Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter (preprint)

ABSTRACT

RT-qPCR is considered the gold standard for diagnosis of COVID-19; however, it is laborious, time-consuming, and expensive. RADTs have evolved recently as relatively inexpensive methods to address these shortcomings, but their performance for detecting different SARS-COV-2 variants remains limited. RADT test performance could be enhanced using different antibody labeling and signal detection techniques. Here, we aimed to evaluate the performance of two Wondfo antigen RADTs for detecting different SARS-CoV-2 variants (i) the conventional colorimetric RADT (Ab-conjugated with gold beads); and (ii) the new FinecareTM RADT (Ab-coated fluorescent beads). FinecareTM is a meter used for the detection of a fluorescent signal. 187 frozen nasopharyngeal swabs collected in Universal transport (UTM) that are RT-qPCR positive for different SARS-CoV-2 variants were selected, including 60 Alpha, 59 multiple Delta, and 108 multiple Omicron variants. 60 flu and 60 RSV-positive samples were included as negative controls (total sample number=349). The conventional RADT showed sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 62.4% (95%CI 54-70), 100% (95%CI 97-100), 100% (95%CI 100-100), and 58% (95%CI 49-67) respectively. These measurements were enhanced using the FinecareTM RADT sensitivity, specificity, PPV, and NPV were 92.6% (95%CI 89.08-92.3), 96% (95%CI 96-99.61), 98% (95%CI 89-92.3), and 85% (95%CI 96-99.6) respectively. The sensitivity of both RADTs could be greatly underestimated because nasopharyngeal swab samples collected UTM and stored at -80 oC were used. Despite that, our results indicate that the FinecareTM RADT is appropriate for clinical laboratory and community-based surveillance due to its high sensitivity and specificity.