Table 4. The limits of detection for the Anyplex assay.

Concentration of mutant DNA (%)*	Positives/total runs	Mutation detection rate (%)
3.000	8/8	100
2.000	8/8	100
1.500	8/8	100
1.000†	8/8	100
0.500	8/8	100
0.100	8/8	100
0.050	8/8	100
0.010	4/8	50
0.005	4/8	50
0.001	1/8	12.5

^*The SNU-790 BRAF V600E-positive cell line was serially diluted with the DMPK-M BRAF V600E-negative cell line; ^†The limit of detection claimed by the manufacturer was 1.000% of BRAF mutations. All results were positive when the concentration was 0.050%. The limit of detection as determined by probit analysis was 0.046% (95% confidence interval:0.019-0.532). Reproducibility was verified at 1.000% and lower concentrations.