GCP-Q Comprehensive Real-Time PCR Kit

Product Overview

Gastrointestinal infections are among the leading causes of diarrheal illness worldwide and can be caused by a wide range of viral, bacterial, and parasitic pathogens. These infections often present with similar symptoms, including diarrhea, abdominal pain, vomiting, fever, dehydration, and loss of appetite, making accurate identification of the causative organism challenging through clinical symptoms alone.

The GCP-Q Comprehensive Real-Time PCR Kit from Genes2Me is a multiplex molecular diagnostic assay designed for the simultaneous detection and differentiation of 14 major gastrointestinal pathogens directly from stool samples or gastric biopsy specimens. The panel covers key viral, bacterial, and parasitic agents responsible for acute gastroenteritis, enabling laboratories to identify the underlying cause of infection quickly and accurately.

By combining broad pathogen coverage with real-time PCR technology, the assay enables faster diagnosis, targeted treatment decisions, improved patient management, and effective outbreak monitoring in healthcare and public health settings.

Targets:
14 Major Gastrointestinal Pathogens: Astrovirus, Rotavirus, Norovirus Genotype I, Norovirus Genotype II, Adenovirus, Clostridium difficile, Campylobacter spp., Salmonella spp. entero-invasive E. coli (EIEC)/Shigella spp., verotoxigenic E. coli (VTEC), Yersinia enterocolitica, Entamoeba histolytica, Cryptosporidium spp., and Giardia duodenalis
Technology:
Multiplex Real-Time RT-PCR (TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Stool samples or gastric biopsy specimens
Certification:
CE-IVD
GCP-Q Comprehensive

How the Assay Works

The GCP-Q Comprehensive kit utilizes advanced multiplex Real-Time RT- PCR technology to detect nucleic acids from clinically relevant gastrointestinal pathogens. The assay is organized into five optimized reaction mixes, allowing simultaneous detection of multiple targets within a single testing workflow.

The panel includes the viral pathogens Astrovirus, Rotavirus, Norovirus Genotype I, Norovirus Genotype II, and Adenovirus; bacterial pathogens Clostridium difficile, Campylobacter spp., Salmonella spp., verotoxigenic E. coli (VTEC), enteroinvasive E. coli (EIEC)/ Shigella spp., and Yersinia enterocolitica; and parasitic pathogens Entamoeba histolytica, Cryptosporidium spp., and Giardia duodenalis.

An Exogenous Internal Control monitored through the Texas Red channel is incorporated to verify extraction efficiency, detect PCR inhibition, and ensure overall assay integrity. The kit also includes positive and negative controls to validate assay performance and maintain confidence in every test run.

Why Molecular Testing Matters for Gastrointestinal Infections

Traditional methods for diagnosing gastrointestinal infections, such as culture, microscopy, and antigen-based testing, often require extended processing times and may not detect the low pathogen loads due to lack of sensitivity. Additionally, overlapping clinical symptoms caused by the gastrointestinal pathogens make differential diagnosis difficult without laboratory confirmation.

Molecular testing overcomes these limitations by providing rapid, highly sensitive, and highly specific pathogen detection directly from clinical specimens. Multiplex PCR technology allows simultaneous screening for multiple organisms in a single workflow, reducing turnaround time and improving laboratory efficiency.

Early, accurate and comprehensive molecular testing of gastrointestinal pathogens helps clinicians make informed treatment decisions, avoid unnecessary antibiotic use, implement appropriate infection-control measures, and support effective outbreak investigations.

Sample Type & Reporting Output

Sample Type:
Stool samples or gastric biopsy specimens
Reporting Output:
Qualitative detection (Detected / Not Detected)
Targets Detected:
14 Major Gastrointestinal Pathogens: Astrovirus, Rotavirus, Norovirus Genotype I, Norovirus Genotype II, Adenovirus, Clostridium difficile, Campylobacter spp., Salmonella spp. entero-invasive E. coli (EIEC)/Shigella spp., verotoxigenic E. coli (VTEC), Yersinia enterocolitica, Entamoeba histolytica, Cryptosporidium spp., and Giardia duodenalis

Key Features & Benefits

Comprehensive gastrointestinal panel

covering 14 major viral, bacterial, and parasitic pathogens associated with gastroenteritis.

Multiplex testing capability

Multiplex testing capability enabling simultaneous detection of multiple pathogens while reducing testing time and laboratory workload.

Exogenous Internal Control

Exogenous Internal Control included to monitor nucleic acid extraction, PCR performance, and potential inhibition in every sample.

Positive and negative controls

Positive and negative controls provided to ensure assay reliability, workflow validation, and contamination monitoring.

Ready-to-use reagents designed

Ready-to-use reagents designed to minimise hands-on time, simplify assay setup, and reduce the risk of procedural errors.

Broad instrument compatibility

Broad instrument compatibility with leading Real-Time PCR systems including QuantStudio™ 5, Bio-Rad CFX96, LightCycler® 480, and Genes2Me RapiCycler 96.

Applications

  • Clinical & Hospital Laboratories: Supports rapid identification of gastrointestinal pathogens in patients presenting with acute diarrheal disease, enabling accurate diagnosis and targeted treatment.
  • Public Health & Outbreak Surveillance: Enables rapid investigation of community outbreaks, healthcare-associated infections, and foodborne disease events through comprehensive pathogen detection.
  • Reference Laboratories: Provides a reliable molecular testing solution for high-throughput gastrointestinal pathogen screening and confirmatory testing.
  • Infection Control Programs: Supports implementation of timely infection prevention and control measures through accurate identification of causative organisms.

Analytical Performance

  • Simultaneous detection and differentiation of 14 major gastrointestinal pathogens.
  • Detection of viral, bacterial, and parasitic organisms within a single testing workflow.
  • Built-in Exogenous Internal Control for assay validation and inhibition monitoring.
  • Ct cut-off value of ≤30 for qualitative result interpretation.
  • Stable reagents with a shelf life of up to 12 months when stored under recommended conditions.

Data Analysis and Report

GCP-Q Comprehensive Real Time PCR

GCP-Q Comprehensive Real Time PCR specific amplification plot of 14 major Gastrointestinal positive sample (FAM, HEX, and Cy5) along with internal control (Texas Red)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
GCP-Q comprehensive Real Time PCR Kit G2M803621 G610003 25 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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