A Tool to Eliminate IgM Immunoassay Interference

Alexander Pöhler1, Uwe Wessels2, Roland F Staack2

  • 1Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalysis & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377, Penzberg, Germany. alexander.poehler@roche.com.

The AAPS Journal
|April 11, 2025
PubMed

IgM-selective proteolytic cleavage can become a groundbreaking tool for immunoassay-based bioanalysis. We tested the utility of a newly introduced IgM-selective protease in three different bioanalytical applications and showed that protease treatment can eliminate rheumatoid factor interference and simplify IgM isotyping. Surprisingly, we discovered that a gene therapy-induced immune response was underestimated in an anti-capsid IgG assay when treatment-emergent IgM were present in the matrix. Selective IgM digestion eliminated this interference.