Table 3.

Case-level agreement between automated scoring of central tissue microarrays and clinical HER2 status: impact of core-to-case collapsing method

Clinical HER2 status in the medical record
NegativePositiveTotal
Central TMA HER2 status
Weighted core-to-case collapsing methoda
 Negative1,312531,365
 Positive31163194
 Total1,3432161,559
 Agreement95%
 Kappa (95% CI)0.76 (0.72–0.81)
NegativePositiveTotal
Any positive core-to-case collapsing methodb
 Negative1,181371,218
 Positive67173240
 Total1,2482101,458
 Agreement93%
 Kappa (95% CI)0.73 (0.68–0.78)
NegativePositiveTotal
Hybrid core-to-case collapsing methodc
 Negative1,300481,348
 Positive69174243
 Total1,3692221,591
 Agreement93%
 Kappa (95% CI)0.71 (0.66–0.76)
  • aWeighted method: Case level positivity is weighted by the tumor cellularity of each contributing core.

  • bAny positive method: Case is positive if any core is positive.

  • cHybrid method: Case is positive if classified as positive by either the weighted or any positive method.

  • an = 106 (6%), bn = 207 (12%), and cn = 74 (4%) cases with equivocal (2+) central HER2 status.

    n = 50 (3%) cases with equivocal (2+) clinical HER2 status in the medical record.