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For Research Use Only (RUO)
$1,236.00
Sku: 1503604
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), specifically qPCR, for detection of Mycobacterium. Available as defined nominal concentrations (10 CFU/tube and 100 CFU/tube), the standards are not intended for culture. To prepare test samples, add the specified volume of sample matrix to the standards to reach the desired final concentration (for 10 CFU tubes supplement to a total volume of 400 µL), then perform DNA extraction and real-time PCR. The product is intended as a positive control/validation standard and is compatible with the MycoSHENTEK® Mycobacteria DNA Extraction Kit and MycoSHENTEK® Mycobacteria DNA Detection Kit. Compliant with recommendations from EP, USP and ChP for replacing culture methods with validated NAT.
Technical Specifications
| Parameter | Details |
|---|---|
| Nominal concentration (format) | 10 CFU per tube (NNE002) and 100 CFU per tube (NNE001) |
| Tube count per kit | 3 tubes of mycobacterium standard + 3 tubes DNA Dilution Buffer per kit |
| DNA Dilution Buffer (DDB) | 1.5 mL × 3 tubes (NND001) |
| Storage temperature | Strains: -65 °C; DNA Dilution Buffer: -20 °C |
| Shelf life | 12 months (check label expiration date) |
| Intended use | Validation of NAT/qPCR sensitivity and robustness; positive control standards (non-infectious) |
| Preparation guidance | Thaw at 2-8 °C; add specified sample matrix volume (for 10 CFU tubes supplement to 400 µL), vortex 10 s, centrifuge briefly, extract DNA, perform qPCR |
| Restriction | Not intended for culture; do not dilute strain tubes |
Features
- Ready-to-use sensitivity standards: Provided at defined nominal concentrations (10 CFU and 100 CFU) to support assay sensitivity verification.
- Non-infectious materials: Standards are non-infectious and supplied for NAT/qPCR validation without culture handling risk.
- Pharmacopeia-aligned: Designed to support validated NAT approaches recommended by EP, USP and ChP as alternatives to lengthy culture methods.
- Compatible with MycoSHENTEK kits: Validated workflow includes MycoSHENTEK Mycobacteria DNA Extraction Kit and Mycobacteria DNA Detection Kit for full assay validation.
- Convenient format: Supplied in multiple tubes with accompanying DNA dilution buffer for sample preparation and reproducible use.
Applications
- Validation of NAT/qPCR methods for Mycobacterium detection
- Assay sensitivity verification and limit-of-detection checks
- Method qualification and performance verification per EP/USP/ChP
- Quality control and proficiency testing in R&D and QC laboratories
- Operator training for sample processing, extraction and qPCR workflows
Kit Contents
Mycobacterium phlei (10 CFU) NNE002-65 °C (store strain tubes frozen)
DNA Dilution Buffer (DDB) NND001 — 1.5 mL × 3 tubes (supplied with 10 CFU kit)-20 °C
Mycobacterium phlei (100 CFU) NNE001-65 °C (store strain tubes frozen)
DNA Dilution Buffer (DDB) NND001 — 1.5 mL × 3 tubes (supplied with 100 CFU kit)-20 °C
* Total: Not applicable — supplied as positive control standards (3 tubes per concentration) | Method: qPCR (NAT)
Attention
• Each strain tube must not be diluted; dilution causes uneven distribution and may create undetected contamination risk.
• Equilibrate reagents to room temperature before use and avoid repeated freeze–thaw cycles.
• Use appropriate sample DNA extraction before PCR to reduce inhibition and maximize assay sensitivity.
• Do not mix reagents from different batches.
• Do not use reagents beyond their expiration date; check label expiration.
• Operational deviations from the user guide may affect results.
• PCR inhibition may be caused by the sample matrix; include a negative control sample using the sample matrix.
• Include at least one negative control for each test run.
• Intended for research use only — not for clinical diagnosis or treatment.
• Wear appropriate laboratory clothing and disposable gloves for safety.
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 are the available concentrations of the MycoSHENTEK sensitivity standards?
Standards are provided as Mycobacterium phlei at nominal concentrations of 10 CFU per tube and 100 CFU per tube, each supplied as 3 tubes per kit.
Q2: How should the standards be stored?
Store mycobacterium strain tubes at -65 °C. Store DNA Dilution Buffer (DDB) at -20 °C. The kit shelf life is 12 months; check the expiration date on the label.
Q3: Can these standards be used for culture?
No. These standards are non-infectious and not intended for culture; they are supplied for NAT/qPCR validation only.
Q4: What controls should be included when using these standards?
Include at least one negative control with the same sample matrix for each test. Also follow DNA extraction and qPCR kit recommendations to monitor inhibition and assay performance.
Research Use Only
✔
Research Use Only (RUO) — Not for clinical diagnostic or therapeutic use – 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.
