Evidence map›Paper›PMID 27767098›Full record

ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2017

A novel quantitative immunohistochemistry method for precise protein measurements directly in formalin-fixed, paraffin-embedded specimens: analytical performance measuring HER2.

Kristian Jensen, Rikke Krusenstjerna-Hafstrøm, Jesper Lohse, Kenneth H Petersen, Helene Derand

Open access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 82 citations in OpenAlex.

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  5. Repurposing HER2 IHC: Pan-HER2 and Low-HER2.Applied immunohistochemistry & molecular morphology : AIMM · 2026
    Review
  6. Unveiling the developmental and tumor-suppressive roles of the p53 variant p53psi.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Kristian JensenDako Denmark A/S, an Agilent Technologies Company, Produktionsvej 42, Glostrup, Denmark.
Rikke Krusenstjerna-HafstrømDako Denmark A/S, an Agilent Technologies Company, Produktionsvej 42, Glostrup, Denmark.
Jesper LohseDako Denmark A/S, an Agilent Technologies Company, Produktionsvej 42, Glostrup, Denmark.
Kenneth H PetersenDako Denmark A/S, an Agilent Technologies Company, Produktionsvej 42, Glostrup, Denmark.
Helene DerandDako Denmark A/S, an Agilent Technologies Company, Produktionsvej 42, Glostrup, Denmark.
Agilent Technologies (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In clinical routine pathology today, detection of protein in intact formalin-fixed, paraffin-embedded tissue is limited to immunohistochemistry, which is semi-quantitative. This study presents a new and reliable quantitative immunohistochemistry method, qIHC, based on a novel amplification system that enables quantification of protein directly in formalin-fixed, paraffin-embedded tissue by counting of dots. The qIHC technology can be combined with standard immunohistochemistry, and assessed using standard bright-field microscopy or image analysis. The objective was to study analytical performance of the qIHC method. qIHC was tested under requirements for an analytical quantitative test, and compared with ELISA and flow cytometry for quantitative protein measurements. Human epidermal growth factor receptor 2 (HER2) protein expression was measured in five different cell lines with HER2 expression from undetectable with immunohistochemistry to strong positive staining (IHC 3+). Repeatability, reproducibility, robustness, linearity, dynamic range, sensitivity, and quantification limits were evaluated. Reproducibility and robustness were assessed in a setup to resemble daily work in a laboratory using a commercial immunohistochemistry platform. In addition, qIHC was correlated to standard HER2 immunohistochemistry in 44 breast cancer specimens. For all evaluated parameters, qIHC performance was either comparable or better than the reference methods. Furthermore, qIHC has a lower limit of detection than both immunohistochemistry and the ELISA reference method, and demonstrated ability to measure HER2 accurately and precise within a large dynamic range. In conclusion, the results show that qIHC provides a sensitive, quantitative, accurate, and robust assay for measurement of protein expression in formalin-fixed, paraffin-embedded cell lines, and tissue.

Indexed as

Biomarkers, TumorBreast NeoplasmsCell Line, TumorErb-b2 Receptor Tyrosine KinasesGene Expression Regulation, NeoplasticHumansImmunohistochemistryParaffin EmbeddingReproducibility of ResultsBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID27767098
OpenAlexW2538484238

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.