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 characteristic morphology of the tissue and the spatial distribution of oncogene copies in 

individual uncultured primary breast carcinomas are retained. Aberrations in chromosome 17 

copy number (aneusomy) are also commonly found in breast tumors. These may present as 

chromosome deletions or gains (polysomy). This chromosomal variation has critical impact on 

the interpretation and reporting of HER2 gene amplification status. Therefore, measurement of 

chromosome 17 copy number in conjunction with HER2 is critically important (4).
The Leica HER2 FISH System - 30 Test contains the LSI HER2 DNA probe, a 226 Kb 

SpectrumOrange

™

 directly labeled fluorescent DNA probe specific for the HER2 gene 

locus (17q11.2-q12) and the CEP17 DNA probe, a 5.4 Kb SpectrumGreen

™

 directly labeled 

fluorescent DNA probe specific for the alpha satellite DNA sequence at the centromeric region 

of chromosome 17 (17p11.1-q11.1). The probe solution has been specially formulated and 

validated for use on the Leica BOND-MAX and BOND-III System and should not be modified 

or used in a manual setting.

The Leica HER2 FISH System - 30 Test was developed to provide a fully automated alternative 

to current methodologies used to determine HER2 gene amplification status. The performance 

of the Leica HER2 FISH System - 30 Test on the Leica BOND-MAX System was evaluated in an 

independent study comparing the results of the Leica HER2 FISH System - 30 Test to the Abbott 

Molecular PathVysion

 

HER-2 DNA Probe Kit Assay on 300 breast tumor specimens. None of 

these tumor specimens were obtained from patients in the Herceptin clinical studies. The results 

indicated a 99.33% concordance in a 2x2 analysis (95% confidence intervals of 97.61–99.92%). 

The concordance data also indicates that a positive result with the Leica HER2 FISH System - 

30 Test is highly likely to correspond with a positive result on the Abbott Molecular PathVysion 

HER-2 DNA Probe Kit assay. The Leica HER2 FISH System - 30 Test is interpreted as negative 

for HER2 gene amplification when the HER2:CEP17 gene ratio is less than 2.0 and positive 

when the HER2:CEP17 gene ratio is greater than or equal to 2.0. Equivocal (borderline) results, 

where the HER2:CEP17 gene ratio is between or equal to 1.8-2.2, should be interpreted with 

caution. Count an additional 20 nuclei and recalculate the ratio.

The Leica HER2 FISH System - 30 Test was developed to provide a fully automated alternative 

to current methodologies used to determine HER2 gene amplification status. The performance 

of the Leica HER2 FISH System - 30 Test on the Leica BOND-III System was evaluated in an 

independent study comparing the results of the Leica HER2 FISH System - 30 Test to the Abbott 

Molecular PathVysion HER-2 DNA Probe Kit Assay on 300 breast tumor specimens. None of 

these tumor specimens were obtained from patients in the Herceptin clinical studies. The results 

indicated a 99.67% concordance in a 2x2 analysis (95% confidence intervals of 98.16–99.99%). 

The concordance data also indicates that a positive result with the Leica HER2 FISH System - 

30 Test is highly likely to correspond with a positive result on the Abbott Molecular PathVysion 

HER-2 DNA Probe Kit assay. The Leica HER2 FISH System - 30 Test is interpreted as negative 

for HER2 gene amplification  when the HER2:CEP17 gene ratio is less than 2.0 and positive 

when the HER2:CEP17 gene ratio is greater than or equal to 2.0. Equivocal (borderline) results, 

where the HER2:CEP17 gene ratio is between or equal to 1.8-2.2, should be interpreted with 

caution. Count an additional 20 nuclei and recalculate the ratio.

The Leica HER2 FISH System - 30 Test contains components required to complete a fluorescence 

in situ  hybridization  based  staining  procedure  for  formalin-fixed,  paraffin-embedded  tissues. 

Following appropriate pretreatment, incubation with the ready-to-use LSI HER2/CEP17 Dual 

Probe and appropriate stringency washing, tissue sections are then dehydrated and mounted 

with DAPI. Results are interpreted by fluorescence microscopy using the recommended filters 

at the appropriate wavelengths.