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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%<15% |
| Three samples of known concentration were tested in twenty assays to assess. |
Test parameter | specification | test result | ||||||
Positive control | >0.8 | 1.174 | ||||||
Negative control | <0.20 | 0.187 | ||||||
Positive rate | 20,Positive | 100% | ||||||
Negative rate | 20,Negative | 100% | ||||||