Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation.
| Autor: | Krüger LJ; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Tanuri A; 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., Lindner AK; 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., Gaeddert M; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Köppel L; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Tobian F; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Brümmer LE; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Klein JAF; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Lainati F; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Schnitzler P; Virology, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Nikolai O; 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., Mockenhaupt FP; 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., Seybold J; Medical Directorate, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Pl. 1, Berlin 13353, Germany., Corman VM; 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., Jones TC; 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., Drosten C; 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., Gottschalk C; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Weber SF; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, Heidelberg 69120, Germany., Weber S; Acomed Statistik, Fockestraße 57, Leipzig 04275, Germany., Ferreira OC; 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., Mariani D; 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., Dos Santos Nascimento ER; 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., Pereira Pinto Castineiras TM; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil., Galliez RM; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil., Faffe DS; Instituto de Biofísica Carlos Chagas Filho, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil., Leitão IC; Instituto de Biofísica Carlos Chagas Filho, Universidade Federal do Rio de Janeiro, Cidade Universitária, Rio de Janeiro, RJ 21941-902, Brazil., Dos Santos Rodrigues C; Serviço de Atendimento Especializado / Centro de Testagem e Aconselhamento, Avenida Roberto Silveira, 46 - 3° Andar, Maricá, Brazil., Frauches TS; Laboratório Central Dr. Francisco Rímolo Neto, R. Álvares de Castro, n° 346, Maricá, RJ 24900-880, Brazil., Nocchi KJCV; Secretaria Municipal de Saude de Macaé, R. Darcílio Possati, 134 - Virgem Santa, Macaé, RJ 27948-000, Brazil., Feitosa NM; 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., Ribeiro SS; Secretaria Municipal de Saúde de Guapimirim, Rua Pastor Francisco Antônio Rosa - S/N, Guapimirim, RJ 25946-253, Brazil., Pollock NR; Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States., Knorr B; Department Public Health Rhein Neckar Region, Kurfürsten-Anlage 38-40, Heidelberg 69115, Germany., Welker A; Department Public Health Rhein Neckar Region, Kurfürsten-Anlage 38-40, Heidelberg 69115, Germany., de Vos M; FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland., Sacks J; FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland., Ongarello S; FIND, Campus Biotech, Building B, Level 0, Chemin des Mines 9, Geneva 1202, Switzerland., Denkinger CM; 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: claudia.denkinger@uni-heidelberg.de. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | EBioMedicine [EBioMedicine] 2022 Jan; Vol. 75, pp. 103774. Date of Electronic Publication: 2021 Dec 24. |
| DOI: | 10.1016/j.ebiom.2021.103774 |
| Abstrakt: | 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. Competing Interests: Declaration of interests We declare no competing interests. (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|