Ua loaʻa iā Siemens Healthineers ka ʻae ʻana i ka hoʻohana ʻana i ka FDA no ka hoʻāʻo antibody SARS-CoV-2

New York-I ka pule i hala aku nei, ua hāʻawi ka US Food and Drug Administration i ka mana hoʻohana ulia pōpilikia iā Siemens Healthineers no kāna Advia Centaur SARS-CoV-2 IgG a i ʻole sCOVG hōʻike.
Hoʻolālā ʻia ʻo Chemiluminescence immunoassay no ka qualitative a semi-quantitative detection o immunoglobulin G a i ʻole IgG e kūʻē iā SARS-CoV-2 i ka serum a me ka plasma.Holo ʻia ka hoʻāʻo ma Siemens 'Advia Centaur XP, Advia Centaur XPT a me Advia Centaur CP immunoassay system.
Wahi a ka FDA, hiki ke hoʻohana ʻia kēia hoʻāʻo e kekahi keʻena hoʻokolohua CLIA-accredited e hana i nā hoʻokolohua haʻahaʻa a paʻakikī paha.
I Malaki o kēia makahiki, ʻo ka SARS-CoV-2 IgG immunoassay e holo ʻia e Siemens, i hoʻokumu ʻia ma Erlangen, Kelemānia, ma kāna mea anana Atellica IM, lanakila i ka EUA o ka FDA.
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