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Table 4.

Sensitivity and specificity of the system

Sensitivity Specificity
PNA‐LNA PCR clamp for mutations with detection probes  1.00 1.00
PNA‐LNA PCR clamp for all mutations >0.98 1.00
Cancer cell content is more than 1%  0.99 § 1.00
Overall >0.97 1.00

Our system detects 267 out of 269 mutation occurrences listed in Fig. 2C. Step 3 detects 240 occurrences (89%). Step 4 detects additional 27 occurrences (10%). Two occurrences which failed to be detected are those of G719A.

More than 200 controls did not demonstrate any false results.

§

At Step 2, 59 of 59 specimens had a cancer content of more than 1% (see Fig. 4).

Specificity of the pathological examination is assumed to be 1.0 in this study. PNA‐LNA PCR, peptide nucleic acid‐locked nucleic acid polymerase chain reaction.