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| Test parameter | specification | test result | |||||||
| Positive control | >1.0 | 1.482 | |||||||
| Negative control | <0.1 | 0.084 | |||||||
| Positive rate | 10，Positive | 100% | |||||||
| Negative rate | 10，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. | |||||||||
