Table 3.

HER-2 status determined by immunohistochemistry or FISH done in outside laboratories compared with HER-2 status determined in the BCIRG central laboratory by FISH

AssayNo. positive/negativeSensitivity (95% CI)Specificity (95% CI)κ (95% CI)Accuracy (95% CI)
All immunohistochemistry (n = 1,457)637/820369/405 = 0.91 (0.88-0.94)784/1,052 = 0.75 (0.72-0.77)0.56 (0.52-0.60)0.79 (0.77-0.81)
DAKO (n = 862)396/466232/251 = 0.92 (0.88-0.95)447/611 = 0.73 (0.69-0.77)0.56 (0.51-0.61)0.79 (0.76-0.81)
Ventana (n = 153)65/8834/36 = 0.94 (0.81-0.99)86/117 = 0.74 (0.65-0.81)0.53 (0.40-0.66)0.78 (0.71-0.85)
T250 and CB11 (n = 23)8/155/5 = 1.0 (0.48-1.0)15/18 = 0.83 (0.59-0.96)0.68 (0.37-1.00)0.87 (0.66-0.97)
T250 (n = 37)9/285/7 = 0.71 (0.29-0.96)26/30 = 0.87 (0.69-0.96)0.52 (0.19-0.85)0.84 (0.68-0.94)
CB11 (n = 63)25/3818/19 = 0.95 (0.74-1.0)37/44 = 0.84 (0.70-0.93)0.72 (0.55-0.90)0.87 (0.77-0.94)
FISH (n = 131)50/8141/42 = 0.98 (0.87-1.0)80/89 = 0.90 (0.82-0.95)0.83 (0.73-0.93)0.92 (0.86-0.96)