Table 3.
Transcript identity | Unique specimens | Valid measurements | Positive results | Detected, % | LOD (MR) | LOD (%IS) |
---|---|---|---|---|---|---|
e13a2 | 3 | 179 | 172 | 96.1 | 4.70 | 0.002 |
e14a2 | 7 | 420 | 400 | 95.2 | 4.70 | 0.002 |
The LOD of the test was estimated using Probit analysis (Figure 2) and validated using the nonparametric method, wherein >95% of all low-level specimens targeted near the expected LOD of MR4.7 (≥0.002%IS) were detected. MR measurements formed the definitive acceptance criteria. %IS values are shown for historical reference.
IS, international scale; LOD, limit of detection; MR, molecular response.