Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison - 12/05/21
, Pau Rodo b, Dan Ouchi b, Antoni E. Bordoy c, Emilio N. Saya Amaro c, Sergi V. Salsench c, Sònia Molinos c, Andrea Alemany b, c, d, Maria Ubals b, c, d, Marc Corbacho-Monné b, d, e, Pere Millat-Martinez a, Michael Marks f, g, Bonaventura Clotet b, c, h, i, Nuria Prat j, Oriol Estrada c, j, Marc Vilar c, j, Jordi Ara c, j, Martí Vall-Mayans b, c, Camila G-Beiras b, Quique Bassat a, k, l, m, n, Ignacio Blanco c, j, Oriol Mitjà b, c, o
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Highlights |
• | Ag-RDTs sensitivity for SARS-CoV-2 in unexposed asymptomatic individuals was 29–52%. |
• | Sensitivity increased to 70–87% for specimens with high risk of viral transmission. |
• | Four Ag-RDTs (Abbott, Siemens, Roche, and Surescreen) showed specificity >96%. |
• | In mass-screening campaigns, positive Ag-RDT results should be confirmed by PCR. |
Summary |
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.
Le texte complet de cet article est disponible en PDF.Keywords : SARS-CoV-2, Antigen-detecting rapid diagnostic test, Head-to-head comparison, Mass screening
Plan
Vol 82 - N° 6
P. 269-275 - juin 2021 Retour au numéro
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