I-Siemens Healthineers ithole ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo kwe-FDA ukuze kuhlolwe i-antibody ye-SARS-CoV-2

E-New York-Ngesonto eledlule, i-Food and Drug Administration inikeze i-Siemens Healthineers imvume yokusebenzisa izimo eziphuthumayo ngokuhlolwa kwayo kwe-Advia Centaur SARS-CoV-2 IgG noma i-sCOVG.
I-Chemiluminescence immunoassay yakhelwe ukutholwa kwekhwalithi kanye nengxenye yobuningi be-immunoglobulin G noma i-IgG ngokumelene ne-SARS-CoV-2 ku-serum ne-plasma.Ukuhlola kwenziwa ku-Siemens' Advia Centaur XP, Advia Centaur XPT kanye ne-Advia Centaur CP immunoassay systems.
Ngokusho kwe-FDA, lokhu kuhlola kungasetshenziswa yinoma iyiphi ilabhorethri egunyazwe yi-CLIA ukwenza izivivinyo ezimaphakathi noma eziyinkimbinkimbi kakhulu.
NgoMashi walo nyaka, i-SARS-CoV-2 IgG immunoassay eqhutshwa yi-Siemens AG, ikomkhulu layo e-Erlangen, eJalimane, kumhlaziyi wayo we-Atellica IM, yathola i-EUA evela ku-FDA.
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Isikhathi sokuthumela: Jun-28-2021