EliGene® STD CHT/NEI/TRI RT (RUO)

Intended use

EliGene® STD CHT/NEI/TRI RT kit is intended for DNA detection of pathogenic species Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis from isolated DNA sample.

Principle of the method

This kit is based on RealTime PCR method. In this kit 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: QuantStudio 5
• Bio-Rad: CFX96
• Bio Molecular Systems: MIC cycler

Introduction

Chlamydia trachomatis, a gram-negative bacterium that parasitize inside the susceptible cells due to their disability to synthesize ATP, is the most frequently reported sexually transmitted pathogen when up to 10 % of population is infected. Chlamydia trachomatis is responsible for several clinically different diseases as cervicitis, pelvic inflammatory disease (PID), infant pneumonia and conjunctivitis (pink eye) in newborns, urethritis, prostatitis or epididymitis. In men Chlamydia trachomatis often cause non-gonococcal urethritis. In women, untreated infection can cause serious problems mainly due to the fact that app. 75 % of these infections are asymptomatic. For this reason, there is a lot of non-diagnosed and untreated cases resulted in other problems mainly in pregnant women. Newborns of mothers with cervical Chlamydia infections have very high risk (60– 70%) to be infected. Also, these newborns have a very high risk of Chlamydia pneumonia and conjunctivitis (pink eye).

Neisseria gonorrhoeae (gonococci) is gram-negative, non-motile and non-sporulated diplococcic. Of the eleven species of Neisseria colonizing humans, only two are pathogens, N. gonorrhoeae and N. meningitidis. N. gonorrhoeae is the causative agent of sexual transmitted disease gonorrhea which is the third most common sexual disease, worldwide is registered about 62.2 million cases of gonorrhea. In males and females the gonorrhea is clinically manifested as urethritis with a purulent (or pus-like) discharge from the genitals, in females also as cervicitis. Complication can be infection in pelvic region leading up to infertility in females. The classical penicillin family of antibiotics is relatively well effective in therapy, but the number of resistance strains is increasing. Also the simultaneous infection by Chlamydia infection is common. As samples the urine, urethral swab or vaginal swab are recommended.

Trichomonas vaginalis is an anaerobic parasitic protozoan, that causes trichomoniasis, a sexually transmitted disease. There are about 30 million infections in sub-Saharan Africa each year. Based on a systematic review of articles published in recent years, estimated prevalence of Trichomonas vaginalis in Europe is 0.2 % in men and 1.6 % in women. The infection is asymptomatic in about 50 % of women. However, when symptoms appear, women suffer for vaginal discharge, pruritus or dysuria, vaginitis and cervicitis. In men, symptoms include urethritis, prostatitis and decreased fertility. As samples the urine, urethral swab or vaginal swab are recommended.

Clinical material and recommended DNA isolation procedure

Urine, swabs

Manual: EliGene® Urine Isolation Kit (ELISABETH PHARMACON)

Automatic: ZEPHYRUS Magneto (ELISABETH PHARMACON)

Research Use Only (RUO)