immunohistochemistry quality assurance program in...

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Immunohistochemistry Quality Assurance Program in Australasia:

An Update.

Glenn Francis

President, The Australasian Immunohistochemistry Society

•Member RCPA QAP Immunohistochemistry Module

Eugen Petcu

The Australasian Immunohistochemistry Society

Griffith University School of Medicine

•Pathologist InfinityPath, Pathology Director Genomics For

Life,

Adjunct Associate Professor,

Australian Institute for Bioengineering and

Nanotechnology

Regenerative Medicine Centre and

Menzies Health Institute Queensland

©2012 RCPA Quality Assurance Programs Pty Ltd. All rights reserved.

Nanotechnology,

University of Queensland

• Adjunct Associate Professor, School of Medicine, Griffith

University.

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IHC QAP• Pathologist

– Private and publicp

• Member RCPA General Pathology Advisory Committee

• RCPA General Pathology Examiner

• Member RCPA Genetic Pathology Advisory Committee

• Member

– AMP

– ESMO

ASCO– ASCO

• MSAC Expert standing committee

• Advisory Boards

– Roche

– Astra Zeneca

– Merck Serano

– Pfizer

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IHC QAP• Immunohistochemistry QAP

IHC Diagnostic– IHC Diagnostic

– IHC Technical

– IHC Breast markers (Introduced in 2003)• Audit (Introduced 2005)

– HER2 BRISH (Breast introduced in 2007)• Gastric 2011

– IHC Lymphoma (Introduced in 2007)

– Molecular (Introduced 2011)• HPV ISH (On hold)

• EBV ISH (on Hold)

• KRAS (Molecular)

• BRAF (Molecular)

• EGFR (Molecular) – IHC/ISH 2012 on hold

• NRAS (Molecular) – Pilot 2014

– Neuropathology (Introduced 2012)

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IHC QAP

• Homogeneity and stability testing are performed on the sections.

– Every 20th section is stained to ensure representative tissue.

– IHC was performed on slides over a period of 4 p pmonths to ensure antigenic site stability.

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IHC QAP

• Evaluation from 0 – 5Th t it i d• The assessment criteria used are:

– Intensity of true positivity is of reasonable strength

– Absence of background staining (good signal to noise ratio)

– Sensitivity – all target tissues labelled

– Localisation – only target antigenic sites labelled

– Chromogen character – crisp and distinct

– Counterstain quality – complementary not obscuring

– Absence of artefacts

– Score– Score • <2.5 is considered unsatisfactory

• ≥2.5 and <3.0, borderline

• ≥3.0 is satisfactory.

• Control slides are no longer assessed

– Not stained at the same time as test

– Control material results unknown

– Majority satisfactory (strong positive) but do not reflect test samplesMajority satisfactory (strong positive) but do not reflect test samples

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IHC QAP

• IHC Diagnosticg– Four cases with relevant clinical details, a macroscopic

description of the tissue and other relevant patient information are provided.

– Multiple unstained slides are provided for staining with immunohistochemical markers to enable the pathologist to make a diagnosis on the casemake a diagnosis on the case.

– One case is a laboratory practice questionnaire common to all the immunohistochemistry modules.

– Practical issues• A minimum of 10 blocks are required for each case.

– Limitations in availability of cases and material– Limitations in availability of cases and material.

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IHC QAPResponses IHD14-01129 responses were assessed.

Responses IHD13-02128 responses were assessed.

Diagnosis: Metastatic serous papillary carcinoma (female genital tract origin)

Diagnosis: Malignant mesothelioma

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IHC QAPResponses IHD14-03129 responses were assessed.

Responses IHD14-04129 responses were assessed.

Diagnosis: Metastatic epithelioid GIST Diagnosis: Strumal carcinoid/Struma ovarii

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IHC QAP

Responses IHD14-04129 responses were assessed129 responses were assessed.

Diagnosis: Strumal carcinoid/Struma ovarii.

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IHC QAP

• IHC Technical

– Two cases per year in the area of immunohistochemistry staining to assess technical proficiency.

– One case is a laboratory practice questionnaire common to all the immunohistochemistry modulescommon to all the immunohistochemistry modules.

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IHC QAP IT14-1 SMASMAThere were 148 participants enrolled for this survey and 126 slides were received in time for assessment of SMA staining. 10 participants indicated that this exercise was not relevant to their laboratory.

The average assessment was 3.2. 85% were satisfactory with

IT14‐1 : alpha smooth muscle actin

25%

20%

9% borderline and the remaining 6% were unsatisfactory.

Average Mark 15%

10%

5%

0%

0.2 0.6 1.0 1.4 1.8 2.2 2.5 2.8 3.2 3.6 4.0 4.4 4.8

Mark (out of 5)

% Participan

ts

( )

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IHC QAP IT14-1 SMASatisfactory Borderline

Fig.7 Fig.8

Unsatisfactory Unsatisfactory

Fig.9 Fig.10

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IHC QAP IT14-1 TTF1TTF1There were 148 participants enrolled for this survey and 118 slides were received in time for assessment of TTF1 staining. 13 participants did not submit any slides and 17 participants indicated that this exerciseof TTF1 staining. 13 participants did not submit any slides and 17 participants indicated that this exercise was not relevant to their laboratory.

The average assessment was 3.3. 80% were satisfactory with

11% borderline and the remaining 9% were unsatisfactory.

% Participan

ts

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IHC QAP IT14-1 TTF1Satisfactory Satisfactory

Unsatisfactory Unsatisfactory

Fig. 17 Fig. 18

Fig. 19

Fig. 20

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IHC QAP IT14-2

IT14‐2: Ki‐67 Distribution of marks

16%

The average assessment score was 3.3. 84% were satisfactory,

16%

14%

12%

10%

8%

6%

4%

2%

0%

Ave mark

% Participan

ts

7% were marked borderline and the remaining 9% were unsatisfactory.

0.8 1.0 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.3 3.4 3.6 3.8 4.0 4.2 4.4 4.6 4.8 5.0

Mark out of 5 (n= 137)

IT14‐2: c‐Kit Distribution of marks

20%

18%

16%

14%

12%

Ave mark

pan

ts

The average assessment was 3.4, 91% were satisfactory, 6% borderline and the remaining 3% were unsatisfactory.

12%

10%

8%

6%

4%

2%

0%

1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.3 4.4 4.6 4.8

Mark out of 5 (n=123)

% Particip

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IHC QAP IT11-1

AE1/AE3There were 148 participants enrolled for this survey and 134 slides were received in time for assessment of AE1/AE3 staining. 10 participants indicated that this exercise was not relevant to their laboratory.

The average assessment was 2.5.35% were satisfactory with 6% borderline and the remaining 59% were unsatisfactory.

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IHC QAP IT11-1

AE1/AE3AE1/AE3Unsatisfactory• Lack of staining

of the basal layer.

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IHC QAP

• IHC Lymphoma Markersy p

– Staining to assess technical proficiency.

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IHC QAP IL14-01CD15ResultsThere were 81 participants enrolled for this survey and 75 slides (93% participation) were received in time for assessment. 3participants indicated this exercise was not relevant to their laboratory.The average assessment was 3.4. 84% of the participants were scored as satisfactory, 3% of the participants were marked borderline and the remaining participants 13% were scored unsatisfactory.

There was a marked overall improvement in the repeat CD15

MMA LeuM1 performed well. CD15 Performance Comparison ‐ IHL13‐01 and

IHL14‐0130% repeat CD15

exercise, 3.4/5.0 compared with 2.6 (IHL13-01). The clones MMCarb-2 and MMA LeuM1 performed well.

25%

20%

15%

10%

IHL13‐02

IHL14‐01

5%

0%

% o

f p

arti

cip

ants

0.8 1 1.2 1.4 1.6 1.8 2 2.2 2.4 2.6 2.8 3 3.2 3.4 3.6 3.8 4 4.2 4.4 4.6

Mark (out of 5.0)

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IHC QAP IL14-01 CD15

Fig.1 Fig.2

Fig.1: MMCarb‐3 clone. Top score of 4.6. (X10) Fig.2: LeuM1 clone. Low score of 1.4/5.0. No staining of T‐cells (X20)

Fig.3 Fig.4

Fig.3: Over‐retrieved. (X10) Fig.4: Contaminant. (X20)

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IHC QAP IL14-01CD20ResultsThere were 81 participants enrolled for this survey and 75 slides (93% participation) were received in time for assessment. p p y ( % p p )

The average assessment was 3.6. 93% of the participants were

d ti f t

participation) were received in time for

assessment. IHL14‐01 CD20 Performance25%

20%

scored satisfactory. 1% of participants had a borderline score and the remainder were marked unsatisfactory

15%

10%

5%

0%

% o

f p

arti

cip

ants

unsatisfactory.0 2 2.4 2.8 3 3.2 3.4 3.6 3.8 4 4.2 4.4 4.6 4.8

Mark (out of 5.0)

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Fig.5: Clone MJ1. Score = 4.2/5.0. (X20) Fig.6: Clone L26. Score = 3.2/5.0. (X10):

Fig.6

Fig.7: Clone L26. Weak positivity. Score = 2.4/5.0. (X10) Fig.8: Clone L26. Follicular Lymphoma unstained. Score = 2.0/5.0. (X10)

Fig.7 Fig.8

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IHC QAP IL14-02CD30ResultsThere were 82 participants enrolled in this survey and 81 slides (99% participation) were received in time for assessment.The average assessment score was 3.0. 75% of the participants were scored as satisfactory, 10% were marked borderline and theremaining 15% were assessed as unsatisfactory.

Participants in the previous survey (IHL14-1) obtained an average

IHL14‐1 and IHL14‐2 Performance CD30Distribution of marks

30% score of 2.8. 63% of the participants were scored as satisfactory, 14% of the participants were marked borderline and the remaining 23% participants were assessed as

30%

25%

20%

15%

10%

5%

0%

IHL14‐1

IHl14‐2% Participan

ts

unsatisfactory.0.0 0.8 1.2 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 5.0

Mark (out of 5)

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Fig.9: Clone JCM182. Score = 4.0/5.0. (X10)) Fig.12: Clone BerH2. Score = 1.8/5.0. Background stain. False negativity. (X10).

Fig.9 Fig.12

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IHC QAP IL14-02CD43ResultsThere were 82 participants enrolled for this survey and 65 slides (79% participation) were received in time for assessment.

The average assessment was 3.6. 80% of the participants were scored satisfactory, 17% had a b d li d th

IHL14‐2 CD43Distribution of marks

18% 16%

Ave mark borderline score and the remainder 3% were marked unsatisfactory.

14%

12%

10%

8%

6%

4%

2%

0%

Ave mark

0.0 1.8 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 4.6 4.8


% Participan

ts


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IHC Neuropathology QAPTau‐AT8There were 13 participants enrolled for this survey and 8 slides were received in time for assessment of Tau‐ AT8 staining. Three participants indicated that this exercise was not relevant to their laboratory .p p y

The average assessment was 2.3.Two laboratories were assessed as

i fsatisfactory, two were borderline and the remaining four laboratories were assessed as unsatisfactory.

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IHC QAP IN14-01 (Neuropathology)IDH1 – R132HThe survey was distributed to 15 participants and 12 slides were submitted to the RCPAQAP in time for assessment.

Of the submissions, 92% were assessed as satisfactory and 8% (one) was unsatisfactory. The

IN14‐1 (IDH1‐R132H) Assessment 4.5

4

3.5

3

pan

ts

average mark was 3.3 out of 5.0.

2.5

2

1.5

1

0.5

0

1.0 1.2 1.3 1.4 1.5 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.3 3.5 4.0 4.2 4.6 4.8 5.0

A k t f 5

Count of Particip

Average mark out of 5

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IHC QAP IN14-01 (Neuropathology)

Satisfactory (X20)) Unsatisfactory (X20).

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IHC QAP IHB

• IHC QAP breast module

– Introduced in 2003Introduced in 2003• Two technical exercises per year

• Assessment of oestrogen receptor, progesterone receptor and HER2 IHC and HER2 BRISH

• Audit introduced 2005

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IHC QAP IHB14-02 ER

– 66 participants submitted a slide for assessment in the first survey in 2003.

– 110 participants submitted a slide for assessment in IHB14‐1 and 106 for IHB14‐2.

– The average mark for the first 2003 survey was 2.5.

– The average mark for the IHB14‐1 survey was 3.5 and 3.7 for IHB14 2for IHB14‐2.

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IHC QAP IHB14-02 ERERResultsThe average assessment score for this exercise was 3.7. 93% of the participants had satisfactory results, 4% were borderline and the

IHB14‐1 and IHB14‐2 PerformanceER Distribution of marks

18%

16%

remaining 3% were unsatisfactory for assessment.

In comparison, in the previous survey (IHB14-1), the average assessment score was 3 5 91% f th14%

12%

10%

8%

6%

4%

2%

0%

IB14‐1

IB14‐2

0.2 0.6 1.0 1.4 1.8 2.2 2.5 2.8 3.2 3.6 4.0 4.4 4.6 5.0

% Participan

ts

3.5. 91% of the participants had satisfactory results, 7% were borderline and the remaining 2% were unsatisfactory for assessment.

Mark (out of 5)

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IHC QAP IHB ER

ER high score 6F11 ER overretrieved

ER overstained

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IHC QAP IHB14-02 ER

Antigen retrieval methods, average mark: % participants

4% 1% 1% Roche/Ventana Benchmark Ultra (3.6) Roche/Vent. Benchmark XT (4.0)

9%

37% Leica/Vision Biosystems (3 7)

11% 37% Leica/Vision Biosystems (3.7)

PT Link (3.6)

13% LEICA BOND III (3.2)

26% Pressure cooker (2.8)

DAKO OMNIS (4.2)

Mi (4 2)Microwave (4.2)

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IHC QAP IHB14-02 ER

IHB Trend of Satisfactory Results - ER 2004-2014

100% 90% 80% 70%

ants

60% 50% 40% 30% 20% 10% 0%

Survey number

% p

arti

cip

a

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IHC QAP IHB14-02 PR

– 66 participants submitted a slide for assessment in the first survey in 2003.survey in 2003.

– 106 participants submitted a slide for assessment in 2014.

– The average mark for the first 2003 survey was 3.4.

– The average mark for the 2014 IHB14‐01 survey was 3.2 and the IHB14‐02 survey was 3.5.y

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IHC QAP IHB14-02 PRPRResultsThe average assessment score for this exercise was 3.5. 88% of the participants had satisfactory scores, 2% were borderline and the remaining 10% were unsatisfactory in this exercise.

There was a decrease in performance compared to the previous survey (IHB14-1) where the

3 2

IHB14‐1 and IHB14‐2 PerformancePR Distribution of Marks

25%

average score was 3.2, 93% of the participants had satisfactory scores, 5% were borderline and the remaining 2% were unsatisfactory.

20% 15% 10% IHB14‐1

IHB14‐25% 0%

0.2 0.6 1.0 1.4 1.8 2.2 2.5 2.8 3.2 3.6 4.0 4.4 4.8

% Participan

ts

Mark (out of 5)

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IHC QAP IHB PR

PR PGR636 PR SAN27

PR over retrievedPR over retrieved

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IHC QAP IHB PR

PR non specific staining PR

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IHC QAP IHB PR

IHBR Trend of Satisfactory Results ‐ PR 2004‐2014

100% 90% 80%80% 70% 60% 50% 40% 30% 20% 10% 0%

Survey number

% participan

ts

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IHC QAP IHB PR

Staining methods, average mark: % Participants

3% 1% 1% 1% 1%

5%

7%

37%

9%

Roche/Ventana BenchMarkUltra (3.6)

Roche/Ventana BenchMarkXT (3.4)

Leica BondMax (3.7)

Leica Bond III (3.7)

13%

23%

Dako AutostainerLink (3.3)

Manual/in house(3.1)

Dako Autostainer (3.5)

Roche/Ventana BenchMarkGX (3.0)

DAKO OMNIS (3.6)

Roche/Ventana ES(3.6)

( )Sequenza (3.4)

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IHC QAP IHB14 HER2

– 43 participants submitted a slide for assessment in the first43 participants submitted a slide for assessment in the first survey in 2003.

– 88 participants returned slides for evaluation for HER2 for the IHBR14‐02 module.

– The average mark in 2003 was 4.g

– The average mark for IHB14‐1 HER2 and IHB14‐2 HER2 was 3.4.

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IHC QAP IHB14-02 HER2HER2ResultsThe average assessment score for this exercise was 3.4. 74% of the participants had satisfactory scores, 9% were borderline and the remaining 17% were unsatisfactory.

A significant decrease in performance from the previous survey (IHB14-1) was seen where the

hi d

IHB14‐1 and IHB14‐2 PerformanceHER2 IHC Distribution of marks

18%

16%

average score achieved was 3.4 with 94% of the participants achieving satisfactory scores, 2% were borderline and the remaining 4% were unsatisfactory.

14%

12%

10%

8%

6%

4%

2%

0%

IHB14‐1

IHB14‐2

0.0 1.0 1.2 1.4 1.6 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 4.6 4.8 5.0

Mark (out of 5)

% Participan

ts

Mark (out of 5)

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HER2 Immunohistochemistry

4B5

HER2 4B5 HER2 cytoplasmic staining

Fig.31 Fig.32

Fig. 31: HER2 IHC – Satisfactory stain; clone 4B5; 3+ positive case. X20 Fig. 32: HER2 IHC – Unsatisfactory stain; False negative, clone 4B5; 3+ positive case. X20

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IHC QAP IHB14 HER2

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IHC QAP IHB14-02 HER2 BRISHHER2 BRISHResults35 laboratories submitted slides for assessment. The average assessment score in this exercise was 3.3, similar to the previous survey, where the average score was 3.4. 82% of the participants had satisfactory scores, 5% were borderline and the remaining 13% were unsatisfactory.

In comparison, the previous assessment showed 77% of the participants with

ti f t 10%

IHB14‐1 and IHB14‐2 PerformanceHER2 BRISH Distribution of marks

25%

20%

g y

satisfactory scores, 10% with borderline and the remaining 13% with unsatisfactory scores.

20%

15%

10% IHB14‐1

IHB14‐2

5%

0%

% Participants

Mark (out of 5)

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IHC QAP IHB14 HER2 BRISH

IHBR Trend of Satisfactory results ‐ HER2 BRISH 2011‐2014

90%

80%

70%

60%

50%

icip

ants

40%

30%

20%

10%

0%

IH11‐2 IH11‐3 IH12‐1 IH12‐3 IH13‐1 IH13‐2 IH14‐1 IH14‐2

Survey Number

% p

art

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Unsatisfactory

Fig.37

HER2 BRISH – Unsatisfactory stain; Silver deposit; Single probe; Low Amplification. X40

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HER2 BRISH Assessment of participants’ overall concordance .

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RCPA QAP-06 Audit

• Francis G, Dimech M, Giles L, Hopkins A. Frequency and reliability of oestrogen receptor, progesterone receptor andreliability of oestrogen receptor, progesterone receptor and HER2 in breast carcinoma determined by immunohistochemistry in Australasia: Results of the RCPA Quality Assurance Program. J Clin Pathol, 2007; 60(11): 1277‐1283.

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RCPA QAP-14 Audit

Test result Total (7739) Proportion Expected

ER+ 6263 81% 75-80%

PR+ 5462 71% 55-65%

ER- PR+ 123 2% <5%

ER- PR - 1356 18% 15-25%

HER2 IHC+ 957 15% 11-20%

ER+ PR+ 5336 69%

ER+ PR- 924 12%

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IHBR14-Audit

Test result HER2 IHC positive HER2 IHC equivocal HER2 IHC negativeTotal

ERPR and HER2 IHC

ER+ PR+ 370 39% 847 72% 3207 75% 4424

ER+ PR‐ 170 18% 162 14% 428 10% 760

ER‐ PR+ 27 3% 18 2% 48 1% 93

ER‐ PR‐ 388 41% 148 13% 609 14% 1145

Total 955 15% 1175 18% 4292 67% 6422

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RCPA QAP-14 Audit

Proportion of ER positive results by number of tests per laboratory (n=7739)There were submissions of sufficient sample size (more than 50 ER results) from 81 laboratories. Of these, 25 (31%) were significantly outside the expected range of ER positive results (i.e. <70% or >86%) and received the comment “Review required”. One submission received the comment”Review recommended”. A further 37 (46%) participants were marginally outside the same range of ER positive results.

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RCPA QAP-14 Audit

Proportion of PR positive results by number of tests per laboratory (n=7736)There were submissions of sufficient sample size (more than 50 PR results) from 81 laboratories. Of these, 5 laboratories fell outside the expected range of PR positive results (i.e. 55 – 65 %).

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RCPA QAP-14 Audit

Proportion of ER‐PR+ results by number of tests per laboratory (n=122)There were submissions of sufficient sample size for evaluation (more than 50 ER results) from 81 laboratories. Of these, 2 laboratories were significantly outside the expected range of ER‐PR+ results and received the comment “Review required”.

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RCPA QAP-14 Audit

Proportion of HER2 IHC+ results by number of tests per laboratory n=6437There were submissions of sufficient sample size for evaluation (more than 50 HER2 IHC results) from 81 laboratories. Of these, 29 laboratories (36%) were significantly outside the expected range of HER2 positive results and received the comment “Review required”. A further 5 laboratories (6%) were marginally outside the range of expected HER2 positive results and received the comment “Review recommended”.

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RCPA QAP-14 Audit

Distribution of ER positive results (more than 50 responses) (Expected range = 75‐80%)

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RCPA QAP-14 Audit

Distribution of PR positive results (more than 50 responses) (Expected range 55‐65%)

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RCPA QAP-14 Audit

Distribution of ER‐PR+ results (more than 50 responses) (Expected range <5%)

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RCPA QAP-14 Audit

Distribution of HER2 positive results (more than 50 responses) (Expected range 11‐20%)

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RCPA QAP-14 Audit

Correlation of HER2 IHC with HER2 CISH results (n=242).

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RCPA QAP-14 Audit

Correlation of HER IHC with HER2 SISH results 60

55

50

45

40

35

30

25

SIS

H r

esu

lt

25

20

15

10

5

0

IHC neg confirmed by SISH

IHC pos notconfirmed by SISH

Negative Positive

HER2 IHC lt

Equivocal

HE

R2

Correlation HER2 IHC with HER2 SISH results (n=3742).

HER2 IHC result

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RCPA QAP-14 Audit

40IH14‐2 Breast Marker Audit >50 tests

40

35

30

25

20 o

f Participan

ts

15

10

5

0

Concordant Minor discordance

AssessmentDiscordant

Count o

IH14‐2 Breast Marker Audit survey performance

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RCPA QAP-14 Audit

Breast Marker Audit results (2013 ‐ 2014)( )40

35

30

25

20

Concordant

Minor discordance

Participan

ts

Discordant 15

10

5

0

IH13 1 IH14 1

Count of P

Assessment of concordance 2013 to 2014

IH13‐1 IH14‐1Assessment

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RCPA QAP-14 Audit

Distribution of ER positive results 2009 ‐ 2014Distribution of ER positive results 2009 2014 40

35

30

25

20

2014

2013

2012of Participan

ts

15

10

5

0

2012

2011

2010

2009

20‐28 39‐48 49‐54 55‐59 60‐64 65‐69 70‐74 75‐80 81‐84 85‐89 90‐100

ER+ % ranges

Count o

Distribution of ER+ results 2009‐2014.

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Conclusion

• Generally the IHC modules are performed reasonable well

– However wide variation exists in results between laboratories and this is reflected in clinical practice.

• Breast module

– All exercises show variation in the results for oestrogen receptor, progesterone receptor and HER2.p

– Oestrogen receptor is relatively poorly performed.

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Conclusion

• Breast module

– The IHBR‐audit exercise was introduced due to concerns from participants about the supplied tissue

– Overall results are good, but there is significant variation in individual laboratories’ results which has the potential to impact on patient treatment.

– It is not possible to identify any definitive factor in those with unsatisfactory results.

– Optimisation of retrieval is considered to be critical in achieving satisfactory results.

– Validation of testing methods is essential.

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New Modules

• Gastric HER2 BRISH

– Two exercises per year

– TMA construct• 30 cores per slide

– Limited number of reporting laboratories• Interpretation is different to breast HER2 (cut offs different)

• Tumour heterogeneity

• Some Abs cross react with HER3

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BRISH QAP HG12

HER2 HG12‐1 Case performance.

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BRISH QAP HG12

HER2 HG12‐1 Assessment of participants’ overall HER2 concordance .

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New Modules

• Molecular AP

– EBV and HPV ISH• Two exercises per year

• TMA construct

– ~20 cores per slide

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BRISH QAP EBV12-02

There were 19 participants enrolled for this survey and 18 EBV ISH submissions received in time for assessment.

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BRISH QAP EBV12-02

There were 5 participants enrolled for this survey and 3 HBV ISH submissions received in time for assessment.

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Acknowledgments• Dr Glenn Francis

• Dr Beena Kumar

• Ms Ruth Davies

• Mr Jim Brennan

• Ms Xiaojuan Wu

• Ms Sharita Meharry

• Mr Michael Platten

• Mr David Gan

• Mr Alex Laslowski

• RCPA QAP

– Martyn Peck

– Zenobia Haffajee

immunohistochemistry quality assurance program in...

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