학술논문
Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation
Document Type
article
Author
Lisa J. Krüger; Amilcar Tanuri; Andreas K. Lindner; Mary Gaeddert; Lisa Köppel; Frank Tobian; Lukas E. Brümmer; Julian A.F. Klein; Federica Lainati; Paul Schnitzler; Olga Nikolai; Frank P. Mockenhaupt; Joachim Seybold; Victor M. Corman; Terence C. Jones; Christian Drosten; Claudius Gottschalk; Stefan F. Weber; Stephan Weber; Orlando C. Ferreira; Diana Mariani; Erika Ramos dos Santos Nascimento; Terezinha M. Pereira Pinto Castineiras; Rafael Mello Galliez; Debora Souza Faffe; Isabela de Carvalho Leitão; Claudia dos Santos Rodrigues; Thiago Silva Frauches; Keity J. Chagas Vilela Nocchi; Natalia Martins Feitosa; Sabrina Santana Ribeiro; Nira R. Pollock; Britta Knorr; Andreas Welker; Margaretha de Vos; JilianA. Sacks; Stefano Ongarello; Claudia M. Denkinger
Source
EBioMedicine, Vol 75, Iss , Pp 103774- (2022)
Subject
Language
English
ISSN
2352-3964
Abstract
Summary: 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, multi-centre 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 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.