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www.fdanews.com/articles/91244-fda-clears-rapid-meningitis-test

FDA CLEARS RAPID MENINGITIS TEST

March 19, 2007

The FDA announced it cleared for marketing a test that uses molecular biology to detect the presence of viral meningitis.

The Xpert EV test, when used with other laboratory tests, will help physicians distinguish between viral meningitis and the less-common, but more severe, bacterial meningitis.

It can usually take up to a week to get results from diagnostic tests for meningitis, according to the FDA. However, results from the Xpert EV test are available in two-and-a-half hours.

The Xpert EV test is the first fully automated diagnostic test that isolates and amplifies viral genetic material from a patient's cerebrospinal fluid using a process called reverse-transcription polymerase chain reaction.