RapidQ: A reader-free microfluidic platform for the quantitation of antibodies against the SARS-CoV-2 spike protein.

We describe RapidQ, a fast, disposable, easy-to-use microfluidic assay for the quantitation of the anti-SARS-CoV-2 spike (S) protein IgG in plasma samples. The assay utilizes antigen-coated paramagnetic microbeads, which are induced to aggregate inside the RapidQ microfluidic device in the presence of the target antibody. Aggregation occurs via interaction between the biotinylated detection antibody and polymeric streptavidin. The mobility of the beads inside the two microchannels of the device depends on their aggregation state, with larger clusters moving at higher velocities under a given liquid flow rate. One of the microchannels incorporates a permanent magnet that captures arriving beads and forms a localized constriction that retards liquid flow. Since the constriction grows faster when the beads are more aggregated, the length of the liquid column accumulated downstream from the constriction relative to that of the unconstricted control channel is proportional to the sample antibody concentration. The assay demonstrates a detection limit of 4 μg/ml of monoclonal anti-S protein antibody diluted in plasma with CV ≤ 13%, as well as negative and positive percent agreements of 100% (95% CI: 92.75%-100%) and 100% (95% CI: 80.5%-100%), respectively, when compared to a nucleic acid amplification test used to identify COVID-19 positive individuals, whose samples were collected ≥17 d from a positive PCR test. Finally, the RapidQ assay was used to monitor the kinetics of antibody responses to COVID-19 vaccination in a small study cohort.