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







