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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
F. Lot-to-Lot Precision Study
The lot-to-lot precision study was performed in a randomized and blinded fashion. Lot-to-Lot
precision was determined on three independently manufactured lots of the Leica HER2 FISH
System - 30 Test, manufactured under Good Manufacturing Practice (GMP). Each lot was
tested 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 lot-to-lot reproducibility enables a larger volume of cases covering a wider
range of HER2 expression to be tested between lots.
On enumeration of the slides stained in the Lot-to-Lot Precision Study, 534/540 cases
evaluated demonstrated a concordant result giving an overall concordance of 98.89% with
a lower 95% CI of 97.60%.
Precision Testing – Leica BOND-III System
G. 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, 540/540 cases
evaluated demonstrated a concordant result giving an overall concordance of 100% with a
lower 95% CI of 99.45%.
H. 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 Run Precision Study, 1620/1620 cases
evaluated demonstrated a concordant result giving an overall concordance of 100% with a
lower 95% CI of 99.82%.
I. 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, 891/900 cases
evaluated demonstrated a concordant result giving an overall concordance of 99.00% with
a lower 95% CI of 98.11%.
J. 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, 511/513
cases evaluated demonstrated a concordant result giving an overall concordance of 99.61%
with a lower 95% CI of 98.60%.