NewBio EIA Syphilis Test

The principle of the EIA test

The NewBio Syphilis (Treponema pallidum) EIA test 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 easy use and assay control.

Description

• One step sandwich assay for Syphilis IgG, IgM and IgA
• Recombinant antigens 15kDa, 17kDa and 47kDa
• All reagents ready to use (excluding 20 x wash buffer)
• Positive control
  Negative control
  Solid phase 8 well strips
  HRP conjugate
  TMB substrate
  Stop solution
  Wash buffer 20 x concentration
• Simple protocol: 2 x 30 minute incubations
  Manual
  Automatable
• Standard 50μL
• Sample and reagent check
  Single visual/readable color change (OD) upon addition of conjugate to sample

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 involving 100 syphilis positive samples showed 100% sensitivity (95% confidence limits 99.7–100%).

Detection limit

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

• Instructions for use / IFU (PDF)

Key features

• Quality assured – 25 years of experience
• Ready to use and stable liquid reagents
• 24-month shelf life at 2–8°C
• Qualitative protocols
• Results ready in 60 minutes
• Automated reading
• Suitable for automation
• Convenient kit sizes
• IVDR certified
• CH Rep available