Introduction and Clinical Validation of Metrology Standards for Immunohistochemistry

Published

December 21, 2020

Author(s)

Emina E. Torlakovic, Seshi Sompuram, Vani Kodela, Anika Schaedle, Paul DeRose, Steve Bogen, Lili Wang

Abstract

Despite the widespread integration of immunohistochemistry (IHC) into routine surgical pathology, its use suffers from significant inter-laboratory disparities. The root cause and an unsolved technical challenge is the lack of metrology standards, the absence of which frustrates test standardization. We describe a unique technical solution for creating IHC metrology standards, the first of which is for estrogen receptor (ER). To validate the new tools, ER standards were deployed across clinical IHC laboratories in a national external quality assessment program. The lower limit of detection (analytic sensitivity) was measured with the standards and correlated with tumor staining. The test disparities strongly correlated with a laboratory's analytic sensitivity. The metrology standards reliably determine IHC analytical sensitivity and can predict which laboratories are at risk for generating false positive or false negative results. The data highlight the urgent need to standardize IHC testing using quantitative reference standards.

Citation

Clinical Chemistry

Pub Type

Journals

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Citation

Torlakovic, E. , Sompuram, S. , Kodela, V. , Schaedle, A. , DeRose, P. , Bogen, S. and Wang, L. (2020), Introduction and Clinical Validation of Metrology Standards for Immunohistochemistry, Clinical Chemistry, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=930849 (Accessed October 6, 2025)