1)       Block Rate formula: [ ( OD of Negative Control ➖ OD of Sample) ÷ OD of Negative Control ]×100%.
2)       Immunization Qualified: Block Rate of the samples≥Block Rate of Critical Value.
3)       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 condition. 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.