ROCKVILLE, Md. -- The FDA has approved a rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.
ROCKVILLE, Md., March 19 -- The FDA has approved a rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.
The FDA said 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 using reverse transcription-polymerase chain reaction.
The test has the potential of preventing unnecessary and potentially harmful administration of antibiotics for bacterial meningitis to patients with viral meningitis. The test identifies Enterovirus infections, which are responsible for 90% of viral meningitis cases. within two days
Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, noted that standard meningitis assays take up to a week.
"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.
The rapid test "should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics," he added.
In a multisite study at six institutions 255 patient samples were tested. The Xpert EV test demonstrated a 96% positive predictive value and a 97% negative predictive value.
Blaise Congeni, M.D., director of pediatric infectious diseases at Akron (Ohio) Children's Hospital, said his hospital, as is the case with many tertiary centers, has its own PCR lab, allowing rapid analysis without the new test/
But he pointed out that most community hospitals don't have that ability and in those cases "this will be useful test that should cut down on the inappropriate use of antibiotics."
Dr. Congeni said, however, that there was no treatment for viral meningitis other than supportive care.
Patients with viral meningitis usually recover within two weeks without any medical intervention. Bacterial meningitis, however, can lead to brain damage, hearing loss, and even death if not treated properly.
For patients older than two years, symptoms of meningitis 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 who may only appear slow or inactive, or be irritable, have vomiting or feed poorly.
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.