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Table 2 Methods comparison study data summary

From: A novel detection methodology for HER2 protein quantitation in formalin-fixed, paraffin embedded clinical samples using fluorescent nanoparticles: an analytical and clinical validation study

Parameter

n (%)

PID/Cell

(Mean, Median, St.Dev.)

PID/ROI100μm2

(Mean, Median, St.Dev.)

N Total

108

  

IHC

 0

13 (12.0)

(3.5, 3.4, 1.6)

(2.4, 2.4, 1.2)

 1+

16 (14.8)

(5.3, 4.6, 3.4)

(3.8, 2.7, 3.6)

 2+

56 (51.9)

(31.9, 11.4, 56.5)

(16.3, 7.3, 24.1)

 3+

23 (21.3)

(221.5, 204.4, 144.2)

(110.9, 125.6, 58.9)

FISH Ratio

  < 2

59 (54.6)

(7.9, 5.2, 7.3)

(5.4, 3.5, 5.9)

  ≥ 2

49 (45.4)

(133.6, 74.8, 141.6)

(66.1, 39.8, 63.4)

HER2 Copy #

  < 4

30 (27.8)

(6.6, 4.3, 7.4)

(5.0, 2.6, 7.0)

  ≥ 4, <  6

30 (27.8)

(8.8, 6.3, 7.1)

(6.1, 4.7, 5.0)

  ≥ 6

48 (44.4)

(136.5, 81.1, 141.7)

(67.1, 40.3, 63.6)

FISH Results

 Pos

56 (51.9)

(118.5, 57.1, 138.4)

(58.5, 23.3, 62.6)

 Eq

23 (21.3)

(8.5, 6.2, 6.5)

(5.9, 4.7, 4.9)

 Neg

29 (26.9)

(6.3, 4.0, 7.3)

(4.8, 2.6, 7.0)

IHC/FISH Result

 Neg/Neg

26 (24.1)

(4.4, 3.8, 3.0)

(3.1, 2.5, 3.0)

 Eq/Eq

22 (20.4)

(8.7, 7.0, 6.5)

(6.1, 4.8, 4.8)

 Eq/Pos

32 (29.6)

(48.9, 20.8, 69.9)

(23.6, 10.8, 29.5)

 Pos/Pos

22 (20.4)

(229.9, 207.2, 141.9)

(114.3, 127.3, 57.9)

 Neg/Pos

2 (1.9)

(5.5, 5.5, N/A)

(3.9, 3.9, N/A)

 Neg/Eq

1 (0.9)

(4.7, 4.7, N/A)

(2.8, 2.8, N/A)

 Eq/Neg

2 (1.9)

(15.5, 15.5, N/A)

(11.4, 11.4, N/A)

 Pos/Neg

1 (0.9)

(37.6, 37.6, N/A)

(35.2, 35.2, N/A)

  1. N: total sample size, n: subset sample size, (%): percentage of subset to total sample size, IHC immunohistochemistry, FISH fluorescent in situ hybridization, neg negative, pos positive, eq equivocal, st.dev standard deviation