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) | ||