Design of immunoassay based biosensor platforms for SARS-CoV-2 detection using highly specific monoclonal antibodies.

The global expand of SARS-CoV-2 has highlighted the importance of early and rapid detection to control the spread of a pandemic. In this study, specific and high-affinity monoclonal antibodies (mAbs) were developed against the conserved nucleocapsid protein of the virus among variants. Appropriate antibody pairs were selected to develop a lateral flow immunoassay (LFIA) and an unconventional application of an amperometric biosensor using unmodified screen-printed electrodes and external magnetic bead preparation. In the study, the LFIA we developed detected the SARS-CoV-2 virus at 10 PFU/mL, while the amperometric biosensor enabled sensitive detection of inactivated SARS-CoV-2 with an LOD of 5.5 PFU/mL. After validating the developed systems, it is considered that the mAbs we have obtained will enable the sensitive and selective detection of SARS-CoV-2 in LFIA and amperometric immunosensor platforms for clinical diagnosis.