Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Treponema pallidum (Tp) in human plasma and sera.

The kit is for use in screening of blood units and the follow-up of Tp-infected patients. For “in vitro” diagnostic use only.

Microplates are coated with purified Treponema pallidum synthetic antigens, derived from immunodominant protein of the bacterium.

The solid phase is first treated with the diluted sample and captures antibodies if present. After the washing step, the specifically bound antibodies are detected with an anti-human IgG&M antibody, labeled with peroxidase (HRP).

A substrate/chromogen solution is added and the intensity of the color developed by the bound enzyme is proportional to the amount of anti-Tp antibodies in the sample. Results are evaluated against a cut-off value able to discriminate Treponema pallidum antibody negative individuals from positive ones.