|
Test parameter |
specification |
test result |
|
Positive control |
≥0.6 |
0.867 |
|
Negative control |
≤0.25 |
0.184 |
|
Positive rate |
20,Positive |
100% |
|
Negative rate |
20,Negative |
100% |
|
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%<15% |
|
Three samples of known concentration were tested in twenty assays to assess. |
