ANA 8, DIAspot

The test is based on the principle of an Enzyme Immunoassay.

The test strip is composed of a membrane fixed on a plastic support.

During test procedure, the strips are incubated with diluted patients’ sera. Human antibodies, if present, bind to the corresponding specific antigen(s) on the membrane.

Unbound or excess antibodies are removed by washing and AP-conjugated goat antibodies against human IgG are added to the strips.

This enzyme conjugate binds to the antigen-antibody complexes.

After a second washing step to remove excess conjugate, substrate solution is added.

Enzyme activity, if present, leads to the development of purple dots on the membrane pads.

The intensity of the coloration is directly proportional to the amount of antibody present in the sample.

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For registration requirements in countries outside of European market, please contact regulatory.affairs@diasource.be.