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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

 

Numbers

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
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BMC Cancer

ISSN: 1471-2407

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