· Microtitre wells are coated with the monoclonal antibody to human IgM.
· Total IgM antibodies in the sample, including the specific anti-T.pallidum antibodies (if present), bind to the anti-human IgM antibodies in quantities proportionate to their presence.
· Specific antibodies bound to the solid phase are subsequently labelled with the Conjugate (containing specific antigens of T. pallidum, particularly p47 and p17 conjugated with horseradish peroxidase) and detected through colour reaction with substrate (TMB-Complete).
· III. generation kit, high sensitivity and specificity.
· The kit enables 96 tests (including controls) within the microtitre plate made of colour-coded strips and breakable wells.
· Total assay time: approximately 2 h 15 min.
· CUT-OFF included.
· Semiquantitative evaluation using the index of positivity (IP).
· Sample diluent, TMB-Complete and Avidity Solution are interchangeable if provided with identical numeric marking (i.e. Sample Diluent 2, Sample Diluent 3, etc.). Stop Solution and Wash Solution are interchangeable in all TestLine kits.
· Reagents are supplied in final working strength.
· Colour reagents for easy pipetting.
· Shelf life: 12 months.
· Highly sensitive and specific ELISA method for detection of anti-treponema IgM antibodies is suitable for screening as well as confirmation of non-treponemal (VDRL, RPR, etc.) and treponemal (TPHA, etc.) test results.
· Determination of IgG and IgM antibodies enables to distinguish between contemporary and previously undergone infection, diagnostics of congenital infection, antibiotic treatment efficiency monitoring.
Brief assay procedure:
1. Dilute serum/plasma samples (1:51).
2. Pipette controls and diluted samples.
3. Incubate for 60 min at 37 °C.
4. Aspirate and wash the wells 5 times.
5. Add Conjugate.
6. Incubate for 30 min at 37 °C.
7. Aspirate and wash the wells 5 times.
8. Add substrate (TMB-Complete).
9. Incubate for 30 min at 37 °C.
10. Add Stopping solution (H2SO4).
11. Read photometrically at 450 nm.
12. Evaluate results.