SARS-CoV-2 Variant of Concern B.1.1.7: Diagnostic Sensitivity of Three Antigen-Detecting Rapid Tests

Abstract

Virus mutations have the potential to impact the accuracy of diagnostic tests. The SARS-CoV-2 B.1.1.7 lineage is defined by a large number of mutations in the spike gene and four in the nucleocapsid (N) gene. Most commercially available SARS-CoV-2 antigen-detecting rapid tests (Ag-RDTs) target the viral N-protein, encoded by the N-gene. We conducted a manufacturer-independent, prospective diagnostic accuracy study of three SARS-CoV-2 Ag-RDTs that are currently under review by the WHO Emergency Use Listing Procedure (Espline - Fujirebio Inc.; Sure Status - Premier Medical Corporation Private Limited; Mologic - Mologic Ltd.) and report here on an additional sub-analysis regarding the B.1.1.7 lineage. During the study, in Berlin and Heidelberg, Germany, from 20 January to 15 April 2021, B.1.1.7 rapidly became the dominant SARS-CoV-2 lineage at the testing sites and was detected in 220 (62%) of SARS-CoV-2 RT-PCR positive patients. All three Ag-RDTs yielded comparable sensitivities irrespective of an infection with the B.1.1.7 lineage or not. There is only limited data on how N-gene mutations in variants of concern may impact Ag-RDTs. Currently, no major changes to test performance are anticipated. However, test developers and health authorities should assess and monitor the impact of emerging variants on the accuracy of Ag-RDTs.Competing Interest StatementThe authors have declared no competing interest.Funding StatementC.M. Denkinger reports grants from Foundation for Innovative New Diagnostics (FIND), and Ministry of Science, Research and Culture, State of Baden Wuerttemberg, Germany, to conduct of the study. This work was funded as part of FIND's work as co-convener of the diagnostics pillar of the Access to COVID-19 Tools (ACT) Accelerator, including support from Unitaid [grant number: 2019-32-FIND MDR], the government of the Netherlands [grant number: MINBUZA-2020.961444], from the UK Foreign, Commonwealth and Development Office [FCDO, formerly DFID, grant number 300341-102], and the World Health Organization. T.C. Jones is in part funded through NIAID-NIH CEIRS contract HHSN272201400008C. FIND supplied the test kits for the study. The study was support by Heidelberg University Hospital and Charité University Hospital internal funds.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval…