Design, development, testing and validation of a novel filter for integration into a home care test for the detection of Chlamydia trachomatis

Chlamydia trachomatis is one of the smallest bacteria (0.25 to 0.5 microns). It is an intracellular human pathogen that can be transmitted sexually. Genital chlamydial infections predominantly affects women between the age of 16 to 19 years and men between the age of 20 and 24 years. Infections are asymptomatic in approximately 50-80 % of all cases and therefore often remain undetected. If left untreated, in case of women Chlamydia sp. can cause ascending infection, these include, e. g., purulent inflammation of the urethra and cervix, as well as fallopian tubes inflammation and reactive arthritis (joint inflammation). The often asymptomatic progress of the infection promotes long term consequences such as infertility.
Since C. trachomatis infections are mostly treatable with antibiotic therapies, the primary task is to improve diagnostics to ensure early detection of pathogens in order to initiate therapy and to prevent propagation. The detection of C. trachomatis in urine (e. g. nucleic acid amplification assay), from swab of urethra or cervix and tissue samples, are conducted almost exclusively in specially equipped laboratories. The currently used proceeds are time consuming and expensive. At the moment only a few home care tests are available. The detection is mostly based on antigen detection with low specificity and sensitivity.
The SelfD Technologie GmbH has developed a test system for Chlamydia sp. in a project funded by the Sächsische Aufbaubank (SAB). Bacterial contamination in urine samples is detected using a high performance nucleic acid amplification technique (loop-mediated isothermal amplification - LAMP). However, a pre-enrichment of the pathogen by centrifugation is necessary.
The aim of the ZIM project in collaboration with SelfD Technologie GmbH is the design, development, testing and validation of a novel filter system for the enrichment of C. trachomatis without the need of a centrifuge or applying vacuum. The filter system will be designed to capture pathogens embedded in human cells as well as germs suspended in urine samples of several milliliters, within a few minutes. This system will then be embedded in the test system of SelfD Technologie GmbH described above.
Thereby a user-friendly, non-instrumented C. trachomatis test with the same features as complex professional laboratory tests will be provided for the home and point-of-care usage, for the first time.