Author: Blairon, Laurent; Cupaiolo, Roberto; Thomas, Isabelle; Piteüs, Sébastien; Wilmet, Alain; Beukinga, Ingrid; Tréâ€Hardy, Marie
Title: Efficacy comparison of three rapid antigen tests for SARSâ€CoVâ€2 and how viral load impact their performance Cord-id: wy81ey2x Document date: 2021_6_4
ID: wy81ey2x
Snippet: More and more rapid antigen tests for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARSâ€CoVâ€2) appear in the market with varying performance. The sensitivity of these tests heavily depends on the viral load, extrapolated by the threshold cycle (Ct). It is therefore essential to verify their performance before their inclusion in routine. The Coronavirus Ag Rapid Test Cassette Bioâ€Rad, the GSD NovaGen SARSâ€CoVâ€2 (COVIDâ€19) Antigen Rapid Test, and the Aegle Coronavi
Document: More and more rapid antigen tests for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARSâ€CoVâ€2) appear in the market with varying performance. The sensitivity of these tests heavily depends on the viral load, extrapolated by the threshold cycle (Ct). It is therefore essential to verify their performance before their inclusion in routine. The Coronavirus Ag Rapid Test Cassette Bioâ€Rad, the GSD NovaGen SARSâ€CoVâ€2 (COVIDâ€19) Antigen Rapid Test, and the Aegle Coronavirus Ag Rapid Test Cassette were evaluated on 199 samples: 150 fresh samples from the routine and positive in quantitative reverseâ€transcription polymerase chain reaction (RTâ€qPCR), nine fresh samples negative in RTâ€qPCR, and 40 frozen samples, taken before the discovery of SARSâ€CoVâ€2 but positive for other respiratory viruses. Positive RTâ€qPCR samples were categorized according to their Ct: Ct < 20 (18.7%), ≥ 20–< 25 (27.3%), ≥ 25–< 30 (18.7%), ≥ 30–35 (17.3%), and > 35 (18.0%). Sensitivities (95% confidence interval) for Ct below 25 were 95.7% (92.4–98.9), 97.1% (94.4–99.8), and 97.1% (94.4–99.8) for GSD NovaGen, Bioâ€Rad, and Aegle, respectively but drastically dropped when Ct exceeded 27. Among samples with previously diagnosed viruses, seven falseâ€positive results were found with GSD NovaGen only (specificity 85.7%). Equivalent, high sensitivities were observed with the highest viral load samples. The GSD NovaGen assay showed less specificity. Although the three kits tested in this study are inadequate for routine testing in a high throughput laboratory, they can help to quickly identify the most infectious patients and screen their close contacts in an environment where molecular tests are not readily available.
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