New assay detects viruses bacteria in one sample

The FDA recently expanded the use for a diagnostic test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

The expanded use of the panel adds the bacteria Bordetella pertussis, Mycoplasma pneumoniae and Chlamydophila pneumoniae. The FilmArray Respiratory Panel (Idaho Technology) is the first FDA-cleared molecular diagnostic test able to identify the three bacteria, according to an FDA press release.

The FDA originally cleared the diagnostic test in December to detect 15 viral causes of respiratory infections. The expanded panel detects two additional forms of the coronavirus, besides the three bacteria, and now detects 17 viruses and three bacteria.

The panel detects infections by obtaining a swab sample from the patient’s nasopharynx. If a patient has a respiratory infection in other areas of the respiratory tract, additional testing for a suspected respiratory infection may be necessary.

To learn more, go to www.fda.gov.