AffiPCR® Mycoplasma genitalium Real Time PCR

Target Disease Type: Sexually trasmitted diseases

Specific Application: Ureaplasma species and Mycoplasma

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Mycoplasma genitalium RT-PCR (CE) B4-100FRT 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 gonorrhea, 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, gon[1]orrhea, herpes, HIV, HPV, syphilis, mycoplasma, gardnerella and trichomoniasis.

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

Kit Mycoplasma genitalium Real-TM is a test for the qualitative detection of Mycoplasma genitalium in the urogenital swabs, urine, prostatic liquid and other biological materials.

PRINCIPLE OF ASSAY

Kit Mycoplasma genitalium Real-TM is based on two major processes: isolation of DNA from specimens and Real Time amplification. Mycoplasma genitalium DNA is extracted from the specimens, amplified using Real-Time amplification and detected fluorescent reporter dye probes specific for Mycoplasma genitalium DNA and Internal Control. Internal Control (IC) serves as an amplification control for each individually processed specimen and to identify possible reaction inhibition. IC is detected in a channel other than the Mycoplasma genitalium.