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Table 5 Gene-protein IHC (comparator) vs. single IHC (reference) agreement analyses

From: A gene-protein assay for human epidermal growth factor receptor 2 (HER2): brightfield tricolor visualization of HER2 protein, the HER2 gene, and chromosome 17 centromere (CEN17) in formalin-fixed, paraffin-embedded breast cancer tissue sections

Single IHC

 

Gene-protein IHC

Positive

Negative

Total

Reader A

Positive

50

2

52

 

Negative

0

131

131

 

Total

50

133

183

 

PPA: n/N (%) (95% CI)

50/50 (100.0) (92.9–100.0)

  
 

NPA: n/N (%) (95% CI)

131/133 (98.5) (94.7–99.6)

  
 

OPA: n/N (%) (95% CI)

181/183 (98.9) (96.1–99.7)

  
 

Kappa coefficient (95% CI)

0.97 (0.94–1.00)

  

Reader B

Positive

47

3

50

 

Negative

1

132

133

 

Total

48

135

183

 

PPA: n/N (%) (95% CI)

47/48 (97.9) (89.1–99.6)

  
 

NPA: n/N (%) (95% CI)

132/135 (97.8) (93.7–99.2)

  
 

OPA: n/N (%) (95% CI)

179/183 (97.8) (94.5–99.1)

  
 

Kappa coefficient (95% CI)

0.94 (0.89–1.00)

  

Reader C

Positive

54

1

55

 

Negative

0

128

128

 

Total

54

129

183

 

PPA: n/N (%) (95% CI)

54/54 (100.0) (93.4–100.0)

  
 

NPA: n/N (%) (95% CI)

128/129 (99.2) (95.7–99.9)

  
 

OPA: n/N (%) (95% CI)

182/183 (99.5) (97.0–99.9)

  
 

Kappa coefficient (95% CI)

0.99 (0.96–1.00)

  
  1. IHC: immunohistochemistry; PPA: positive percent agreement; NPA: negative percent agreement; OPA: overall percent agreement.