Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation

Background Antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are important diagnostic tools. We assessed clinical performance and ease-of-use of seven Ag-RDTs in a prospective, manufacturer-independent, multicentre cross-sectional diagnostic accuracy study to inform global decision makers. Methods Unvaccinated participants suspected of a first SARS-CoV-2 infection were recruited at six sites (Germany, Brazil). Ag-RDTs were evaluated sequentially, with collection of paired swabs for routine reverse transcription polymerase chain reaction (RT-PCR) testing and Ag-RDT testing. Performance was compared to RT-PCR overall and in sub-group analyses (viral load, symptoms, symptoms duration). To understandusability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed. Findings 7471 participants were included in the analysis. Sensitivities across Ag-RDTs ranged from 70.4%-90.1%, specificities were above 97.2% for all Ag-RDTs but one (93.1%).Ag-RDTs, Mologic, Bionote, Standard Q, showed diagnostic accuracy in line with WHO targets (> 80% sensitivity, > 97% specificity). All tests showed high sensitivity in the first three days after symptom onset (>= 87.1%) and in individuals with viral loads >= 6 log(10)SARS-CoV2 RNA copies/mL (>= 88.7%). Usability varied, with Rapigen, Bionote and Standard Q reaching very good scores; 90, 88 and 84/100, respectively. Interpretation Variability in test performance is partially explained by variable viral loads in population evaluated over the course of the pandemic. All Ag-RDTs reach high sensitivity early in the disease and in individuals with high viral loads, supporting their role in identifying transmission relevant infections. For easy-to-use tests, performance shown will likely be maintained in routine implementation. Copyright (C) 2021 The Authors. Published by Elsevier B.V.

Automated summary

This study evaluated the clinical performance and ease-of-use of seven SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs). The results showed high sensitivity and specificity of the Ag-RDTs, especially in early-stage disease and individuals with high viral loads. The tests from Mologic, Bionote, and Standard Q demonstrated good usability.