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Table 1.

Characteristics tested tissue specimens of patients with invasive breast cancer with Leica HER2 FISH.

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Fig 1.

The design of the D-Sight HER2 FISH analysis module (software version 2012 2.1.2).

“Pictures”: at least 4 areas of interest are selected for analysis and pictures are taken automatically. Captured images from different focus planes are combined generating a picture with all signals clearly detectable after removal of unspecific background. “Objectives and tools”: automated nucleus selection and spot counting of the red (HER2) and the green (chromosoom 17 = CEP17) signal is evaluated and corrected by the observer if needed. “Analysis”: supervised-automated scoring is performed on at least two pictures and the ratio between HER2 and CEP17 was generated.

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Table 2.

Comparisons of automated Leica HER2 FISH with digital analysis and manual Abbott HER2 FISH with manual analysis in 20 full-sized slides of tissue specimens used for TMA blocks of invasive breast cancer.

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Table 3.

Comparisons of automated Leica HER2 FISH with digital analysis and manual Abbott HER2 FISH with manual analysis in tissue micro arrays (TMAs) including 328 invasive breast cancer tissue specimens.

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Fig 2.

The appearance of Leica FISH HER2 staining.

Representative pictures of HER2 non-amplified invasive breast cancer specimens are shown in A) with a HER2 (red signals) to chromosoom 17 (= CEP17; green signals) ratio <2 and C) with supervised-automated nuclei and spot detection. Examples of HER2 amplified invasive breast cancer specimens are depicted in B) with a HER2/CEP17 ratio >2 and D) with supervised-automated nucleus and spot detection. DAPI counterstaining and original magnification with 100x objective.

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Table 4.

Comparisons of automated Leica HER2 FISH with digital analysis and manual Abbott HER2 FISH with manual analysis of 50 invasive breast cancer tissue specimens (resection / biopsy) with IHC 2+ scores.

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Table 5.

Comparisons of Leica HER2 FISH and DAKO HER2 IHC of 50 consecutively collected invasive breast cancer tissue specimens (resection / biopsy) from routine practice.

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