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1)         Block Rate formula: [(Negative Control O.D. ?Sample O.D.)÷Negative Control O.D.]×100%;

2)         Immunization Qualified: Block rate of samples ≥ 40%.

3)         Immunization Unqualified: Block rate of samples ＜40%.

1)      Sensitivity: 100%

2)      Specificity: there is no cross-reaction with other substances in the samples.

3)      Security: Pre-coated antigen, HRP-conjugated antibodies and controls only have immunogenicity, non-microorganism toxicity and infectivity.

4)      Intra-assay: CV＜10% (n=3).

5)      Inter- assay: CV＜15% (n=9).

6)      The experimental results should meet the following conditions. Should any of these criteria not be fulfilled, the test is invalid and the assay should be repeated: Mean OD of Negative control is OD450nm＞0.50.