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Rapid Meningitis Diagnostic Test Set for Commercial Use


Larry Hand

October 10, 2011 The technology transfer office of University College, Dublin, Ireland, has licensed a novel rapid meningitis diagnostic test to an Irish start-up company for worldwide commercial development, the university announced October 6. The company, HiberGene Diagnostics, Ltd, plans to begin commercializing the test in early 2012 in the United States and Europe. The test employs a molecular technique called loop-mediated isothermal amplification, which provides a "reliable diagnosis in less than an hour" and has shown a sensitivity of 100% and a specificity of 99.7% in clinical studies, according to the announcement. Current laboratory tests for meningitis can take 24 hours or longer to show results. The test "specifically identifies [the bacterium] if meningitis is present," pediatrician Mike Shields, MD, professor of child health at Queen's University, Belfast, Northern Ireland, and lead researcher on the project, wrote in an email to Medscape Medical News. The test does not detect viral meningitis. It also eases the uncertainty involved when a child first presents with symptoms, he added, when ambiguous influenza-like symptoms of meningitis make diagnosis of the disease difficult. "About half of children who present with rapidly progressive meningococcal infection have been seen in the preceding 24 hours and falsely reassured by medical staff. We hope the test will allow a more rapid diagnosis, and perhaps even be usable when a child is first seen." The test most often is used with a blood sample but can be used with a lumbar puncture, Dr. Shields wrote in his email. The test is currently being evaluated at the Royal Belfast Hospital for Sick Children. With this type of test, a lumbar puncture is still necessary to confirm the diagnosis, said Amanda Cohn, MD, a meningitis expert with the US Centers for Disease Control and Prevention in Atlanta, Georgia. "Instead of having to wait for tests that can take 2 or 3 days to identify whether or not it's meningococcal disease, with this test you could test the cerebrospinal fluid that you collect directly at the bedside and get a result while you're managing the patient," she told Medscape Medical News. "We don't currently have any test like this," she said. Although a lot of research has been conducted in efforts to develop a rapid diagnosis tool, she said she was unaware of any other test like this one offered by any other companies. The 2 major ways to detect meningococcal disease in the United States currently are polymerase chain reaction tests and culture growth and analysis, both of which involve processes that take 24 hours or more, she added. To compensate for the time, patients who are suspected of having meningococcal disease are treated for it until tests prove otherwise, she said. Meningococcal disease is rare in the United States, and most cases of meningitis do not progress to the more serious meningococcal disease, Dr. Cohn said. Such a test will greatly benefit Africa and Europe, however, where the disease is more common. Still, "I think this test might be a valuable contribution to diagnostic testing in the United States if it's priced affordably and it's implementable in the hospital laboratory," she said. Two recently published research papers described how the loop-mediated isothermal amplification assay is being studied also for malaria in Thailand and for human granulocytic anaplasmosis, an infectious disease transmitted to humans by ticks, in China.
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