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Licensing opportunity DI 05/35

New rapid diagnostic tests for Neisseria meningitidis serogroups A, W135, C, and Y.

Inventors: S. Chanteau, F. Nato et al.

Description of invention: 

BACKGROUND: Outbreaks of meningococcal meningitis (meningitis caused by Neisseria meningitidis) are a major public health concern in the African "meningitis belt," which includes 21 countries from Senegal to Ethiopia. Of the several species that can cause meningitis, N. meningitidis is the most important cause of epidemics in this region. In choosing the appropriate vaccine, accurate N. meningitidis serogroup determination is key. To this end, we developed and evaluated two duplex rapid diagnostic tests (RDTs) for detecting N. meningitidis polysaccharide (PS) antigens of several important serogroups.

METHODS AND FINDINGS: Mouse monoclonal IgG antibodies against N. meningitidis PS A, W135/Y, Y, and C were used to develop two immunochromatography duplex RDTs, RDT1 (to detect serogroups A and W135/Y) and RDT2 (to detect serogroups C and Y). Standards for Reporting of Diagnostic Accuracy criteria were used to determine diagnostic accuracy of RDTs on reference strains and cerebrospinal fluid (CSF) samples using culture and PCR, respectively, as reference tests. The cutoffs were 105cfu/ml for reference strains and 1 ng/ml for PS. Sensitivities and specificities were 100% for reference strains, and 93.8%-100% for CSF serogroups A, W135, and Y in CSF. Both RDTs were equally reliable at 25 degrees C and 45 degrees C.

CONCLUSIONS: These RDTs are important new bedside diagnostic tools for surveillance of meningococcus serogroups A and W135, the two serogroups that are responsible for major epidemics in Africa.

 Specific advandages

 Rapid: results could be obtained within 10 minutes
 Simple (in one step) and easy to read
 Highly specific (due to monoclonal antibodies)
 Low cost

 Potential applications
 Surveillance of epidemics due to N. meningitidis in the countries of African meningitis belt but also in South America and Asia
 Individual and differential diagnosis of suspected cases of meningitis
 Serotyping of invasive strains of N. meningitides
Patent Status:
 Dépôt CNCM n° I-3609, I-3610, I-3611

 Recent pertinent publications:
 New rapid diagnostic tests for Neisseria meningitides serogroups A, W135, C and Y
Chanteau S, Dartevelle S, Mahamane AE, Djibo S, Boisier P, Nato F.
PLoS Med. 2006;3(9):e337.
 From genomics to surveillance, prevention and control : new challenges for the African meningitis belt. Meeting report, Niamey 26-29 November 2005.
Alonso JM, Bertherat E, Borrow R, Chanteau S et al.
Vaccine, 2006, 24, 4279-4284.

Contact : Christophe Poquet, Business Development Manager - Office of Technology Transfer
 Institut Pasteur - 28 Rue du Docteur Roux - 75724 Paris Cedex 15 FRANCE
Tel : 33.1.40 61 33 97 - Fax : - email :