TABLE 2.
QC levela | Sample matrix stabilityb |
Injection matrix stabilityc |
Heat stability (whole-blood DBS) or freeze-thaw cycles (plasma)d |
||||||
---|---|---|---|---|---|---|---|---|---|
Control mean | Treated mean | % Difference | Control mean | Treated mean | % Difference | Control mean | Treated mean | % Difference | |
Whole-blood DBS | |||||||||
RPT | |||||||||
Low | 161 | 153 | −4.97 | 156 | 156 | −0.51 | 144 | 142 | −1.32 |
Medium | 2,670 | 2,554 | −4.34 | 2,448 | 2,620 | 7.03 | 2,474 | 2,468 | −0.24 |
High | 65,320 | 62,780 | −3.89 | 66,720 | 68,300 | 2.37 | 67,160 | 66,380 | −1.16 |
desRPT | |||||||||
Low | 149 | 147 | −1.21 | 142 | 147 | 3.38 | 158 | 164 | 4.13 |
Medium | 2,374 | 2,486 | 4.72 | 2,278 | 2,308 | 1.32 | 2,656 | 2,734 | 2.94 |
High | 61,060 | 63,640 | 4.23 | 64,220 | 67,660 | 5.36 | 73,920 | 73,880 | −0.05 |
Plasma | |||||||||
RPT | |||||||||
Low | 131 | 141 | 7.65 | 130 | 138 | 6.63 | 148 | 148 | 0.11 |
Medium | 2,510 | 2,265 | −9.76 | 2,548 | 2,535 | −0.52 | 2,635 | 2,435 | −7.59 |
High | 70,150 | 66,625 | −5.02 | 72,550 | 67,650 | −6.75 | 70,150 | 68,200 | −2.78 |
desRPT | |||||||||
Low | 137 | 133 | −2.74 | 145 | 136 | −6.59 | 130 | 135 | 3.85 |
Medium | 2,743 | 2,605 | −5.01 | 2,652 | 2,682 | 1.13 | 2,775 | 2,588 | −6.76 |
High | 69,400 | 67,800 | −2.31 | 70,933 | 66,200 | −6.67 | 69,400 | 69,300 | −0.14 |
QC levels are defined as follows: low, 150 ng/ml; medium, 2,500 ng/ml; high, 70,000 ng/ml.
n = 5 for whole-blood DBS (2 days in the light at room temperature) and n = 4 for plasma (1 day in the light at room temperature).
n = 5 for whole-blood DBS (3 days in injection matrix on a reanalyzed curve) and n = 6 for plasma (5 days in injection matrix on a reanalyzed curve).
n = 5 for whole-blood DBS (1 day at 45°C with 100% humidity with samples stored in plastic bag with desiccant) and n = 4 for plasma (3 freeze-thaw cycles).