Vaginalis (TGC III)-Q Real- Time PCR Kit

Product Overview

Vaginitis is one of the most common gynaecological conditions affecting women worldwide, frequently caused by Trichomonas vaginalis, Gardnerella vaginalis, and Candida species. These pathogens often present with overlapping clinical symptoms such as vaginal discharge, irritation, itching, inflammation, and discomfort, making accurate diagnosis challenging through symptoms alone. Early and precise identification is essential for effective treatment, preventing complications, reducing recurrence, and improving patient outcomes.

The Vaginalis (TGC III)-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific CE-IVD molecular diagnostic assay designed for the qualitative detection of T. vaginalis DNA while simultaneously differentiating and detecting G. vaginalis and Candida spp. from vaginal swab specimens. Using multiplex real-time PCR technology, the assay delivers rapid, reliable, and clinically actionable results in a single reaction.

Targets:
Trichomonas vaginalis (TV), Gardnerella vaginalis (GV) & Candida spp. DNA
Technology:
Multiplex Real-Time PCR (TaqMan Chemistry)
Detection:
Qualitative (Positive / Negative)
Sample Type:
Vaginal Swab
Certification:
CE-IVD
Vaginalis (TGC III)-Q

How the Assay Works

The Vaginalis (TGC III)-Q kit utilizes multiplex real-time PCR technology with pathogen-specific primers and fluorescent probes for simultaneous detection of multiple vaginitis-causing organisms. The assay employs:

  • Texas Red channel for T. vaginalis
  • HEX channel for G. vaginalis
  • FAM channel for Candida spp.
  • Cy5 channel as an Internal Control

The Internal Control verifies nucleic acid extraction quality and PCR amplification efficiency, ensuring confidence in every result. Positive and negative controls further validate assay performance and workflow integrity.

Why Molecular Testing Matters for Vaginitis

The clinical manifestations of Trichomoniasis, Bacterial Vaginosis, and Vulvovaginal Candidiasis frequently overlap, making syndromic diagnosis unreliable. Conventional microscopy and culture methods may be labor-intensive, operator-dependent, and less sensitive, particularly in low-pathogen-load infections.

Molecular detection through Real-Time PCR offers rapid, highly sensitive, and specific identification of causative pathogens directly from patient samples. Simultaneous detection of multiple organisms enables comprehensive evaluation of vaginitis cases, supports targeted therapy decisions, reduces unnecessary antimicrobial use, and improves patient management.

Sample Type & Reporting Output

Sample Type:
Vaginal Swab
Reporting Output:
Qualitative Detection (Positive / Negative)
Targets Detected:
T. vaginalis, G. vaginalis, Candida spp. DNA

Key Features & Benefits

Multiplex detection in a single assay

Simultaneously detects T. vaginalis, G. vaginalis, and Candida spp., enabling comprehensive vaginitis diagnosis from a single sample.

Differentiated pathogen identification

Four-color fluorescence chemistry clearly distinguishes each target organism, supporting precise clinical interpretation and treatment decisions.

Robust internal control

Cy5-channel Internal Control validates extraction quality and PCR performance, minimizing the risk of false-negative results.

High diagnostic confidence

Ct cut-off of ≤35 enables reliable pathogen detection while maintaining excellent assay specificity and result accuracy.

Positive and negative controls included

Built-in assay controls verify reagent integrity, workflow performance, and contamination-free testing in every run.

Rapid and streamlined workflow

Ready-to-use reagents simplify assay setup, reduce hands-on time, and improve laboratory efficiency.

12-month shelf life

Stable reagents under recommended storage conditions support convenient inventory management and consistent performance.

Compatible with leading PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480 for seamless laboratory integration.

Applications

  • Clinical & Hospital Laboratories: Supports accurate molecular diagnosis of vaginitis-causing pathogens, enabling evidence-based treatment decisions and improved patient care.
  • Women's Health & Gynecology Clinics: Facilitates rapid differentiation between Trichomoniasis, Bacterial Vaginosis, and Candidiasis in symptomatic patients.
  • Reproductive Health Programs: Provides reliable pathogen identification for women presenting with recurrent vaginal infections and reproductive tract complications.
  • Pregnancy & Prenatal Care: Supports timely detection of infections associated with adverse pregnancy outcomes and maternal health risks.
  • STI Screening Programs: Enables sensitive detection of T. vaginalis, a common sexually transmitted pathogen, supporting comprehensive sexual health screening.
  • Reference & Diagnostic Laboratories: Ideal for high-throughput molecular testing environments requiring accurate and reproducible vaginitis pathogen detection.

Analytical Performance

  • Multiplex detection of three clinically significant vaginitis pathogens
  • Ct cut-off of ≤35 for positive result interpretation
  • Internal Control (Cy5) validates extraction and amplification processes
  • Positive and Negative Controls included for assay verification
  • Simultaneous differentiation of T. vaginalis, G. vaginalis, and Candida spp.
  • Compatible with major Real-Time PCR platforms
  • Ready-to-use reagents with 12-month shelf life
  • CE-IVD validated for routine diagnostic use

Data Analysis and Report

Vaginalis (TGC III)-Q

Vaginalis (TGC III)-Q Real Time PCR specific amplification plot of T.vaginalis Positive Control (TEXAS RED Channel), G.vaginalis Positive Control (HEX Channel) & Candida spp. Positive Control (FAM Channel) along with Internal Control (Cy5 Channel).

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
Vaginalis (TGC III)-Q Real- Time PCR Kit G2M706621 G610012 50 Tests

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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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