EBioMedicine (Jan 2022)
Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation
- 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
Affiliations
- Lisa J. Krüger
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Amilcar Tanuri
- Laboratório de Virologia Molecular, Instituto de Biologia - Departamento de Genética, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Andreas K. Lindner
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Tropical Medicine and International Health, Augustenburger Pl. 1, Berlin 13353, Germany
- Mary Gaeddert
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Lisa Köppel
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Frank Tobian
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Lukas E. Brümmer
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Julian A.F. Klein
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Federica Lainati
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Paul Schnitzler
- Virology, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Olga Nikolai
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Tropical Medicine and International Health, Augustenburger Pl. 1, Berlin 13353, Germany
- Frank P. Mockenhaupt
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Tropical Medicine and International Health, Augustenburger Pl. 1, Berlin 13353, Germany
- Joachim Seybold
- Medical Directorate, Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Pl. 1, Berlin 13353, Germany
- Victor M. Corman
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Virology, Rahel-Hirsch-Weg 3, Berlin 10117, Germany; German Centre for Infection Research (DZIF), Partner Site Charité, Charitépl. 1, Berlin 10117, Germany
- Terence C. Jones
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Virology, Rahel-Hirsch-Weg 3, Berlin 10117, Germany; German Centre for Infection Research (DZIF), Partner Site Charité, Charitépl. 1, Berlin 10117, Germany; Centre for Pathogen Evolution, Department of Zoology, University of Cambridge, Downing Street, Cambridge CB2 3EJ, UK
- Christian Drosten
- Charité − Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Virology, Rahel-Hirsch-Weg 3, Berlin 10117, Germany; German Centre for Infection Research (DZIF), Partner Site Charité, Charitépl. 1, Berlin 10117, Germany
- Claudius Gottschalk
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Stefan F. Weber
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany
- Stephan Weber
- Acomed Statistik, Fockestraße 57, Leipzig 04275, Germany
- Orlando C. Ferreira
- Laboratório de Virologia Molecular, Instituto de Biologia - Departamento de Genética, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Diana Mariani
- Laboratório de Virologia Molecular, Instituto de Biologia - Departamento de Genética, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Erika Ramos dos Santos Nascimento
- Laboratório de Virologia Molecular, Instituto de Biologia - Departamento de Genética, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Terezinha M. Pereira Pinto Castineiras
- Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Rafael Mello Galliez
- Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Debora Souza Faffe
- Instituto de Biofísica Carlos Chagas Filho, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Isabela de Carvalho Leitão
- Instituto de Biofísica Carlos Chagas Filho, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil
- Claudia dos Santos Rodrigues
- Serviço de Atendimento Especializado / Centro de Testagem e Aconselhamento, Avenida Roberto Silveira, 46 - 3° Andar, Maricá, Brazil
- Thiago Silva Frauches
- Laboratório Central Dr. Francisco Rímolo Neto, R. Álvares de Castro, n° 346, Maricá, RJ 24900-880, Brazil
- Keity J. Chagas Vilela Nocchi
- Secretaria Municipal de Saude de Macaé, R. Darcílio Possati, 134 - Virgem Santa, Macaé, RJ 27948-000, Brazil
- Natalia Martins Feitosa
- Instituto de Biodiversidade e Sustantabilidade NUPEM, Universidade Federal do Rio de Janeiro, Campus Macaé, Av. São José Barreto, 764 - São José do Barreto, Macaé, RJ 27965-045, Brazil
- Sabrina Santana Ribeiro
- Secretaria Municipal de Saúde de Guapimirim, Rua Pastor Francisco Antônio Rosa - S/N, Guapimirim, RJ 25946-253, Brazil
- Nira R. Pollock
- Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States
- Britta Knorr
- Department Public Health Rhein Neckar Region, Kurfürsten-Anlage 38-40, Heidelberg 69115, Germany
- Andreas Welker
- Department Public Health Rhein Neckar Region, Kurfürsten-Anlage 38-40, Heidelberg 69115, Germany
- Margaretha de Vos
- FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland
- JilianA. Sacks
- FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland
- Stefano Ongarello
- FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland
- Claudia M. Denkinger
- Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany; German Centre for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Im Neuenheimer Feld 672, Heidelberg 69120, Germany; Corresponding author at: Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany.
- Journal volume & issue
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Vol. 75
p. 103774
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.
