Table 1 Summary of method validation data
Parameters | YPEIEEK (P1) | GTVVVPTLDSVLYDNQEFPDPEK (P2) | IS-P1 | IS-P2 | ||||
|---|---|---|---|---|---|---|---|---|
Linear range | 5–100,000 fg/µl | 100–12,500 fg/µl | NA | NA | ||||
Linearity | r2 = 0.991 ± 0.007 | r2 = 0.998 ± 0.001 | NA | NA | ||||
LLOQ | 5 fg/µl | 100 fg/µl | NA | NA | ||||
Specificity | CV = 4.0 ± 0.04 % | CV = 15.9 ± 0.42 % | CV = 2.42 ± 0.05 % | CV = 14.2 ± 0.57 % | ||||
Quality control: | L | M | H | L | M | H | NA | NA |
Intra-day | ||||||||
Accuracy, % | 99.2 | 99.8 | 98.2 | 41.0 | 69.2 | 70.6 | NA | NA |
Precision, CV% | 3.64 | 4.79 | 10.93 | 55.14 | 5.32 | 17.13 | NA | NA |
Inter-day | ||||||||
Accuracy, % | 91.75 | 105.08 | 90.09 | 70.8 | 82.6 | 84.14 | NA | NA |
Precision, CV% | 9.76 | 4.56 | 0.77 | 42.54 | 12.62 | 20.13 | NA | NA |