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

Expert Rev Mol Diagn. 2015 Jan;15(1):23-32. doi: 10.1586/14737159.2015.983477. Epub 2014 Nov 17.

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.

Keywords: RSV; automation; influenza A; influenza B; multiplex PCR; point of care; rapid diagnosis; respiratory infection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Betainfluenzavirus / genetics*
  • Humans
  • Influenza A virus / genetics*
  • Influenza, Human / diagnosis*
  • Influenza, Human / virology
  • Molecular Diagnostic Techniques / instrumentation*
  • Multiplex Polymerase Chain Reaction
  • Respiratory Syncytial Viruses / genetics*
  • Sensitivity and Specificity