Quicker Meningitis diagnosis gets underway by FDA

A test to aid physicians rapidly discern and treat viral meningitis from its more perilous bacterial counterpart, the U.S. Food and Drug Administration on Friday cleared for marketing the Xpert EV test developed by Sunnyvale, California based Cepheid.

The test when used in combination with other laboratory procedures is capable of distinguishing between viral and bacterial meningitis.

The first fully-automated medical diagnostic test, the Xpert EV test segregates and magnifies viral genetic material present in a patient's cerebrospinal fluid by a process called reverse transcription-polymerase chain reaction.

The test is designed to identify infections from an array of viruses called enterovirus, responsible for approximately 90 percent of all viral meningitis cases.

An infection of the cerebrospinal fluid surrounding a person's spinal cord and brain, Meningitis causes inflammation of the tissues leading to high fever and severe headache. Other first grade symptoms include Nausea and Vomiting.

Laboratory testing of the fluid obtained during the patients spinal tap helps diagnoses of the illness.

Unlike traditional diagnostic tests for meningitis which take up to a week to deliver results, the newly approved test delivers results within 3 hours of inspection.

While symptoms of viral meningitis settle within weeks without medical help, bacterial meningitis is a medical emergency that can lead to brain damage, hearing loss and possible death if untreated. Bacterial version requires urgent treatment with antibiotics, while viral meningitis cannot be cured by antibiotics.

"Because this test is significantly faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients.
Swift recognition of the cause and appropriate treatment is critical to patient recovery," Daniel Schultz, director of the Center for Devices and Radiological Health commented.

“This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics," Schultz added.

Upon filling the cartridge directly with the sample, the cartridge is loaded into the GeneXpert DX instrument, which conducts all the necessary laboratory procedures.

A single use, disposable cartridge costing $69 each aids the test, while the system to test the samples cost between $25,000 and $125,000.