Fluorescence PCR · Gastrointestinal
Clostridium difficile Toxin A/B Gene Detection Kit (Fluorescence PCR)
Qualitative detection of Clostridium difficile toxin A and B genes in stool specimens from patients with suspected C. difficile infection. For in vitro diagnostic use.
- SKU Code
AENE-OT031A- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
Qualitative detection of Clostridium difficile toxin A and B genes in stool specimens from patients with suspected C. difficile infection. For in vitro diagnostic use.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Gastrointestinal |
Certificate
CE
Epidemiology
Clostridium difficile (C. difficile) is a Gram-positive, anaerobic, spore-forming bacterium that represents a major cause of nosocomial intestinal infections. Clinically, approximately 15–25% of antibiotic-associated diarrhea, 50–75% of antibiotic-associated colitis, and 95–100% of pseudomembranous enteritis are attributable to C. difficile infection (CDI). This organism is an opportunistic pathogen, existing as both toxigenic and non-toxigenic strains.
Work Flow
Option 1.
Add 180 μL of lysozyme buffer (prepared by diluting lysozyme to 20 mg/mL with lysozyme diluent) to the pellet, mix by pipetting, and incubate at 37°C for at least 30 minutes. For the positive control and negative control, dispense 180 μL each into separate 1.5 mL RNase/DNase-free centrifuge tubes. Add 10 μL of internal control to each of the test sample, positive control, and negative control. Proceed with DNA extraction using a commercial nucleic acid extraction/purification kit, meticulously following the manufacturer’s protocol. Elute with DNase/RNase-free water, with a recommended elution volume of 100 μL.
Option 2.
For the positive control and negative control, transfer 200 μL each to individual 1.5 mL RNase/DNase-free centrifuge tubes. Add 10 μL of internal control to the test sample, positive control, and negative control. Use a viral DNA/RNA extraction kit and an automated nucleic acid extractor. Perform the extraction in strict accordance with the kit instructions, using a recommended elution volume of 80 μL.
| SKU code | AENE-OT031A |
|---|---|
| Storage | ≤-18℃ |
| Shelf-life | 12 months |
| Specimen Type | stool |
| Tt | ≤38 |
| CV | ≤5.0% |
| LoD | 200CFU/mL |
| Specificity | use this kit to detect other intestinal pathogens such as Escherichia coli, Staphylococcus aureus, Shigella, Salmonella, Vibrio parahaemolyticus, Group B Streptococcus, Clostridium difficile non-pathogenic strains, Adenovirus, rotavirus, norovirus, influenza A virus, influenza B virus and human genomic DNA, the results are all negative. |
| Applicable Instruments | Applied Biosystems 7500 Real-Time PCR Systems Applied Biosystems 7500 Fast Real-Time PCR Systems QuantStudio ® 5 Real-Time PCR Systems SLAN-96P Real-Time PCR Systems (Hongshi Medical Technology Co. Ltd.) LightCycler ® 480 Real-Time PCR system LineGene 9600 Plus Real-Time PCR Detection System( FQD-96A ， Hangzhou Bioer technology) MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co. Ltd.) BioRad CFX96 Real-Time PCR System BioRad CFX Opus 96 Real-Time PCR System |
| Approval | On request |
|---|---|
| Documents | Datasheet, IFU, SDS, COA / conformance, origin, and export documents where available |
FAQ
What should be confirmed before quotation?
Sample context, collection method, and extraction workflow should be confirmed before final kit selection.
Which documents can be requested?
Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.
Can the format be adjusted for different workflows?
Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.
Inquiry
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