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Updated: Jun 13, 2026

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
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Analytical Sensitivity and HER2-Low: To Measure or Not to Measure, That Is the Question.

Emina Emilia Torlakovic1

  • 1Department of Pathology and Laboratory Medicine and Canadian Biomarker Quality Assurance, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.

Laboratory Investigation; a Journal of Technical Methods and Pathology
|June 11, 2026
PubMed
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Analytical sensitivity, measured by the lower limit of detection (LOD), is crucial for accurate HER2 testing. Methodological limitations in a Dutch study obscured the link between LOD and HER2-low prevalence.

Area of Science:

  • Biomarker Assay Validation
  • Immunohistochemistry Performance
  • Oncology Diagnostics

Background:

  • Analytical sensitivity, specifically the lower limit of detection (LOD), is a critical assay characteristic.
  • The relationship between LOD and the diagnostic/clinical sensitivity of immunohistochemistry (IHC) biomarkers is under active investigation.
  • HER2 (Human Epidermal growth factor Receptor 2) is a key biomarker in breast cancer diagnostics.
Keywords:
HER2-lowanalytical sensitivitycalibratorsdiagnostic sensitivityimmunohistochemistry

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