E. coli Pathotyping (5) Real-Time PCR Kit

Product Overview

This in vitro qualitative diagnostic kit utilizes multiplex real-time PCR technology to simultaneously detect and differentiate five major pathogenic Escherichia coli pathotypes from human stool specimens. The targeted pathotypes include Enterohaemorrhagic E. coli (EHEC), Enterotoxigenic E. coli (ETEC), Enteroinvasive E. coli (EIEC), Enteropathogenic E. coli (EPEC) and Enteroaggregative E. coli (EAEC), which are the leading causes of bacterial gastroenteritis worldwide. This kit enables rapid and accurate pathotyping of E. coli infections, supporting timely clinical diagnosis, appropriate antimicrobial treatment and effective public health infection control measures for foodborne and waterborne diarrheal diseases. The assay employs TaqMan probe-based real-time fluorescent PCR technology. Highly specific primers and dual-labeled hydrolysis probes are designed targeting 11 conserved virulence genes specific to different E. coli pathotypes, including escV, bfp, stx1, stx2, ipaH, lt, stp, sth, aggR, pic and astA. The detection system is divided into three independent reaction mixes to achieve comprehensive and unambiguous pathotyping. A human uidA housekeeping gene internal control is integrated into each reaction mix and detected via the CY5 fluorescence channel, which effectively monitors specimen sampling quality, nucleic acid extraction efficiency and potential PCR inhibition, ensuring the validity of each individual test result. This kit delivers exceptional analytical performance with a limit of detection of 5 copies per reaction, enabling sensitive identification of low-level bacterial loads in stool samples. It demonstrates high analytical specificity with no cross-reactivity with a broad panel of common enteric pathogens including Rotavirus, Norovirus, Vibrio cholerae, Listeria monocytogenes, Vibrio parahaemolyticus, Campylobacter jejuni, Campylobacter coli, Yersinia enterocolitica, Nontyphoidal salmonella, Shigella and other clinically relevant microorganisms. The assay exhibits excellent precision with coefficient of variation values less than 5% for both repeatability and within-laboratory reproducibility. It is fully compatible with all mainstream real-time PCR instruments including Bioperfectus STC-96A, STC-96A PLUS, Applied Biosystems 7500, QuantStudio™ 5, Roche LightCycler® 480, Bio-Rad CFX96™, QIAGEN Rotor-Gene Q and Analytik Jena qTOWER3. The kit is available in two standard specifications: 25 tests per kit (REF: YJB11201NW-25T) and 50 tests per kit (REF: YJB11201NW-50T). All components should be stored at -20±5°C protected from light, and repeated freezing and thawing should be avoided to maintain reagent stability. This CE certified product is intended for professional in vitro diagnostic use only. All patient specimens must be processed in strict accordance with laboratory biosafety requirements. Test results should be interpreted by trained healthcare professionals in conjunction with patient clinical history, signs and symptoms, and other diagnostic findings to support accurate clinical decision-making.

Key Features & Advantages

- time PCR technology to simultaneously detect and differentiate five major pathogenic Escherichia coli pathotypes from human stool specimens. The targeted pathotypes include Enterohaemorrhagic E. coli (EHEC), Enterotoxigenic E. coli (ETEC), Enteroinvasive E. coli (EIEC), Enteropathogenic E. coli (EPEC) and Enteroaggregative E. coli (EAEC), which are the leading causes of bacterial gastroenteritis worldwide. This kit enables rapid and accurate pathotyping of E. coli infections, supporting timely clinical diagnosis, appropriate antimicrobial treatment and effective public health infection control measures for foodborne and waterborne diarrheal diseases. The assay employs TaqMan probe - based real - time fluorescent PCR technology. Highly specific primers and dual - labeled hydrolysis probes are designed targeting 11 conserved virulence genes specific to different E. coli pathotypes, including escV, bfp, stx1, stx2, ipaH, lt, stp, sth, aggR, pic and astA. The detection system is divided into three independent reaction mixes to achieve comprehensive and unambiguous pathotyping. A human uidA housekeeping gene internal control is integrated into each reaction mix and detected via the CY5 fluorescence channel, which effectively monitors specimen sampling quality, nucleic acid extraction efficiency and potential PCR inhibition, ensuring the validity of each individual test result. This kit delivers exceptional analytical performance with a limit of detection of 5 copies per reaction, enabling sensitive identification of low - level bacterial loads in stool samples. It demonstrates high analytical specificity with no cross - reactivity with a broad panel of common enteric pathogens including Rotavirus, Norovirus, Vibrio cholerae, Listeria monocytogenes, Vibrio parahaemolyticus, Campylobacter jejuni, Campylobacter coli, Yersinia enterocolitica, Nontyphoidal salmonella, Shigella and other clinically relevant microorganisms. The assay exhibits excellent precision with coefficient of variation values less than 5% for both repeatability and within - laboratory reproducibility. It is fully compatible with all mainstream real - time PCR instruments including Bioperfectus STC

Clinical Applications

Clinical laboratories, hospitals, public health departments, and diagnostic testing centers for infectious disease detection.

Comparison & Competitive Advantages

Unlike conventional culture methods that require 48-72 hours for results, this real-time PCR kit delivers definitive pathogen detection in under 2 hours. The molecular method offers superior analytical sensitivity, detecting low-copy-number targets that culture may miss.

Technical Specifications

• limit of detection: of 5 copies per reaction, enabling sensitive identification of low-level bacterial loads in stool samples. It demonstrates high analytical specificity with no cross-reactivity with a broad panel of common enteric pathogens including Rotavirus, Norovirus, Vibrio cholerae, Listeria monocytogenes, Vibrio parahaemolyticus, Campylobacter jejuni, Campylobacter coli, Yersinia enterocolitica, Nontyphoidal salmonella, Shigella and other clinically relevant microorganisms. The assay exhibits excellent precision with coefficient of variation values less than 5% for both repeatability and within-laboratory reproducibility. It is fully compatible with all mainstream real-time PCR instruments including Bioperfectus STC-96A, STC-96A PLUS, Applied Biosystems 7500, QuantStudio™ 5, Roche LightCycler® 480, Bio-Rad CFX96™, QIAGEN Rotor-Gene Q and Analytik Jena qTOWER3. The kit is available in two standard specifications: 25 tests per kit (REF: YJB11201NW-25T) and 50 tests per kit (REF: YJB11201NW-50T). All components should be stored at -20±5°C protected from light, and repeated freezing and thawing should be avoided to maintain reagent stability. This CE certified product is intended for professional in vitro diagnostic use only. All patient specimens must be processed in strict accordance with laboratory biosafety requirements. Test results should be interpreted by trained healthcare professionals in conjunction with patient clinical history, signs and symptoms, and other diagnostic findings to support accurate clinical decision-making.

Frequently Asked Questions

Q: What is the detection limit of this E. coli Pathotyping (5) PCR kit?

A: The kit achieves a limit of detection (LOD) of approximately 5 copies per reaction, enabling sensitive identification of low-level infections. This molecular method is significantly more sensitive than conventional culture or antigen-based approaches.

Q: What sample types are compatible with this kit?

A: This kit is optimized for the appropriate clinical specimen type (e.g., stool, blood, swab). The integrated internal control monitors extraction efficiency and detects PCR inhibition, ensuring reliable results across different sample matrices.

Q: How long does the PCR test take?

A: The real-time PCR assay delivers results in approximately 2 hours, compared to 48-72 hours required for conventional culture-based methods. This enables same-day clinical decisions and faster outbreak response.

Q: What instruments is this kit compatible with?

A: The kit is compatible with mainstream real-time PCR instruments including Applied Biosystems 7500, QuantStudio 5, Roche LightCycler 480, Bio-Rad CFX96, QIAGEN Rotor-Gene Q, and Analytik Jena qTOWER3.