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Sun 1 Apr 2007 01:40 PM

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Meningitis test approved

The FDA has approved a more rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.

The FDA has approved a more rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.

The administration said the Xpert EV test is the first fully automated medical diagnostic test that isolates and amplifies viral genetic material present in a patient's cerebrospinal fluid using reverse transcription-polymerase chain reaction.

The test has the potential of preventing unnecessary administration of antibiotics for bacterial meningitis to patients with viral meningitis. The test identifies Enterovirus infections, which are responsible for 90% of viral meningitis cases within two days.

Dr Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said that standard meningitis assays take up to a week.

"Since bacterial meningitis can be deadly within as little as two days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial meningitis," Schultz said.

The rapid test "should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics," he added.

In a multisite study at six institutions, 255 patient samples were tested. The Xpert EV test demonstrated a 96% positive predictive value and a 97% negative predictive value.

For patients older than two years, symptoms of meningitis include fever, severe headache, stiff neck, nausea, sleepiness, confusion, and sensitivity to bright lights or seizures. These symptoms may be absent or difficult to detect in newborns and small infants who may only appear slow or inactive, or be irritable, have vomiting or feed poorly.

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