Table 1 Overview of True Dose kit versions and experimental Use; comparison of design features and specific experimental applications of True Dose kit versions 1.0 to 4.0 evaluated in 2024 for analytical equivalence, stability, and clinical validation studies.
Feature | 1.0 | 2.0 | 3.0 | 4.0 |
|---|---|---|---|---|
Release Date | May 2024 | October 2024 | November 2024 | December 2024 |
Matrix Type | PP version 1.0 | PP version 2.0 | PP version 3.0 | PP version 3.0 |
Internal Standard (Conc.) | 400 nM Dox/Dauno + additives | 1 µM Dox/Dauno + additives | 1 µM Dox/Dauno + additives | 1 µM Dox/Dauno + additives |
Microtube Volume | 1.5 mL | 1.5 mL | 2.0 mL | 2.0 mL |
Precipitation Solvent Volume | 500 µL | 500 µL | 1000 µL | 1000 µL |
Precipitation Solvent Composition | Organic solvents mixture | Organic solvents mixture | Organic solvents mixture | Organic solvents mixture |
Steel Beads for mixing | Yes | Yes | Yes | Yes |
Sample Volume (Blood) | 20 or 50 µL | 50 µL | 50 µL | 50 µL |
Incubation time prior analytical work up | 18 h, 3 days, 7 days, 14 days | 3 days | 3 days | 3 days |
Used for | Analytical equivalence, post-activation stability, hematocrit and initial clinical evaluation | Pre-activation stability and clinical evaluation | Pre-activation stability and clinical evaluation | Final analytical equivalence and pre/post-activation stability. |
