Rapid Test for Viral Meningitis Approved by FDA

Xpert EV test has a sensitivity of 97 percent and a specificity of 96 percent at detecting enterovirus

FRIDAY, March 16 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new rapid test that can detect viral meningitis in as little as 2.5 hours. The test, known as the Xpert EV test, should help distinguish viral from bacterial meningitis.

The test was developed by Cepheid, of Sunnyvale, Calif., and uses reverse transcription-polymerase chain reaction to detect enteroviruses. Such viruses cause 90 percent of viral meningitis cases.

To conduct the test, a sample is loaded in a disposable cartridge, which is tested using a GeneXpert DX instrument. The one-step procedure minimizes error. In tests using 255 patient samples, the Xpert EV test had a sensitivity of 97 percent and a specificity of 96 percent.

"Because this test is significantly faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients," said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, in a statement. "This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics."

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Theresa Tamkins

Theresa Tamkins

Published on March 16, 2007

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