MERISCREEN Syphiline is a single test device for the qualitative detection of Syphilis antibodies (IgM, IgG & IgA) in Human Serum/Plasma/Whole Blood samples
| Intended Use | One step test for qualitative detection of antibodies against Treponema pallidum |
| Principle | Sandwich Immunoassay |
| Technique | Lateral flow (ICT) |
| Detection | Antibodies to Treponema pallidum (IgM, IgG and IgA) |
| Capture | Treponema pallidum antigens (15kDa, 47kDa, 17kDa) |
| Conjugate | Recombinant Treponema pallidum antigens (15kDa, 47kDa, 17kDa)-Colloidal gold |
| Type of Specimen required | Serum, Plasma and Whole Blood |
| Specimen Volume | 10 ml for Serum and Plasma; 20 ml for whole blood |
| Result interpretation time | 20 minutes |
| Diagnostic Sensitivity | 100% |
| Diagnostic Specificity | 100% |
| Evaluations | National Institute of Biologicals |