Siemens Healthineers yabonye uruhushya rwo gukoresha FDA byihutirwa byo gupima antibody ya SARS-CoV-2

New York-Icyumweru gishize, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika bwahaye uburenganzira bwo gukoresha byihutirwa abashinzwe ubuzima bwa Siemens kubushakashatsi bwabwo bwa Advia Centaur SARS-CoV-2 IgG cyangwa sCOVG.
Immunoassay ya Chemiluminescence yagenewe kumenya neza na kimwe cya kabiri cyo kumenya immunoglobuline G cyangwa IgG kurwanya SARS-CoV-2 muri serumu na plasma.Ikizamini gikorerwa kuri Siemens 'Advia Centaur XP, Advia Centaur XPT na sisitemu ya immunoassay ya Advia Centaur CP.
Nk’uko FDA ibivuga, iki kizamini gishobora gukoreshwa na laboratoire yemewe na CLIA kugirango ikore ibizamini biciriritse cyangwa bikomeye.
Muri Werurwe uyu mwaka, SARS-CoV-2 IgG immunoassay ikorwa na Siemens, ifite icyicaro i Erlangen mu Budage, ku isesengura ryayo rya Atellica IM, yatsindiye EUA ya FDA.
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Igihe cyo kohereza: Nyakanga-21-2021