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Intra-assay Precision (Precision within an assay):Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision.
Intra-Assay CV: ≤3.2
Inter-assay Precision (Precision between assays):Three samples of known concentration were tested in five separate assays to assess inter-assay precision.
Inter-Assay CV: ≤7.1
Recovery was determined by spiking various levels of Alpha-amylase 1 into serum and plasma .
Sample Type |
Average(%) |
Recovery Range (%) |
Serum |
96 |
92-103 |
Plasma |
89 |
79-95 |
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Alpha-amylase 1 and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.
Sample |
1:2 |
1:4 |
1:8 |
1:16 |
serum(n=5) |
89-98% |
93-105% |
95-103% |
92-105% |
EDTA plasma(n=5) |
95-103% |
90-99% |
89-95% |
84-97% |
heparin plasma(n=5) |
85-94%
|
85-97% |
88-101% |
92-101% |
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