Development and characterization of a Zaire Ebola (ZEBOV) specific IgM ELISA

Immunoglobulin M (IgM) is the first antibody induced after the onset of an adaptive immune response against a pathogen or vaccine. Serological assays play a central role in evaluating these adaptive immunological responses. Such assays are not only crucial for the assessment of vaccine immunogenicity, but also inform on exposure to pathogens and cross-reactivity with other viruses. To date, there is no ELISA-based assay available that measures IgM responses against Zaire Ebola virus (ZEBOV). To address this critical need, our laboratory has developed a novel immunoassay capable of detecting total IgM against ZEBOV glycoprotein in serum samples from individuals exposed to the antigen through infection or vaccination. Here, we describe a sensitive, high-throughput, and inexpensive assay that can be performed in any laboratory. The performance criteria of the newly developed ZEBOV glycoprotein-based IgM ELISA were assessed using antisera collected from human patients immunized with the rVSVΔG-ZEBOV-GP vaccine being tested in a phase 1 clinical trial. This assay demonstrates high specificity and sensitivity and will also be a valuable tool in the mission to find immune correlates of protection for a successful Ebola vaccine.