The Xpert EV test was developed by Cepheid and gives the results in two and one-half hours. Meningitis is the inflammation of the tissues surrounding the brain and spinal cord. Typically the diagnosis is established after the cerebrospinal fluid is assessed following a spinal tap. Results are only available within a week, which can sometimes adversely affect the patient.

The new test is able to give out the results quickly and diagnoses infection caused by a group of viruses called Enteroviruses. The latter are responsible for nearly 90 percent of all vial meningitis cases.

The test is simple to use in that the sample is directly loaded onto a cartridge, which is then transferred to a GeneXpert DX instrument. All procedures thereafter are automated. The accuracy of the test was established through a study of 235 samples among which 96 percent of those tested did have viral meningitis. On the other hand 97 percent who tested negative did not have this type of meningitis.

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

Bacterial meningitis is an emergency condition that requires aggressive treatment. It can sometimes be fatal if treatment is not given quickly. That is why doctors have to know the origin of the infection before treating it. Viral meningitis is not such a serious illness and patints usually recover within couple of weeks.

Unfortunately the symptoms of both types of meningitis are very similar. They present as fever, stiff neck, severe headache, confusion, seizures and sensitivity to bright lights.

Doctors cannot distinguish between viral and bacterial meningitis based on symptoms alone. The introduction of Xpert EV test will go a long way in helping them diagnose the type of meningitis swiftly. The test is based on reverse transcription-polymerase chain reaction and amplifies the viral genetic material present in the patient's cerebrospinal fluid.

"Since bacterial meningitis can be deadly within as little as two days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial meningitis," Dr Schultz said. "This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics." 

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