Table 1

Concordance analysis between manual and automated HER2 FISH for HER2 amplification status
Parameter Manual HER2 FISH Automated HER2 FISH
0+ (n = 20) 1+ (n = 20) 2+ (n = 30) 3+ (n = 30) Total 0+ (n = 20) 1+ (n = 20) 2+ (n = 30) 3+ (n = 30) Total Concordance rate (%) Cohen’s kappa
HER2 amplification status (HER2/CEP17 ratio >2.2)
 Non-amplified (ratio < 1.8) 20 (100) 15 (75) 9 (30) 0 44 (44) 20 (100) 19 (95) 10 (33) 1 (3) 50 (50)
 Equivocal (ratio 1.8-2.2) 0 5 (25) 1 (3) 0 6 (6) 0 1 (5) 2 (7) 1 (3) 4 (4) 96 # 0.920 #
 Amplified (ratio > 2.2) 0 0 20 (67) 30 (100) 50 (50) 0 0 18 (60) 28 (93) 46 (46)
HER2 amplification status (HER2/CEP17 ratio >2.0)
 Non-amplified (ratio < 2.0) 20 (100) 18 (90) 9 (30) 0 47 (47) 20 (100) 20 (100) 10 (33) 1 (3) 51 (51) 96 0.920
 Amplified (ratio ≥ 2.0) 0 2 (10) 21 (70) 30 (100) 53 (53) 0 0 20 (67) 29 (97) 49 (49)
HER2 amplification status (Mean HER2 number >6.0
 Non-amplified (number <  6.0) 20 (100) 20 (100) 12 (40) 3 (10) 55 (55) 20 (100) 20 (100) 14 (47) 4 (13) 58 (58) 97 0.939
 Amplified (number >6.0) 0 0 18 (60) 27 (90) 45 (45) 0 0 16 (53) 26 (87) 42 (42)

# Concordance rate and Cohen’s kappa value refer to the evaluation of amplified versus non-amplified HER2 status. Equivocal HER2 status (HER2/CEP 17 ratio 1.8-2.2) was considered as non-amplified for the calculation of concordance rate and Cohen’s kappa value.

Öhlschlegel et al.

Öhlschlegel et al. BMC Clinical Pathology 2013 13:13   doi:10.1186/1472-6890-13-13

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