Real World Performance of SARS-CoV-2 Antigen Rapid Diagnostic Tests in Various Clinical Settings

Regev-Yochay, G.; Kriger, O.; Beni, S.; Rubin, C.; Mina, M. J.; Mechnik, B.; Hason, S.; Biber, E.; Nadaf, B.; Kreiss, Y.; Amit, S.

Background: Several uses of Antigen rapid diagnostic tests (Ag-RDT) have been suggested. Analytical studies reported high specificity yet with lower sensitivity for detecting SARS-CoV-2 compared to qRT-PCR. Here, we present the use of these tests as a decision support tool in several settings. Methods: Samples were collected for both Ag-RDT and qRT-PCR in three different clinical settings; 1. Symptomatic patients presenting at the Emergency Departments 2. Asymptomatic patients screened upon hospitalization and 3. Health-care workers (HCW) following SARS-CoV-2 exposure. Positive percent agreement (PPA), negative percent agreement (NPA), positive predictive value (PPV) and negative predictive value (NPV) were calculated. To estimate the association between Ct value, Ag-RDT and the number of days since SARS-CoV-2 exposure or symptomatic COVID-19, a mixed model was applied. Results: A total of 5172 samples were obtained from 4595 individuals, with Ag-RDT and qRT-PCR results. Of these, 485 samples were positive by qRT-PCR. The PPA of Ag-RDT was greater for lower Ct values, reaching 93% in cases where Ct value was lower than 25 and 85% where Ct value was lower than 30. PPA was similar between symptomatic and asymptomatic individuals. The NPV and PPV were 96.8% and 99.1%, respectively. We observed a significant correlation between Ct value and time from infection onset (p<0.001). Lower Ct values were significantly associated with a positive Ag-RDT (p=0.01). Conclusions: Ag-RDT can be used as a decision support tool in various clinical settings and play a major role in early detection of SARS-CoV-2 infected individuals, highly specific and with high sensitivity to the infectious stage of disease, whether symptomatic or asymptomatic.