|
 The
slide to be analysed for HER-2
amplification was identical with the one for HER-2 IHC comprising:
|
|
HER-2 protein status* |
HER-2 gene status* |
|
1. Cell line
JIMT-1 |
2+ |
Amplified (7,0 -
11,0) |
|
2. Cell line
MDA-453 |
2+ |
Amplified (2,2 -
3,1)** |
|
3. Cell line
MCF-7 |
1+ |
Non-amplified (0,8 - 1,3) |
|
4. Cell line
BT474 |
3+ |
Amplified (4,0 -
9,7) |
|
5. Breast
ductal carcinoma |
0 |
Non-amplified (1,0 - 1,2)*** |
|
6. Breast
ductal carcinoma |
1+ |
Non-amplified (1,1 - 1,4) |
|
7. Breast
ductal carcinoma |
3+ |
Amplified (5,5 -
13,8) |
|
8. Breast
ductal carcinoma |
3+ |
Amplified (3,6 -
8,5) |
* as defined in four reference
laboratories.
** Most labs. found amplification
suggesting a mix-up, the specimen was excluded.
*** In most slides carcinoma in situ
dominated, the specimen was excluded.
28 laboratories participated in the assessment.
21 submitted FISH and 7 CISH stains. As shown in Fig. 1 (data only
available for 17), when only
looking at the scoring amplified v. non-amplified, the there were
two false positives in cell line MCF-7, one borderline in cell line
BT474 and one false negative in carcinoma no. 8. In total, 97 of 102
scores were concordant (95%). In reading CISH in 40
assays available from the 7 labs., 38 were concordant (95%).
The laboratories participating submitted their
protocols. However, it became clear that an analysis of the
protocols and comparison with the staining results were not feasible
in the current setting, and future HER-2 FISH should probably be
based on the participants own reading.
Conclusion
Even though the
material is rather small and technical problems partly hampered the
analysis, it appears that both FISH and CISH give high
concordance rates. |
