekurapa kusiyanisa chikonzero chemasoja ekudzivirira chirwere kubva kuSARS-CoV-2 uye anoagadzira paOrtho's yakavimbika VITROS® system.
"MuUnited States, majekiseni ese akabaiwa akagadzirwa kuti agadzire mhinduro yekurwisa hutachiona hwehutachiona hweSARS-CoV-2," akadaro Ivan Sargo, MD, Ortho Clinical Diagnostics, mukuru wezvemushonga, zvekiriniki nesainzi."Ortho's new quantitative IgG antibody test, pamwe neiyo nucleocapsid antibody test, inogona kupa rumwe ruzivo rwekubatsira kuona kana mhinduro yeantibody ichibva kuhutachiona hwechisikigo kana spike protein-yanangwa yekudzivirira."1
Ortho's VITROS® Anti-SARS-CoV-2 IgG quantitative antibody bvunzo ndiyo yekutanga antibody bvunzo muUnited States kupa hunhu hwakayerwa zvinoenderana neWorld Health Organisation (WHO) mazinga epasi rose.2 Iyo yakamisikidzwa yehuwandu antibody bvunzo inobatsira kuwiriranisa iyo SARS-CoV- 2 serological nzira uye inobvumira yunifomu data kuenzanisa mumarabhoritari.Iyi data yakabatana inhanho yekutanga mukunzwisisa kusimuka uye kudonha kwemasoja ega ega uye kukanganisa kwenguva refu kwedenda reCCIDID-19 munharaunda uye nehuwandu hwese.
Ortho's itsva IgG yehuwandu bvunzo yakagadzirirwa kuyera nemhando uye muhuwandu kuyera IgG masoja ekudzivirira ekurwisa SARS-CoV-2 muserum yemunhu uye plasma, iine 100% chaiyo uye yakanakisa kunzwa.3
Ortho's new VITROS® Anti-SARS-CoV-2 Yese Nucleocapsid Antibody Test ndeyechokwadi 4 bvunzo yemhando yekuonekwa kweSARS-CoV-2 nucleocapsid muvarwere vakatapukirwa neSARS-CoV-2 hutachiona Antibody.
"Tiri kugara tichidzidza ruzivo rutsva nezvehutachiona hweSARS-CoV-2 mazuva ese, uye Ortho yakazvipira kugadzirira marabhoritari nemhinduro dzakasimba dzekuvabatsira kutsungirira matambudziko aripo uye emangwana edenda riri kuramba richienderera mberi," akadaro Dr. Chockalingam Palaniappan. , Chief Innovation Officer weOrtho Clinical Diagnostics.
Ortho's COVID-19 quantitative antibody bvunzo yakapedza chirongwa cheUS Food and Drug Administration (FDA) chiziviso chekukurumidza kushandiswa (EUN) muna Chivabvu 19, 2021, uye yakaendesa mvumo yekushandisa emergency (EUA) bvunzo kuFDA.Yayo VITROS® Anti-SARS-CoV-2 yakazara nucleocapsid antibody bvunzo yakapedza maitiro eEUN muna Chivabvu 5, 2021, uye zvakare yakaendesa EUA.
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1. Varwere vanobaiwa nemishonga inodzivirira utachiona husina kuvharwa vachagadzira masoja ekudzivirira chirwere anonzi anti-N uye anorwisa S.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. 100% chaiyo, 92.4% senitivity kupfuura mazuva 15 mushure mekutanga kwezviratidzo 4. 99.2% chaiyo uye 98.5% PPA ≥ Mazuva gumi nemashanu mushure mekutanga kwezviratidzo
Nguva yekutumira: Jun-22-2021