ArticleThe journal of histochemistry and cytochemistry : official journal of the Histochemistry Society2017
Analytic Response Curves of Clinical Breast Cancer IHC Tests.
Article in The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed.
- Quantitative immunohistochemistry and the use of cellular calibrators for HER2 receptor number determination.Scientific reports · 2026Article
- A Consortium for Analytic Standardization in Immunohistochemistry.Archives of pathology & laboratory medicine · 2022Review
- Development and Validation of Measurement Traceability for In Situ Immunoassays.Clinical chemistry · 2021Article
- Tissue Multiplex Analyte Detection in Anatomic Pathology - Pathways to Clinical Implementation.Frontiers in molecular biosciences · 2021Review
- Synthetic Antigen Gels as Practical Controls for Standardized and Quantitative Immunohistochemistry.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2019Article
- Selecting an Optimal Positive IHC Control for Verifying Antigen Retrieval.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2019Article
- The Importance of Epitope Density in Selecting a Sensitive Positive IHC Control.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2017Article
- A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry.Applied immunohistochemistry & molecular morphology : AIMMArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
An important limitation in the field of immunohistochemistry (IHC) is the inability to correlate stain intensity with specific analyte concentrations. Clinical immunohistochemical tests are not described in terms of analytic response curves, namely, the analyte concentrations in a tissue sample at which an immunohistochemical stain (1) is first visible, (2) increases in proportion to the analyte concentration, and (3) ultimately approaches a maximum color intensity. Using a new immunostaining tool ( IHControls), we measured the analytic response curves of the major clinical immunohistochemical tests for human epidermal growth factor receptor type II (HER-2), estrogen receptor (ER), and progesterone receptor (PR). The IHControls comprise the analytes HER-2, ER, and PR at approximately log concentration intervals across the range of biological expression, from 100 to 1,000,000 molecules per test microbead. We stained IHControls of various concentrations using instruments, reagents, and protocols from three major IHC vendors. Stain intensity at each analyte concentration was measured, thereby generating an analytic response curve. We learned that for HER-2 and PR, there is significant variability in test results between clinical kits for samples with analyte concentrations of approximately 10
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Registered trials
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