Enhanced serological diagnosis of invasive meningococcal disease by determining anti-group C capsule IgM antibody by enzyme immunoassay

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Abstract
Summary Aims To describe the development and evaluation of a diagnostic enzyme immunoassay (EIA) for IgM antibody to serogroup C capsular polysaccharide of Neisseria meningitidis (CCPS). Methods Purified CCPS was used as the antigen. The optical densities (OD) that determined the cut-off values for the assay were derived using sera from blood bank donors, and the accuracy was evaluated with sera from patients with culture-confirmed serogroup C and non-serogroup C invasive meningococcal disease (IMD), other infectious diseases, culture-confirmed pharyngeal carriage of N. meningitidis and immunoproliferative disorders. Results In sera collected between days 5 and 20 following positive culture, the assay had a sensitivity of 92%. The two negative sera were from a single patient but showed a significant rise in OD. The sensitivity declined to 80% on days 21-40 then to 75% on days 41-70. No positive reactions were detected in five samples collected after 71 days. The specificity of the assay was at least 97%. Conclusions An EIA for IgM antibody to CCPS was evaluated for local conditions and had acceptable sensitivity and specificity. Use of the assay, based on a single blood sample, provided clinically and epidemiologically relevant information for individual and public health management of IMD.