| Why carry out this study? |
| The SARS-CoV-2 pandemic has led to a surge in demand for reliable, mass diagnostic tests worldwide. |
| A thorough clinical evaluation of a fully automated high-throughput Elecsys® SARS-CoV-2 Antigen assay on a total of 3139 clinical samples pre-characterized by quantitative RT-PCR was carried out. |
| What was learned from the study? |
| The assay demonstrated excellent specificity (99.9%) and good relative sensitivity, with an overall sensitivity of 60.2% and a sensitivity of 93.7% for samples containing ≥ 104 viral RNA copies/ml. |
| The Elecsys SARS-CoV-2 Antigen assay is a viable high-throughput, automated alternative to manual lateral flow antigen tests. |
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