The FilmArray® respiratory panel: an automated, broadly multiplexed molecular test for the rapid and accurate detection of respiratory pathogens

Abstract

The FilmArray Respiratory Panel (RP) (BioFire^™ Diagnostics, Inc., Salt Lake City, UT, USA) is the first multiplex molecular panel cleared by the US FDA for the detection of both bacterial and viral respiratory pathogens in nasopharygeal swabs. The FilmArray RP targets 20 pathogens including 17 viruses and subtypes and three bacteria, and is performed with minimal sample manipulation. The FilmArray RP has a fully automated sample-to-answer workflow with a turn-around-time of approximately 1 h. The reported sensitivity and specificity of the assay ranges from 80 to 100 and 100%, respectively, with the sensitivity for the adenovirus as low as 46%. A new version of the FilmArray RP assay (version 1.7) with improved sensitivity for the adenovirus was released in 2013. The performance characteristics and simplified workflow have allowed its implementation in a wide range of laboratories. The FilmArray RP has changed the diagnostic landscape and will have a significant impact on the care of patients with respiratory tract infection.

Keywords::

• automation
• multiplex PCR
• rapid diagnosis
• respiratory tract infection

Financial & competing interests disclosure

The author has no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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

Key issues

• • Respiratory tract infections occur all year long with different pathogens peaking at different times but overlapping in their seasonal distributions.

• • Clinical symptoms caused by respiratory pathogens, including bacteria and viruses are non-specific.

• • There are currently four highly multiplexed respiratory panels that are US FDA approved for diagnosis of respiratory infections.

• • The FilmArray Respiratory Panel is sensitive and specific, has the simplest workflow and fastest turn-around-time of all assays.

• • The FilmArray Respiratory Panel is the only panel that includes both viral and bacterial causes of upper respiratory tract infections/lower respiratory tract infections.

Notes