Development of surface-enhanced Raman scattering-based immunoassay platforms using hollow Au nanostars for reliable SARS-CoV-2 diagnosis.

We developed a novel surface-enhanced Raman scattering (SERS)-based SARS-CoV-2 assay platform using hollow Au nanostars to realize high-sensitivity diagnosis of SARS-CoV-2. The assay was performed using SARS-CoV-2 lysate as the target in a wide dynamic range with virus concentrations ranging from 0 to 10 PFU/ml and has a limit of detection (LOD) of 5.1 PFU/ml. This LOD value shows 100 times and 10 times better sensitivity compared to the LODs measured on the same sample using a commercially available rapid kit and enzyme-linked immunosorbent assay, respectively. Therefore, we believe that this SERS-based SARS-CoV-2 assay platform has high diagnostic accuracy for early or asymptomatic infected patients with low virus concentrations. Furthermore, the probability of a false-negative diagnosis is likely to be very low.