Background Testing plays a critical role in treatment and prevention responses to the COVID-19 pandemic. Compared to nucleic acid tests (NATs), antigen-detection rapid diagnostic tests (Ag-RDTs) can be more accessible, but typically have lower sensitivity and specificity. By quantifying these trade-offs, we aimed to inform decisions about when an Ag-RDT would offer greater public health value than reliance on NAT. Methods Following an expert consultation, we selected two use cases for analysis: rapid identification of people with COVID-19 amongst patients admitted with respiratory symptoms in a ‘hospital’ setting and early identification and isolation of people with mildly symptomatic COVID-19 in a ‘community’ setting. Using decision analysis, we evaluated the health system cost and health impact (deaths averted and infectious days isolated) of an Ag-RDT-led strategy, compared to a strategy based on NAT and clinical judgement. We adopted a broad range of values for ‘contextual’ parameters relevant to a range of settings, including the availability of NAT and the performance of clinical judgement. We performed a multivariate sensitivity analysis to all of these parameters. Results In a hospital setting, an Ag-RDT-led strategy would avert more deaths than a NAT-based strategy, and at lower cost per death averted, when the sensitivity of clinical judgement is less than 90%, and when NAT results are available in time to inform clinical decision-making for less than 85% of patients. The use of an Ag-RDT is robustly supported in community settings, where it would avert more transmission at lower cost than relying on NAT alone, under a wide range of assumptions. Conclusions Despite their imperfect sensitivity and specificity, Ag-RDTs have the potential to be simultaneously more impactful, and have a lower cost per death and infectious person-days averted, than current approaches to COVID-19 diagnostic testing. Supplementary Information The online version contains supplementary material available at 10.1186/s12916-021-01948-z.
【저자키워드】 COVID-19, Antigen, Rapid diagnostic tests, 【초록키워드】 Treatment, public health, COVID-19 pandemic, hospital, diagnostic, Transmission, Antigen, nucleic acid, sensitivity, Health, Testing, Sensitivity and specificity, Rapid diagnostic test, diagnostic tests, symptomatic, nucleic acid test, response, Patient, diagnostic testing, Decision analysis, Isolation, death, Community, sensitivity analysis, health system, respiratory, Ag-RDT, Critical, nucleic acid tests, parameters, patients, Analysis, respiratory symptoms, community settings, use cases, supplementary material, Ag-RDTs, respiratory symptom, e parameters, NATs, offer, trade-offs, parameter, approach, Result, greater, selected, performed, evaluated, supported, less, adopted, antigen-detection, people with COVID-19, 【제목키워드】 Rapid diagnostic test, Analysis, antigen-detection,