Display options
Cite
Krüger LJ, Tanuri A, Lindner AK, et al. Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation. EBioMedicine. 2021;75:103774doi: 10.1016/j.ebiom.2021.103774.
Krüger, L. J., Tanuri, A., Lindner, A. K., Gaeddert, M., Köppel, L., Tobian, F., Brümmer, L. E., Klein, J. A. F., Lainati, F., Schnitzler, P., Nikolai, O., Mockenhaupt, F. P., Seybold, J., Corman, V. M., Jones, T. C., Drosten, C., Gottschalk, C., Weber, S. F., Weber, S., Ferreira, O. C., Mariani, D., Dos Santos Nascimento, E. R., Pereira Pinto Castineiras, T. M., Galliez, R. M., Faffe, D. S., Leitão, I. C., Dos Santos Rodrigues, C., Frauches, T. S., Nocchi, K. J. C. V., Feitosa, N. M., Ribeiro, S. S., Pollock, N. R., Knorr, B., Welker, A., de Vos, M., Sacks, J., Ongarello, S., Denkinger, C. M. (2021). Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation. EBioMedicine, 75103774. https://doi.org/10.1016/j.ebiom.2021.103774
Krüger, Lisa J, et al. "Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation." EBioMedicine vol. 75 (2021): 103774. doi: https://doi.org/10.1016/j.ebiom.2021.103774
Krüger LJ, Tanuri A, Lindner AK, Gaeddert M, Köppel L, Tobian F, Brümmer LE, Klein JAF, Lainati F, Schnitzler P, Nikolai O, Mockenhaupt FP, Seybold J, Corman VM, Jones TC, Drosten C, Gottschalk C, Weber SF, Weber S, Ferreira OC, Mariani D, Dos Santos Nascimento ER, Pereira Pinto Castineiras TM, Galliez RM, Faffe DS, Leitão IC, Dos Santos Rodrigues C, Frauches TS, Nocchi KJCV, Feitosa NM, Ribeiro SS, Pollock NR, Knorr B, Welker A, de Vos M, Sacks J, Ongarello S, Denkinger CM. Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation. EBioMedicine. 2021 Dec 24;75:103774. doi: 10.1016/j.ebiom.2021.103774. Epub 2021 Dec 24. PMID: 34959134; PMCID: PMC8702380.
Copy Download .nbib Format: NLM
Share it on

EBioMedicine. 2021 Dec 24;75:103774. doi: 10.1016/j.ebiom.2021.103774. Epub 2021 Dec 24.

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

EBioMedicine

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

  1. Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany.
  2. 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.
  3. 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.
  4. Virology, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany.
  5. Medical Directorate, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Pl. 1, Berlin 13353, Germany.
  6. 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.
  7. 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.
  8. Acomed Statistik, Fockestraße 57, Leipzig 04275, Germany.
  9. Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil.
  10. Instituto de Biofísica Carlos Chagas Filho, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil.
  11. Serviço de Atendimento Especializado / Centro de Testagem e Aconselhamento, Avenida Roberto Silveira, 46 - 3° Andar, Maricá, Brazil.
  12. Laboratório Central Dr. Francisco Rímolo Neto, R. Álvares de Castro, n° 346, Maricá, RJ 24900-880, Brazil.
  13. Secretaria Municipal de Saude de Macaé, R. Darcílio Possati, 134 - Virgem Santa, Macaé, RJ 27948-000, Brazil.
  14. 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.
  15. Secretaria Municipal de Saúde de Guapimirim, Rua Pastor Francisco Antônio Rosa - S/N, Guapimirim, RJ 25946-253, Brazil.
  16. Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States.
  17. Department Public Health Rhein Neckar Region, Kurfürsten-Anlage 38-40, Heidelberg 69115, Germany.
  18. FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland.
  19. 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. Electronic address: [email protected].

PMID: 34959134 PMCID: PMC8702380 DOI: 10.1016/j.ebiom.2021.103774

Abstract

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 log

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.

Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.

Keywords: Antigen-detecting rapid diagnostic tests; COVID-19; SARS-CoV-2; Sensitivity; Specificity

Conflict of interest statement

Declaration of interests We declare no competing interests.

Publication Types

Grant support