Implementation of a Canadian external quality assurance program for breast cancer biomarkers: an initiative of Canadian Quality Control in immunohistochemistry (cIQc) and Canadian Association of Pathologists (CAP) National Standards Committee/Immunohistochemistry.
Immunohistochemistry results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 are used to guide breast carcinoma patient management and it is essential to monitor these tests in external quality assurance (EQA) programs. Canadian Immunohistochemistry Quality Control is a web-based program with novel approach to EQA. Canadian Immunohistochemistry Quality Control RUN2 included tissue microarray slides with 38 samples tested by 18 immunohistochemical laboratories. Deidentified results were posted for viewing at www.ciqc.ca including all used protocols matched with scanned slides for virtual microscopy and garrattograms. Sensitivity, specificity, Kendall W test (concordance between laboratories), and kappa statistics (agreement with designated reference values) were calculated. Kappa values were within the target range (>0.8, or "near perfect" agreement) for 85% results. Kendall coefficient was 0.942 for estrogen receptor, 0.930 for progesterone receptor, and 0.958 for human epidermal growth factor receptor 2. The anonymous participation, quick feedback, and unrestricted full access in EQA results provides rapid insight into technical or interpretive deficiencies, allowing appropriate corrective action to be taken whereas the use of tissue microarrays enables meaningful statistical analysis.
Department of Pathology, Vancouver General Hospital and University of British Columbia, Vancouver, Canada.
Jefferson
J
Terry
Emina Emilia
EE
Torlakovic
John
J
Garratt
Denise
D
Miller
Martin
M
Köbel
Jesse
J
Cooper
Shakir
S
Bahzad
Dragana
D
Pilavdzic
Frances
F
O'Malley
Anne E
AE
O'Brien
Sandip
S
SenGupta
Edward
E
Alport
Bernard
B
Têtu
Bryan
B
Knight
Norman M
NM
Pettigrew
Richard
R
Berendt
Robert
R
Wolber
Martin J
MJ
Trotter
Robert H
RH
Riddell
Louis
L
Gaboury
Ford
F
Elms
Anthony
A
Magliocco
Penny
P
Barnes
Allen M
AM
Gown
C Blake
CB
Gilks
D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology*; D002170:Canada; D018734:Genes, erbB-2; D006801:Humans; D007150:Immunohistochemistry; D020407:Internet; D011785:Quality Assurance, Health Care; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D012680:Sensitivity and Specificity
D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone