| (A) |
2X Bi-Directional Sanger Sequencing |
MD
Codon 12/13 |
MD
Codon 61 |
NMD |
Total |
| cobas KRAS Kit Lot 1 |
MD Codon 12/13 |
90 |
0 |
6 |
96 |
| MD Codon 61 |
0 |
1 |
1 |
2 |
| NMD |
5 |
1 |
91 |
97 |
| Totals |
95 |
2 |
98 |
195a |
| Positive agreement, 93.8% (95% CI, 87.2%–97.1%); Negative agreement, 92.9% (95% CI, 86.0%–96.5%); Overall agreement, 93.3% (95% CI, 88.9%–96.1%) |
| (B) |
| |
2X Bi-Directional Sanger Sequencing |
MD
Codon 12/13 |
MD
Codon 61 |
NMD |
Total |
| cobas KRAS Kit Lot 2 |
MD Codon 12/13 |
90 |
0 |
8 |
98 |
| MD Codon 61 |
0 |
1 |
1 |
2 |
| NMD |
5 |
1 |
88 |
94 |
| Totals |
95 |
2 |
97 |
194a |
| Positive agreement, 93.8% (95% CI, 87.2%–97.1%); Negative agreement, 90.7% (95% CI, 83.0%–95.0%); Overall agreement, 92.3% (95% CI, 87.6%–95.3%) |
| (C) |
| |
2X Bi-Directional Sanger Sequencing and
Discordant Resolution |
MD
Codon 12/13 |
MD
Codon 61 |
NMD |
Total |
| cobasKRAS Kit Lot 1 |
MD Codon 12/13 |
96 |
0 |
0 |
96 |
| MD Codon 61 |
0 |
1 |
1* |
2 |
| NMD |
3* |
0 |
94 |
97 |
| Totals |
99 |
1 |
95 |
195a |
| Positive agreement, 97.0% (95% CI, 91.5%–99.0%); Negative agreement, 98.9% (95% CI, 94.3%–99.8%); Overall agreement, 97.9% (95% CI, 94.8%–99.2%); *All four samples with discordant results were at <5% mutation frequency. |
| (D) |
| |
2X Bi-Directional Sanger Sequencing and
Discordant Resolution |
MD
Codon 12/13 |
MD
Codon 61 |
NMD |
Total |
| cobas KRAS Kit Lot 2 |
MD Codon 12/13 |
98 |
0 |
0 |
98 |
| MD Codon 61 |
0 |
1 |
1* |
2 |
| NMD |
0 |
0 |
94 |
94 |
| Totals |
98 |
1 |
95 |
194a |
| Positive agreement, 100.0% (95% CI, 96.3%–100.0%); Negative agreement, 98.9% (95% CI, 94.3%–99.8%); Overall agreement, 99.5% (95% CI, 97.1%–99.9%) |
| *The sample with a discordant result was at <5% mutation frequency.MD mutation detected, NMD no mutation detected—wild-type for codons 12/13 and 61aN=194: One specimen is a double mutant (at codons 12 and 61) by Sanger sequencing. One of the 194 specimens produced an invalid result by cobas® Kit Lot 1. |
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