This week FDA expanded the use for the FilmArray Respiratory Panel, the first 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 is the first FDA-cleared molecular diagnostic test able to identify the three bacteria.
Bordetella pertussis is the cause of pertussis, or whooping cough, a serious disease in very young children. Mycoplasma pneumoniae is a common cause of respiratory infection and community-acquired pneumonia, sometimes resulting in large outbreaks, especially in children and young adults. Chlamydophila pneumoniae is a cause of community-acquired pneumonia that can be more serious in older people.
FDA cleared the FilmArray Respiratory Panel in December 2011 to detect 15 viral causes of respiratory infections. The expanded panel detects two additional forms of the coronavirus in addition to the three bacteria, and now detects a total 17 viruses and three bacteria.
“The expansion of the FilmArray Respiratory Panel to include bacterial causes of respiratory infection is a step forward in the development of multiplex tests that can simultaneously detect several causes of infection,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA’s Center for Devices and Radiological Health.
The FilmArray Panel detects infections by obtaining a swab sample from the patient’s area where the throat and nose meet (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. The test does not detect all causes of respiratory infection.
Idaho Technology of Salt Lake City manufactures the FilmArray Panel.