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Comparative Study
. 2006 Sep;3(9):e337.
doi: 10.1371/journal.pmed.0030337.

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

Affiliations
Comparative Study

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

Suzanne Chanteau et al. PLoS Med. 2006 Sep.

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 10(5) 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.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist. Farida Nato, Suzanne Chanteau, and Sylvie Dartevelle declared they have deposited an Enveloppe Soleau (DI 2005–35).

Figures

Figure 1
Figure 1. RDT Results by Serogroup
Results of RDT1 and RDT2 are shown for each N. meningitidis serogroup.
Figure 2
Figure 2. Predictive Values for N. meningitidis Diagnosis
PVPs and NPVs for the diagnosis of N. meningitidis serogroup A (A) and serogroup W135 (B), according to prevalence. PVP is represented by the purple line with open circles, and NPV by the blue line with filled circles.

References

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