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.
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.
Centre for Clinical Infection and Diagnostics Research, King's College London and Guy's and St Thomas' NHS Foundation Trust, London SE1 7EH, UK.
Simon D
SD
Goldenberg
Jonathan D
JD
Edgeworth
D006801:Humans; D009980:Influenza A virus / Q000235:genetics*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D029524:Betainfluenzavirus / Q000235:genetics*; D025202:Molecular Diagnostic Techniques / Q000295:instrumentation*; D060885:Multiplex Polymerase Chain Reaction; D012136:Respiratory Syncytial Viruses / Q000235:genetics*; D012680:Sensitivity and Specificity
RSV; automation; influenza A; influenza B; multiplex PCR; point of care; rapid diagnosis; respiratory infection