Baro, Bàrbara; Rodo, Pau; Ouchi, Dan; Bordoy, Antoni E; Saya Amaro, Emilio N; Salsench, Sergi V; Molinos, Sònia; Alemany, Andrea; Ubals, Maria; Corbacho-Monné, Marc; +12 more... Millat-Martinez, Pere; Marks, Michael; Clotet, Bonaventura; Prat, Nuria; Estrada, Oriol; Vilar, Marc; Ara, Jordi; Vall-Mayans, Martí; G-Beiras, Camila; Bassat, Quique; Blanco, Ignacio; Mitjà, Oriol; (2021) Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison. Journal of Infection, 82 (6). pp. 269-275. ISSN 0163-4453 DOI: https://doi.org/10.1016/j.jinf.2021.04.009
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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) <30 in RT-qPCR, all Ag-RDT achieved a sensitivity ≥70%. The modelled negative- and positive-predictive value for 1% prevalence were >99% and <50%, respectively. CONCLUSIONS: When screening unexposed asymptomatic individuals, two Ag-RDTs achieved sensitivity ≥80% for specimens with Ct<30 and specificity ≥96%. The estimated negative predictive value suggests the suitability of Ag-RDTs for mass screenings of SARS-CoV-2 infection in the general population.
Item Type | Article |
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Faculty and Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
Research Centre | Covid-19 Research |
Elements ID | 159079 |
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Filename: Baro_etal_202-Performance-characteristics-of-five-antigen-detectingYJINF-D-21-00509_R1.pdf
Licence: Creative Commons: Attribution-Noncommercial-No Derivative Works 3.0
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