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2021-06-01

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cc-by-nc-nd (c) Baro, Barbara et al., 2021
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/230183

Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison

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https://doi.org/10.1016/j.jinf.2021.04.009

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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.

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Enzimoimmunoassaig sobre fase sòlida, SARS-CoV-2

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Enzyme-linked immunosorbent assay, SARS-CoV-2

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Articles publicats en revistes (Ciències Clíniques)

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BARO, Barbara, et al. 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. 2021. Vol. 82, num. 6, pags. 269-275. ISSN 0163-4453. [consulted: 8 of July of 2026]. Available at: https://hdl.handle.net/2445/230183

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