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?:abstract
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Background: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDT) offer the ability to diagnose COVID-19 rapidly and at low cost; however, lower sensitivity has limited adoption of Ag-RDT in clinical settings. Methods: We compared Ag-RDT, nucleic acid amplification tests (NAAT), and clinical judgment alone for diagnosing COVID-19 among symptomatic patients. We investigated two scenarios: a high-prevalence hospital setting with 24-hour NAAT turnaround, and a lower-prevalence outpatient setting with 3-day NAAT turnaround. We simulated transmission from cases and contacts and relationships between time, viral burden, transmission, and case detection. We used decision curve analysis to compare diagnostic approaches, estimating the time- and infectivity-dependent benefit of each true-positive diagnosis. Results: In the primary analysis comparing Ag-RDT and NAAT, greater net benefit was achieved with Ag-RDT in the outpatient setting and with NAAT in the hospital setting. In the hospital setting, Ag-RDT becomes more beneficial if NAAT turnaround times exceed 2 days or Ag-RDT sensitivity increases to at least 95% (relative to NAAT) during acute illness. Similarly, in the outpatient setting, NAAT could be more beneficial when NAAT turnaround time remains under 2 days or patients strictly isolate while awaiting results. Clinical judgment was preferred only if clinical diagnoses generated a robust clinical and public health response and false-positive diagnoses produced minimal harm. Conclusions: For diagnosing symptomatic COVID-19, Ag-RDT may provide greater net benefit than either NAAT or clinical judgment when NAAT turnaround times are more than two days. NAAT is likely to remain optimal for hospitalized patients with prolonged symptoms prior to admission.
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