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.
Keywords: Antigen-detecting rapid diagnostic test; Head-to-head comparison; Mass screening; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, Mass screening, Antigen-detecting rapid diagnostic test, Head-to-head comparison, 【초록키워드】 COVID-19, SARS-CoV-2, SARS-COV-2 infection, diagnostic test, diagnostic, Screening, Predictive value, Antigen, Prevalence, sensitivity, specificity, RT-qPCR, Asymptomatic individuals, Mass screening, Rapid diagnostic test, cycle threshold, comparison, Isolation, General population, Head-to-head comparison, disease spread, Ag-RDT, Roche, RDTs, Negative predictive value, Abbott, 95%CI, head, mass, individual, Ag-RDTs, specimen, Roche Diagnostics, Siemens, nasopharyngeal specimen, Surescreen, parameter, Antigen-detecting rapid diagnostic tests, FIVE, asymptomatic individual, collected, reducing, 【제목키워드】 SARS-CoV-2, Characteristics, Asymptomatic, performance, FIVE,