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Results - module 49, B23, H11 & C1 available

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CD5: 278 labs assessed, 92% sufficient, 68% optimal. Ready-To-Use (RTU) systems obtained superior pass rates and higher proportion of optimal results compared to laboratory developed (LD) tests. Within LD tests, optimal results required efficient HIER, preferable in alkaline buffer, and careful calibration of the primary Ab titre.

CK-LMW: 229 labs assessed, 80% sufficient, 31% optimal. The mAb clone cocktail B22.1/B23.1, rmAb clone cocktail EP17/30 and rmAb clone EP17 were the most successful antibodies for immunohistochemical demonstration of CK-LMW. In contrast mAb clone 34βH11 and in particular clones CAM5.2 are less successful and prevent improvement of the overall pass rate for CK-LMW.

MLA: 255 labs assessed, 60% sufficient, 32% optimal. The Ready-To-Use system for MLA from Dako (IR633/IS633 – AS48) based on mAb clone A103 applied according to the vendor recommended protocol settings provided the highest proportion of sufficient and optimal results. However, the clone showed less successful performance on the fully automated IHC platforms Omnis (Dako) and BenchMark (Ventana).

MLH1: 224 labs assessed, 59% sufficient, 30% optimal. Clone ES05 was most successful, both as concentrate and as RTU format (Dako/Agilent and Leica/Novocastra). The mAb clone M1 could not be used to obtain optimal staining for MHL1 due to aberrant nuclear staining in colon adenocarcinoma known to lack MLH1 expression.

NKX3.1: 49 labs assessed, 65% sufficient, 45% optimal. rmAb clone EP356 and pAb CP422 were the most successful antibodies. With LD assays, efficient HIER in an alkaline buffer and use of a sensitive and specific 3-step polymer/multimer based detection system gave the highest proportion of optimal results. Testis and normal prostate can be used as positive tissue controls

PSA: 284 labs assessed, 89% sufficient, 68% optimal. Careful calibration of the Ab concentration and sufficient HIER are required.

Results breast cancer IHC module - run B23

ER: 394 labs assessed, 92% sufficient, 56% optimal. The most used clones 6F11, EP1 and SP1 are all recommended.     RTU systems obtained superior pass rates and higher proportion of optimal results compared to LD assays. For LD assays, too low concentration of the Ab and insufficient HIER were major reasons for insufficient assays.

HER-2 IHC: 372 labs assessed, 95% sufficient, 82% optimal. The FDA-/CE-IVD approved PATHWAY®/CONFIRM™ (Ventana) and HercepTest™ (Dako) were the most precise assays for the semi-quantitative IHC determination of HER-2 protein expression. LD assays produced a lower pass-rate and were less precise for the HER-2 status requiring an additional ISH test for final evaluation. Inclusion of 2+ tumours with and without HER-2 gene amplification in the control material for both EQA and internal quality control is essential to evaluate precision and performance stability of the IHC HER-2 assays used by laboratories.

Results companion module - run C1

PD-L1: 68 labs assessed, 50% sufficient, 37% optimal. Suboptimal results are mostly related to unexplained technical issues, which prevent recommendations for improvement. The Dako/Agilent 22C3 pharmDx assay SK006, applied by protocol settings in compliance with the vendor recommendations, was most successful with an overall pass rate of 92%. LD assays were used by 44% of the labs and a pass rate of 20% was seen.

Results breast cancer ISH module - run H11

HER-2 ISH: 123 labs assessed (BRISH only), 60% sufficient, 32% optimal. Suboptimal results are mostly related to unexplained technical issues, which prevent recommendations for improvement. 

 

April 21st 2017

Mogens Vyberg

 

Scheme director 

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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