Elecsys® immunoassay on COBAS ® (Roche Diagnostics)

The Elecsys® immunoassay system on COBAS® platforms (Roche Diagnostics) is an automated in vitro diagnostic (IVD) electrochemiluminescence (ECL)–based technology used for the qualitative and quantitative detection of antibodies, antigens, and other analytes relevant to clinical diagnostics and clinical research. Depending on the specific validated Elecsys assay employed, the system is applicable to a broad range of infectious pathogens, including SARS‑CoV‑2, hepatitis B virus (HBV), hepatitis C virus (HCV), HIV‑1/2, Epstein–Barr virus (EBV), cytomegalovirus (CMV), rubella virus, Treponema pallidum, Toxoplasma gondii, and others. The assays typically use sandwich or competitive immunoassay formats and provide automated result interpretation against calibrated cut‑off values. Elecsys assays are widely implemented in clinical and vaccine‑related studies and are suitable for use in line with EMA expectations for validated serological and immunogenicity assessments, provided the specific assay is appropriately qualified for its intended purpose. During the COVID-19 pandemic, VisMederi employed COBAS technology for the analysis of extensive sample sets generated within SARS-CoV-2 vaccine clinical trials (Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial), confirming its robustness and suitability for high-throughput applications.