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Intra-assay Precision (Precision within an assay): CV%<8% | ||||||||||||
Three samples of known concentration were tested twenty times on one plate to assess. | ||||||||||||
Inter-assay Precision (Precision between assays): CV%<10% | ||||||||||||
Three samples of known concentration were tested in twenty assays to assess. | ||||||||||||
Intra-Assay PrecisionInter-Assay PrecisionSample123123n202020202020Mean(ng/ml)1.3541.2721.2161.1081.2411.297SD0.0340.0330.0260.0340.0430.046CV(%)3.7283.7673.0554.2454.9885.186 |
To assess the linearity of the assay, samples were spiked with high concentrations of human t-PA in various matrices and diluted with the Sample Diluent to produce samples with values within the dynamic range of the assay. | ||||||||||||
Sample | Serum(n=4) | |||||||||||
1:1 | Average % | 88 | ||||||||||
Range % | 84-92 | |||||||||||
1:2 | Average % | 94 | ||||||||||
Range % | 90-98 | |||||||||||
1:4 | Average % | 99 | ||||||||||
Range % | 95-104 | |||||||||||
1:8 | Average % | 102 | ||||||||||
Range % | 96-108 | |||||||||||
The recovery of human t-PA spiked to levels throughout the range of the assay in various matrices was evaluated. Samples were diluted prior to assay as directed in the Sample Preparation section. | ||||||||||||
Sample Type | Average % Recovery | Range | ||||||||||
Serum (n=5) | 89 | 83-96 | ||||||||||
EDTA plasma (n=4) | 100 | 95-105 | ||||||||||
These standard curves are provided for demonstration only. A standard curve should be generated for each set of samples assayed. | ||||||||||||
ng/ml | OD1 | OD2 | Average | Corrected | ||||||||
10 | 2.264 | 2.298 | 2.281 | 2.134 | ||||||||
5 | 1.841 | 1.869 | 1.855 | 1.708 | ||||||||
2.5 | 1.274 | 1.297 | 1.286 | 1.139 | ||||||||
1.25 | 0.862 | 0.897 | 0.880 | 0.733 | ||||||||
0.625 | 0.597 | 0.574 | 0.586 | 0.439 | ||||||||
0.313 | 0.415 | 0.439 | 0.427 | 0.280 | ||||||||
0.156 | 0.251 | 0.272 | 0.262 | 0.115 | ||||||||
0 | 0.146 | 0.148 | 0.147 | |||||||||
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