Clostridium difficile toxin A/B gene(C.diff)

Short Description:

This kit is intended for the in vitro qualitative detection of clostridium difficile toxin A gene and toxin B gene in stool samples from patients with suspected clostridium difficile infection.


Product Detail

Product Tags

Product name

HWTS-OT031A Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene (C.diff) (Fluorescence PCR)

Certificate

CE 2797 (IVDR)

Epidemiology

Clostridium difficile (CD) is a Gram-positive, anaerobic, spore-forming bacillus and one of the major pathogens responsible for nosocomial intestinal infections, which clinically caused approximately 15%~25% of antibiotic-associated diarrhea, 50%~75% of antibiotic-associated colitis, and 95%~100% of pseudomembranous colitis [1]. As an opportunistic pathogen, C. difficile could be toxigenic and non-toxigenic strains. Only the toxigenic strains have been reported pathogenicity to date due to the C. difficile toxin A (tcdA) and cytotoxin B (tcdB). The Clostridium difficile (CD) was accordingly classified as type A−B−, type A−B+, and type A+B+ [2]. The type A−B− is a non-toxigenic strain without virulent genes, type A−B+ and A+B+ are toxigenic strains with toxin genes. CDI might result in diarrhea or life-threatening conditions in severe cases. A simple and rapid detection assay for C. difficile [3,4] is important for aiding clinical diagnosis and patient management.

A negative result does not rule out Clostridium difficile infection and should not be used as the sole basis for diagnosis, treatment, or other management decisions. A positive result does not rule out bacterial infection or other co-infection outside Clostridium Difficile.

Channel

FAM tcdA gene
ROX tcdB gene
VIC/HEX Internal Control

Technical Parameters

Storage

≤-18℃

Shelf-life 12 months
Specimen Type unformed stool samples
Tt ≤38
CV ≤5.0%
LoD 200CFU/mL
Specificity There is no cross-reactivity with Enterovirus A - Coxsackievirus A16 (CoXA16), Enterovirus B - Coxsackievirus B5 (CB5), Enterovirus C - Poliovirus Type 1, Enterovirus D - Enterovirus 68 (EV68), Vibrio parahaemolyticus, Vibrio cholerae, Norovirus, Astrovirus, Human calicivirus, Rotavirus, Human enteric adenovirus, Yersinia enterocolitica, Escherichia coli, Bacillus cereus, Salmonella enteritidis, Staphylococcus aureus, Shigella boydii, Shigella dysenteriae, Shigella sonnei, Shigella flexneri.
Applicable Instruments Type I: Applied Biosystems 7500 Real-Time PCR Systems; SLAN-96P Real-Time PCR Systems (Hongshi Medical Technology Co., Ltd.)Type II: EudemonTM AIO800 by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

 

 

Acid Detection Kit1

Work Flow

Reagents/Instrument need but not provided:

1) 1×PBS

2) Lysozyme (RT401) produced by Tiangen Biotech (Beijing) Co., Ltd.

3) Bacterial Genome DNA Extraction Kit (YDP302) produced by Tiangen Biotech

(Beijing) Co., Ltd., or Macro & Macro & Micro-Test DNA/RNA Kit (HWTS-3019)

(which can be used with Macro & Micro-Test Automatic Nucleic Acid Extractor

(HWTS-EQ011)) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., Macro &

Micro-Test Viral DNA/RNA Kit (HWTS-3019)(used with EudemonTM AIO800

(HWTS-EQ007) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Consumables need but not provided:

DNase/RNase free Tips, disposable gloves, 1.5 DNase/RNase free EP tubes, 0.2mL

PCR tube, desktop centrifuge, and vortex.


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