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

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:

• automation
• influenza A
• influenza B
• multiplex PCR
• point of care
• rapid diagnosis
• respiratory infection
• RSV

Financial & competing interests disclosure

The authors have received research grants from Enigma Diagnostics Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Influenza and respiratory syncytial virus (RSV) are pathogens of global importance with the potential to cause large outbreaks in the community and hospital setting.

• Diagnosis based on clinical signs and symptoms alone is unreliable because the features of infection are poorly discriminating. Diagnostic tests are required to confirm the presence of infection.

• Rapid influenza antigen tests are poorly sensitive and thus cannot be relied on to exclude infection.

• There are a number of commercially available molecular assays that are able to detect influenza and RSV from clinical specimens, many of which are suited to a rapid testing laboratory.

• The Enigma^® ML FluAB-RSV assay is one such commercially available test, providing a result in 95 min. There are limited data on its performance but early reports suggest high sensitivity and specificity.

• There is a need to study the clinical use of these assays, which include data on patient outcomes and cost–effectiveness.