Intended use:

For in vitro diagnostic use. This RIDASCREEN® Chlamydia IgG/IgM test is a enzyme immunoassay for the determination of IgG and/or IgM antibodies against Chlamydia (C.) species in human serum. The tests should be used for confirmation purposes when there is a suspected case of infection with Chlamydia or for clarifying the immune status.

General information:

In the group of the Chlamydia, there are three human pathogens: Chlamydia trachomatis, Chlamydophila psittaci and Chlamydophila pneumoniae. Chlamydia trachomatis is the most frequently sexually transmitted bacterial pathogen worldwide. Previously it was generally thought that Chlamydia pneumoniae was a subspecies of Chlamydia psittaci. The existence of this third Chlamydia species was established in 1989. More recent investigations have led to the formation of the genus Chlamydophila and herewith to a separation of the two respiratory pathogens from the sexually transmitted Chlamydia trachomatis. Depending on factors specific to the host, Chlamydophila pneumoniae can give rise acute diseases of the upper respiratory system, bronchi and lung. Chlamydophila psittaci is pathogen which is very common among birds and mammals. With humans, it occurs only rarely and usually causes respiratory disorders. Antigen detection (smear) or determination of serum antibodies is necessary for diagnosis of a Chlamydia infection. LPS antigen shows a high cross-reactivity between the different species. Antibodies against all three species can react in an ELISA based on LPS.

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. KGM3101
Test format Article no. KGM3101
Chlamydia IgG/IgM (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 96.0% (IgG)
92.0% (IgM)
Specificity 98.0% (IgG)
100.0% (IgM)
Files
InstructionsGerman
English
Spanish
French
Italian
SDSKGM3101_german.zip (German)
KGM3101_french.zip (French)
KGM3101_english.zip (English)
KGM3101_spanish.zip (Spanish)
KGM3101_italian.zip (Italian)
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