I-Ortho Clinical Diagnostics, enye yezona nkampani zinkulu ezicocekileyo ze-vitro zokuxilonga, ibhengeze ukuphehlelelwa kovavanyo lokuqala lwe-COVID-19 IgG antibody kunye novavanyo olubanzi lwe-COVID-19 ye-nucleocapsid antibody.
I-Ortho kuphela kwenkampani e-United States ebonelela ngendibaniselwano yovavanyo lobungakanani kunye novavanyo lwe-nucleocapsid kwiilabhoratri.Zombini ezi mvavanyo zinceda iqela lezonyango ukuba lahlule unobangela wee-antibodies ezichasene ne-SARS-CoV-2 kwaye zisebenze kwinkqubo ye-Ortho's ethembekileyo ye-VITROS®.
"EUnited States, zonke izitofu ezigonyiweyo zenzelwe ukuvelisa impendulo ye-antibody kwiprotein ye-spike yentsholongwane ye-SARS-CoV-2," utshilo u-Ivan Sargo, MD, i-Ortho Clinical Diagnostics, intloko yeyeza, ikliniki kunye nemicimbi yesayensi."Uvavanyo olutsha lobungakanani be-IgG ye-IgG, kunye novavanyo lwayo olutsha lwe-nucleocapsid, lunokubonelela ngedatha eyongezelelweyo ukunceda ukufumanisa ukuba impendulo ye-antibody iphuma kusulelo lwendalo okanye isitofu sokugonya esijolise kwiprotein."1
I-Ortho's VITROS® Anti-SARS-CoV-2 IgG yovavanyo lobungakanani be-antibody luvavanyo lokuqala lwe-antibody e-United States ukubonelela ngexabiso elilinganisiweyo ngokwemigangatho yamazwe ngamazwe yoMbutho wezeMpilo weHlabathi (i-WHO).2 Uvavanyo olusemgangathweni lwe-antibody lunceda ukulungelelanisa iindlela ze-SARS-CoV-2 ze-serological kwaye zivumela ukuthelekiswa kwedatha efanayo kuzo zonke iilabhoratri.Le datha imanyanisiweyo linyathelo lokuqala lokuqonda ukunyuka kunye nokuwa kwezilwa-buhlungu zomntu ngamnye kunye nefuthe lexesha elide lobhubhani we-COVID-19 kuluntu nakuluntu luphela.
Uvavanyo olutsha lobungakanani be-IgG ye-Ortho yenzelwe ukulinganisa ngokomgangatho nangokobungakanani izilwa-buhlungu ze-IgG ngokuchasene ne-SARS-CoV-2 kwiserum yabantu kunye neplasma, ene-100% ethile kunye novelwano olubalaseleyo.3
I-Ortho entsha ye-VITROS® ye-Anti-SARS-CoV-2 iyonke yoVavanyo lwe-Nucleocapsid Antibody luvavanyo olu-4 oluchaneke kakhulu lokubona umgangatho we-SARS-CoV-2 nucleocapsid kwizigulana ezosulelwe yi-SARS-CoV-2 Antibody.
“Sihlala sifunda ulwazi olutsha malunga nentsholongwane ye-SARS-CoV-2 yonke imihla, kwaye u-Ortho uzibophelele ekuxhobiseni iilabhoratri ngezisombululo ezichaneke kakhulu ukubanceda bamelane nemingeni yangoku neyexesha elizayo yalo bhubhani uqhubekayo,” utshilo uGqr. Chockalingam Palaniappan. , IGosa eliyiNtloko le-Innovation ye-Ortho Clinical Diagnostics.
Uvavanyo lwe-Ortho's COVID-19 lobungakanani be-antibody lugqibe inkqubo ye-US yoKutya kunye noLawulo lweDrugs (i-FDA) yesaziso sosetyenziso olungxamisekileyo (EUN) ngoMeyi 19, 2021, kwaye yangenisa isigunyaziso sosetyenziso olungxamisekileyo (EUA) kuvavanyo kwi-FDA.I-VITROS® Anti-SARS-CoV-2 iyonke yovavanyo lwe-antibody ye-nucleocapsid igqibe inkqubo ye-EUN ngoMeyi 5, 2021, kwaye nayo yangenisa i-EUA.
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1. Izigulane ezigonywe ngezitofu zentsholongwane ezingasebenziyo ziya kuphuhlisa i-anti-N kunye ne-anti-S antibodies.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. Ukucaciswa kwe-100%, uvakalelo lwe-92.4% ngaphezu kweentsuku ze-15 emva kokuqala kweempawu 4. I-99.2% ekhethekileyo kunye ne-98.5% ye-PPA ≥ iintsuku ezili-15 emva kokuqala kweempawu
Ixesha lokuposa: Jun-22-2021