Ortho Clinical Diagnostics, e leng e 'ngoe ea lik'hamphani tse kholo ka ho fetisisa lefatšeng tsa tlhahlobo ea in vitro, e phatlalalitse ho thakholoa ha tlhahlobo ea pele ea palo ea antibody ea COVID-19 IgG le tlhahlobo e felletseng ea COVID-19 ea nucleocapsid antibody.
Ortho ke eona feela k'hamphani United States e fanang ka tlhahlobo e kopaneng ea tlhahlobo ea bongata le tlhahlobo ea nucleocapsid bakeng sa lilaboratori.Liteko tsena ka bobeli li thusa sehlopha sa bongaka ho khetholla sesosa sa li-antibodies khahlanong le SARS-CoV-2 le ho li sebetsana le sistimi ea Ortho e tšepahalang ea VITROS®.
"United States, liente tsohle tse entetsoeng li etselitsoe ho hlahisa karabelo ea antibody ho protheine ea spike ea vaerase ea SARS-CoV-2," ho boletse Ivan Sargo, MD, Ortho Clinical Diagnostics, hlooho ea bongaka, litaba tsa bongaka le tsa mahlale."Teko e ncha ea "IgG" ea Ortho, hammoho le tlhahlobo ea eona e ncha ea "nucleocapsid antibody", e ka fana ka lintlha tse ling ho thusa ho tseba hore na karabelo ea antibody e tsoa tšoaetsong ea tlhaho kapa ente e lebisitsoeng ho protheine ea spike."
Ortho's VITROS® Anti-SARS-CoV-2 IgG quantitative antibody test ke teko ea pele ea antibody United States ho fana ka litekanyetso tse lekantsoeng ho latela litekanyetso tsa machaba tsa Mokhatlo oa Lefatše oa Bophelo (WHO).2 Teko e emeng ea li-antibody e thusa ho hokahanya mekhoa ea serological ea SARS-CoV-2 mme e lumella papiso e ts'oanang ea data ho pholletsa le lilaboratori.Lintlha tsena tse kopaneng ke mohato oa pele oa ho utloisisa ho phahama le ho oa ha li-antibodies le phello ea nako e telele ea seoa sa COVID-19 sechabeng le sechabeng ka kakaretso.
Teko e ncha ea Ortho ea tekanyo ea IgG e etselitsoe ho lekanya li-antibodies tsa IgG ka boleng le ka bongata khahlano le SARS-CoV-2 ho serum ea motho le plasma, ka 100% e ikhethang le kutlo e ntle haholo.3
Tlhahlobo e ncha ea Ortho's VITROS® Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test ke teko e nepahetseng haholo e 4 bakeng sa tlhahlobo ea boleng ba SARS-CoV-2 nucleocapsid ho bakuli ba tšoaelitsoeng ke kokoana-hloko ea SARS-CoV-2 Antibody.
"Re lula re ithuta tsebo e ncha ka vaerase ea SARS-CoV-2 letsatsi le leng le le leng, 'me Ortho e ikemiselitse ho hlomella lilaboratori ka litharollo tse nepahetseng haholo ho li thusa ho sebetsana ka katleho le mathata a hona joale le a kamoso a seoa sena se ntseng se tsoela pele," ho boletse Dr. Chockalingam Palaniappan. , Mookameli ea ka sehloohong oa Innovation oa Ortho Clinical Diagnostics.
Teko ea Ortho's COVID-19 quantitative antibody e phethetse ts'ebetso ea tsebiso ea ts'ebeliso ea tšohanyetso ea US Food and Drug Administration (EUN) (EUN) ka la 19 Motšeanong 2021, mme ea fana ka tumello ea ts'ebeliso ea tšohanyetso (EUA) bakeng sa tlhahlobo ho FDA.Teko ea eona ea VITROS® Anti-SARS-CoV-2 kakaretso ea anti-nucleocapsid e phethetse ts'ebetso ea EUN ka la 5 Mots'eanong, 2021, hape ea kenya EUA.
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1. Bakuli ba entetsoeng ka liente tse sa sebetseng tsa kokoana-hloko ba tla hlahisa li-anti-N le anti-S antibodies.2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. 100% specificity, 92.4% sensitivity ho feta matsatsi a 15 ka mor'a ho qala ha matšoao 4. 99.2% e tobileng le 98.5% PPA ≥ matsatsi a 15 kamora ho qala ha matšoao
Nako ea poso: Jun-22-2021