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

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1 Production de Protéines Recombinantes et d-Anticorps Plate-Forme 2 National Reference Center for Meningitis

Abstract : 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 105 cfu-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. For CSF serogroup A, the positive and negative likelihood ratios +- 95% confidence intervals CIs were 31.867 16.1-63.1 and 0.065 0.04-0.104, respectively, and the diagnostic odds ratio +- 95% CI was 492.9 207.2-1,172.5. For CSF serogroups W135 and Y, the positive likelihood ratio was 159.6 51.7-493.3 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.

Author: Suzanne Chanteau - Sylvie Dartevelle - Ali Elhadj Mahamane - Saacou Djibo - Pascal Boisier - Farida Nato -



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