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Table 6 Gene-protein BISH (comparator) vs. single 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 BISH

 

Gene-protein BISH

Amplified

Non-amplified

Total

Reader A

Amplified

43

2

45

 

Non-amplified

2

118

120

 

Total

45

120

165

 

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

43/45 (95.6) (85.2–98.8)

  
 

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

118/120 (98.3) (94.1–99.5)

  
 

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

161/165 (97.6) (93.9–99.1)

  
 

Kappa coefficient (95% CI)

0.94 (0.88–1.00)

  

Reader B

Amplified

47

1

48

 

Non-amplified

3

121

124

 

Total

50

122

172

 

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

47/50 (94.0) (83.8–97.9)

  
 

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

121/122 (99.2) (95.5–99.9)

  
 

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

168/172 (97.7) (94.2–99.1)

  
 

Kappa coefficient (95% CI)

0.94 (0.89–1.00)

  

Reader C

Amplified

41

5

46

 

Non-amplified

2

125

127

 

Total

43

130

173

 

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

41/43 (95.3) (84.5–98.7)

  
 

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

125/130 (96.2) (91.3–98.3)

  
 

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

166/173 (96.0) (91.9–98.0)

  
 

Kappa coefficient (95% CI)

0.89 (0.82–0.97)

  
  1. BISH: brightfield in situ hybridization; PPA: positive percent agreement; NPA: negative percent agreement; OPA: overall percent agreement.