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U.S. Department of Health and Human Services

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Rapid Test Detects Viral Meningitis

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FDA cleared for marketing in March 2007 a test that uses molecular biology to quickly detect the presence of viral meningitis. When used in combination with other laboratory tests, the Xpert EV test, made by Cepheid, Sunnyvale, Calif., will help doctors distinguish between viral meningitis and the less-common but more severe version of meningitis caused by bacteria.

About meningitis:

  • Meningitis is an infection of the cerebrospinal fluid surrounding a person's spinal cord and brain. The infection causes inflammation of the tissues in these areas.
  • Bacterial meningitis can lead to brain damage, hearing loss, and death if not treated properly. It can be deadly within as little as two days.
  • People with viral meningitis usually recover within two weeks without medical treatment.
  • Knowing whether meningitis is viral or bacterial is imperative to early, effective treatment.
  • Distinguishing between the two types of infection is difficult because their symptoms are similar.
  • Symptoms for patients over two years old 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.
  • People who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial meningitis.

About the Xpert EV test:

  • It is the first, fully automated medical diagnostic test that isolates and amplifies viral genetic material present in a patient's cerebrospinal fluid.
  • It is performed by adding a sample directly to a disposable, single-use cartridge.
  • It identifies infection resulting from a class of viruses known as Enterovirus, which are responsible for about 90% of all viral meningitis cases.
  • The test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics.
  • Results of the Xpert EV test are available in 2-l/2 hours. Typically, it can take up to a week to get results from diagnostic tests for meningitis.
  • Because results are faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients.
  • Accuracy of the test was confirmed in a multi-site study at six institutions.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: May 14, 2007

 
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