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Results - module 48, B22, H10 available

Runs 48/B22/H10 were accomplished from September to December 2016. A very short summary of the technical test results is given below. Click on the epitope name to see the complete general assessment results for each marker, including recommended clones and protocols, as well as major causes of insufficient staining results, and for HER2 IHC/ISH and Ki67 also concordance of interpretation. Individual results are available for the participants by logging in.

Results general module - run 48

CDX2: 268 labs assessed, 80% sufficient, 58% optimal. Careful calibration of the Ab concentration and a sensitive visualization system are required. The old clones CDX-88 and AMT28 cannot be recommended. DAK-CDX2 should not be applied on the Ventana BenchMark platform.

Desmin (DES): 275 labs assessed, 87% sufficient, 48% optimal. Efficient Heat induced epitope retrieval (HIER) and a sensitive detection system are mandatory for an optimal result. Clone D33 should not be used on the Dako Omnis platform. RTU VMS mAb DE-R-11 (760-2513 for Ultra/XT) performed better with laboratory modified protocols than with the vendor recommended protocol (61% vs 0% optimal). In contrast RTU Dako mAb D33 (IR606/IS606 for AS48) performed better with the vendor recommended protocol than with laboratory modified protocols (80% vs 57% optimal).

MUM1: 211 labs assessed, 60% sufficient, 40% optimal. Efficient HIER, careful calibration of the Ab concentration and a sensitive visualization system are required for optimal performance. The clones rmAb MRQ-43, mAb MRQ-8 and mAb BC5 all produce insufficient results and cannot be recommended.

p40: 188 labs assessed, 74% sufficient, 42% optimal. Careful calibration of the Ab concentration and a sensitive visualization system are required. Polyclonal Abs cannot be recommended. RTU VMS mAb BC28 (790-4950 for Ultra/XT) performed better with laboratory modified protocols than with the vendor recommended protocol (57% vs 40% optimal).

p63: 274 labs assessed, 82% sufficient, 44% optimal. Efficient HIER, careful calibration of the Ab concentration and a sensitive visualization system are required for optimal performance. Clone 7JUL cannot be recommended, as almost all labs failed with this clone. RTU VMS mAb 4A4 (790-4509 for Ultra/XT) performed better with laboratory modified protocols than with the vendor recommended protocol (60% vs 20% optimal).

SOX10: 121 labs assessed, 68% sufficient, 50% optimal. Careful calibration of the Ab concentration and a sensitive visualization system are required. Polyclonal Abs cannot be recommended.

Results breast cancer IHC module - run B22

HER2 IHC: 387 labs assessed, 84% sufficient, 71% optimal. Pathway®/ConfirmTM (Ventana) and HercepTestTM (Dako) gave pass rates above 90% while the pass rates for OracleTM (Leica) and the laboratory developed kits were too low. Several labs are using approved systems off-label, which gives a lower pass rate and should be omitted, also for legal reasons. 

Ki67: 409 labs assessed, 93% sufficient, 69% optimal. Efficient HIER and careful calibration of the primary Ab concentration are mandatory. RTU systems gave a higher pass rates than laboratory developed protocols. MIB-1 showed an inferior performance on Bond, Leica.

Results breast cancer ISH module - run H10

HER2 ISH: 118 labs assessed (BRISH only), 68% sufficient, 32% optimal. Suboptimal results are mostly related to unexplained technical issues, which prevent recommendations for improvement. 

 

December 9th 2016

Mogens Vyberg

Scheme director