Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation.
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Krüger Lisa J, Tanuri Amilcar, Lindner Andreas K, Gaeddert Mary, Köppel Lisa, Tobian Frank, Brümmer Lukas E, Klein Julian A F, Lainati Federica, Schnitzler Paul, Nikolai Olga, Mockenhaupt Frank P, Seybold Joachim, Corman Victor M, Jones Terence C, Drosten Christian, Gottschalk Claudius, Weber Stefan F, Weber Stephan, Ferreira Orlando C, Mariani Diana, Dos Santos Nascimento Erika Ramos, Pereira Pinto Castineiras Terezinha M, Galliez Rafael Mello, Faffe Debora Souza, Leitão Isabela de Carvalho, Dos Santos Rodrigues Claudia, Frauches Thiago Silva, Nocchi Keity J Chagas Vilela, Feitosa Natalia Martins, Ribeiro Sabrina Santana, Pollock Nira R, Knorr Britta, Welker Andreas, de Vos Margaretha, Sacks JilianA, Ongarello Stefano, Denkinger Claudia M, Study Team
Аннотация
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 log10SARS-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.
FUNDING: Ministry of Science, Research and Arts, State of Baden-Wuerttemberg, Germany, internal funds from Heidelberg University Hospital, University Hospital Charité - Universitätsmedizin Berlin, UK Department of International Development, WHO, Unitaid.