Syphilis EIA Total Antibody

principle of the test

NewBio-Syphilis TA is a one step sandwich assay using recombinant antigens for enhanced sensitivity and specificity. The assay is for use with plasma and serum samples and will detect antibodies at all stages of infection. Antibodies are captured by recombinant antigens on the plate and marked by HRP recombinant conjugates for visualisation with TMB substrate. The reagents and protocol ensure ease of use and assay control.

Specificity

A study on 300 donor serum showed 100% specificity. (95% confidence limits 99.7-100%)

A study on 300 donor EDTA plasma showed 100% specificity. (95% confidence limits 99.7-100%)

Sensitivity

A study on 100 syphilis positive samples showed 100% sensitivity. (95% confidence limits 99.6-100%)

Analytical Sensitivity

NewBio-Syphilis TA has a sensitivity of 0.0015 IU/ml against the 1st IS for human syphilitic plasma IgG and IgM NIBSC code: 05/132