Antibody Levels Over Time Following SARS-CoV-2 Vaccinations
NIH/NLM NCT04944095 (clinicaltrials.gov)

Southlake Diagnostics has initiated an antibody study, registered on clinicaltrials.gov, testing program in selected nursing homes involving more than 10,000 residents and employees to assess and track specific IgG antibody and total (IgM + IgG) antibody responses with time post-vaccination. IgG and total antibodies to SARS-CoV-2 in human plasma (lithium-heparin) will be determined using the Siemen’s Atellica® IM SARS-CoV-2 IgG (sCOVG) assay (EUA Number: EUA202669) and Siemen’s Atellica® IM SARS-CoV-2 Total (COV2T) assay (EUA Number: EUA201367), respectively, which are highly sensitive chemiluminescent immunoassays intended for qualitative and semi-quantitative detections using the Atellica® IM Analyzer. The data which will be sorted and analyzed as a whole and according to various parameters as gender, age groups, known disease states and immunocompetencies, physical characteristics and time after vaccination. The results of this study will provide a threshold for protection or immunity, confirm an initial neutralizing antibody response shortly after vaccination, and a bridge to additional larger population studies. Thus, critically needed information regarding degree of protection from infection after vaccination will be obtained.

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