CE 0483 IVD
The Chlamydia trachomatis PCR kit is provided for fast and qualitative detection of Chlamydia trachomatis DNA in samples extracted from urethral swab specimens, endocervical and vaginal smears, urine samples, by means of Real-Time PCR for diagnosis of C. trachomatis presence.
| Assay Principle
|| Real-time PCR kit for detection of chlamydiosis
| Test results
||Total DNA can be extracted from urethral swab specimens, endocervical and vaginal smears, urine samples
||600 copies of genomic DNA of Chlamydia trachomatis/ mL / mL
| Controls included in the kit
|| positive control
internal control for monitoring DNA extraction and PCR amplification steps
|| DNA Extraction
Analysis of data
| Validated extraction methods
Multi DNA Extraction kit (Astra Biotech GmbH)
Rapid DNA Extraction kit (Astra Biotech GmbH)
-30°C, transportation for 7 days at room temperature possible
||for in-vitro Diagnostics, CE 0483
|| REF 84-09 - 112 tests
REF 84-09-56 - 56 tests
REF 84-09-24 - 24 tests
| REF 84-10 - 112 Tests
REF 84-10-56 - 56 Tests
REF 84-10-24 - 24 Tests
| Format Description
|| Liquid reaction mixes aliquoted in 0.2 ml low profile 8-well strips
|| Liquid reaction mixes aliquoted in 0.2 ml regular profile tubes
| Kit content
||PCR-Mix C. trachomatis, Taq DNA polymerase, positive control, internal control, negative control
||PCR Mix C. trachomatis, Taq DNA polymerase, positive control, internal control, negative control
| Validated Thermocycler
||CFX96, Light Cycler 96 (LC 96), DTprime, DTlite, SaCycler
||Rotor-Gene Q, Rotor-Gene 3000/6000
Infections with members of the family Chlamydiaceae (Chlamydia), 0,2-0,4 μm Gram-negative bacteria, are called chlamydioses.
Chlamydia infects epithelial cells of the urogenital tract or respiratory tract in humans and is one of the largest causes of bacterial urogenital infections worldwide. One of the most prominent representatives is Chlamydia trachomatis.
An urogenital infection with chlamydia is completely symptomless in about 70% to 80% of women and in 50% of men. In women, such an infection can lead to a painful inflammation of the female genital tract, which can result in perihepatitis and sealing of the fallopian tubes. This in turn may be the reason for the absence of pregnancy of the affected patients and be remedied only in about 20% to 60% of cases by means of surgery. In men, an acute chlamydial infection can lead to inflammation of the genitourinary tract, characterized by pain on urination and, if left untreated, to inflammation of the epididymis. An influence on the fertility of the man is also considered possible.
For these reasons, the early diagnosis of an acute chlamydial infection in women and men is of crucial importance in order to treat them and their sexual partner in time with antibiotics.