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Table 5 Multivariable logistic regression testing the impact of department, year, and immunohistochemical assay on the odds of being classified as either HER2 positive or HER2 score 0—performed for both the entire study period and for the last six years

From: High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients

 

2007–2019

2014–2019

Positive versus negative

0 versus 1+, 2+, and 3+

Positive versus negative

0 versus 1+, 2+, and 3+

OR

95% CL

OR

95% CL

OR

95% CL

OR

95% CL

Dept. 1

1.06

0.96–1.17

0.71

0.66–0.77

1.13

0.99–1.28

0.52

0.47–0.57

Dept. 2

1.04

0.94–1.15

0.74

0.68–0.80

1.00

0.88–1.14

0.68

0.61–0.75

Dept. 3

0.91

0.61–1.36

0.97

0.72–1.31

–*

 

–*

 

Dept. 4

1

 

1

 

1

 

1

 

Dept. 5

0.88

0.78–1.00

1.12

1.03–1.23

0.85

0.72–1.01

1.26

1.12–1.42

Dept. 6

0.84

0.73–0.97

0.77

0.69–0.86

0.91

0.75–1.12

0.76

0.66–0.88

Dept. 7

0.89

0.77–1.03

0.38

0.33–0.43

1.01

0.82–1.23

0.30

0.25–0.36

Dept. 8

1.04

0.92–1.17

0.52

0.47–0.57

1.15

0.97–1.36

0.26

0.22–0.31

Dept. 9

0.87

0.77–0.98

0.46

0.42–0.51

0.98

0.83–1.16

0.11

0.09–0.14

Dept. 10

1.20

0.91–1.58

0.57

0.45–0.72

–*

 

–*

 

Dept. 11

1.27

1.10–1.46

0.25

0.22–0.30

0.98

0.79–1.23

0.19

0.15–0.24

Dept. 12

1.16

1.03–1.30

0.83

0.76–0.91

1.45

1.25–1.68

0.59

0.52–0.66

Dept. 13

0.86

0.76–0.98

1.36

1.24–1.49

0.91

0.75–1.09

1.27

1.12–1.44

Dept. 14

1.08

0.87–1.34

1.41

1.19–1.67

1.22

0.86–1.73

0.80

0.61–1.06

Year 2007

0.91

0.74–1.14

2.39

2.01–2.83

 

 

Year 2008

0.96

0.81–1.14

2.42

2.11–2.77

 

 

Year 2009

0.87

0.74–1.01

1.92

1.70–2.17

 

 

Year 2010

1.03

0.90–1.19

1.11

0.99–1.25

 

 

Year 2011

0.96

0.84–1.09

1.27

1.13–1.42

 

 

Year 2012

0.87

0.77–1.00

1.19

1.06–1.33

 

 

Year 2013

0.89

0.78–1.02

1.15

1.03–1.29

 

 

Year 2014

1

 

1

 

1

 

1

 

Year 2015

0.91

0.80–1.04

1.25

1.12–1.40

0.91

0.80–1.04

1.25

1.12–1.40

Year 2016

0.93

0.82–1.06

1.55

1.39–1.73

0.94

0.82–1.07

1.54

1.38–1.72

Year 2017

1.04

0.91–1.18

1.61

1.45–1.79

1.04

0.92–1.19

1.64

1.47–1.82

Year 2018

1.06

0.94–1.20

1.60

1.44–1.78

1.06

0.93–1.21

1.62

1.45–1.80

Year 2019

1.03

0.90–1.17

1.46

1.31–1.62

1.01

0.89–1.15

1.45

1.30–1.62

Assay 4B5 790–2991

1

 

1

 

1

 

1

 

Assay 4B5 800–2996

1.17

0.97–1.43

0.81

0.70–0.94

 

 

Assay CB11

2.25

1.17–4.33

0.62

0.32–1.18

 

 

Assay K5204

1.15

0.88–1.50

0.57

0.47–0.70

 

 

Assay K5206

1.31

0.88–1.94

0.78

0.56–1.07

 

 

Assay K5207

1.24

1.05–1.48

0.74

0.65–0.85

1.13

0.74–1.71

1.04

0.74–1.45

Assay SK001

1.00

0.88–1.14

1.27

1.15–1.41

 

 

Unknown assay

1.09

0.77–1.54

0.44

0.33–0.59

 

 
  1. OR odds ratio, CL confidence level
  2. *Excluded from the model due to shutdown of the laboratory (Dept. 3) or low patient count (Dept. 10)
  3. As SK001 was only used by Dept. 14, the estimates for SK001 are identical to the estimates for Dept. 14