In the age of precision medicine, diagnostic accuracy is paramount. The monitoring of biologic drug levels and anti-drug antibodies (ADAb) — particularly in inflammatory bowel disease (IBD) patients treated with infliximab (IFX) — has become a cornerstone of therapeutic decision-making. Yet, as with other diagnostic targets like hepatitis E virus (HEV) or dengue virus (DENV), variations between commercial ELISA kits can significantly impact clinical interpretation.
What This Means for Biotech Diagnostics
Whether the target is a therapeutic monoclonal antibody or a viral antigen, the following principles hold true:
- All ELISA kits are not created equal — technical differences in antigen capture, revelation methods, and standardization can cause significant result variation.
- Consistency in assay usage is key for longitudinal monitoring — particularly for chronic conditions like IBD where treatment adjustments hinge on lab values.
- Cross-comparisons of research data from different kits should be interpreted with caution — numerical disparities may not always reflect true biological differences.