Heterophilic antibody interference in immunometric assays

Area of Science:

• Clinical Chemistry
• Immunology
• Diagnostic Assay Development

Background:

• Immunometric assays are susceptible to interference from heterophilic antibodies, which are endogenous antibodies that can bind to assay components.
• This interference can lead to clinically significant errors, potentially impacting patient diagnosis and treatment.
• The prevalence of heterophilic antibody interference necessitates proactive management strategies.

Purpose of the Study:

• To review and discuss strategies for minimizing the impact of heterophilic antibody interference in immunometric assays.
• To guide clinicians, laboratorians, and the immunoassay industry in addressing this diagnostic challenge.
• To highlight future challenges posed by evolving antibody-based therapeutics and diagnostics.

Main Methods:

• Review of existing literature on heterophilic antibody interference and mitigation techniques.
• Discussion of clinical and laboratory best practices for managing assay interference.
• Analysis of immunoassay design considerations to incorporate protective measures.

Main Results:

• Heterophilic antibody interference can cause devastating consequences, including false positive or negative results.
• Effective strategies involve careful test ordering by clinicians, confirmatory testing by laboratorians, and specific design measures by manufacturers.
• Use of antibody fragments and blocking agents are examples of protective measures in assay design.

Conclusions:

• Addressing heterophilic antibody interference requires a multi-faceted approach involving all stakeholders in the diagnostic process.
• Clinicians must critically evaluate results, laboratorians must implement confirmatory methods, and manufacturers must build interference resistance into assays.
• Proactive measures are essential to maintain the integrity of diagnostic testing in the face of evolving antibody technologies.