Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples

Table 5 Confirmatory testing using routine reference approaches

Sample ID	Idylla™	Therascreen	Confirmatory result	Reference approach	VAF (%)
S8470	A146P/T/V	N/A	A146T	MPS	31
S8476	A146P/T/V	N/A	A146T	MPS	20
S8342	A146P/T/V	N/A	A146V	MPS	2
S9195	A146P/T/V	N/A	A146T	MPS	30
S8426	A146P/T/V	12VAL	A146V	Sanger	N/A
S8383	A146P/T/V	N/A	A146T	Sanger	N/A
S8397	K117N	12CYS	K117N	Sanger	N/A
S8250	K117N	N/A	Q61K	MPS	23
S8475	K117N	N/A	K117N	MPS	70
S8431	A59T/E/G	N/A	No mutation detected	MPS	N/A
S8233	Q61H	N/A	Q61H	Sanger	N/A
S8377	Q61H	N/A	Q61H	Sanger	N/A
S8956	Q61H	N/A	Q61H	MPS	42
S8494	G12V	12SER	G12V	MPS	37
S8546	G13D	12SER	G12C	MPS	33

Confirmatory testing of Idylla results using massive parallel sequencing (MPS) or Sanger Sequencing. Samples 1–13 were discordant-by-design mutations and Samples 14–15 were mutant-mutant discordants. Samples 1–13 were not taken into account for agreement calculations

ISSN: 1471-2407