FDA OKs Multipathogen Nucleic Acid Test for CNS Infections

Disclosures

October 08, 2015

The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.

The FilmArray Meningitis/Encephalitis (ME) Panel (BioFire Diagnostics) is designed to test CSF specimens from patients who have signs and symptoms of these two conditions. The test can yield results in about 60 minutes. In contrast, it may take up to 3 days to identify a bacterial infection using current diagnostic technology, according to an FDA news release. The wait time for viral infections can be longer, given that specimens often must be shipped to specialized laboratories.

The quicker turnaround with the FilmArray ME Panel, the agency said, "may enable clinicians to make informed treatment decisions earlier."

The FilmArray ME Panel uses a small CSF sample. "Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests," the FDA said.

The new test identifies the following pathogens:

Bacteria and yeast

  • Escherichia coli K1

  • Haemophilus influenzae

  • Listeria monocytogenes

  • Neisseria meningitidis

  • Streptococcus agalactiae

  • Streptococcus pneumoniae

  • Cryptococcus neoformans/gattii

Viruses

  • Cytomegalovirus

  • Enterovirus

  • Herpes simplex virus 1

  • Herpes simplex virus 2

  • Human herpesvirus 6

  • Human parechovirus

  • Varicella zoster virus

The FDA cautions that the FilmArray ME Panel does not identify all causes of CNS infections or pinpoint which antimicrobial drug may work the best against a bacterial kind. Accordingly, clinicians should still perform standard CSF bacterial and fungal cultures because the new test can produce false negatives and false positives. In addition, bacterial growth is needed for drug susceptibility testing in the case of positive results.

In a prospective study of CSF samples taken from 1560 patients with suspected meningitis or encephalitis, there was "high agreement" between the results from the FilmArray ME Panel and those from other test methods, including culture. The new test also proved accurate in identifying pathogens already known to exist in other CSF samples.

More information on todays announcement is available on the FDA website.

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