recomWell Chlamydia trachomatis IgG
recomWell ChIamydia trachomatis IgA
Enzyme immunoassay with antigens produced by recombinant techniques for the detection of IgG and IgA antibodies against Chlamydia trachomatis in serum and plasma
Chlamydia trachomatis is one of the most common causes of sexually transmitted diseases (STD) in industrial nations. According to estimations of the US Center for Disease Control and Prevention (CDC), more than 700 million people are infected with Chlamydia trachomatis worldwide. The annual incidence is 50 million cases, in Germany approximately 1.15 million.
19 different serotypes of Chlamydia trachomatis are known, causing different ranges of disease. Serotypes A-C cause trachoma, a chronic inflammation of the eye (keratoconjunctivitis), which is the most common cause of preventable blindness worldwide (distribution: Africa, Asia, Australia, Oceania). Serotypes L1-L3 are prevalent in tropical regions and are sexually transmitted. The clinical picture (lymphogranuloma venereum) shows heavily inflamed genital ulcers with partially purulent swollen lymph nodes. Similarly, sexually transmitted in the northern hemisphere (industrial nations) are the serotypes D-K which may cause sterility or arthritis after infections of the genitals or the joints both in women and in men. Perinatal transmission of the pathogen from the infected mother to the newborn results in the so-called neonatal conjunctivitis or neonatal pneumonia.
The primary infection often persists in an uncharacteristic and oligosymptomatic clinical course, thus supporting proliferation and spread of the infection. Since a primary infection apparently does not induce complete immunity, reinfections are not a rare event. Accordingly, the therapy is often a tedious process and will only be successful if antibiotics, which reach a high intracellular active ingredient level, are used. According to the course of Chlamydia infection an antibiotic therapy of the respective sexual partner(s) is recommended to avoid reinfections and increase the success of therapy.
Product advantages
- Recombinant antigens:
- High sensitivity and specificity
- Excellent discrimination between negative and positive results
- New species specific recombinant Chlamydia trachomatis antigens TARP and CPAF in addition to the approved MOMP antigen clearly reduce cross-reactivities with C. pneumoniae
- Optimised use for diagnosis of tubal factor infertility caused by Chlamydia trachomatis
- 3-fold increase of IgA-sensitivity compared to gold standard MIF together with both consistent specificity in IgG / IgA and consistent sensitivity in IgG
- Shortening of the diagnostic window for PCR
- Separate detection of IgG and IgA antibodies possible
- Identical procedure for IgG and IgA determination
- Easy to quantify
- Easy test procedure; automation possible
- Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
- Break-a-parts: Single sample examination possible
- CE label: The recomWell Chlamydia trachomatis 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 IgA 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.
Evaluation
Specificity
1 C. pneumoniae positive / C. trachomatis negative (IgG: n=32/79; IgA: n= 7/94) using recomLine Chlamydia
Seroprevalence
2 Mikrogen serum bank (n=41) and Großhadern Hospital, Department of Obstetrics and Gynecology Grosshadern, Ludwig Maximilians University, Munich, Germany, (n=76)
3 Schwabing Hospital, Munich, Germany, (n=9) and University Hospital Freiburg, Germany, Department of Pediatrics and Adolescents (n=31)
Sensitivity
4 Method: SDA (strand displacement amplification), Laboratory Enders and Partner, Stuttgart, Germany
5 MIF: In-House Micro immuno fluorescence assay, Laboratory Enders and Partner, Stuttgart, Germany
