Analytical validation of the Oncotype DX prostate cancer assay – a clinical RT-PCR assay optimized for prostate needle biopsies

Table 3 Linear range

Gene Assay	Linear Range (ng/well)	Quadratic p-value	Cubic p-value	Maximum Absolute Deviation from Linearity
ARF1	2^-5.3 to 2^7.7	<.0001	0.1191	0.37
ATP5E	2^-3.3 to 2^7.7	<.0001	0.0418	0.82
AZGP1	2^-3.3 to 2^7.7	0.0006	0.1143	0.46
BGN	2^-5.3 to 2^7.7	0.0030	0.4064	0.57
CLTC	2^-5.3 to 2^7.7	0.0145	0.2198	0.28
COL1A1	2^-5.3 to 2^7.7	0.2406	0.0268	0.31
FAM13C1	2^-3.3 to 2^7.7	0.9180	0.0026	0.81
FLNC	2^-1.3 to 2^7.7	0.0002	0.0001	0.17
GPS1	2^-3.3 to 2^7.7	0.3704	<.0001	0.40
GSN	2^-2.3 to 2^7.7	<.0001	0.8081	0.57
GSTM2	2^-1.3 to 2^7.7	0.2461	0.0009	0.23
KLK2	2^-5.3 to 2^7.7	0.3600	0.0008	0.16
PGK1	2^-3.3 to 2^7.7	0.0224	0.5250	0.30
SFRP4	2^-2.3 to 2^7.7	0.5033	0.1019	N/A
SRD5A2	2^0.7 to 2^10.7	0.0002	0.1016	0.34
TPM2	2^-5.3 to 2^7.7	<.0001	0.2190	0.43
TPX2	2^0.7 to 2^10.7	0.5396	0.5799	N/A

N/A: No statistically significant departure from linearity.
Estimated linear ranges, associated p-values for quadratic or cubic regression models and maximum deviations from linearity for each of the 17 genes. The results were calculated using the data obtained from the 15-point dilution series.

ISSN: 1471-2164