NordiQC - update

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NordiQC - update 00-0 EQUALIS Uppsala 0 Tomas Seidal

NordiQC participants

NordiQC participants n:30 S DK N 6 F Ice Bel 54 NL 4 Ger 6 Aust USA 0 It 8 Argent 8.. 96% participation in S,DK & N ~ 60% in Finland (LabQuality) 3

Pathologists & Histotechnologists - Generel module Tomas Seidal (S), Mogens Vyberg (DK), Ari Risimäki (Fi), Jan Klos (N), Ole Nielsen (DK), Michael Bzorek (DK) & Søren Nielsen (DK) Pathologists & Histothecnologists - Breast module Vibeke Jensen (DK), Gunilla Chebil (S), Päivi Heikkilä (F) Søren Nielsen (DK). Pathologists & Histotechnologists - HER BRISH Anne-Vibeke Lænkholm (DK), Ole Nielsen (DK), Søren Nielsen (DK) NordiQC Histotechnologists staff Aalborg Lise Emanuelsen (DK), Charlotte Jensen (DK), Anna Steensgaard (DK), 4

Over-all assessment results NordiQC consensus marks (average 003-) 45 runs = 30.000 slides Optimal: 36 % Good: 33 % Borderline: Poor: } 3 % { too weak / false neg.: ~ 90 % over-stained / false pos.: ~ 0 % 5

NordiQC over-all assessment results Major causes of insufficient stains: Less successful antibodies 8 % Inappropriate antibody dilution 39 % Inappropriate epitope retrieval 3 % Other inappropriate lab. performance % Inappropriate calibration / home brews Endogenous biotin reaction (EBR) Section drying-out after HIER Technical stainer errors Use of low sensitive detection systems Unexplained 6

8

9

Liver, optimal SCC optimal 0

Nordic performance CK-Pan run 30 00 00% 90% 0 5 80% 0% 6 4 60% 3 0 5 50% 40% P B G O 30% 0% 0 4 0% 0% DK N S FI 85% % 63% 5% 68 laboratories participated in this assessment. 65 % achieved a sufficient mark.

3

Appendix optimal CGA CSQI: Periph. nerves Nerves, optimal 4

Low antigen expressors Critical Staining Quality Indicators (CSQI) CGA = peripheral nerves Run 3, NordiQC CGA 4/0 laboratories failed (5%) /36 used pancreas as control (High expressor) /36 used carcinoid as control (High expressor) 5/36 used tumour as control (?? expressor) 5/36 used appendix as control (High and low expressor) /36 used Multi block as control (High and low expressor) 4/36 = 66% of the laboratories failing the CGA assessment used control with only high antigen expression 5

Low antigen expressors Critical Staining Quality Indicators (CSQI) CGA = peripheral nerves Run 3, NordiQC CGA 8/0 laboratories passed (5%) /08 used pancreas as control (High expressor) 4/08 used carcinoid as control (High expressor) 3/08 used tumour as control (?? expressor) /08 used appendix as control (High and low expressor) 58/08 used Multi block as control (High and low expressor) 85/08 = 9% of the laboratories passing the CGA assessment used control with low antigen expression 6

Biocare BioGenex Cell Marque Epitomics Leica NeoMarkers Roche

Nordic performance CGA run 3 00 00% 90% 80% 0 00% 90% 4 80% 4 0 0% 60% 50% 40% 30% 0% 0% 0% 0% 0 4 5 60% 50% 40% 5 30% 0% 3 0% 5 5 0 0% DK DK N N S S FI FI 6 Improved 0P B 4G 5 O 95% 9% 8% 83% 0 laboratories participated in this assessment. 5 % achieved a sufficient mark. 8

Nordic performance CGA run 008 00% 80% 0 00% 90% 80% 8 0% 0 5 3 0 0 4 60% 60% 4 6 50% 4 40% 40% 30% 6 0 5 0% 0% 9 3 0% 0% 0% DK DK N N S S FI FI 0P B 8G 0 O 90% 65% 50% 9% laboratories participated in this assessment. 6 % achieved a sufficient mark. 9

0

Adrenal, optimal MM, optimal Granul cell tumour, optimal 3

Nordic performance Melan A run 3 00 00% 80% 60% 40% 0% 0% 0 0 00% 90% 6 3 80% 0% 8 0 5 60% 4 6 50% 40% 8 30% 9 6 5 0% 4 0% 3 6 0% DK DK N N S S FI FI P0 B G8 O9 90% 9% 5% 3% 66 laboratories participated in this assessment. 66 % achieved a sufficient mark. 4

5

6

CD3 A0 (n=8) JC0A (n=48) 0 % pass rate 6 % pass rate Protease (n=5) 0 % pass rate HIER in low ph Ci (n=) 45 % pass rate HIER in high ph (n=9) 66 % pass rate step pol./mult. (n=39) 53 % pass rate 3 step pol./mult. (n=0) 95 % pass rate

Liver, optimal Tonsil 8

Nordic performance CD3 run 3 0 00% 90% 80% 0 00% 90% 80% 5 0 5 4 6 0 0% 0% 0 60% 60% 50% 50% 9 6 40% 30% 0% 0% 0% Improved 40% 5 30% 8 5 0% 8 3 0% 0% DK DK N N S S FI FI 0P B 5G O 89% 93% 63% 88% 6 laboratories participated in this assessment. 60 % achieved a sufficient mark. 9

Nordic performance - CD3 run 6 009 00% 90% 80% 0% 0 60% 50% 40% 30% 0% 0% 0% 6 5 3 DK N S FI P B G O 94% % 35% 50% 6 laboratories participated in this assessment. 5 % achieved a sufficient mark. 30

3

3

33

34

35

36

Ep-CAM mab BER-EP4 Ber-EP4 Ber-EP4 Protease (n=36) HIER (n=5) 8 % pass rate 56 % pass rate Ber-EP4 HIER + Protease (n=0) 0 % pass rate Dako Autostainer HIER in Dako low ph (n=35) 85 % pass rate Ventana system HIER in high ph (n=9) 0 % pass rate 3

38

39

Nordic performance Ep-Cam run 3 0 00% 90% 80% 0% 60% 50% 40% 30% 0% 0% 0% 0 00% 90% 5 80% 4 8 4 0% 0 60% 6 50% 5 6 40% 30% 6 5 0% 6 3 3 0% 3 0% DK DK N N S S FI FI P B8 G5 O6 55% 60% 43% 43% 4 laboratories participated in this assessment. 45 % achieved a sufficient mark. 40

NQC follow-up - 00 4

ER-RTU > conc. 4

NordiQC EQA: Estrogen Receptor 003- No. participants 00 80 60 40 0 00 80 6 84 6 9 8 4 6 90 60 40 45 0 0 8 0 3 B B3 B5 B B8 B0 B 003 006 RUN 009 0 PASS RATE (%) No. OF PARTICIPANTS 43

Nordic performance ER run B 0 00% 90% 80% 0 00% 90% 80% 0 4 0 0% 0% 0 6 60% 50% 40% 30% 0% 0% 0% 60% 50% 5 6 40% 30% 5 5 0% 0% 3 0% DK DK N N S S FI FI 0P 0B G 5 O 00% 9% 93% 00% 98 laboratories participated in this assessment. 90 % achieved a sufficient mark. 44

Pass rate for NordiQC IHC runs 30-3: DK 86% N % Fi % S 6% 45

Thus Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives (William A Foster) You may add: It is greatly aided by EQA 46

Tack för mig tomas.seidal@regionhalland.se Västra stranden Halmstad 4