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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 | 1.124 | |||||||||
Negative control | <0.1 | 0.045 | |||||||||
Positive rate | 10,Positive | 100% | |||||||||
Negative rate | 10,Negative | 100% | |||||||||