recomWell Treponema IgG
recomWell Treponema IgM
Enzyme immunoassay with antigens produced by recombinant techniques for the deÂtecÂtion of IgG and IgM antibodies against Treponema pallidum
Treponema pallidum subsp. pallidum is the causative agent of Syphilis, a chronic disease occuring only in humans. The disease progresses through stages. After a short propagation period at the site of infection (primary stage) the hematogenic spreading of the pathogen throughout the entire organism follows (secondary stage). After the decline of acute symptoms Treponema pallidum can persist for years or lifetime in the human organism (stage of latency) and then can cause late complications (tertiary Syphilis). During pregnancy the pathogen can be transmitted to the fetus (Syphilis connata). In approximately 40 % of the cases infection results in abortion or death of the child shortly after birth. The propability of infection in utero is around 40-70 %.
The serodiagnosis of syphilis is performed in steps. As a rule, the T. pallidum hemagglutination assay (TPHA) is used as an antibody screening test. As modern screening test system, the recomWell Treponema IgG, IgM is an excellent alternative. The main advantages of the recomWell Treponema tests are the possibility to distinguish between IgG and IgM antibodies and the capacity to process large numbers of samples accompanied by an automated readout. In addition, by the use of purified, recombinant antigens, the recomWell Treponema tests offer a reproducible higher specificity with maximum sensitivity.
Product advantages
- Recombinant antigens, therefore
- Highest sensitivity and specificity
- No cross reactions
- Separate detection of IgG and IgM antibodies possible
- No RF absorbance necessary in the case of IgM determination
- Identical procedure for IgG and IgM determination
- Easy to quantify
- Easy test procedure; automation possible
- Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
- Break-a-parts: single simple examination possible
- CE label: The recomWell Treponema tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices.
Testprinciple and procedure
Indirect sandwich test.
Recombinant antigens are bound to the solid phase.
1st Incubation
Add patient samples diluted 1:101 (sample: 10 µl of serum or plasma), incubate for 1 h at 37 °C.
Wash 4 times
2nd Incubation
Add peroxidase conjugated anti-human IgG or IgM antibodies (conjugate), incubate for 30 min at 37 °C.
Wash 4 times
Color reaction
Add ready-to-use TMB solution and incubate for 30 min at room temperature. Stop the substrate reaction with H3PO4 and measure the extinction at 450 nm.
Recombinant Antigens
1) Norris SJ and the Treponema Pallidum Polypeptide Research Group Polypeptides of Treponema pallidum: Progress toward Understanding Their Structural, Functional, and Immunologic Roles. Microbiol. Rev. 1993, 57(3), 750-79
2) Chamberlain NR, Brandt ME, Erwin AL, Radolf, JD and Norgard MV Major integral membrane protein immunogens of Treponema pallidum are proteolipids. Infect. Immun. 1989, 57, 2872-7
3) Atkins DR, Purcell BK, Mitra MM, Norgard MV and Radolf JD Lipid modification of the 17-kilodalton membrane immunogen of Treponema pallidum determines macrophage activation as well as amphilicity. Infect. Immun. 1993, 61, 1202-10
