Leica TA9217 사용자 설명서

  

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Leica Biosystems  Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013

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-

fixed  paraffin-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%.

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-fixed paraffin-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%.

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 -fixed paraffin-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%.

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-fixed paraffin-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%.

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, reflecting 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%