10 years of NordiQC Why are 30% of labs still getting it wrong?
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- Hilary Gilmore
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1 Mogens Vyberg & Søren Nielsen NordiQC Institute of Pathology Aalborg University Hospital Aalborg, Denmark May 29th years of NordiQC Why are 30% of labs still getting it wrong?
2 Nothing to declare
3 Nordic immunohistochemical Quality Control 3 International organization for quality assurance of IHC Founded 2003 by Nordic pathologists Independent, scientific, not-for-profit organisation Institute of Pathology, Aalborg University Hospital, DK General module: 3 runs/year different marker challenges Breast cancer IHC module: 2 runs/y HER-2, ER/PR, Ki67/E-Cad HER-2 ISH module: 2 runs/year BRISH, FISH
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7 Test material Multi-tissue FFPE blocks 10% NBF h (ASCO/CAP guidelines ) Normal and clinically relevant tumour tissues Different levels of antigen expression high, moderate, low, none 2 unstained slides for each marker send to the participants 1 stained slide returned for central assessment
8 Test material 8 The slide to be stained for Bcl-6 comprised: 1. Tonsil, 24 h. 2. Tonsil, 48 h. 3. Follicular lymphoma, grade I 4. Follicular lymphoma, grade II 5. Diffuse large B-cell lymphoma HE NE Tissue selection High Low None Expressor LE
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10 Nordic immunohistochemical Quality Control Participants
11 ~ 90 Markers in NordiQC runs Tested 1-15 times
12 NordiQC test - haempath 1x 2x 3x 4x 5x CD8, CD14, CD19, CD163, IgL, MUM1 X ALK, BSAP, Bcl2, CD45, CD56, CD138, p53, TdT X Bcl6, CD4, CD20, CD34, CD68, CD79a, IgK, Ki67 X CD3, CD10, CD23, CD30, Cyclin D1, IgM X CD5, CD15 X
13 NordiQC assessment results General module ~ 20,000 slides ( ~ core sections) Insufficient 32% 21% 11% 33% 35% Optimal Good Borderline Poor
14 NordiQC assessment results Breast cancer module ~ 9,000 slides (~35,000 core sections) Insufficient 21% 9% 12% 21% 58% Optimal Good Borderline Poor
15 Publications AJCP 2005,124:782 AIMM 2011, 19:437 AIMM 2013, 21:64 AIMM 2014, 22:449
16 Publications AIMM 2015, 23:1 AIMM 2014, 22:241
17 Serial sections stained for Estrogen receptor Lab. A Lab. B ER in ductal breast carcinoma
18 Serial sections stained for Estrogen receptor Lab. A Lab. B False neg.
19 Serial sections stained for Estrogen receptor Control: uterine cervix Lab. A Lab. B False neg. 19
20 Serial sections stained for Estrogen receptor Control: uterine cervix Clone SP1/EP1/1D5 in 225 labs Clone 6F11 in 15/37 labs False pos. 20
21 NordiQC runs for HER2 IHC 21 CK7 Optimal Ampl. 3+ Ampl. 2+ Unampl. 2+ Unampl. 0 Poor Ampl. 3+ Ampl. 1+ Unampl. 1+ Unampl. 0 21
22 NordiQC runs for HER2 IHC 22 CK7 Optimal Ampl. 3+ Ampl. 2+ Unampl. 2+ Unampl. 0 Poor Ampl. 3+ Ampl. 2+ Unampl. 3+ Unampl. 1 22
23 NordiQC general results Optimal: 36% Good: 33% Borderline: Poor: } 31% { too weak / false neg.: ~ 90% over-stained / false pos.: ~ 10% 23
24 NordiQC general results Major causes of insufficient stains in ~ 9,000 slides Less successful antibodies/rtus 17 % Inappropriate antibody dilution 20 % Inappropriate epitope retrieval 27 % Inappropriate detection kit 19 % Other inappropriate lab. performance 17 % Endogenous biotin reaction (EBR) Section drying-out after HIER Technical platform error.... Unexplained 24
25 NordiQC general results Less successful antibodies 17 % Poor antibodies Poor ready-to-use formats Less robust antibodies Platform dependent antibodies Other error-prone antibodies Lot-to-lot variation Mouse-anti-Golgi (MAG) reaction Poor cocktail composition NordiQC. regrets any offence caused to laboratories and companies 25
26 Poor antibodies 26
27 Poor antibodies (few examples) Antigen Clone High expressor Low expressor Non expressor CD5 CD5/54/F6 FN CD23 MHM6 FN CD31 1A10 ( ) FN CD31 SP38 * ( ) FN CD138 5F7 ( ) FN CDX2 SP54 * ( ) FN FP CDX2 CDX2-88 FN FP CEA TF-3H8-1 FP CGA DAK. A3 FN PR SP2 * FP SYP SY38 FN 27
28 Poor antibodies: CD5 CD5 N Sufficient* Optimal* 4C7 conc % 49% SP19 conc 11 91% 46% CD5/54/F6 conc 28 4% 0% * With optimal protocol settings 28
29 Poor antibodies: CD5 SP19 TP Tonsil B-CLL CD5/54/F6 FN TP FN 29
30 Poor antibodies: CD31 JC70A 1A10 Optimal (16%)
31 Poor antibodies: CD31 JC70A 1A10 Optimal (16%)
32 Poor antibodies: CD31 JC70A 1A10 Optimal (16%) Haemangiosarcoma
33 NordiQC performance Dako Not Dako
34 Poor antibodies MLH1 MLH1 clone ES05 MLH1 clone EPR3894
35 Poor RTU formats 35
36 NordiQC performance Ready-To-Use system potential: Replace laboratory developed assays Reduce workload to calibrate and validate IHC assays Reduce need for technical competences in IHC Optimize workflow / reduce protocol variables Add value to inter- and intra-laboratory consistency Requires a correctly calibrated system Requires precise information on protocol and control
37 NordiQC performance Proportion of protocols based on concentrates vs. RTU formats in NordiQC AMACR CD10 CK LMW CK HMW MLA BCL2 BCL6 BSAP CD99 EMA WT1 BCL6 CD15 GLP3 MLA PAX8
38 NordiQC assessment CD45 RTU format Vendor protocol Off-label protocol Epitope retrieval None HIER CC1, 64 min. Primary Ab inc. 16 min. 16 min. Detection system 2-step multimer 3-step multimer : HIER Control Tonsil Tonsil + liver Reaction pattern Lymphocytes Lymphocytes + macroph. Assessment score Borderline False neg. Optimal Tonsil + liver Plasmacytoma
39 Poor RTU formats: CD5 CD5 Run 24 N Sufficient* Optimal* SP19 conc 11 91% 46% SP19 RTU Dako 3 100% 100% SP19 RTU VMS 14 79% 14% CD5 Run 34 N Sufficient* Optimal* SP19 RTU VMS 33 97% 97% * With optimal protocol settings FN
40 Poor RTU formats: CGA Medullary carcinoma LK2H10 REF pab RTU Company 1 mab LK2H10 RTU Company 2 mab LK2H10 RTU Company 3
41 Poor RTU formats: CGA Small cell carcinoma LK2H10 REF pab RTU Company 1 mab LK2H10 RTU Company 2 mab LK2H10 RTU Company 3
42 Platform dependant antibodies 42
43 Platform dependent antibodies Antigen Clone XT / Ultra automated Bond-max automated Autostainer semiautomated CD4 1F6 FN Weak SP35 CD56 123C3 FN Weak MRQ-42? CD79a JCB117 Weak SP18 BSAP/Pax5 24 FN Weak SP34 BCL6 PG-B6p FN Weak GI191E/A8 SYP 27G12 Weak MRQ-40 43
44 Platform dependent antibodies: PAX5 Hodgkin lymphoma NS clone SP34 RTU VMS/CM x200 clone 24 RTU VMS/CM x200
45 Inappropriate antibody dilution 45
46 Inappropriate antibody dilution Ig light chains IgK: Dako pab A0191 ~1:300 ~1:3.000 ~1:30.000
47 Inappropriate antibody dilution Ig light chains 239 IgK tests, 12 Abs: 12% optimal Dako pab A0191: 17% optimal +TRS/Ci : 29 % optimal All other Abs: 0% optimal
48 Inappropriate visualization system 48
49 NordiQC run 41/ MMR 1 generation 3-step multimer, VMS 2 generation 3-step multimer, VMS MMR MLH1 mab clone ES05, 1:20 Leica UltraView + Amplification OptiView + Amplification (Tyr.)
50 NordiQC run PMS2 131 labs Optimal: 47% Insufficient: 15% NO mutation
51 NordiQC run PMS2 131 labs Optimal: 47% Insufficient: 15% Mutation
52 NordiQC run PMS2 131 labs Optimal: 47% Insufficient: 15% Mutation Too dilute Ab Insufficient HIER Insensitive viz system
53 Inappropriate epitope retrieval & Misleading data sheets 53
54 Inappropriate retrieval (31%) AE1/AE3 + HIER TP Liver RCC FN AE1/AE3 + proteolysis TP 54 FN
55 Misleading datasheets Giving false negative results when only LMW-CKs are present 55
56 Misleading datasheets improved information
57 IHC - NordiQC 2014 AE1/AE3 : Optimal results only obtained by HIER in NordiQC runs Dako: RTU HIER Leica: RTU Proteolysis Thermo: VMS: RTU - Proteolysis Conc: Proteolysis or HIER Conc: HIER Conc: HIER Quanto Proteolysis UltraVision Misleading data sheets + Wrong control material used 57
58 Improved datasheets By 17 th October 2014
59 NordiQC run ECAD 271 labs Fra: Galloway, Mary Sendt: 13. november :14 Til: Søren Nielsen / Region Nordjylland Emne: RE: Changes Made to Package Inserts Sören, Thanks for identifying and alerting us to the issues with anti-pan Keratin. The package inserts are now changed (see links below). I hope we can continue to learn of any future staining problems you may uncover. False positive: EP700Y Much appreciated! Mary RCC TP FN
60 Misleading datasheets Antigen Clone Company Datasheet Result CGA Lk2H10 VMS No retrieval FN CK8 5D3 Leica RTU: HIER Conc: proteolysis Confound FN CK19 RCK108 BioGenex Proteolysis FN CK19 B170 Leica Proteolysis FN CKPan AE1/AE3 VMS/Dako Proteolysis FN CD34 QBEnd 10 Leica RTU: HIER Conc: proteolysis CD34 QBEnd 10 VMS Changed from no retrieval to HIER Confound FN CD68 KP1 Thermo Proteolysis FN DES DE-R-11 Cell Marque Proteolysis FN PLAP PL8-F6 BioGenex No retrieval FN VIM 3B4 VMS Proteolysis FN FN / OK WT1 6F-H2 Dako RTU: HIER Confound 60
61 Misleading datasheets Giving false negative results in low expressing cells and tumours
62 Tailored NordiQC recommendations 62
63 Tailored recommendations Replace less successful antibodies (conc./rtu) Calibrate the antibody concentration Use HIER (instead of proteolysis or no retrieval) Increase HIER time / temperature / buffer ph For 95% of epitopes ph 8-9 is preferable to ph 6 Use a non-biotin based viz. system Use FDA approved kits instead of home-brews..... Improve the internal QC: Identify the right controls 63 Select well defined normal low expressor cells/tissues
64 Results of NordiQC recommendations 419 advices for 11 markers No. Improved % Positive Negative
65 NordiQC EQA: Estrogen Receptor % % B1 B3 B5 B7 B8 B10 B11 B13 B15 B17 PASS RATE (%)
66 NordiQC EQA: Estrogen Receptor % 70 Participants % B1 B3 B5 B7 B8 B10 B11 B13 B15 B17 PASS RATE (%)
67 HER-2 staining results in 17 runs
68 Roche NordiQC joint venture Normalized to the American breast cancer population * * The large majority due to 1+ reactions in amplified 2+ tumours
69 Roche NordiQC joint venture Normalized to the American breast cancer population
70 Roche NordiQC joint venture For each 1$ saved by the pathology lab by usage of cheaper reagents, the healthcare system is ultimately burdened with ~ 6$ Immunohistochemical expression of HER2 in breast cancer: Socioeconomic impact of inaccurate tests Vyberg M, Nielsen S, Røge R, Sheppard B, Ranger-Moore J, Walk E, Gartemann J, Rohr UP, Teichgräber V NordiQC, Aalborg, DK, Ventana Medical Systems Inc, Tucson, AZ, F. Hoffmann-La Roche Ltd, Basel, Switzerland Submitted for publication
71 Perspective Almost 1/3 of all IHC stains produced by NordiQC participants are still insufficient! New labs New antibodies, techniques, platforms Increasing demands How many IHC stains produced by labs not participating in an EQA scheme are insufficient? How many scientific publications are based on insufficient IHC stains? What are the consequences for the patients?
72 Conclusion External Quality Assurance (EQA) Provides objective evidence of lab performance Identifies methodological errors Provides directions for improvements & controls The results of the NordiQC work indicate that Improvement of IHC is strongly needed EQA schemes, industry and KOL must align - describing the requirements for optimal IHC performance. 72
73 73
74 Thank you for your attention! 74
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