FDA Clears Rapid Test for Meningitis

Mar 19, 08:49 AM

Current Headlines: FDA clears rapid test for meningitis WASHINGTON, March 16 (Xinhua) -- The U.S. Food and Drug Administration (FDA) cleared on Friday for marketing a test that uses molecular biology to quickly detect the presence of viral meningitis.

The Xpert EV test, when used in combination with other laboratory tests, will help physicians distinguish between viral meningitis and the less-common, but more severe, version of meningitis caused by bacteria.

Meningitis is an infection of the cerebrospinal fluid surrounding a person's spinal cord and brain, causing inflammation of the tissues in these areas. The illness is diagnosed by testing the fluid obtained from a patient during a spinal tap. Typically, diagnostic tests for meningitis can take up to a week to get results. But results from the Xpert EV test are available in two and one-half hours.

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 by a process called reverse transcription-polymerase chain reaction. The test identifies infection resulting from a class of viruses known as Enterovirus, which are responsible for approximately 90 percent of all viral meningitis cases.

The Xpert EV test is performed by adding the sample directly to a disposable, single-use cartridge. The cartridge is loaded into the GeneXpert DX instrument which then conducts all the necessary laboratory procedures in a one-step, easy-to-use format that helps minimize errors.

The Xpert EV test was developed by Cepheid, a company located in Sunnyvale, California.

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