Rapid Molecular Test Developed for Meningitis

A novel rapid test has been created for the diagnosis of meningitis, which is difficult due to ambiguous symptoms initially making early verification challenging.

The test uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP) which is a form of rapid polymerase chain reaction, to provide the result.

The new test, which provides a reliable diagnosis in less than one hour, was developed by scientists in the Royal Victoria Hospital laboratories (Belfast, UK). Standard laboratory tests take at least 24 hours, so there is a need for rapid, sensitive, and specific tests to allow earlier confirmation of the diagnosis and earlier treatment.

The invention is a rapid in vitro diagnostic method for detecting nucleic acids (RNA or DNA) from the pathogenic bacterium Neisseria meningitidis (NMG) in clinical specimens, without the use of expensive laboratory instruments. This provides physicians with a useful diagnostic test, which will detect this pathogen, without referral to the laboratory. In its current format, the test allows detection of all of the major serotypes of NMG with high sensitivity and specificity, in less than one hour. The invention makes the established benefits of nucleic acid testing with high specificity, high sensitivity, and high positive and negative predictive values available in a format, which enables the test to be performed near the patient, in a nonlaboratory setting, by nonlaboratory staff, with immediate feedback to clinicians.

The test has been licensed to HiberGene Diagnostics, an Irish start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at University College Dublin (Ireland). Brendan K. Farrell, CEO at HiberGene Diagnostics said, "We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7%, which is excellent. HiberGene plans to commercialize the test in the first half of 2012 and is already in discussions with a number of potential distribution partners in the USA and Europe. We look forward to further collaboration with the Trust." HiberGene is also currently working on a series of additional molecular assays to detect rapidly pathogenic microorganisms.

Related Links:
Royal Victoria Hospital
University College Dublin