Il test HER2 : Standard di qualità - overgroup.eu _Oscar_Nappi.pdf · Il test HER2 : Standard di...
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Il test HER2 : Standard di qualità Linee Guida ASCO-CAP Controllo di qualità AIOM-SIAPEC nella pratica clinica Oscar Nappi UOSC Anatomia patologica AORN A. Cardarelli - Napoli
Transcript of Il test HER2 : Standard di qualità - overgroup.eu _Oscar_Nappi.pdf · Il test HER2 : Standard di...
Il test HER2
Standard di qualitagrave
Linee Guida ASCO-CAP
Controllo di qualitagrave AIOM-SIAPEC
nella pratica clinica
Oscar Nappi
UOSC Anatomia patologica
AORN A Cardarelli - Napoli
Controllo di qualitagrave esterno
bull Secondo le linee-guida EUSOMA tra i requisiti indispensabili di una Breast Unit figura il Controllo di qualitagrave esterno dei marcatori predittivi
bull Le Regioni Italiane ( in Lombardia giagrave egrave previsto dallrsquo anno in corso) si avviano a considerarlo un requisito obbligatorio
Il progetto Nazionale di CQ della mammella
bull Consiglio Direttivo
bull SIAPEC-Servizi
bull Coordinamento Nazionale
bull Segretari regionali
bull Centri partecipanti
bull ROCHE
bull NordiQC
NordiQC is an independent scientific organization promoting the quality of immunohistochemistry by arranging schemes for pathology laboratories assessing tissue stains giving recommendations for improvement and providing good protocols
1722
11
6
7
12
16
4
1
3
3
1
175 2
14
6
1
10
158 centri
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Controllo di qualitagrave esterno
bull Secondo le linee-guida EUSOMA tra i requisiti indispensabili di una Breast Unit figura il Controllo di qualitagrave esterno dei marcatori predittivi
bull Le Regioni Italiane ( in Lombardia giagrave egrave previsto dallrsquo anno in corso) si avviano a considerarlo un requisito obbligatorio
Il progetto Nazionale di CQ della mammella
bull Consiglio Direttivo
bull SIAPEC-Servizi
bull Coordinamento Nazionale
bull Segretari regionali
bull Centri partecipanti
bull ROCHE
bull NordiQC
NordiQC is an independent scientific organization promoting the quality of immunohistochemistry by arranging schemes for pathology laboratories assessing tissue stains giving recommendations for improvement and providing good protocols
1722
11
6
7
12
16
4
1
3
3
1
175 2
14
6
1
10
158 centri
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Il progetto Nazionale di CQ della mammella
bull Consiglio Direttivo
bull SIAPEC-Servizi
bull Coordinamento Nazionale
bull Segretari regionali
bull Centri partecipanti
bull ROCHE
bull NordiQC
NordiQC is an independent scientific organization promoting the quality of immunohistochemistry by arranging schemes for pathology laboratories assessing tissue stains giving recommendations for improvement and providing good protocols
1722
11
6
7
12
16
4
1
3
3
1
175 2
14
6
1
10
158 centri
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
NordiQC is an independent scientific organization promoting the quality of immunohistochemistry by arranging schemes for pathology laboratories assessing tissue stains giving recommendations for improvement and providing good protocols
1722
11
6
7
12
16
4
1
3
3
1
175 2
14
6
1
10
158 centri
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
1722
11
6
7
12
16
4
1
3
3
1
175 2
14
6
1
10
158 centri
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
La richiesta di partecipazione al controllo di qualitagrave della Societagrave scientifica italiana per tutti i Centri Nazionali ha indotto Nordiqc a programmare una Run speciale denominata
B19xA tale run hanno aderito 158 Centri
La run B20ordinariaha visto lrsquoadesione di 123 Centri
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Gli Strumenti del Coordinamento Nazionale
bull Mail progettoher2gmailcom
bull News letters
bull Tutorials
bull Disponibilitagrave telefonica
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
13 Aprile 2015
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Cliccare sul link relativo alla Run B19x
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Criteri HER2
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Criteri ER
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Criteri PR
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
HER-2
FDACE IVD approved
HER2 assays
n Vendor O G B P Suff
PATHWAY rmAb clone
4B5 790-2991
51 Ventana 39 8 0 4 92
CONFIRM rmAb clone
4B5 790-4493
7 Ventana 6 1 0 0 100
HercepTest SK001 20 Dako 9 8 0 3 85
HercepTest K5207 8 Dako 0 4 1 2 50
HercepTest K5204 7 Dako 0 5 1 1 71
Oracle mAb clone
CB11 TA9145
8 Leica 0 2 0 6 25
Antibodies for
laboratory developed
HER2 assays
concantibody
n Vendor O G B P Suff
mAb clone CB11 10 LeicaCell Marque 1 5 1 3 60
pAb clone A0485 10 Dako 1 7 0 2 80
Antibodies for
laboratory developed
HER-2 assays RTU
n Vendor O G B P Suff
pAb E2441 1 Spring Bioscience 0 0 0 1 nv
Total 122 56 40 3 23
Proportion 46 33 2 19 79
Risultati HER2-Run (Tabella 4)B20
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
PR
Concentrated antibodies n Vendor O G B P Suff
mAb clone PgR 1294 5 Dako 3 2 0 0 100
mAb clone PgR 636 22 Dako 16 6 0 0 100
mAb clone 1A6 5 Leica 1 2 0 2 60
mAb clone 16 13 Leica 11 1 0 1 92
Ready to use n Vendor O G B P Suff
mAb clone 16 PA0312 6 Leica 5 1 0 0 100
mAb PgR 636 IRISO68 10 Dako 7 3 0 0 100
mAb clone PgR 1294 1 Dako 0 1 0 0 nv
rmAb clone 1E2 790-
22234296
60 Ventana 17 31 10 2 80
mAb clone PR88 AM328-5
ME
1 Biogenex 1 0 0 0 nv
Total 123 61 47 10 5
Proportion 50 38 8 4 88
Risultati PR-Run (Tabella 3) B201
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
RunB19x Her2 scoring consensus92111 (83)
RunB20 Her2 scoring consensus94113 (83)
Distribuzione risultati nazionali
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Andamento dei risultati HER2 nazionali tra le due Run
Sufficiente rarrInsufficiente 16 (13)
(In)Sufficienterarr(In)Sufficiente 94(77)
InsufficienterarrSufficiente 12(10)
Un risultato Optimal o Good egrave stato ritenuto Sufficiente
Un risultato Borderline o Poor egrave stato ritenuto Insufficente
dei 94 casi rimasti invariati 11 (12) partivano da score insufficiente
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
VenetoTotlabs 17 16 14 14
nr ()
Her2 ER PR Her2
Poor 1(6) 1(6) 0 3(22)
Borderline 0 7(44) 0 1(7)
Good 0 2(12) 7(50) 1(7)
Optimal 16 (94) 6(38) 7(50) 9(64)
Consensus score 17 14
Yes 15(88) 13(93)
No 2(12) 1(7)
PiemonteTot labs 22 21 19 18
nr()
Her2 ER PR Her2
Poor 5(23) 7(33) 2(10) 2(11)
Borderline 0 0 1(5) 1(5)
Good 1(4) 9(43) 6(32) 10(56)
Optimal 16(73) 5(24) 10(53) 5(28)
Consensus score 22 17
Yes 16(72) 13(76)
No 6(28) 4(24)
e Val DAosta
Emilia Romagna Totlabs 11 11 11 11
nr()
Her2 ER PR Her2
Poor 5(45) 4(37) 0 3(27)
Borderline 0 0 0 0(0)
Good 0 5(45) 7(64) 1(9)
Optimal 6(55) 2(18) 4(36) 7(64)
Consensus score 11 11
Yes 10(91) 10(91)
No 1(9) 1(9)
FVGTotlabs 7 7 5 5
nr()
Her2 ER PR Her2
Poor 0 3(43) 0 0
Borderline 0 1(14) 0 0
Good 1(14) 2(29) 1(20) 3(60)
Optimal 6(86) 1(14) 4(80) 2(40)
Consensus score 6 5
Yes 4(67) 5(100)
No 2(33) 0
e TAA
LiguriaTotlabs 7 6 6 6
nr()
Her2 ER PR Her2
Poor 3(43) 2(33) 0 1(17)
Borderline 0 0 0 0
Good 0 1(17) 2(33) 1(17)
Optimal 4(57) 3(50) 4(67) 4(66)
Consensus score 6 6
Yes 5(83) 4(67)
No 1(17) 2(33)
Nord Italia
Distribuzione risultati regionali
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
J Clin Pathol 2015 Nov68(11)879-82 doi 101136jclinpath-2014-202705 Getting controls under control the time is now for immunohistochemistryTorlakovic EE1 Nielsen S2 Vyberg M2 Taylor CR3
AbstractFor several decades immunohistochemistry (IHC) more specifically diagnostic IHC (dIHC) has been considered an art rather than a laboratory test There was no clarity about what test performance characteristics are relevant to dIHC test performance characteristics were not fully defined for dIHC and partly as a consequence of that there were no standardisedcontrols or reference standards Herein we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC
Grazie
Grazie
