The Chlamydia trachomatis DNA Real-Time PCR kit coded CTDNA.CE is intended for the qualitative detection of Chlamydia trachomatis DNA in human urethral/cervical swabs and urine with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).
The kit has been adapted for the use on the Real-Time Thermacyclers and ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) or MX3000P (Software MxPro version 4.01, Stratagene™***).
NTRODUCTION
Chlamydia trachomatis (CT), an obligate intracellular bacterium, is the most common sexually transmitted infection worldwide. CT infection may cause urethritis, cervicitis and pelvic inflammatory disease in women. Than 50% of Chlamydia trachomatis infections are asymptomatic, they may remain undetected for extended periods of time. Untreated or undiagnosed cervical infections in females can ascend into the upper genital tract, causing pelvic inflammatory disease and ectopic pregnancy. Infertility in males and females can result from untreated or undiagnosed chlamydial infections.
RINCIPLE OF THE TEST
The CTDNA.CE Kit is based on a Real Time chemistry which uses specific Primers and Probes.
Chlamydia trachomatis DNA, recovered from the biological sample under investigation through an extraction step, is amplified using Real Time amplification system. The amplified product is detected using a fluorescent reporter dye probe specific for a Chlamydia Trachomatis highly repeated (1 to 10 times) genomic sequence.
Heterologous Internal Control (IC) serves as an Extraction/Amplification control for each individually processed specimen aiming to the identification of reaction inhibitors.
An High Positive control (CTRL-H) and Low Positive control (CTRL-L) are supplied as controls for the PCR reaction.