· Microtitre wells are coated with the purified human immunoglobulin IgG as an antigen.
· If present, specific antibodies bind to the antigen. The complex is labelled with Conjugate and detected through a colour reaction with substrate (TMB-Complete).
· The kit enables 96 tests (including controls and calibrators) within the microtitre plate made of colour-coded strips and breakable wells.
· High sensitivity and specificity.
· Total assay time: approximately 1.5 h.
· Calibrators (5, 20, 80, 320 U/ml) included.
· Semiquantitative evaluation using the index of positivity (IP) or quantitative evaluation in units U/ml.
· Reagents and substrate (TMB-Complete) are supplied in working strength.
· 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.
· Colour reagents for easy pipetting.
· Detection of rheumatoid factor in serum of patients with rheumatoid arthritis and, at lower frequency, also in case of other diseases (e.g. Sjögren´s syndrome, SLE or bacterial endocarditis).
· Checking of therapy results using the quantitative determination.
Brief assay procedure:
1. Dilute samples (1:101).
2. Pipette controls and diluted samples.
3. Incubate for 30 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.