1)         Block Rate formula: [ ( OD of Negative Control ➖ OD of Sample) ÷ OD of Negative Control ] × 100%.

2)         Block Rate of Critical Value = 1:64 Liquid phase ratio.

3)         Immunization Qualified: Block Rate of the samples ≥ Block Rate of Critical Value.

4)         Immunization Unqualified: Block Rate of the samples ＜ Block Rate of Critical Value.

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 OD_450nm＞0.50.