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Table 7 Gene-protein IHC/BISH (comparator) vs. single IHC/BISH (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/BISH assay

 

Gene-protein IHC/BISH

Positive

Negative

Total

Reader A

Positive

50

2

52

 

Negative

1

112

113

 

Total

51

114

165

 

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

50/51 (98.0) (89.7–99.7)

  
 

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

112/114 (98.2) (93.8–99.5)

  
 

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

162/165 (98.2) (94.8–99.4)

  
 

Kappa coefficient (95% CI)

0.96 (0.91–1.00)

  

Reader B

Positive

50

2

52

 

Negative

3

117

120

 

Total

53

119

172

 

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

50/53 (94.3) (84.6–98.1)

  
 

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

117/119 (98.3) (94.1–99.5)

  
 

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

167/172 (97.1) (93.4–98.8)

  
 

Kappa coefficient (95% CI)

0.93 (0.87–0.99)

  

Reader C

Positive

52

3

55

 

Negative

2

116

118

 

Total

54

119

173

 

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

52/54 (96.3) (87.5–99.0)

  
 

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

116/119 (97.5) (92.8–99.1)

  
 

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

168/173 (97.1) (93.4–98.8)

  
 

Kappa coefficient (95% CI)

0.93 (0.88–0.99)

  
  1. IHC: immunohistochemistry; BISH: brightfield in situ hybridization; PPA: positive percent agreement; NPA: negative percent agreement; OPA: overall percent agreement.
  2. Note: IHC/BISH status: positive = IHC is positive or BISH is amplified; negative = IHC is negative and BISH is non-amplified.