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Immunoassay Interference on Thyroid Function Tests During Treatment with Nivolumab.

Rosa Maria Paragliola1, Andrea Corsello1, Giampaolo Papi1

  • 1Department of Endocrinology and Università Cattolica del Sacro Cuore-Fondazione Policlinico "Gemelli" IRCCS, Rome, Italy.

Thyroid : Official Journal of the American Thyroid Association
|March 4, 2020
PubMed
Summary

Immune checkpoint inhibitors like nivolumab can cause thyroid issues. This case highlights a potential nivolumab interference with thyroid hormone assays, leading to misdiagnosis of thyrotoxicosis.

Keywords:
hypothyroidismimmune checkpoint inhibitorsimmunoassay interferencenivolumabone-step immunoassaythyrotoxicosis

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Area of Science:

  • Endocrinology
  • Oncology
  • Clinical Chemistry

Background:

  • Immune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 inhibitors, are linked to endocrine dysfunctions, notably thyroid disorders.
  • Thyroid dysfunction is a known side effect of ICIs, with a higher incidence observed with PD-1/PD-L1 inhibitors.

Observation:

  • An 85-year-old patient on nivolumab for metastatic melanoma developed severe thyrotoxicosis.
  • Thyroid function tests (TFTs) showed biochemical interference, with inappropriately elevated free thyroxine (fT4) levels on a Siemens Centaur immunoassay.
  • Re-analysis with a Roche Elecsys immunoassay and post-polyethylene glycol (PEG) precipitation confirmed hypothyroidism, suggesting nivolumab-induced assay interference.

Findings:

  • Nivolumab therapy in a metastatic melanoma patient was associated with severe thyrotoxicosis.
  • A significant biochemical interference was observed in fT4 assays, potentially misrepresenting thyroid status.
  • Polyethylene glycol (PEG) precipitation resolved the interference, confirming drug-induced assay artifact.

Implications:

  • This case suggests a novel biochemical interference of nivolumab with fT4 immunoassays.
  • Accurate diagnosis of ICI-related thyroid dysfunction may require alternative assay methods or pre-analytical sample processing.
  • Further research is needed to elucidate the biochemical mechanisms of nivolumab-induced assay interference.