Table 3.
Summary of Stability Parameters for ELX, TEZ, and IVA Detection
| %DEV (%CV) | ||||||
|---|---|---|---|---|---|---|
| 10 ng/mL | 30 ng/mL | 2000 ng/mL | 8000 ng/mL | 30,000 ng/mL | ||
|
| ||||||
| A&P (intra-day) matrix: plasma |
ELX | −6.8 (9.3) | −8.3 (6.6) | −4.7 (8.8) | −0.5 (3.1) | - |
| TEZ | −10.2 (5.6) | −9.3 (3.4) | −3.5 (8.6) | 0.9 (4.1) | - | |
| IVA | 6.8 (5.1) | −1.9 (4.6) | −5.2 (2.0) | −2.0 (0.8)_ | - | |
|
| ||||||
| A&P (intra-day) matrix: cell lysate |
ELX | −5.4 (6.1) | −1.1 (8.2) | 3.2 (7.8) | 2.9 (6.3) | - |
| TEZ | −4.9 (5.8) | 5.4 (3.3) | 4.6 (6.4) | 3.3 (7.1) | - | |
| IVA | −3.1 (4.6) | 6.2 (3.8) | 4.9 (5.3) | 1.3 (2.9) | - | |
|
| ||||||
| A&P (inter-day) matrix: plasma |
ELX | −2.3 (8.9) | −4.7 (5.6) | −6.0 (5.4) | −2.2 (2.8) | - |
| TEZ | −6.6 (6.3) | −5.0 (4.8) | −4.3 (4.9) | −0.8 (2.8) | - | |
| IVA | −2.6 (11.0) | −4.5 (6.9) | −4.1 (5.2) | −0.5 (3.1) | - | |
|
| ||||||
| A&P (inter-day) matrix: cell lysate |
ELX | −1.0 (3.9) | 4.3 (11.5) | 5.9(7.3) | 7.3 (4.1) | - |
| TEZ | −2.0 (3.7) | 9.8 (3.7) | 7.0 (5.2) | 6.2 (2.9) | - | |
| IVA | 0.8 (3.1) | 10.6 (4.6) | 7.6 (1.1) | 2.1 (1.0) | - | |
|
| ||||||
| Partial Volume/Dilution Integrity | ELX | - | - | −8.4 (5.6) | - | −6.1 (2.5) |
| TEZ | - | - | −11.1 (4.2) | - | −4.2 (2.0) | |
| IVA | - | - | −8.9 (4.3) | - | −3.3 (1.5) | |
|
| ||||||
| Freeze/Thaw 10 cycles |
ELX | - | −2.2 (3.4) | - | −0.2 (2.1) | - |
| TEZ | - | −1.2 (2.4) | - | −3.3 (1.9) | - | |
| IVA | - | −0.6 (4.4) | - | −5.3 (3.4) | - | |
|
| ||||||
| Plasma Stability 324 days @ −80°C |
ELX | - | 5.3 (4.7) | - | 6.7 (5.1) | - |
| TEZ | - | −0.8 (1.7) | - | −1.0 (4.8) | - | |
| IVA | - | −2.0 (2.9) | - | 0.7 (3.9) | - | |
|
| ||||||
| Plasma Stability 667 hours @ Ambient (≈24°C) |
ELX | - | −1.4 (4.1) | - | 4.6 (0.8) | - |
| TEZ | - | 0.1 (2.7) | - | 0.8 (1.2) | - | |
| IVA | - | 3.1 (4.2) | - | 2.4 (2.8) | - | |
|
| ||||||
| −11.2 | ||||||
| Post Preparative Reinjection Stability 96 hours @ 15°C Original Curve |
ELX | - | (4.3) | - | −8.6 (2.6) | - |
| TEZ | - | −7.3 (3.7) | - | −4.7 (1.6) | - | |
| IVA | - | 0.8 (3.3) | - | −2.6 (1.3) | - | |
|
| ||||||
| Post Preparative Reinjection Stability 96 hours @ 15°C Reinjected Curve |
ELX | - | −0.7 (4.3) | - | 0.7 (2.5) | - |
| TEZ | - | −6.1 (3.7) | - | −2.2 (1.6) | - | |
| IVA | - | 2.4 (3.3) | - | −0.7 (1.3) | - | |
| Post Preparative Stability 99 hours @ 15°C |
ELX | - | −1.6 (3.7) | - | −0.8 (1.4) | - |
| TEZ | - | 0.7 (2.5) | - | −0.5 (0.8) | - | |
| IVA | - | 1.9 (5.3) | - | −0.3 (1.0) | - | |
Calculations determined from n=6 replicates from n=1 run, except inter-day A&P which had n=18 replicates across n=3 runs