Bioanalytical and Biomarker Assay Development for COVID-19 Therapeutics and Vaccines


All clinical trials for COVID-19 need PCR assays that detect the virus and determine an active infection. Antibody and neutralizing assays are necessary to identify if a therapy or vaccine produces antibodies against the virus. There are also essential biomarkers to measure in COVID-19 trials. Cytokines can be measured in the blood to characterize the cytokine storm that SARS-CoV-2 creates in the lungs. Other functional biomarker assays such as the ELISPOT determine if T cells are helping produce antibodies after vaccination.