EliGene® STD GAR/URE/MYC RT

Intended use

EliGene® STD GAR/URE/MYC RT kit is intended for DNA diagnostics of pathogenic species Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, Ureaplasma parvum and Gardnerella vaginalis from isolated DNA sample.

Principle of the method

This diagnostic kit is based on RealTime PCR. In this kit specific primers and dual labeled fluorescent probes for the detection of DNA are used.

Compatible instruments

The following list represents instruments on which the above mentioned kits were tested. Please contact us for compatibility with other instruments.

• Thermofisher Scientific: Quant Studio 5
• Bio-Rad: CFX96 Touch Real-Time PCR Detection System
• Bio Molecular Systems: MIC qPCR Cycler

Introduction

Mycoplasma is a genus of bacteria belonging to the family of Mycoplasmataceae, which include a group of microorganisms, which may be responsible for diseases of the respiratory and genital tract. These bacteria are found approximately in 70 % of sexually active individuals.

Mycoplasma hominis is associated with pelvic inflammatory diseases, bacterial vaginosis, postpartum fevers, sepsis, and central nervous system infections leading to serious consequences.

Mycoplasma genitalium provides strong evidence for its role in non-chlamydial and non-gonococcal urethritis (NCNGU) in men and cervicitis in women.

Ureaplasma is bacterium belonging to the family Mycoplasmataceae. It is a spherical-shaped, facultative anaerobic microorganism that characteristically lacks a cell wall. A characteristic feature of this microorganism is a synthesis of urease. Ureaplasma species colonize the lower urogenital tract in many healthy persons, yet, they can also cause urethritis, endometritis, chorioamnionitis, spontaneous abortion, arthritis and urinary calculi in susceptible adults, as well as prematurity/low birth weight, bacteraemia and meningitis. Clinical studies have demonstrated that infants born to infected mothers become infected with these bacteria, and colonization of the respiratory tract of infants has been associated with pneumonia, respiratory distress and meningitis. Ureaplasma sp. is the main cause of non-gonococcal, non-chlamydial urethritis, acute prostatitis and acquired arthritis in men.

Gardnerella vaginalis are gram-variable pleomorphic rods growing in a carbon dioxide enriched atmosphere (5- 10 %) or in a microaerophilic atmosphere and in some strains only under anaerobic conditions. Due to difficult cultivation culture testing often leads to false negative results. Therefore, PCR diagnostics is the most appropriate method for the primary detection of infection. In women, Gardnerella vaginalis infection manifests as unpleasant vaginal secretions, vaginal inflammations, urethritis with pain or discomfort when urinating. Vaginal discharge may or may not be present. In men, the infection manifests as urethritis, pain when urinating, urethral pain or discomfort in the urethra. Untreated infection can result in prostatitis.

Clinical material and recommended DNA isolation procedure

Urine, swabs

Manual: EliGene® Urine Isolation Kit (ELISABETH PHARMACON)

Automatic: ZEPHYRUS Magneto (ELISABETH PHARMACON)

CE IVD