ArticleApplied immunohistochemistry & molecular morphology : AIMM
A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry.
Article in Applied immunohistochemistry & molecular morphology : AIMM. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 40 citations in OpenAlex.
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- Quantitative immunohistochemistry and the use of cellular calibrators for HER2 receptor number determination.Scientific reports · 2026Article
- Toward Optimizing the Impact of Digital Pathology and Augmented Intelligence on Issues of Diagnosis, Grading, Staging, and Classification.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2025Review
- Augmented reality microscopy to bridge trust between AI and pathologists.NPJ precision oncology · 2025Article
- The single-cell spatial landscape of stage III colorectal cancers.NPJ precision oncology · 2025Article
- Multiplexed immunolabelling of cancer using bioconjugated plasmonic gold-silver alloy nanoparticles.Nanoscale advances · 2024Article
- Review
- Clinical Proteomics for Solid Organ Tissues.Molecular & cellular proteomics : MCP · 2023Article
- Article
- A Consortium for Analytic Standardization in Immunohistochemistry.Archives of pathology & laboratory medicine · 2022Review
- Recent advances in nanomaterials-based electrochemical immunosensors and aptasensors for HER2 assessment in breast cancer.Mikrochimica acta · 2021Review
- Development and Validation of Measurement Traceability for In Situ Immunoassays.Clinical chemistry · 2021Article
- Conjugating immunoassays to mass spectrometry: Solutions to contemporary challenges in clinical diagnostics.Trends in analytical chemistry : TRAC · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
Abstract
The field of Clinical Immunohistochemistry (IHC) is beset with a high error rate, an order of magnitude higher than in other types of clinical laboratory testing. Despite the many improvements in the field, these errors have persisted over the last 2 decades. The improvements over the years include an extensive literature describing the potential causes of errors and how to avoid them. More stringent regulatory guidelines have also been implemented. These measures reflect the standard view is that fixing the broad confluence of causes of error will address the problem. This review takes a different tack. To understand the high error rates, this review compares Clinical IHC laboratory practice to practices of other clinical laboratory disciplines. What aspects of laboratory testing that minimize errors in other clinical laboratory disciplines are not found in Clinical IHC? In this review, we seek to identify causal factors and underlying root causes that are unique to the field of Clinical IHC in comparison to other laboratory testing disciplines. The most important underlying root cause is the absence of traceable units of measure, international standards, calibrators that are traceable to standards, and quantitative monitoring of controls. These tools and practices (in other clinical laboratory disciplines) provide regular accurate feedback to laboratory personnel on analytic test performance.
Identifiers
What OpenQuestion holds
Registered trials
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.