Abstract
Objectives: To evaluate the performance of nasal mid-turbinate self-testing using rapid antigen detection tests (RDT) for persons with suspected coronavirus disease 2019 (COVID-19) in the community. Self-testing for COVID-19 infection with lateral flow assay severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RDT, provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2.
Methods: Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for quantitative RT-PCR (qRT-PCR) testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture dropped below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined.
Results: A total of 3201 participants were included (BD-RDT n = 1595; Roche-RDT n = 1606). Sensitivity and specificity of self-testing compared with the qRT-PCR results with a Ct-value below the Ct-value cut-off were 78.4% (95% CI 73.2%-83.5%) and 99.4% (95% CI 99.1%-99.7%), respectively. A higher age was independently associated with a false-negative self-testing result with an odds ratio of 1.024 (95% CI 1.003-1.044).
Conclusions: Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness.
Keywords: Coronavirus disease 2019; Public health; Rapid antigen detection test; Self-testing; Severe acute respiratory syndrome coronavirus 2.
【저자키워드】 public health, Coronavirus disease 2019, Severe acute respiratory syndrome coronavirus 2., rapid antigen detection test, self-testing, 【초록키워드】 COVID-19, coronavirus disease, severe acute respiratory syndrome coronavirus 2, public health, SARS-CoV-2, Coronavirus disease 2019, coronavirus, qRT-PCR, nasal, severe acute respiratory syndrome Coronavirus, RT-PCR, lateral flow, Probability, sensitivity, specificity, Culture, COVID-19 infection, SARS-CoV-2 testing, RDT, Rapid, Community, Ct value, Ct-value, age, Swab, determinants, SARS-CoV-2 antigen, viral culture, antigen detection, Roche, disease, Quantitative, false-negative, Odds ratio, determinant, acute respiratory syndrome, 95% CI, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, Quantitative RT-PCR, chance, individual, participant, contagiousness, cut-off, positive, positive sample, Public, System, identify, collected, evaluate, was performed, provide, determine, dropped, 【제목키워드】 COVID-19, SARS-COV-2 infection, rapid antigen test, Community,