Human-Parvovirus-Q Real-Time PCR Kit - Genes2Me™

Product Overview

Helicobacter pylori (H. pylori) is a Gram-negative, spiral-shaped bacterium that colonizes the gastric mucosa and is recognized as one of the most prevalent chronic bacterial infections worldwide. It is estimated that nearly two-thirds of the global population may be infected with H. pylori, with a significantly higher prevalence observed in developing countries. Although many infected individuals remain asymptomatic, persistent infection can lead to serious gastrointestinal disorders including chronic gastritis, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.

Early and accurate detection of H. pylori infection is essential for appropriate clinical management and prevention of long-term complications. The H. Pylori-Q Real-Time PCR Kit from Genes2Me is a highly sensitive molecular diagnostic assay designed for the qualitative detection of H. pylori DNA directly from stool samples. Utilizing advanced Real-Time PCR technology, the assay enables rapid and reliable identification of H. pylori infection, supporting clinicians in making informed treatment decisions and improving patient outcomes.

Targets:

Helicobacter pylori (H. pylori) DNA

Technology:

Real-Time PCR (TaqMan)

Detection:

Qualitative Detection of H. pylori DNA (Detected / Not Detected)

Sample Type:

Stool Samples

Certification:

CE-IVD

How the Assay Works

The H. Pylori-Q Real-Time PCR Kit employs TaqMan-based Real-Time PCR technology for the specific detection of Helicobacter pylori DNA in clinical stool specimens. The assay utilizes highly specific primers and fluorescent probes targeting conserved regions of the H. pylori genome to ensure accurate pathogen identification.

The assay is configured as a single-tube multiplex reaction that simultaneously detects the H. pylori target and an endogenous Internal Control. The H. pylori target is detected through the FAM fluorescence channel, while RNase P serves as the Internal Control and is monitored through the HEX channel.

The Internal Control helps identify potential reaction failures or inhibitory substances. Positive and negative controls are included to validate assay performance and ensure confidence in every testing run. The streamlined workflow minimizes hands-on time while delivering reliable molecular results suitable for routine laboratory testing.

Why Molecular Testing Matters for H. pylori Detection

Accurate diagnosis of H. pylori infection is critical because untreated infections can persist for decades and may progress to severe gastrointestinal diseases. While traditional diagnostic methods remain widely used, their performance can be affected by bacterial load, sample quality, medication use, or the need for invasive procedures.

Real-Time PCR enables the identification of H. pylori even when bacterial concentrations are low, improving diagnostic confidence and reducing the likelihood of false-negative results. Additionally, PCR-based testing eliminates many of the limitations associated with culture-based methods and provides laboratories with a reliable, standardized diagnostic solution.

Key Features & Benefits

Targeted Detection of H. pylori

Specifically detects Helicobacter pylori DNA from stool samples, enabling accurate identification of infection for improved patient management.

Single-Tube Multiplex Assay

Simultaneously detects the H. pylori target and Internal Control in a single reaction, simplifying workflow and reducing hands-on time.

Built-in Internal Control Monitoring

Incorporates endogenous RNase P as an Internal Control to verify sample quality, extraction efficiency, and PCR performance, ensuring reliable results.

High Sensitivity for Early Detection

Real-time PCR technology enables sensitive detection of low target levels, supporting the identification of infections that may be missed by conventional methods.

Compatible with Leading PCR Platforms

Validated for use on major real-time PCR instruments including QuantStudio™, CFX96™, LightCycler® 480, and RapiCycler 96 for seamless laboratory integration.

Applications

Clinical & Hospital Laboratories: Supports accurate diagnosis of H. pylori infection in patients presenting with gastritis, dyspepsia, peptic ulcer disease, and other gastrointestinal symptoms.
Diagnostic Laboratories: Offers a standardized and reliable testing solution for routine screening and confirmation of H. pylori infection from stool specimens.
Preventive Healthcare Programs: Facilitates early identification of chronic H. pylori infections that may increase the risk of gastric ulcers and gastric cancer.
Research & Epidemiological Studies: Supports investigations into H. pylori prevalence, disease burden, transmission patterns, and infection-associated gastrointestinal disorders.

Analytical Performance

Qualitative detection of Helicobacter pylori DNA directly from stool samples.
Single-tube multiplex assay for simultaneous pathogen detection and Internal Control monitoring.
Internal Control (RNase P) validates nucleic acid extraction and amplification efficiency.
Positive and negative controls support assay verification and contamination monitoring.
Ct cut-off value of ≤35 for qualitative result interpretation.
Stable reagents with a shelf life of up to 12 months under recommended storage conditions.

Commercial Name	Old Cat No.	New Cat No.	Pack Size
H. Pylori-Q Real-Time PCR Kit	G2M706321	G610001	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.

H. Pylori-Q Real-Time PCR Kit

Product Overview

How the Assay Works

Why Molecular Testing Matters for H. pylori Detection

Sample Type & Reporting Output