Table 3. Comparison of local and central laboratory HER2 testing.
|
Central Lab, n |
||||||||
|---|---|---|---|---|---|---|---|---|
| Local Labs, n | IHC 0/1+, 584 | IHC 2+, 86 | IHC 3+, 51 | HER2 Pos, 78 | HER2 Neg, 643 | Agreement rate | Kappa values (95% CI) | |
| IHC 0/1+, 566 | 534 | 32 | 0 | - | - | 86.7% | 0.71 (0.65-0.77) | |
| IHC 2+, 91 | 47 | 42 | 2 | - | - | |||
| IHC 3+, 64 | 3 | 12 | 49 | - | - | |||
| HER2 POS, 86 | - | - | - | 72 | 14 | 97.2% | 0.86 (0.80-0.92) | |
| HER2 NEG, 635 | - | - | - | 6 | 629 | |||
IHC, immunohistochemistry; CI, confidence interval; HER2 POS, HER2-positive, defined as IHC 3+ or IHC 2+/ISH-amplified; HER2 NEG, HER2-negative.