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Table 2 Overview of precision studies

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

Study variable Study 1 Study 2
Samples 8 16
Intra-run replicates 3 3
Runs per device 6 9
Runs per day 2 1
Reagent lots per site 1 3/2a
Operators per site 1 1
Runs per site 6/12b 9/27c
Sites 3 3
Different qPCR instruments 4 4d
Operators 2 3
Total tests per device 48 144/288a
Total tests 192 720
  1. aThree different lots of MammaTyper and two lots of RNXtract were used at BioNTech Diagnostics to account for inter-lot precision
  2. bIncluding two devices at BioNTech Diagnostics
  3. cIncluding inter-lot precision and 1 Roche qPCR system at BioNTech Diagnostics
  4. dIncluding 1 Roche qPCR system at BioNTech Diagnostics in order to address variations caused by different instruments