The Siemens Healthineers SARS-CoV-2 antibody assays* detect antibodies to the S1 RBD antigen and are well-positioned to aid vaccine development efforts. S1 RBD antibodies are relevant to vaccines incorporating this immunodominant region with the goal to elicit neutralizing antibodies in vaccinated subjects.1 The spike protein and particularly the RBD are the most common target of vaccine designs.
The Siemens Healthineers SARS-CoV-2 antibody assays can be used with a full range of systems such as the Atellica® IM Analyzer,* ADVIA Centaur® Immunoassay Systems,* and Dimension® systems.* This enables accurate SARS-CoV-2 antibody testing on a large scale for both reference laboratories and acute care settings with a global installed base of over 20,000 instruments.†
*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.
†Installed base of ADVIA Centaur® XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica® Solution, Dimension Vista®, and Dimension® EXL™ analyzers.
1. Mulligan, MJ et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: InterimReporthttps://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1.full.pdf