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Table 2 Concordance between PathVysion and other HER2-testing protocols

From: Comparison of different commercial kits for HER2 testing in breast cancer: looking for the accurate cutoff for amplification

Comparison with PathVysion

κ coefficient*

Degree of agreement

Agreement (percentage)

Sensitivity (percentage)

Specificity (percentage)

PharmDx

1.000

Excellent

100

100

100

INFORM (at least six signals per nucleus)

0.916 ± 0.058

Excellent

98

100

94

INFORM (at least five signals per nucleus)

0.799 ± 0.085

Good

91

100

88

INFORM (more than four signals per nucleus)

0.532 ± 0.111

Moderate

76

100

57

CISH (at least six signals per nucleus)

0.876 ± 0.070

Excellent

94

100

94

CISH (at least five signals per nucleus)

0.762 ± 0.091

Good

89

100

88

In-house IHC (positive 3+, negative 0, 1+, 2+)

0.792 ± 0.089

Good

91

89

91

In-house IHC (positive 3+, 2+, negative 0, 1+)

0.475 ± 0.111

Moderate

72

100

57

HercepTest (positive 3+, negative 0, 1+, 2+)

0.645 ± 0.104

Good

83

89

80

HercepTest (positive 3+, 2+, negative 0, 1+)

0.350 ± 0.119

Poor

64

94

49

  1. HER2, human epidermal growth factor receptor 2; CISH, chromogenic in situ hybridisation; IHC, immunohistochemistry. (* errors given as ± SD)