Table 4.

Case-level agreement between automated scoring of central TMAs and clinical estrogen receptor (ER), progesterone receptor (PR), and HER2 status: impact of core cellularity and diameter

Clinical ER, PR, and HER2 status in the medical recorda
ERPRHER2
NegativePositiveTotalNegativePositiveTotal0/1+3+Total
Central TMA ER, PR, and HER2 statusa
Cellularity ≥ median
 Negative27134305Negative336323680/1+63924663
 Positive6509515Positive313764073+30104134
 Total277543820Total367408775Total669128797
 Agreement95%Agreement92%Agreement93%
 Kappa (95% CI)0.89 (0.86–0.93)Kappa (95% CI)0.84 (0.80–0.88)Kappa (95% CI)0.75 (0.69–0.82)
NegativePositiveTotalNegativePositiveTotal0/1+3+Total
Cellularity < median
 Negative15666222Negative229763050/1+66124685
 Positive9586595Positive434274703+3970109
 Total165652817Total272503775Total70094794
 Agreement91%Agreement85%Agreement92%
 Kappa (95% CI)0.75 (0.70–0.80)Kappa (95% CI)0.67 (0.62–0.73)Kappa (95% CI)0.64 (0.56–0.73)
NegativePositiveTotalNegativePositiveTotal0/1+3+Total
1.0 mm cores
 Negative35053403Negative470545240/1+93329962
 Positive9788797Positive596016603+45115160
 Total3598411,200Total5296551,184Total9781441,122
 Agreement95%Agreement90%Agreement93%
 Kappa (95% CI)0.88 (0.85–0.91)Kappa (95% CI)0.81 (0.77–0.84)Kappa (95% CI)0.72 (0.66–0.78)
NegativePositiveTotalNegativePositiveTotal0/1+3+Total
0.6 mm cores
 Negative7747124Negative95541490/1+36719386
 Positive6307313Positive152022173+245983
 Total83354437Total110256366Total39178469
 Agreement88%Agreement81%Agreement91%
 Kappa (95% CI)0.67 (0.59–0.75)Kappa (95% CI)0.59 (0.51–0.68)Kappa (95% CI)0.68 (0.59–0.77)
  • aUsing a 10% threshold to define ER and PR positivity for ER and PR analysis and excluding HER2 2+ cases from HER2 analyses.