Leica TA9217 사용자 설명서

  

Page 5 of 24

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

The Leica HER2 FISH System - 30 Test is for use only on the Leica BOND-MAX and BOND-III 

System.

The materials listed below (Table 1) are sufficient to stain 30 tests (30 slides stained with LSI 

HER2/CEP17 Dual Probe).

Contains ready-to-use LSI HER2/CEP17 Dual Probe.
Contains <60% (v/v) formamide.

Contains ready-to-use post hybridization wash solution.
Contains <50% (v/v) formamide.

Contains Proteinase K solution at 1.7 mg/mL.

Contains Enzyme Diluent.

BOND Open Container used for Enzyme 5.

Refer to individual MSDS for further product safety information, available from  

www.LeicaBiosystems.com/TA9217-IFU

All reagents supplied are formulated specifically for use with this assay and lot numbers are 

specific for each Leica HER2 FISH System - 30 Test. For the assay to be valid, no substitutions 

should be made.

Store at 2–8 °C. Do not freeze. Return to 2–8 °C immediately after use. Any deviation from these 

conditions will invalidate the assay. Ensure the Leica HER2 FISH System - 30 Test is used within 

its designated expiry date. The signs indicating contamination and/or instability of the Leica 

HER2 FISH System - 30 Test are turbidity of the solutions (except for the probe solution) and 

odor development. The user must verify storage conditions other than those specified above.

Standard methods of tissue processing should be used for all specimens (19). It is recommended 

that tissues are prepared in formalin-based fixatives and are routinely processed and paraffin-

embedded. For example, specimens should be sampled at a thickness of 3–4 mm and fixed 

for 18–24 hours in 10% neutral-buffered formalin. The tissues should then be dehydrated in a 

series of alcohols and cleared through xylene, followed by impregnation with molten paraffin 

wax, held at no more than 60 °C. Tissue specimens should be sectioned between 4–6 µm.