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

Unexpected FISH staining, or variations in the staining, may be a result of alterations in the 

expression levels of the encoding genes. Any change in expected staining patterns should be 

interpreted in association with all other diagnostic investigations. Staining interpretation should 

be complemented by morphological studies and the use of suitable control material, and should 

be evaluated within the context of the patient’s clinical history and any other diagnostic tests, by 

a qualified pathologist.
The performance of the assay (i.e. assessment of adequacy of control materials) and the 

interpretation of any staining or its absence must be carried out in an appropriately accredited/

licensed laboratory under the supervision of a suitably qualified and experienced pathologist, 

who is responsible for the overall assessment of the in situ hybridization assay and its 

interpretation. False positive results in FISH may be due to cross-reactivity of the probe to other 

nucleic acid sequences and/or nonspecific binding. Appropriate controls must be employed and 

documented, and tests should take into account all relevant expiration dates.
Technical and interpretational variation may also be seen when FISH is utilized on cell line 

derived materials (23).

This product is not designed for use in any other DNA-based diagnostic assay. 
Do not replace Leica HER2 FISH System - 30 Test reagents with any other components either 

supplied by Leica Biosystems or by other manufacturers. To do so will invalidate the assay. The 

user must validate any deviation from the recommended procedures.
It is recommended that tissues fixed only in formalin-based fixatives be used in the assay. The 

use of any other type of fixative may invalidate the assay.
Tissue sections cut outside of the recommended thickness range have not been validated.  The 

use of any other section thickness may invalidate the assay.

This study examined the suitability of the Leica HER2 FISH System - 30 Test for use as an aid 

in determination of treatment for Herceptin (trastuzumab) therapy. The study was designed to 

examine the concordance between the Leica HER2 FISH System - 30 Test and a previously 

approved diagnostic device, the Abbott Molecular PathVysion HER-2 DNA Probe Kit, considered 

as the ‘gold standard’ for this assay. The acceptance criterion for testing was that the lower limit 

of the 95% one-sided confidence interval is above 90% between the Leica HER2 FISH System 

- 30 Test and the manual Abbott Molecular PathVysion HER-2 DNA Probe Kit, between positive 

(amplified)  and  negative  (non-amplified)  formalin-fixed,  paraffin-embedded  (FFPE)  invasive 

breast cancer cases.
The  study  was  conducted  as  a  three-site,  masked  evaluation  of  clinical  invasive  breast  

carcinoma samples. Each of the investigational sites were supplied with archived formalin-fixed, 

paraffin-embedded  invasive  breast  carcinoma  tissue  blocks  with  known  HER2  oncoprotein 

expression levels. A cohort of 300 specimens consisting of 75, 0/1+ previously characterized 

IHC cases; 150, 2+ previously characterised IHC cases; and 75, 3+ previously characterized 

IHC cases were selected, and split equally across each of the three investigational trial sites.
All cases were stained with the manual Abbott Molecular PathVysion HER-2 DNA Probe Kit 

Assay according to the manufacturer’s instructions for use, as specified in the package insert. 

Sequential sections from each case were then stained with the Leica HER2 FISH System - 30 

Test on the Leica BOND-MAX and BOND-III System. 
All stained slides were masked and scored in a randomized fashion by a single trained 

observer at each of the three investigational trial sites. Scores were interpreted as negative 

with a calculated HER2/CEP17 gene ratio of <2.0 and positive with a calculated HER2/CEP17 

gene ratio of ≥2.0. Data was then analyzed for concordance, positive staining agreement and 

negative staining agreement.