Comparison of SARS-CoV-2 Antigen Tests in Asymptomatic Testing of Passengers at German Airports under Time Constraints: Application of Three Different Antigen Test Formats

Abstract

People infected asymptomatically with SARS-CoV-2 can spread the virus very efficiently. To break infection chains, massive testing efforts are underway. While the value of RT-PCR in asymptomatic patients is established, point-of-care (POC) antigen tests against SARS-CoV-2 are considered inferior to RT-PCR in terms of sensitivity and specificity but have demonstrated utility, mostly in symptomatic patients. We compared the performance of three different antigen tests with colorimetric (Roche), fluorometric (Quidel Sofia 2), and instrument-based chemiluminescent (Fujirebio Lumipulse® G) readout. Sensitivities for Roche, Quidel, and Fujirebio were 62.5%, 90.9%, 97.5% (≤ct 26); 43.8%, 90.9%, 95.1% (≤ct 30); and 4.3%, 0.0%, 57.6% (˃ct 30), respectively. The two assays with increased sensitivity were employed to screen > 35,000 passengers at German airports under time constraints. Under real-world conditions, the rate of false positives was low: 0.15% (Quidel) and 0.06% for the instrument based Fujirebio assay. Our study exemplifies that antigen tests with enhanced detection methods have an acceptable sensitivity of >90% in samples containing SARS-CoV-2 RNA that are considered to be infectious. Therefore, our results support the view of the WHO that discourages the use of antigen assays with a sensitivity of “only” 80% for screening travelers.

Clinical evaluation of DIAGNOVIR SARS-CoV-2 ultra-rapid antigen test performance compared to PCR-based testing

“…Scale-up of testing can prevent the spread and tackle the pandemic. As shown in Tables 3 and 4, the sensitivity of the DIAGNOVIR rapid test was found to be 100% among asymptomatic patients, and it was 97.5%, 48.1%, 48.1% and 71.43% for the Lumipulse, Panbio, SD Biosensor, and Roche, respectively [33][34][35][36] . Some studies suggested that the peak of transmissibility is at or even before the time of symptom onset.…”