Table 6.
Stability data established in the method validation.
Analyte Name | GS-5734 | GS-441524 | GS-704277 |
---|---|---|---|
Stock Solution Stability in | 243 Days at −20 °C | 243 Days at −20 °C | 70 Days at −20 °C |
Acetonitrile:Dimethyl Sulfoxide at 50:50 (v:v) | 8 h at RT | 8 h at RT | 6 h at RT |
Processed Sample Stability | 145 h at 4 °C | 155 h at 4 °C | 185 h at 4 °C |
Benchtop Stability in Formic Acid-Treated Plasma | 8 h in an Ice Bath | 8 h in an Ice Bath | 8 h in an Ice Bath |
Freeze/Thaw Stability in Formic Acid-Treated Plasma | 5 Cycles at −20 °C and −70 °C | 5 Cycles at −20 °C and −70 °C | 5 Cycles at −70 °C |
Benchtop Stability in Whole Blood | 4 h in an Ice Bath | 4 h in an Ice Bath | 4 h in an Ice Bath |
Long-term Storage Stability in Formic Acid-Treated Plasma |
392 Days at −70 °C | 392 Days at −70 °C | 257 Days at −70 °C |
3 Days at −20 °C | 3 Days at −20 °C | ||
Gamma-Ray Irradiation Stability at Required Radiation Dose of 5 Mrad on Dry Ice for Virus load < 1 × 106 TCID50 | No impact on assay performance | No impact on assay performance | Data negative bias (impact on assay performance) |