1. Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison
- Author
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Bonaventura Clotet, Bàrbara Baro, Antoni E. Bordoy, Marc Corbacho-Monné, Oriol Estrada, Michael Marks, Nuria Prat, Andrea Alemany, Dan Ouchi, Camila G-Beiras, Pau Rodo, Oriol Mitjà, Maria Ubals, Sergi V. Salsench, Emilio N. Saya Amaro, Pere Millat-Martinez, Jordi Ara, Sònia Molinos, Martí Vall-Mayans, Quique Bassat, Marc Vilar, and Ignacio Blanco
- Subjects
0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Silver ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,Population ,Antigen-detecting rapid diagnostic test ,Roche Diagnostics ,Gastroenterology ,Asymptomatic ,Sensitivity and Specificity ,Article ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,education ,Antigens, Viral ,Asymptomatic Infections ,Mass screening ,Rapid diagnostic test ,education.field_of_study ,business.industry ,SARS-CoV-2 ,Diagnostic Tests, Routine ,COVID-19 ,Benchmarking ,Infectious Diseases ,Head-to-head comparison ,medicine.symptom ,business - Abstract
Background: Mass testing for early identification and isolation of infectious COVID-19 individuals is efficacious for reducing disease spread. Antigen-detecting rapid diagnostic tests (Ag-RDT) may be suitable for testing strategies; however, benchmark comparisons are scarce. Methods: We used 286 nasopharyngeal specimens from unexposed asymptomatic individuals collected between December 2020 and January 2021 to assess five Ag-RDTs marketed by Abbott, Siemens, Roche Diagnostics, Lepu Medical, and Surescreen. Results: For the overall sample, the performance parameters of Ag-RDTs were as follows: Abbott assay, sensitivity 38.6% (95%CI 29.1-48.8) and specificity 99.5% (97-100%); Siemens, sensitivity 51.5% (41.3-61.6) and specificity 98.4% (95.3-99.6); Roche, sensitivity 43.6% (33.7-53.8) and specificity 96.2% (92.4-98.5); Lepu, sensitivity 45.5% (35.6-55.8) and specificity 89.2% (83.8-93.3%); Surescreen, sensitivity 28.8% (20.2-38.6) and specificity 97.8% (94.5-99.4%). For specimens with cycle threshold (Ct) = 70%. The modelled negative- and positive-predictive value for 1% prevalence were >99% and 80% for specimens with Ct= 96%. The estimated negative predictive value suggests the suitability of Ag-RDTs for mass screenings of SARS-CoV-2 infection in the general population. (C) 2021 The British Infection Association. Published by Elsevier Ltd. All rights reserved.
- Published
- 2021