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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