Ortho Clinical Diagnostics, imodzi mwamakampani akulu kwambiri padziko lonse lapansi ozindikira matenda a in vitro, yalengeza kukhazikitsidwa kwa mayeso oyamba a anti-COVID-19 IgG komanso mayeso athunthu a COVID-19 nucleocapsid antibody.
Ortho ndi kampani yokhayo ku United States yomwe imapereka kuyesa kwachulukidwe komanso kuyesa kwa nucleocapsid kuma laboratories.Mayeso onsewa amathandizira gulu lachipatala kusiyanitsa chomwe chimayambitsa ma antibodies motsutsana ndi SARS-CoV-2 ndikuwakonza pa Ortho's VITROS® system yodalirika.
"Ku United States, katemera onse omwe amapatsidwa katemera amapangidwa kuti apangitse kuyankha kwa antibody ku puloteni ya SARS-CoV-2," atero a Ivan Sargo, MD, Ortho Clinical Diagnostics, wamkulu wa zamankhwala, azachipatala ndi zasayansi."Mayeso atsopano a Ortho amtundu wa IgG, limodzi ndi mayeso ake atsopano a nucleocapsid antibody, atha kupereka zambiri kuti zithandizire kudziwa ngati kuyankha kwa antibody kumachokera ku matenda achilengedwe kapena katemera wa spike protein."1
Mayeso a Ortho's VITROS® Anti-SARS-CoV-2 IgG ochulukirachulukira ndi mayeso oyamba a antibody ku United States kuti apereke zikhalidwe zoyesedwa malinga ndi miyezo yapadziko lonse lapansi ya World Health Organisation (WHO).2 Mayeso okhazikika a antibody amathandizira kugwirizanitsa njira za serological za SARS-CoV-2 ndikulola kufananitsa kwa data kofananira m'ma labotale.Deta yolumikizana iyi ndi gawo loyamba pakumvetsetsa kukwera ndi kugwa kwa ma antibodies amunthu payekha komanso kukhudzidwa kwanthawi yayitali kwa mliri wa COVID-19 pagulu komanso anthu onse.
Kuyesa kwatsopano kwa IgG kwa Ortho kudapangidwa kuti kuyeza moyenera komanso mochulukira ma antibodies a IgG motsutsana ndi SARS-CoV-2 mu seramu yamunthu ndi plasma, yokhala ndi 100% yeniyeni komanso kumva bwino kwambiri.3
Ortho's VITROS® Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test ndi mayeso 4 olondola kwambiri kuti azindikire mtundu wa SARS-CoV-2 nucleocapsid mwa odwala omwe ali ndi kachilombo ka SARS-CoV-2 Antibody.
"Timaphunzira zambiri zatsopano za kachilombo ka SARS-CoV-2 tsiku lililonse, ndipo Ortho yadzipereka kupereka ma laboratories ndi mayankho olondola kwambiri kuti athe kuthana ndi zovuta zomwe zikuchitika komanso zamtsogolo za mliri womwe ukupitilira," adatero Dr. Chockalingam Palaniappan. , Chief Innovation Officer wa Ortho Clinical Diagnostics.
Mayeso a Ortho's COVID-19 kuchuluka kwa antibody adamaliza njira ya US Food and Drug Administration (FDA) yodziwitsa zadzidzidzi (EUN) pa Meyi 19, 2021, ndikupereka chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) kuti ayesedwe ku FDA.Mayeso ake a VITROS® Anti-SARS-CoV-2 athunthu a nucleocapsid antibody adamaliza ntchito ya EUN pa Meyi 5, 2021, ndikutumizanso EUA.
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1. Odwala omwe alandira katemera wa kachilombo koyambitsa matenda amatha kupanga ma anti-N ndi anti-S.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. 100% yeniyeni, 92.4% kukhudzidwa kuposa masiku 15 chiyambi cha zizindikiro 4. 99.2% mwachindunji ndi 98.5% PPA ≥ masiku 15 chiyambireni zizindikiro
Nthawi yotumiza: Jun-22-2021