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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 | 1.065 | |||||||||
Negative control | <0.20 | 0.163 | |||||||||
Positive rate | 10,Positive | 100% | |||||||||
Negative rate | 10,Negative | 100% |
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