I-Ortho Clinical Diagnostics, enye yezinkampani ezinkulu emhlabeni zokuxilonga i-in vitro, imemezele ukwethulwa kokuhlolwa kokuqala kwe-COVID-19 IgG antibody kanye nokuhlolwa okuphelele kwe-COVID-19 nucleocapsid antibody.
I-Ortho ukuphela kwenkampani e-United States ehlinzeka ngenhlanganisela yokuhlolwa komthamo kanye nokuhlolwa kwe-nucleocapsid kumalabhorethri.Kokubili lokhu kuhlola kusiza ithimba lezokwelapha lihlukanise imbangela yamasosha omzimba ngokumelene ne-SARS-CoV-2 futhi liwacubungule ngohlelo oluthembekile lwe-VITROS® lwe-Ortho.
"E-United States, yonke imigomo egonyiwe yenzelwe ukukhiqiza impendulo ye-antibody kuphrotheni ye-spike yegciwane le-SARS-CoV-2," kusho u-Ivan Sargo, MD, i-Ortho Clinical Diagnostics, inhloko yezokwelapha, izindaba zezokwelapha nezesayensi.“Ukuhlolwa kwe-Ortho kwenani elisha le-IgG antibody, kanye nokuhlolwa kwayo okusha kwe-nucleocapsid antibody, kunganikeza imininingwane eyengeziwe ukuze kutholakale ukuthi ingabe impendulo ye-antibody iqhamuka ekuthelelekeni okungokwemvelo noma emuthini wokugoma oqondiswe yi-spike protein.”1
I-Ortho's VITROS® Anti-SARS-CoV-2 IgG test quantitative antibody iwukuhlola kokuqala kwe-antibody e-United States ukunikeza amanani alinganiswa ngokuvumelana namazinga omhlaba e-World Health Organization (WHO).2 Ukuhlolwa okujwayelekile komthamo we-antibody kusiza ukuvumelanisa izindlela ze-SARS-CoV-2 ze-serological futhi kuvumela ukuqhathaniswa kwedatha okufanayo kuwo wonke ama-laboratories.Le datha ehlanganisiwe iyisinyathelo sokuqala sokuqonda ukukhuphuka nokwehla kwamasosha omzimba ngamanye kanye nomthelela wesikhathi eside womqedazwe we-COVID-19 emphakathini nakuso sonke isibalo sabantu.
Ukuhlolwa kobuningi be-IgG okusha kwe-Ortho kuklanyelwe ukukala ngokwekhwalithi nangokwesilinganiso amasosha omzimba e-IgG ngokumelene ne-SARS-CoV-2 ku-serum yomuntu kanye ne-plasma, enokucaciswa okungu-100% nokuzwela okuhle kakhulu.3
I-Ortho's new VITROS® Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test iyisivivinyo esinembe kakhulu esingu-4 sokuthola ikhwalithi ye-SARS-CoV-2 nucleocapsid ezigulini ezitheleleke nge-SARS-CoV-2 virus Antibody.
“Sihlala sifunda ulwazi olusha ngegciwane le-SARS-CoV-2 nsuku zonke, futhi i-Ortho izimisele ukuhlomisa izindawo zokucwaninga ngezixazululo ezinembe kakhulu ukuze zizisize zibhekane nezinselelo zamanje nezesikhathi esizayo zalolu bhubhane oluqhubekayo,” kusho uDkt. Chockalingam Palaniappan. , Umphathi Omkhulu Wokusungula we-Ortho Clinical Diagnostics.
Ukuhlolwa kwe-Ortho's COVID-19 quantitative antibody kuqedele inqubo ye-US Food and Drug Administration (FDA) yesaziso sokusebenzisa izimo eziphuthumayo (EUN) yase-US ngoMeyi 19, 2021, futhi yathumela ukugunyazwa kokusetshenziswa okuphuthumayo (i-EUA) ukuze kuhlolwe ku-FDA.Ukuhlolwa kwayo kwe-VITROS® Anti-SARS-CoV-2 sekuphelele kwe-nucleocapsid yaqeda inqubo ye-EUN ngoMeyi 5, 2021, yaphinde yahambisa i-EUA.
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1. Iziguli ezigonywe ngemijovo yegciwane engacushiwe zizothuthukisa amasosha omzimba e-anti-N kanye ne-anti-S.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. Ukucaciswa okungu-100%, ukuzwela okungu-92.4% ngaphezu kwezinsuku eziyi-15 ngemuva kokuqala kwezimpawu 4. Ukucaciswa okungu-99.2% kanye ne-98.5% PPA ≥ izinsuku eziyi-15 ngemuva kokuqala kwezimpawu
Isikhathi sokuthumela: Jun-22-2021