ʻO Ortho Clinical Diagnostics, kekahi o nā hui diagnostic in vitro maʻemaʻe nui loa o ka honua, i hoʻolaha i ka hoʻomaka ʻana o ka quantitative COVID-19 IgG antibody test a me kahi hōʻike antibody COVID-19 nucleocapsid.
ʻO Ortho wale nō ka hui ma ʻAmelika Hui Pū ʻIa e hāʻawi i kahi hui o ka hoʻāʻo nui a me ka hoʻāʻo nucleocapsid no nā laboratories.ʻO kēia mau hoʻokolohua ʻelua e kōkua i ka hui lapaʻau e hoʻokaʻawale i ke kumu o nā antibodies e kūʻē iā SARS-CoV-2 a hana iā lākou ma ka ʻōnaehana VITROS® hilinaʻi ʻia ʻo Ortho.
"Ma ʻAmelika Hui Pū ʻIa, ua hoʻolālā ʻia nā maʻi āpau āpau e hana i kahi pane antibody i ka spike protein o ka maʻi SARS-CoV-2," wahi a Ivan Sargo, MD, Ortho Clinical Diagnostics, ke poʻo o ka lāʻau lapaʻau, nā mea lapaʻau a me nā ʻepekema."ʻO kā Ortho hou quantitative IgG antibody test, me kāna hou nucleocapsid antibody test, hiki ke hāʻawi i nā ʻikepili hou e kōkua ai e hoʻoholo inā loaʻa mai ka pane antibody mai kahi maʻi kūlohelohe a i ʻole ka spike protein-targeted kano."1
ʻO Ortho's VITROS® Anti-SARS-CoV-2 IgG quantitative antibody test ka hōʻike antibody mua loa ma United States e hāʻawi i nā waiwai calibrated e like me nā kūlana honua o ka World Health Organization (WHO).2 ʻO ka hoʻāʻo antibody quantitative standardized e kōkua i ka hoʻohālikelike ʻana i nā ʻano serological SARS-CoV-2 a hiki i ka hoʻohālikelike ʻikepili like ʻole ma waena o nā laboratories.ʻO kēia ʻikepili hui ka hana mua i ka hoʻomaopopo ʻana i ka piʻi ʻana a me ka hāʻule ʻana o nā antibodies pākahi a me ka hopena lōʻihi o ka maʻi maʻi COVID-19 i ke kaiāulu a me ka lehulehu holoʻokoʻa.
Hoʻolālā ʻia ka hoʻāʻo nui IgG hou a Ortho e ana i ka qualitatively a quantitatively ana i nā antibodies IgG e kūʻē iā SARS-CoV-2 i ka serum kanaka a me ka plasma, me ka 100% kikoʻī a me ka naʻau maikaʻi loa.3
ʻO ka VITROS® Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test hou o Ortho he hōʻike 4 kūpono loa no ka ʻike qualitative o SARS-CoV-2 nucleocapsid i nā maʻi i loaʻa i ka maʻi SARS-CoV-2 virus Antibody.
"Ke aʻo mau nei mākou i ka ʻike hou e pili ana i ka maʻi maʻi SARS-CoV-2 i kēlā me kēia lā, a ua kūpaʻa ʻo Ortho e hoʻolako i nā hale hana me nā hopena kūpono loa e kōkua iā lākou e hoʻokō i nā pilikia o kēia manawa a me ka wā e hiki mai ana o kēia maʻi maʻi e hoʻomau nei," wahi a Kauka Chockalingam Palaniappan , Luna Nui Hou o Ortho Clinical Diagnostics.
ʻO Ortho's COVID-19 quantitative antibody test i hoʻopau i ka US Food and Drug Administration (FDA) kaʻina hoʻolaha hoʻohana pilikia (EUN) ma Mei 19, 2021, a waiho i kahi mana hoʻohana pilikia (EUA) no ka hōʻike i ka FDA.ʻO kāna VITROS® Anti-SARS-CoV-2 ka nui o ka nucleocapsid antibody test i hoʻopau i ke kaʻina hana EU ma Mei 5, 2021, a waiho pū i ka EUA.
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1. ʻO ka poʻe maʻi i hoʻopaʻa ʻia me nā lāʻau lapaʻau i hoʻohana ʻole ʻia e hoʻomohala i nā antibodies anti-N a me anti-S.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. 100% specificity, 92.4% sensitivity ma mua o 15 mau lā ma hope o ka hoʻomaka ʻana o nā hōʻailona 4. 99.2% kikoʻī a me 98.5% PPA ≥ 15 mau lā ma hope o ka hoʻomaka ʻana o nā hōʻailona
Ka manawa hoʻouna: Iune-22-2021