Table 4.
LOQ Data
| Specimen no. | Transcript identity | Valid measurements | MR (mean) | SD | Result |
|---|---|---|---|---|---|
| 1 | e13a2 | 20 | 4.79 | 0.27 | Pass |
| 2 | e14a2 | 20 | 4.67 | 0.23 | Pass |
| 3 | e14a2 | 19 | 4.80 | 0.34 | Pass |
| 4 | e14a2 | 20 | 4.60 | 0.24 | Pass |
| 5 | e14a2 | 20 | 4.87 | 0.25 | Pass |
| 6 | e13a2 | 20 | 4.82 | 0.25 | Pass |
The LOQ of the assay was validated as MR4.7 (0.002% international scale) by measuring six low-level specimens across 119 valid measurements using two lots of the kit across 3 testing days. All specimens satisfied the error criteria (SDMR ≤ 0.36), supporting a limit beyond (and, therefore, constrained by) the limit of detection of MR4.70.
LOQ, limit of quantitation; MR, molecular response.