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Intra-assay Precision (Precision within an assay): CV%<15% | ||||||
Three samples of known concentration were tested twenty times on one plate to assess. | ||||||
Inter-assay Precision (Precision between assays): CV%<20% | ||||||
Three samples of known concentration were tested in twenty assays to assess. |
To assess the linearity of the assay, samples were spiked with high concentrations of human CA19-9 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 % | 96 | ||||
Range % | 90-110 | |||||
1:2 | Average % | 89 | ||||
Range % | 85-99 | |||||
1:4 | Average % | 93 | ||||
Range % | 87-101 | |||||
1:8 | Average % | 95 | ||||
Range % | 89-98 |
The recovery of human CA19-9 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) | 97 | 93-100 | ||||
EDTA plasma (n=4) | 97 | 90-101 |
These standard curves are provided for demonstration only. A standard curve should be generated for each set of samples assayed. | ||||||
U/ml | OD1 | OD2 | Average | |||
150 | 2.045 | 2.011 | 2.028 | |||
100 | 1.292 | 1.300 | 1.296 | |||
40 | 0.728 | 0.735 | 0.732 | |||
10 | 0.304 | 0.306 | 0.305 |
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