Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 20)

English
Page 20 of 23
English
Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
were blinded and randomized at each site prior to scoring. Inter observer agreement between
the two independent clinical sites, Site B and Site C, was 87.5% (95% CI = 73.3% to 95.8%).
The agreement between Site B and Site C and Leica Biosystems Newcastle, Ltd was 92.5%
(95% CI = 79.6% to 98.4%) and 85% (95% CI = 70.1% to 94.29%) respectively. The analysis
of total concurrence between the three observers (A, B, C) is 82.50%.
F. Between Instrument Precision (BOND-MAX v BOND-III)
Between instrument precision testing using the Bond Oracle HER2 IHC System was
performed at a single independent European investigational site. The samples tested were
obtained from formalin-fixed, paraffin-embedded whole sections from ninety-nine invasive
breast cancer cases (needle core and resection specimens). Testing between instruments
was performed prospectively within the investigational site, staining consecutive sections on
the BOND-MAX and BOND-III platforms. Three cases were considered unsuitable due to
sample/tumor availability removed from the study.
Identical lot numbers of Bond Oracle HER2 IHC System and BOND Instrument ancillary
reagents were used across each instrument. Sections were stained prospectively over the
course of a 4-month period, with a maximum staining window of 5 days between staining
across both platforms to preserve antigenicity. Slides were interpreted at the investigational
site by a single experienced observer to determine between instrument precision.
An evaluation of the slides from between instrument precision showed a 2x2 concordance
between positive (2+, 3+) and negative (0, 1+) of 98.96% (95/96) with a 95% CI of 93.77 to
99.99% and a 3x3 concordance between positive (3+), equivocal (2+) and negative (0, 1+)
concordance of 96.88% (93/96) with a 95% CI of 90.83 to 99.32%.
BOND-MAX
Negative (0/1+) Positive (2/3+) Totals
BOND-III
Negative (0/1+)
72 0 72
Positive (2/3+)
1 23 24
Totals
73 23 96
Overall Concordance (95% CI) = 98.96% (93.77 to 99.99%)
Table 10. 2x2 concordance of Bond Oracle HER2 IHC System staining on BOND-MAX v BOND-III platforms.
BOND-MAX
Negative (0/1+) Equivocal (2+) Positive (3+) Totals
BOND-III
Negative (0/1+)
72 0 0 72
Equivocal (2+)
1 13 0 14
Positive (3+)
0 0 10 10
Totals
73 13 10 96
Overall Concordance (95% CI) = 98.96% (93.77 to 99.99%)
Table 11. 3x3 concordance of Bond Oracle HER2 IHC System staining on BOND-MAX v BOND-III platforms.
In conclusion, the data generated in this study demonstrates a high level of concordance
between the Leica Biosystems’ BOND-MAX and BOND-III Systems when evaluated using
the Bond Oracle HER2 IHC System.