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For Research Use Only (RUO)
$1,236.00
Sku: 1503603
Product Description
The MycoSHENTEK® Mycobacterium Sensitivity Standards are non-infectious reference standards designed to validate the robustness and sensitivity of nucleic acid amplification techniques (NAT) for detection of mycobacteria. Available as defined loads (10 CFU or 100 CFU per tube), the standards are not intended for culture and are used by adding a specified volume of sample matrix to each tube to prepare test solutions for downstream DNA extraction and real-time PCR (qPCR) analysis. These standards support method validation and routine QC for mycobacterial DNA extraction and qPCR assays and are aligned with recommendations from the European Pharmacopoeia (EP), United States Pharmacopoeia (USP) and Chinese Pharmacopoeia (ChP). The product is supplied with a DNA Dilution Buffer (DDB) for preparation of test solutions. Appropriate sample DNA extraction prior to PCR is recommended to reduce inhibition and maximize assay sensitivity.
Technical Specifications
| Parameter | Details |
|---|---|
| Nominal load per tube | 10 CFU or 100 CFU per tube (provided as separate catalogue items) |
| Product formats / pack size | Each format supplied as 3 tubes per pack: 10 CFU × 3 tubes (NNE002) or 100 CFU × 3 tubes (NNE001); DNA Dilution Buffer (NND001) 1.5 mL × 3 tubes |
| Intended use | Reference standard for validation and sensitivity assessment of NAT/qPCR assays for mycobacteria; not for culture, not infectious |
| Storage temperatures | Mycobacterium strains: -65 °C; DNA Dilution Buffer (DDB): -20 °C |
| Shelf life | Stable for 12 months (check label expiration date) |
| Recommended preparation volume | For 10 CFU tubes, supplement sample matrix to a total volume of 400 µL per tube (follow label instructions for other formats) |
| Compatibility | Designed for use with MycoSHENTEK® Mycobacteria DNA Extraction Kit and MycoSHENTEK® Mycobacteria DNA Detection Kit and other validated qPCR workflows |
| Safety / infectivity | Non-infectious material; not intended for culture |
| Warnings on dilution | Each strain must not be diluted — dilution may cause uneven distribution and risk of undetected contamination |
Features
- Defined CFU reference standards: Provided at fixed nominal loads (10 CFU and 100 CFU per tube) for sensitivity assessment and limit-of-detection verification.
- Non-infectious, culture-free: Standards are non-infectious and not intended for culture, reducing biosafety concerns while enabling NAT validation.
- qPCR-compatible: Optimized for downstream DNA extraction and qPCR-based detection workflows; suitable as positive controls and sensitivity standards.
- Regulatory-aligned: Supports validation approaches recommended by EP, USP and ChP to replace lengthy culture-based methods.
- Convenient format: Supplied as multiple tubes with matching DNA Dilution Buffer to simplify test solution preparation.
Applications
- Validation of NAT / qPCR methods for mycobacteria detection
- Limit of detection (LOD) and sensitivity verification of qPCR assays
- Routine quality control and proficiency testing of mycobacterial molecular assays
- Method transfer and regulatory method validation in accordance with EP/USP/ChP recommendations
Kit Contents
Mycobacterium phlei Sensitivity Standard (10 CFU) (NNE002) — 10 CFU × 3 tubes-65 °C
Mycobacterium phlei Sensitivity Standard (100 CFU) (NNE001) — 100 CFU × 3 tubes-65 °C
DNA Dilution Buffer (DDB) (NND001) — 1.5 mL × 3 tubes-20 °C
* Total: 3 tubes per concentration format (each tube contains the stated CFU); use one tube per control/test as required | Method: qPCR
Attention
• Each strain must not be diluted; dilution may cause uneven distribution and risk of undetected contamination.
• Equilibrate reagents to room temperature before use and avoid repeated freeze–thaw cycles.
• Use appropriate DNA extraction prior to PCR to reduce inhibition and maximize assay sensitivity.
• Do not mix reagents from different batches.
• Do not use reagents beyond their expiration date.
• Include at least one negative control (matrix negative control) for each test; sample matrix may cause PCR inhibition.
• This product is intended for research use only and must not be used for clinical diagnosis or treatment.
• For safety, use appropriate laboratory PPE (lab coat, disposable gloves) and follow biosafety cabinet procedures when handling.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the intended use of MycoSHENTEK Mycobacterium Sensitivity Standards?
They are non-infectious reference standards intended to validate NAT/qPCR methods, assess assay sensitivity and serve as positive controls; they are not for culture or clinical diagnosis.
Q2: How should the standards be stored?
Store mycobacterial strain tubes at -65 °C and the DNA Dilution Buffer (DDB) at -20 °C. The kit shelf life is 12 months; check the expiration date on labels.
Q3: Can I dilute the strain tubes to prepare lower concentrations?
No. Each strain must not be diluted because dilution may cause uneven distribution of mycobacteria and risk undetected contamination. Instead use the provided nominal formats or validated dilution procedures if supported by your internal validation.
Q4: Do I need to extract DNA before qPCR?
Yes. Appropriate sample DNA extraction is strongly recommended before PCR to reduce inhibition and maximize assay sensitivity. Follow the instructions of your DNA extraction kit.
Research Use Only
✔
Research Use Only (RUO) – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
