Ureaplasma urealyticum is a cell wall-deficient bacterium belonging to the Mycoplasmataceae family and is commonly found in the human urogenital tract. Although it may exist as part of the normal genital flora in asymptomatic individuals, it can become pathogenic under certain conditions and is associated with several urogenital infections and reproductive health complications. The organism is primarily transmitted through sexual contact and may also be vertically transmitted from mother to infant during childbirth.
Infections caused by Ureaplasma species have been linked to nongonococcal urethritis, bacterial vaginosis, infertility, chorioamnionitis, postpartum endometritis, and adverse pregnancy outcomes such as premature rupture of membranes and preterm birth. Neonatal complications may include respiratory disorders, meningitis, and low birth weight in preterm infants. Since symptoms often overlap with those caused by other sexually transmitted pathogens, rapid and accurate molecular diagnosis is essential for appropriate patient management.
The U. Urealyticum-Q Real-Time PCR Kit from Genes2Me is a CE-IVD marked assay developed for the qualitative detection of Ureaplasma urealyticum DNA in clinical samples. The assay combines sensitive molecular detection with robust internal controls, enabling reliable and efficient pathogen identification in clinical laboratories.
The U. Urealyticum-Q Real-Time PCR Kit is based on multiplex real-time PCR technology utilizing TaqMan chemistry for simultaneous detection of Ureaplasma urealyticum and Ureaplasma parvum DNA. Specific primers and fluorescent probes target conserved genomic regions of both organisms. Detection of U. urealyticum occurs in the FAM channel, while U. parvum is detected in the HEX channel.
The assay is validated on major real-time PCR systems including QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and RapiCycler 96 platforms, enabling seamless integration into existing molecular diagnostic workflows.
An Internal Control labelled with Cy5 dye is included in every reaction to monitor extraction quality, identify PCR inhibition, and validate amplification efficiency. Positive and No Template Controls ensure assay integrity and contamination-free operation throughout the workflow. The kit contains ready-to-use reagents that minimise hands-on preparation time and reduce procedural variability.
Conventional culture-based methods for Ureaplasma detection are time-consuming and may show limited sensitivity due to the fastidious growth requirements of the organism. Molecular testing provides rapid, highly sensitive, and specific detection of pathogen DNA directly from clinical samples, supporting early diagnosis and timely treatment decisions.
Real-time PCR is particularly valuable in reproductive health screening, sexually transmitted infection testing, pregnancy monitoring, and neonatal investigations. Early molecular confirmation can support appropriate antimicrobial management and help reduce complications associated with untreated infections. The assay’s integrated internal controls further ensure confidence in result interpretation and laboratory workflow reliability.
Advanced TaqMan-based real-time PCR technology enables highly sensitive and specific detection of Ureaplasma urealyticum and Ureaplasma parvum, ensuring accurate identification even in samples with low pathogen load.
Simultaneous detection of U. urealyticum (FAM channel) and U. parvum (HEX channel) in a single assay streamlines laboratory workflows, reduces reagent consumption, and improves testing efficiency.
An integrated Internal Control (Cy5 channel) monitors nucleic acid extraction quality, amplification efficiency, and potential PCR inhibition in every reaction, providing confidence in result validity.
Comprehensive Positive Control and No Template Control (NTC) reactions verify assay integrity, monitor contamination, and ensure reliable performance throughout the testing process.
Provides fast and dependable qualitative results, enabling timely clinical decision-making and appropriate patient management in routine diagnostic settings.
Optimised assay chemistry and validated controls ensure reproducible performance, delivering consistent results across operators, instruments, and testing environments.
U. Urealyticum Real Time PCR specific amplification plot of U. urealyticum Positive Control (FAM Channel) & U. parvum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)
| Commercial Name | Old Cat No. | New Cat No. | Pack Size |
|---|---|---|---|
| U. Urealyticum-Q Real-Time PCR Kit | G2M801421 | 50 Tests |
Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.
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