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Run 33 (General module) was
accomplished September to December 2011. 188 laboratories participated, a
total of 824 slides were assessed, and the corresponding protocols
analyzed. The overall distribution of marks were: optimal 30%, good
26%, borderline 13%, and poor 10%. A short
summary of the tests is given below. Click on the epitope name to
see the complete general assessment results for each marker.
CDX2:
Only 51% sufficient stains! The major reasons for insufficient stain
were too low concentration of the primary
antibody, less successful performance of the mAb clones CDX2-88 and
AMT28 in general, and of the mAb clone DAK-CDX2 on the
Ventana BenchMark platform.
CR (calretinin):
76% sufficient stains. The major reasons
for insufficient stains were too low concentration of the primary antibody,
less successful performance of the mAb clone DAK-Calret 1 on the
Ventana BenchMark platform and use of low sensitive detection systems.
CyD1 (cyclin
D1): 90% sufficient stains. For this marker, considerable
improvement has occurred during 4 runs from 2003 to 2011, most
because of the increasing use of rmAb SP4. The old clones DCS6 and
P2D11F11 are not good and should be pruned.
CK-LMW
(cytokeratin, low molecular weight): Only 64% sufficient stains,
in spite of this marker being tested four times before, the major
reasons for insufficient stains were use the poor clone 35ßH11, the
problematic clone CAM5.2, and use of inappropriate protocols (e.g.,
proteolysis where HIER is needed).
TTF-1
(thyroid transcription factor-1): Only 60% sufficient stains,
the major reason for the low pass rate being the use of clone
8G7G3/1, which never gave optimal marks, due to a false negative
staining of the lung carcinoid.
Run B12 (Breast cancer module)
was accomplished in parallel with run 33. There were 228 laboratories
participating.
HER-2 IHC: 78% of the stains were sufficient. The
Pathway/Confirm system (Ventana) gave a close to 100% pass rate
while the Herceptest (Dako) and Oracle (Leica) a slightly lower pass
rate. The major reason for insufficient stains is still the use of
in-house protocols, which fails in about half of all cases!
PR (progesteron):
68% of the stains were sufficient. The major reasons for insufficient stains
were inappropriate protocol settings: Labs that use an efficient
HIER in an alkaline buffer and a sensitive visualization system
performed much better than labs using a citrate buffer and a less
sensitive visualization system.
HER-2
BRISH: 83% of the
71 stains submitted were assessed as
sufficient in this fifth NordiQC test of HER-2 BRISH.
The retrieval settings – HIER + proteolysis –
should be carefully balanced between high sensitivity and preserved
morphology. Attention should also be addressed to the interpretation.
Among labs obtaining a sufficient result, the scoring
consensus (i.e., concordance of participant score vs.
assessor group score in all the breast
carcinomas included) was only 20 %! Run G2 (Gastric cancer pilot module)
HER-2 IHC:
In this second run of the Gastric cancer pilot module, accomplished
in parallel with run 33, 51 labs participated, and 96 % of the stains were sufficient.
There were no
significant difference in the performance between labs using in-house protocols
and CE-IVD approved systems.
Among labs obtaining a sufficient result,
the scoring consensus was only 57%, emphasizing the
need for training.
The 2012 modules Most laboratories participating in the
Breast cancer module has not been able to
exploit the ISH part. NordiQC has
therefore decided to split the Breast cancer module into two:
Breast cancer IHC module and HER-2 ISH module. Removing
ISH from the Breast cancer (IHC) module allows for an extra IHC
marker in each run. In the new HER-2 ISH module laboratories not
using BRISH can do
FISH and report their scores (as external assessment of FISH slides is not
possible). NordiQC has also decided not to implement the Gastric cancer
IHC module in
scheme 2012. This is because of the very high pass rate (compared to
that of HER-2 IHC in the Breast cancer module) in part due to the
scoring system, which refers a high proportion of cases to be
confirmed by ISH. Aalborg 7th December 2011
Updated 15th December 2011
Mogens Vyberg
Scheme director |
