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Table 1 Performance and threshold of the multiplex PCR ctDNA assay for single mutation detection

From: Patient specific circulating tumor DNA fingerprints to monitor treatment response across multiple tumors

ctDNA concentration of standard 0% 0.10% 0.25% 0.50% 1.0% 3.0% 6.0% 10% 15%
 Number of replicates 157 160 160 160 157 155 157 157 157
 Observed allelic frequency
  Mean 0.065 0.122 0.276 0.577 1.132 3.380 6.358 9.858 15.2
  Std. deviation 0.062 0.113 0.168 0.268 0.197 0.466 0.751 0.900 1.142
  Std. error of mean 0.005 0.009 0.013 0.021 0.016 0.037 0.060 0.072 0.091
  Lower 95% CI of mean 0.055 0.105 0.250 0.536 1.101 3.306 6.239 9.716 15.080
  Upper 95% CI of mean 0.075 0.140 0.302 0.619 1.163 3.454 6.476 10.000 15.440
  Minimum 0 0 0 0.020 0.660 2.100 4.740 7.660 11.690
  25% percentile 0.010 0.030 0.123 0.373 1.010 3.050 5.800 9.290 14.310
  Median 0.050 0.070 0.285 0.555 1.110 3.410 6.310 9.760 15.260
  75% percentile 0.105 0.208 0.400 0.760 1.255 3.670 6.950 10.380 15.930
  Maximum 0.230 0.410 0.760 1.430 1.770 4.940 8.200 14.430 18.490
  Coefficient of variation 96.6% 92.2% 60.8% 46.4% 17.4% 13.8% 11.8% 9.1% 7.5%
  Sensitivity (%, threshold = 0.127%) NA 40.6% 75.0% 96.3% 100.0% 100.0% 100.0% 100.0% 100.0%
  1. NA not applicable