AffiCHECK® Clostridium difficile DNA - PCR Qualitative Positive Control
Product Datasheet - AFG-CHK-0466
PRODUCT DESCRIPTION:
AffiCHECK® Clostridium difficile DNA - PCR Qualitative Control is a high-quality, reliable standard containing known quantities of Clostridium difficile DNA. It's designed using modified and non-infectious bacteria to ensure stability, thereby contributing to accurate and reliable results in PCR applications.
INTENDED USE:
AffiCHECK® Clostridium difficile DNA - PCR Qualitative Control serves as a comprehensive process control for the evaluation of the performance of nucleic acid tests for determination of the presence of Clostridium difficile nucleic acid. It's essential in validating the performance of PCR assays in clinical, research, and diagnostic settings.
PRODUCT FEATURES:
- Specificity: Tailored for Clostridium difficile DNA detection.
- Formulation: Lyophilized for enhanced stability.
- Convenience: Ready-to-use upon reconstitution.
- Compatibility: Suitable for a wide range of PCR assays.
CHARACTERISTICS:
- Cultivation & Extraction: Cultivated in cycloserine-cefoxitin fructose agar (CCFA) and extracted using a reliable genomic DNA method.
- Quality Control: Subjected to rigorous testing to ensure batch consistency and reliability.
- Packaging: Provided in a protective, heat-sealed foil pouch with silica gel.
PERFORMANCE CHARACTERISTICS:
- Sensitivity: Optimized for high sensitivity in PCR detection.
- Specificity: Exclusively detects Clostridium difficile DNA.
- Reproducibility: Consistent results across different test runs and batches.
PACK CONTENT :
| Components | Pack Size | Note |
| DNA Control Lyophilized Powder (1x104 to 2x104 Copies/µL) | 1 Vial | Quantified by Real-Time PCR. |
| Buffer | 500 µL | Water, DNase, RNase Free. |
PRECAUTIONS:
- For research use or diagnostic control purposes only.
- Follow standard laboratory practices and use PPE.
- Use Sterile Filter Tips to prevent contamination.
- Handle infectious specimens with precautions.
- Disinfect work surfaces.
- Maintain separate working areas for testing.
- Dispose of unused reagents and waste as per regulations.
- May contain genetic material, handle with care.
- No method ensures total absence of infectious agents.
- Follow local waste disposal rules.
- Dilute below 103 copies/µL immediately before use.
- Avoid freezing for low-copy dilutions to prevent DNA degradation.
INSTRUCTIONS FOR USE:
- Open the foil pouch of AffiCHECK® Clostridium difficile DNA.
- Centrifuge AffiCHECK® Clostridium difficile DNA Lyophilized Powder at 1000 g for 1 minute.
- Add 100 μL of the Buffer and thoroughly mix until fully reconstituted.
- The concentration will be 1x104 to 2x104 Copies/µL once reconstituted.
- Vortex for 1 min for complete dissolution and homogenization.
RECOMMENDED STORAGE:
- Before Reconstitution: Store at 2-8ºC.
- After Reconstitution: Store at -20ºC.
- Shipping: No special instructions
- Shelf Life: 12 months from production date.
ORDERING INFORMATION :
| Catalog Number | Description | Size |
| AFG-CHK-0466 | AffiCHECK® Clostridium difficile DNA PCR Qualitative Positive Control | 1 vial + 500 µL Buffer |