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.
Terry
Jefferson
J
Department of Pathology, Vancouver General Hospital and University of British Columbia, Vancouver, Canada.
Torlakovic
Emina Emilia
EE
Garratt
John
J
Miller
Denise
D
Köbel
Martin
M
Cooper
Jesse
J
Bahzad
Shakir
S
Pilavdzic
Dragana
D
O'Malley
Frances
F
O'Brien
Anne E
AE
SenGupta
Sandip
S
Alport
Edward
E
Têtu
Bernard
B
Knight
Bryan
B
Pettigrew
Norman M
NM
Berendt
Richard
R
Wolber
Robert
R
Trotter
Martin J
MJ
Riddell
Robert H
RH
Gaboury
Louis
L
Elms
Ford
F
Magliocco
Anthony
A
Barnes
Penny
P
Gown
Allen M
AM
Gilks
C Blake
CB
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