AffiPCR® Chlamydia trachomatis Real Time PCR

Target Disease Type: Sexually trasmitted diseases

Specific Application: Chlamydia trachomatis

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Chlamydia trachomatis RT-PCR (CE) B1-100FRT DataSheet

INTRODUCTION

STDs (sexually transmitted diseases) refer to a variety of bacterial, viral and parasitic infections that are acquired through sexual activity. Some STDs, such as syphilis and gon[1]orrhea, have been known for centuries — while others, such as HIV, have been identified only in the past few decades. STDs are caused by more than 25 infectious organisms. As more organisms are identified, the number of STDs continues to expand. Common STDs include: chlamydia, gonorrhea, herpes, HIV, HPV, syphilis, gardnerella and trichomoniasis.

The Chlamydia trachomatis is nonmotile, gram-negative bacterial pathogen and is the most common sexually transmitted bacterial agent. The prevalence of C. trachomatis infection in sexually active adolescent women, the population considered most at risk, generally exceeds 10%, and in some adolescent and STD clinic populations of women, the prevalence can reach 40%. The prevalence of C. trachomatis infection ranges from 4 to 10% in asymptomatic men and from 15 to 20% in men attending STD clinics. Chlamydial infections in newborns occur as a result of perinatal exposure; approximately 65% of babies born from infected mothers become infected during vaginal delivery.

The development of tests based on nucleic acid amplification technology has been the most important advance in the field of STD diagnosis. Because nucleic acid amplification is exquisitely sensitive and highly specific, it offers the opportunity to use noninvasive sampling techniques to screen for infections in asymptomatic individuals who would not ordinarily seek clinical care.

INTENDED USE

Chlamydia trachomatis Real-TM PCR kit is an in vitro nucleic acid amplification test for qualitative detection of Chlamydia trachomatis DNA in the clinical materials (urogenital, rectal, and throat swabs; eye discharge; urine; and prostate gland secretion) by means of real-time hybridization-fluorescence detection.

PRINCIPLE OF PCR DETECTION

Chlamydia trachomatis detection by the polymerase chain reaction (PCR) is based on the amplification of pathogen genome specific region using specific primers. In real-time PCR the amplified product is detected by using fluorescent dyes. These dyes are linked to oligonucleotide probes which bind specifically to the amplified product. The real-time monitoring of fluorescence intensities during the real-time PCR allows the detection of accumulating product without re-opening the reaction tubes after the PCR run. Chlamydia trachomatis Real-TM PCR kit is a qualitative test that contains the Internal Control (IC),which must be used in the extraction procedure in order to control the extraction process of each individual sample and to identify possible reaction inhibition. Chlamydia trachomatis Real-TM PCR kit uses “hot-start”, which greatly reduces the frequency of nonspecifically primed reactions. “Hot-start” is guaranteed by chemically modified polymerase (TaqF), which is activated by heating at 95 ºC for 15 min.