H. Pylori-Q Real-Time PCR Kit

Qualitative Detection of Helicobacter pylori by Real-Time PCR

The assay enables sensitive and specific detection of Helicobacter pylori DNA using probe-based real-time PCR technology. By simultaneously amplifying the target gene and an endogenous internal control, the test ensures reliable detection while monitoring for PCR inhibition and extraction efficiency. This supports accurate identification of infection in clinical samples.

At a Glance

Target: Helicobacter pylori DNA
Technology: Real-Time PCR (TaqMan probe-based chemistry)
Sample Type: Stool samples
Detection Type: Qualitative
Application: Detection of H. pylori infection

Product Overview

The H. Pylori-Q Real-Time PCR Kit is a molecular assay designed for the qualitative detection of Helicobacter pylori specific DNA in clinical stool samples using real-time PCR technology. It enables accurate identification of H. pylori infection to support clinical diagnosis and laboratory decision-making. It utilizes specific primers and fluorescent probes targeting H. pylori DNA sequences for precise detection. The assay is based on TaqMan probe chemistry, ensuring high specificity through probe-based fluorescence detection. The assay includes an endogenous Internal Control (RNase P) to monitor nucleic acid extraction efficiency and detect potential PCR inhibition, ensuring reliability of results.

Detection is performed across fluorescence channels and a positive control is included to validate reagent integrity and confirm proper assay performance.

How the Assay Works

The assay follows a standardized molecular workflow:

Sample Collection & DNA Extraction: DNA is extracted from stool samples using an appropriate DNA extraction method.
Real-Time PCR Amplification: Extracted DNA is amplified using H. pylori-specific primers in a real-time PCR system.
Fluorescent Detection: Amplification signals are detected in real time.
Result Interpretation: Detection is based on Ct values, with defined cut-offs for positive, negative, and invalid results.

Key Features & Benefits

Qualitative detection of H. pylori DNA
TaqMan probe-based chemistry for high specificity
Multiplex detection (target + internal control)
Internal control ensures assay reliability
Positive control for performance validation
Sensitive and accurate detection
Suitable for routine diagnostic laboratory workflows

Why H. pylori Detection Matters

Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that colonizes the gastric mucosa. Infection is associated with multiple gastrointestinal disorders, including chronic gastritis, peptic ulcers, gastric adenocarcinoma, and mucosa-associated lymphoid tissue (MALT) lymphoma.

It is one of the most prevalent chronic bacterial infections globally, affecting a significant portion of the population, particularly in developing regions.

Accurate detection is essential for:

Early diagnosis of infection
Guiding appropriate treatment strategies
Preventing disease progression and complications
Molecular detection using real-time PCR provides improved sensitivity and specificity compared to conventional diagnostic methods.

Targets Detected

H. pylori Target

Detection of Helicobacter pylori DNA

Internal Control

Endogenous Internal Control (RNase P)
Monitors extraction efficiency and PCR inhibition

Sample Type & Reporting Output

Sample Types

Stool samples

Reporting Output

Qualitative result (Positive / Negative / Invalid)

Analytical Performance

The assay demonstrates the following performance characteristics:

Cut-off Ct Value:

≤ 35

Positive Control Acceptance Criteria:

Ct ≤ 28

High specificity:

through probe-based detection

Storage and Stability

Shelf life: 12 months from date of manufacture
Storage temperature: -30°C to -10°C
Working conditions: Reagents maintained at 2°C to 8°C during setup
Avoid repeated freeze-thaw cycles (>6 times)
Protect from direct sunlight

Applications & Use Scenarios

The kit is intended for use in clinical laboratories for:

Detection of Helicobacter pylori infection
Gastrointestinal infection diagnostics
Routine molecular testing workflows
Support for clinical diagnosis of gastric disorders

Ordering Information

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