Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
Zsὁfia Iglὁi, Jans Velzing, Janko van Beek, David van de Vijver, Georgina I. Aron, Roel Ensing, Kimberley Benschop, Wanda G. H. Han, Timo Boelsums, Marion Koopmans, Corine H. GeurtsvanKessel, Richard Molenkamp
Abstract
S evere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged >1 year ago (1) but still keeps a strong grip not only on daily life but also on diagnostic capacities. Reverse transcription PCR (RT-PCR) has been the standard for diagnosis of acute infection (2) but has several limitations, such as the requirement for specialized laboratory infrastructure, trained personnel, and reagents that have been in shortage globally (3). In addition, the current turnaround time from sample collection to reporting of the result may take >48 hours (J. van Beek et al., unpub. data, https://doi.org/10.1101/ 2020.10.13.20211524), compromising effectiveness of triage, isolation, and contact tracing strategies. Rapid antigen detection tests (Ag RDT) for SARS-CoV-2 appeared on the market in early 2020, but initial reports of poor performance and the lack of independent evaluation results made governments reluctant to invest and consider inclusion into testing algorithms. As of February 2021, more than 140 assays are on the market (5), but relatively few have been extensively validated (5-6; V.M. Corman et al., unpub. data. https://doi.org/10.1101/2020.11 .12.20230292). Initial results show that these tests are suitable for detecting early-onset cases with high viral load. As expected, the sensitivity of the tests is lower than that of RT-PCR, but in patients in the early phase of illness who have high viral load, performance meets World Health Organization-set criteria of >80% sensitivity and >97% specifi city compared with nucleic acid detection methods (8). Thus, these tests could be useful in identifying the most infectious persons (4). In an outbreak scenario, diagnostics with lower sensitivity but a faster result can render interventions more effective than standard tests (9). Implementation of Ag RDT into testing algorithms would enable rapid detection and isolation of new cases and thereby support the test, trace, and isolate strategy with the intent to stop transmission chains and reduce the impact of coronavirus disease .