The Enigma ML FluAB-RSV assay: a fully automated molecular test for the rapid detection of influenza A, B and respiratory syncytial viruses in respiratory specimens

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Abstract

The Enigma® ML FluAB-RSV assay (Enigma Diagnostics, Porton Down, Salisbury, UK) is a CE-IVD marked multiplex molecular panel for the detection of influenza A, B and respiratory syncytial viruses in nasopharyngeal swabs. The assay runs on the fully automated Enigma ML platform without further specimen manipulation and provides a sample-to-answer result within 95 min. The reported sensitivity and specificity for influenza A are 100% (95% CI: 98.2–100) and 98.3% (95% CI: 95.5–99.4), respectively, for influenza B are 100% (95% CI: 98.2–100) and 98.7% (95% CI: 96–99.6), respectively, and for respiratory syncytial virus are 100% (95% CI: 98.2–100) and 99.4% (95% CI: 97.2–99.9), respectively.

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