ArticleDiagnostic pathology2024
Interlaboratory variability of HER2 fluorescence in situ hybridization testing in breast cancer: results of a multicenter proficiency-testing ring study in China.
Article in Diagnostic pathology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- A Head-to-Head Comparison of Two Antibodies for HER2 Pretargeted PET Imaging via Bioorthogonal Click Chemistry.Pharmaceuticals (Basel, Switzerland) · 2026Article
- HER2 Heterogeneity in Breast Cancer: Biological Basis, Clinical Implications, and Therapeutic Strategies.Breast cancer (Dove Medical Press) · 2026Review
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Authors and funding
4 authors.
Funding
Abstract
backgroundAccurate detection of human epidermal growth factor receptor 2 (HER2) gene amplification via fluorescence in situ hybridization (FISH) is necessary to determine HER2 status. Although many attempts have been made to increase the consistency of the results, the actual situation still needs to be determined. To investigate the latest interlaboratory variability of HER2 FISH testing for breast cancer, a multicenter proficiency-testing ring study was conducted in China.
methodsA total of ten samples, each exhibiting distinct HER2 signal patterns and genetic heterogeneity, were distributed to 169 laboratories for HER2 FISH analysis. Data comprising both the results of the tests and feedback from questionnaires were compiled for comprehensive evaluation.
resultsThe overall agreement among the participating laboratories was substantial to almost perfect, with a Fleiss' kappa value of 0.765-0.911. However, it is important to note that cases with characteristics of HER2 signals near the critical cutoff range or with genetic heterogeneity showed lower congruence, poorer reproducibility, and higher variability (Fleiss' kappa: 0.582). Our questionnaire showed that 52.2% (86/168) of the participants did not perform validation after their operation procedures or interpretation criteria were updated, and 75.6% (121/160) of the participants did not establish standard interpretation procedures. Since these laboratories showed worse performance (P < 0.05), the lack of validation and interpretation procedures was speculated to be the possible underlying cause.
conclusionsThis study presents the latest landscape of interlaboratory variability and accuracy of HER2 FISH testing in China and highlights potential causes for the variability. Despite many years of effort, the standardization of HER2 status determination still has a long way to go.
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