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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%<20% | ||||||||
Three samples of known concentration were tested in twenty assays to assess. | ||||||||
Test parameter | specification | test result | ||||||
Positive control | ≥0.45 | 1.195 | ||||||
Negative control | ≤0.1 | 0.037 | ||||||
Positive rate | 10,Positive | 100% | ||||||
Negative rate | 10,Negative | 100% |
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