Molecular Dx Significance 7/10

Rapid Immunochromatographic Test Detects and Serogroups N. meningitidis from CSF in Under 15 Minutes

The MeningoSpeed rapid diagnostic test was validated on 560 cerebrospinal fluid specimens from five African countries and France for detection and serogrouping of Neisseria meningitidis. The test achieved 92.7% sensitivity, 93.8% specificity, and 93.2% overall accuracy compared to reference multiplex PCR, with serogroup-specific concordance ranging from 74.4% (serogroup C) to 100% (serogroup X). Its room-temperature storage, minimal sample volume, and 15-minute turnaround make it particularly suited for bedside use in resource-limited meningitis belt settings.

The original study

Validation of a New Rapid Detection Test for Detection of Neisseria meningitidis A/C/W/X/Y Antigens in Cerebrospinal Fluid.

Authors
Haddar CH, Terrade A, Verhoeven P, Njanpop-Lafourcade BM, Dosso M, Sidikou F, et al.
Journal
Journal of clinical microbiology
Type
Journal Article, Research Support, Non-U.S. Gov't, Validation Study
PMID
31915288
Read the original study →

Original abstract

Meningococcal meningitis remains a life-threatening disease worldwide, with high prevalence in the sub-Saharan meningitis belt. A rapid diagnosis is crucial for implementing adapted antimicrobial treatment. We describe the performances of a new immunochromatographic test (MeningoSpeed, BioSpeedia, France) for detecting and grouping Neisseria meningitidis Cerebrospinal fluids (CSFs) were collected from 5 African countries and France. For the rapid diagnostic test (RDT), the CSF sample was deposited on each of the 3 cassettes for a total volume of 90 μl. The results of the RDT were compared to those of a reference multiplex PCR assay detecting the major serogroups of N. meningitidis on 560 CSF specimens. Five specimens were found uninterpretable by RDT (0.9%). The results of interpretable specimens were as follows: 305 positive and 212 negative samples by both techniques, 14 positive by PCR only, and 24 positive by RDT only (sensitivity, specificity, and positive and negative predictive values of 92.7%, 93.8%, 95.6%, and 89.8%, respectively, with an accuracy of 93.2% and a kappa test of 0.89; P < 0.05). From 319 samples positive by PCR for serogroups A, C, W, X, or Y, the grouping results were concordant for 299 specimens (sensitivity of 93.0%, 74.4%, 98.1%, 100%, and 83.3% for serogroups A, C, W, X, and Y, respectively). The MeningoSpeed RDT exhibited excellent performances for the rapid detection of N. meningitidis antigens. It can be stored at room temperature, requires a minimal amount of CSF, is performed in 15 minutes or less, and is easy to use at bedside.