On-Field Evaluation of Exdia COVID-19 Antigen Point-of-Care Testing in the Emergency Department During the COVID-19 Pandemic
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Background: We evaluated the diagnostic performance of the Exdia COVID-19 antigen test(Exdia Ag; Precision Biosensor Inc., Korea) as a point-of-care (POC) test performed in theemergency department (ED) for the rapid detection of severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2) in comparison with the performance of the Real-Q 2019-nCoVDetection KIT (Real-Q; BioSewoom, Korea). Methods: Exdia Ag and Real-Q assays were performed simultaneously for all patients whowere admitted to the ED with or without COVID-19 symptoms between December 2021 andMarch 2022. Results: Among the 2,523 samples analyzed by Real-Q assay, 149 samples (5.9%) showedpositive results, and 2,374 samples showed negative results. The overall sensitivity andspecificity of the Exdia Ag assay were 77.2% (95% confidence interval [CI], 69.6 – 83.7) and99.8% (95% CI, 99.6 – 99.9), respectively. The positive and negative predictive values were96.6% (95% CI, 91.5 – 98.7) and 98.6% (95% CI, 98.1 – 98.9), respectively. The cycle thresholdvalue for 115 concordant Exdia Ag-positive/Real-Q-positive samples was significantly lowerthan that for 34 discordant Exdia Ag-negative/Real-Q-positive samples (P < 0.0001)Conclusion: The Exdia Ag assay showed good diagnostic performance when the diseaseprevalence was high and may be useful for POC testing when the rapid detection of SARSCoV-2 is required for the isolation of patients in the ED.
Abstract
Background: We evaluated the diagnostic performance of the Exdia COVID-19 antigen test(Exdia Ag; Precision Biosensor Inc., Korea) as a point-of-care (POC) test performed in theemergency department (ED) for the rapid detection of severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2) in comparison with the performance of the Real-Q 2019-nCoVDetection KIT (Real-Q; BioSewoom, Korea). Methods: Exdia Ag and Real-Q assays were performed simultaneously for all patients whowere admitted to the ED with or without COVID-19 symptoms between December 2021 andMarch 2022. Results: Among the 2,523 samples analyzed by Real-Q assay, 149 samples (5.9%) showedpositive results, and 2,374 samples showed negative results. The overall sensitivity andspecificity of the Exdia Ag assay were 77.2% (95% confidence interval [CI], 69.6 – 83.7) and99.8% (95% CI, 99.6 – 99.9), respectively. The positive and negative predictive values were96.6% (95% CI, 91.5 – 98.7) and 98.6% (95% CI, 98.1 – 98.9), respectively. The cycle thresholdvalue for 115 concordant Exdia Ag-positive/Real-Q-positive samples was significantly lowerthan that for 34 discordant Exdia Ag-negative/Real-Q-positive samples (P < 0.0001)Conclusion: The Exdia Ag assay showed good diagnostic performance when the diseaseprevalence was high and may be useful for POC testing when the rapid detection of SARSCoV-2 is required for the isolation of patients in the ED.
참고문헌 (15)
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