Runs 37, B15 and H3
were accomplished January to April 2013. About 300 laboratories
participated in one or more modules.
A very short summary of the tests is given below. Click on the
epitope name to see the complete general assessment results for each
marker, including recommendations for clone selection, epitope
retrieval and control tissues.
37 (General module)
219 labs participated. 92% of the stains were sufficient, 66% optimal.
Many clones can be used, and especially the Ready-To-Use systems
from Dako, Leica and Ventana gave a high proportion of optimal results. HIER is mandatory.
205 labs participated. 82% of the stains were sufficient but only
56% optimal. Correct selection of control tissue (liver) and
identification of the critical stain quality indicator in the
control tissue (Kupffer cells) is the basis for optimization. Efficient HIER
196 labs participated. 81% of the stains were sufficient but only
Too low concentration of the primary antibody and less successful performance of the mAb clones 123C3 and 123C3.D5
on the Ventana BenchMark platform are the main reasons for
suboptimal results. Ventana users should change to rmAb clone
Carcinoembryonic antigen (CEA): 190 labs participated. Only
59% of the stains were sufficient and only 20% optimal.
mAb clones TF3H8-1 and 12-140-10 constantly give insufficient
results and should be discarded. mAb clone II-7does not work
properly on the Ventana platform, Ventana used should change to
mAb clones CEA31 or COL-1. A further 20 labs submitted stains
using inappropriate polyclonal Abs, which should not be used for
CEA due to heavy cross reaction with other CEA-like proteins.
102 labs participated. Only 58% of the stains were sufficient
and only 19% optimal.
Too dilute Abs, inefficient HIER, and use of the poor clone SY38
are the main reasons for suboptimal stains. mAb clone 27G12
which works well with mots systems perform poorly on the Ventana
platform. Ventana users should change to rmAb clones MRQ-40 or
Run B15 (Breast
cancer IHC module)
Estrogen receptor (ER): 241 laboratories participated, 85 %
were sufficient but only 58% optimal. Main reason for suboptimal
staining is as usual too dilute Ab and insufficient HIER. Clone
6F11 gave a positive staining reaction in one of the cores found
negative with all other Abs. The reason for this is stil under
272 laboratories participated in this assessment.
90 % achieved a sufficient mark. The performance of FDA approved
kits is consistently better than tha tof in-house validated
Run H3 (HER-2 ISH module)
102 labs participated with BRISH and 30 with FISH. 81% of the
BRISH stains were sufficient. Inappropriate epitope retrieval
was the major cause of suboptimal reactions. Scoring consensus
was slightly higher for FISH than for BRISH due to one of the
non-amplified carcinoma cores scored as amplified by 12/90 labs
16th April 2013