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Table 4 Analytical variation presented as standard deviations of the 40-ΔΔCq values (SD) with 95 % confidence intervals (CI) for LightCycler 480 instrument II, Roche

From: Technical validation of an RT-qPCR in vitro diagnostic test system for the determination of breast cancer molecular subtypes by quantification of ERBB2, ESR1, PGR and MKI67 mRNA levels from formalin-fixed paraffin-embedded breast tumor specimens

LightCycler 480 II

 

Study 1

Study 2

  

Inter-Site

Inter-Run

Inter-run

Intra-Run

Inter-Extraction

Intra-Extraction

    

Device 1 (site 1)

Device 2 (site 2)

Device 3 (site 2)

Device 4 (site 3)

ERBB2

SD

0.20

0.21

0.21

0.18

0.22

0.21

0.20

0.08

0.16

95 % CI

0.15–0.30

0.19–0.23

n.a.

n.a.

n.a.

n.a.

n.a.

0.05–0.19

0.14–0.19

ESR1

SD

0.18

0.27

0.26

0.27

0.21

0.31

0.30

0.52

0.55

95 % CI

0.13–0.29

0.24–0.30

n.a.

n.a.

n.a.

n.a.

n.a.

0.39–0.79

0.48–0.64

PGR

SD

0.14

0.15

0.14

0.12

0.19

0.16

0.22

0.07

0.17

95 % CI

0.11–0.22

0.14–0.17

n.a.

n.a.

n.a.

n.a.

n.a.

0.04–0.26

0.15–0.20

MKI67

SD

0.20

0.18

0.18

0.14

0.15

0.23

0.20

0.05

0.17

95 % CI

0.16–0.30

0.16–0.20

n.a.

n.a.

n.a.

n.a.

n.a.

0.03–0.68

0.15–0.20

  1. All data using models without day (inter-day variance is completely explained (covered) by inter-run variance). The calculations of inter- and within-section SDs are derived from a single instrument (study 2), due to the use of pooled samples in study 1