Skip to main content

Table 5 Analytical variation presented as standard deviations of the 40-ΔΔCq values (SD) with 95 % confidence intervals (CI) for Versant kPCR Cycler, Siemens

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

Versant kPCR AD

Inter-Site

Inter- Extraction

Intra- Extraction

Inter-Run

Intra-Run

Inter-Lot

Device 1 (Site 1)

Device 2 (Site 2)

Device 3 (Site 3)

Inter- Extraction

Intra- Extraction

Inter- Extraction

Intra- Extraction

Inter- Extraction

Intra- Extraction

ERBB2

SD

0.48

0.21

0.41

0.35

0.31

0.15

0.39

0.00b

0.49

0.29

0.16

95 % CI

0.38–0.67

0.16–0.31

0.38–0.44

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

ESR1

SD

0.66

0.22

0.42

0.35

0.27

0.00b

0.29

0.18

0.61

0.26

0.09

95 % CI

0.53–0.90

0.16–0.33

0.39–0.46

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

PGR

SD

0.00a

0.14

0.28

0.07

0.25

0.10

0.25

0.23

0.33

0.25

0.14

95 % CI

n.a.

0.11–0.20

0.26–0.30

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

MKI67

SD

0.40

0.14

0.31

0.19

0.27

0.10

0.26

0.08

0.38

0.27

0.12

95 % CI

0.32–0.55

0.10–0.23

0.29–0.34

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

  1. ainter-site variance is completely explained (covered) by inter-extraction variance
  2. binter-extraction variance is completely explained (covered) by intra-extraction variance