| Autor: |
Mary Gaeddert, Emily R. Adams, Andreas Welker, Claudius Gottschalk, Nira R. Pollock, Christian Drosten, Jilian A. Sacks, Angela H Wright, Hans-Georg Kraeusslich, Claudia M. Denkinger, Lisa Johanna Krueger, Andreas K. Lindner, Isabel Barreto Miranda, Lukas Bruemmer, Konstantina Kontogianni, Britta Knorr, Andrea M. Collins, Frank P. Mockenhaupt, Joachim Seybold, Olga Nikolai, Margaretha DeVos, Lisa Koeppel, Victor M. Corman, Ana I Cubas-Atienzar, Paul Schnitzler |
| Rok vydání: |
2020 |
| Předmět: |
|
| DOI: |
10.1101/2020.10.01.20203836 |
| Popis: |
BackgroundReliable point-of-care (POC) diagnostics not requiring laboratory infrastructure could be a game changer in the COVID-19 pandemic, particularly in the Global South. We assessed performance, limit of detection and ease-of-use of three antigen-detecting, rapid POC tests (Ag-RDT) for SARS-CoV-2.MethodsThis prospective, multi-centre diagnostic accuracy study recruited participants suspected to have SARS-CoV-2 in Germany and the UK. Paired nasopharyngeal swabs (NP) or NP and/or oropharyngeal swabs (OP) were collected from participants (one for clinical RT-PCR and one for Ag-RDT). Performance of each of three Ag-RDTs was compared to RT-PCR overall, and according to predefined subcategories e.g. cycle threshold (CT)-value, days from symptoms onset, etc. In addition, limited verification of the analytical limit-of-detection (LOD) was determined. To understand the usability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.ResultsBetween April 17th and August 25th, 2020, 2417 participants were enrolled, with 70 (3.0%) testing positive by RT-PCR. The best-performing test (SD Biosensor, Inc. STANDARD Q) was 76×6% (95% Confidence Interval (CI) 62×8-86×4) sensitive and 99×3% (CI 98×6-99×6) specific. A sub-analysis showed all samples with RT-PCR CT-values ConclusionThere is large variability in performance of Ag-RDT with SD Biosensor showing promise. Given the usability at POC, this test is likely to have impact despite imperfect sensitivity; however further research and modelling are needed. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
