Analytical assessment of Beckman Coulter Access anti-SARS- CoV-2 IgG immunoassay

A Paper-Based Multiplexed Serological Test to Monitor Immunity against SARS-COV-2 Using Machine Learning

“…19,24 The FDA provided a comprehensive overview of authorized serology tests for COVID-19, 37 where the predominant techniques involved chemiluminescence (CL) or fluorescence signals. [25][26][27][28]38 These benchtop measurement platforms offer enhanced sensitivity and specificity compared to LFAs; however, their bulky and relatively costly designs and laborintensive operation make them unsuitable for POC settings (see Supplementary Table S4 for a comparison of existing CL and LFA-based COVID-19 serology assays). On the contrary, our xVFA has simplified operational steps and provides a portable and cost-effective alternative suitable for multiplexed POC testing.…”

“…Partially motivated by this need, various COVID-19 serology tests have been developed to assess IgG and IgM levels in human blood/serum samples. These benchtop instruments, including e.g ., ELISA, Luminex systems, Chemiluminescent Immunoassays (CLIA), and ELFIA − offer diverse testing options and provide quantitative results for antibody concentrations. While some of these benchtop designs could be multiplexed for IgG and IgM detection using multiple antigens, they require specialized and relatively costly benchtop equipment and reagents, which provide limitations for POC use and resource-limited settings.…”