INTRODUCTION

Strip-Immunoassay with antigens produced by recombinant techniques for the detection of IgG, IgA and IgM antibodies against Chlamydia trachomatis, Chlamydophila pneumoniae and Chlamydophila psittaci

Chlamydia trachomatis is worldwide one of the most causative agents of sexually transmitted diseases with an incidence of about 50 million diseases. Besides the urogenital tract, eyes and the respiratory tract of newborns can be infected by Chlamydia trachomatis. The clinical pictures involve primarily urethritis, Trachoma, Lymphogra­nuloma venereum and can finally cause sterility, conjunctivitis and reactive arthritis.

The importance of the 1986 identified bacterium Chlamydophila pneumoniae is shown by a serological prevalence of about 50%. C. pneumoniae infects mainly the respiratory tract and causes bronchitis, pneumonia and sinusitis amongst others.

Chlamydophila psittaci is the causative agent of ornithosis, a rare anthropozoonosis in Germany. Chlamydia psittaci infects usually only persons which have contact to pet birds and farmbirds.

The recomLine Chlamydia is the only test system, which allows the detection of the immune response against all three humano pathogen Chlamydia-species in one step and on one strip. Primarily it has been designed as a confirmatory assay but it can also be applied as a screening assay. The recomLine Chlamydia comprises of different recombinant, species specific antigens sprayed onto nitrocellulose strips so that it is possible to detect IgG, IgA and IgM antibodies against immunodominant antigens of C. trachomatis, C. pneumoniae and C. psittaci.

PRODUCT ADVANTAGES

• New recombinant speziesspecific antigens (CFAF, TARP, YwbM (only for C. pneumoniae))
• Separate detection of IgG, IgA and IgM antibodies possible
• Safe evaluation due to strip specific controls (cut-off and conjugate control)
• Clarification of the immunestatus of a possible C. trachomatis, C. pneumoniae and C. psittaci - infection in one step and on one strip possible
• The only assay of a specific serological diagnostic of C. psittaci
• Easy test procedure; automation possible - easy and objective evaluation and documentation by recomScan software
• Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable
• Application as well as screening as confirmationassay possible
• CE label: The recomLine Chlamydia tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
A test strip loaded with Chlamydia antigens is incubated with diluted serum or plasma in a dish for 1 hour.

wash 3 times

2^nd Incubation
Peroxidase conjugated anti-human antibodies (IgG, IgA or IgM specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
5 - 10 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

RECOMBINANT CHLAMYDIA ANTIGENS

EXAMPLES

Determination of the immunostatus of different patients after infection with Chlamydia trachomatis, Chlamydophila pneumoniae and Chlamydophila psittaci in one onset.

STORAGE AND SHELF LIVE

At 4 °C 18 months from the date of production

COMMERCIAL PRODUCT