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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
English
Precision Testing – Leica BOND-MAX System
A. Within Run Precision Study
The within run precision study was performed in a randomized and blinded fashion. Within
run precision testing of the Leica HER2 FISH System - 30 Test was evaluated at a single
investigational site on 540 previously HER2 characterized TMA samples containing formalin-
xed parafn-embedded breast cancer cases. The use of TMAs for the determination of
within run precision enabled a larger volume of cases covering a wider range of HER2
expression within a single run on a single instrument.
On enumeration of the slides stained in the Within Run Precision Study, 532/540 cases
evaluated demonstrated a concordant result giving an overall concordance of 98.52% with
a lower 95% CI of 97.10%.
B. Within Instrument Precision Study
The within instrument precision study was performed in a randomized and blinded fashion.
Within instrument precision testing of the Leica HER2 FISH System - 30 Test was evaluated
at a single investigational site on 1620 previously HER2 characterized TMA samples
containing formalin-xed parafn-embedded breast cancer cases. The use of TMAs for the
determination of within instrument precision enabled a larger volume of cases covering a
wider range of HER2 expression within multiple runs on a single instrument.
On enumeration of the slides stained in the Within Instrument Precision Study, 1620/1620
cases evaluated demonstrated a concordant result giving an overall concordance of 100%
with a lower 95% CI of 99.82%.
C. Between Run Precision Study
The between run precision study was performed in a randomized and blinded fashion.
Between run precision testing of the Leica HER2 FISH System - 30 Test was evaluated
at a single investigational site on 900 previously HER2 characterized TMA samples
containing formalin -xed parafn-embedded breast cancer cases. The use of TMAs for the
determination of between run, day-to-day precision testing enabled a larger volume of cases
covering a wider range of HER2 expression to be tested between runs on different days.
On enumeration of the slides stained in the Between Run Precision Study, 894/900 cases
evaluated demonstrated a concordant result giving an overall concordance of 99.33% with
a lower 95% CI of 98.55%.
D. Between Laboratory Precision Study
The between laboratory precision study was performed in a randomized and blinded
fashion. Between laboratory precision testing of the Leica HER2 FISH System - 30 Test
was evaluated between three investigational sites on 513 previously HER2 characterized
TMA samples containing formalin-xed parafn-embedded breast cancer cases. The use of
TMAs for the determination of between laboratory precision testing enabled a larger volume
of cases covering a wider range of HER2 expression to be tested between runs on multiple
instruments.
On enumeration of the slides stained in the Between Laboratory Precision Study, 510/513
cases evaluated demonstrated a concordant result giving an overall concordance of 99.42%
with a lower 95% CI of 98.30%.
E. Between Observer Precision Study
The between observer precision study was performed in a randomized and blinded fashion.
Between observer reproducibility testing of the Leica HER2 FISH System - 30 Test was
evaluated between three investigational sites. A single experienced observer at each
investigational site was used. Eighteen whole section breast cancer cases were used for
between observer precision, reecting samples types used in the clinical setting.
On enumeration of the slides stained in the Between Observer Precision Study, 53/54 cases
evaluated demonstrated a concordant result giving an overall concordance of 98.15% with
a lower 95% CI of 90.11%