Intended use:

For in vitro diagnostic use. The RIDASCREEN® Chlamydia trachomatis IgG/IgM test is a enzyme immunoassay for the determination of IgG and/or IgM antibodies against Chlamydia (C.) trachomatis in human serum.

The test should be used for confirmation purposes when there is a suspected case of infection with C. trachomatis or for clarifying the immune status.

General Information:

Chlamydia trachomatis (serotype D – K) is the most frequently sexually transferred bacterial pathogen. Symptoms are urethritis, cervicitis or salpingitis. Progressive infection can lead to peritonitis and perihepatitis. The newborn children of infected mothers can develop conjunctivitis or pneumonia. Other C. trachomatis serotypes (A – C) cause trachomatous conjunctivitis transferred by smear infection. The lymphogranuloma venereum is also a sexually transmitted disease and caused by serotypes L1 – L3. C. trachomatis has many morphological, cultural and antigenic similarities to Chlamydophila trachomatis and Chlamydophila psittaci, which makes the laboratory diagnosis difficult. Chlamydia are intracellular living bacteria. Therefore suited cell material sampling for antigen detection or determination of serum antibodies is necessary for diagnosis of a Chlamydia infection. Where antigen collection is difficult, the antibody method is preferred. Use of the of the outer-membrane-protein-complexes (COMP) in a test is important for antibody detection. Only by this antibodies are detectable specifically against C. trachomatis.

Test principle:
Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second incubation step by using enzyme-labelled anti-human antibodies (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.

Specifications
Art. No. KGM2901
Test format Article no. KGM2901
Chlamydia trachomatis IgG/IgM (96 determinations)

Article no. K2911
Chlamydia trachomatis IgA (96 determinations)

Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)
Incubation time 45 min at 37 ºC / 30 min at 37 ºC / 20 min at RT
Sensitivity 95.0% (IgA)
96.0% (IgG)
90.0% (IgM)
Specificity 98.0% (IgA)
100.0% (IgG)
100.0% (IgM)
Files
InstructionsGerman
English
French
SDSKGM2901_german.zip (German)
KGM2901_french.zip (French)
KGM2901_english.zip (English)
KGM2901_spanish.zip (Spanish)
KGM2901_italian.zip (Italian)
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