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Aims  We aimed to compare digital image analysis ( DIA ) of human epidermal growth factor receptor 2 ( HER 2) immunohistochemistry ( IHC ) in breast cancer by two platforms: (i) to validate  DIA  against standard diagnostics; and (ii) to evaluate the added value of  DIA  in clinical practice.    Methods and results   HER 2  IHC  and  in‐situ  hybridisation ( ISH ) were performed on 152 consecutive invasive breast carcinomas.  IHC  scores were determined with  DIA  using two independent platforms. Manual scoring was performed by two independent observers.  HER 2 status was considered positive in 3+ and  ISH ‐positive 2+ cases.  HER 2 status using  DIA  was compared to  HER 2 status with standard diagnostics (manual scoring with  ISH  in 2+ cases). Interplatform agreement of  IHC  scores was ‘moderate’ (linear weighted κ = 0.58), agreement between manual scoring and platform A was ‘moderate’ (κ = 0.60) and between manual scoring and platform B ‘almost perfect’ (κ = 0.85). Compared to manual scoring,  DIA  resulted in a reduction of 2+ cases from 17.1 to 1.3% with platform A and from 17.1 to 15.8% with platform B. However, compared to standard diagnostics, there were three false‐negative cases with  DIA  using platform A [81.3% sensitivity, 100% specificity, 100% positive predictive value ( PPV ), 97.8% negative predictive value ( NPV )]. Sensitivity, specificity,  PPV  and  NPV  were 100% with  DIA  using platform B.    Conclusions   DIA  of  HER 2  IHC  is a valid tool in determining  HER 2 status in breast carcinoma. Algorithms in different platforms can behave differently, and optimal calibration is essential. In clinical practice,  DIA  offers an objective alternative to manual scoring, but a reduction in 2+ cases could result in loss of sensitivity.

histopathology

What is the added value of digital image analysis of  HER 2 immunohistochemistry in breast cancer in clinical practice? A study with multiple platforms