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For Research Use Only (RUO)
$1,236.00
Sku: 1501505
Product Description
The MycoSHENTEK® Mycoplasma Sensitivity Standards are non-infectious reference standards designed to validate the robustness and sensitivity of nucleic acid amplification techniques (NAT), such as qPCR, for detection of mycoplasma contamination. The standards provide defined quantities (10 CFU) of specific Mycoplasma strains for use as spike-in or positive controls to assess assay sensitivity and workflow performance. They are intended to support replacement of traditional culture methods with validated NAT approaches in accordance with pharmacopeial guidance (EP, USP, JP). The standards are not intended for culture. The product is supplied with DNA Dilution Buffer (DDB) to prepare test solutions and is compatible with MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit for downstream extraction and real-time PCR analysis.
Technical Specifications
| Parameter | Details |
|---|---|
| Target sensitivity | 10 CFU/mL (prepared by adding sample matrix to 1 mL to achieve final concentration of 10 CFU/mL) |
| Provided concentration per tube | 10 CFU per tube (each strain: 10 CFU × 5 tubes) |
| Included strains | Mycoplasma orale (NNE006), Mycoplasma pneumoniae (NNE009), Mycoplasma hyorhinis (NNE008) |
| Storage conditions | Strains: -65 °C; DNA Dilution Buffer (DDB, NND001): -20 °C |
| Shelf life | 6 months (check expiration on label) |
| Sample preparation volume | Add sample matrix to each tube to a final volume of 1 mL to reach 10 CFU/mL |
| Recommended processing conditions | Thaw at 2–8 °C; vortex 10 seconds; centrifuge 30 min at 16,000 × g at 2–8 °C; remove 500 µL supernatant and retain 500 µL for DNA extraction |
| Intended use | Validation and sensitivity verification of NAT/qPCR assays for mycoplasma; positive control for assay performance |
| Regulatory sensitivity reference | Meets pharmacopeial sensitivity targets referenced in EP/USP/JP (EP 2.6.7: 10 CFU/mL to replace culture methods; 100 CFU/mL to replace indicator cell culture methods) |
| Infectivity | Non-infectious; not intended for culture |
Features
- Defined low-copy mycoplasma standards: Supplied as 10 CFU per tube to permit sensitive limit-of-detection and sensitivity verification of qPCR-based mycoplasma NAT workflows.
- Non-infectious, ready-to-use format: Standards are non-infectious and designed for direct use as spike-in controls after addition of sample matrix—no culture required.
- Pharmacopeial alignment: Designed to support validation against EP/USP/JP guidance for NAT replacement of culture methods (e.g., EP 2.6.7).
- Workflow compatibility: Compatible with MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit for streamlined extraction and qPCR analysis.
- Stable packaged format: Supplied in multiple tubes (5 tubes per strain) with DNA Dilution Buffer for reproducible preparation of test solutions.
Applications
- Validation of NAT/qPCR mycoplasma detection assays
- Limit-of-detection (LOD) verification and sensitivity qualification
- Positive control / spike-in for mycoplasma testing in cell therapy and biologics workflows
- Assay development and performance monitoring
- Proficiency testing and laboratory quality control
Kit Contents
Mycoplasma orale Sensitivity Standard (10 CFU) — Part No. NNE006-65 °C; 10 CFU × 5 tubes
Mycoplasma pneumoniae Sensitivity Standard (10 CFU) — Part No. NNE009-65 °C; 10 CFU × 5 tubes
Mycoplasma hyorhinis Sensitivity Standard (10 CFU) — Part No. NNE008-65 °C; 10 CFU × 5 tubes
DNA Dilution Buffer (DDB) — Part No. NND001-20 °C; 1.5 mL × 5 tubes
* Total: 5 tubes per strain; three strains provided (total 15 sensitivity standard tubes). Each tube prepared to 1 mL yields one 10 CFU/mL test solution. | Method: qPCR (nucleic acid amplification technique, NAT)
Attention
• Do not mix reagents from different batches.
• Do not use reagents beyond their expiration date; kit shelf life is 6 months.
• Each strain must not be diluted prior to preparing the 1 mL test solution; dilution may cause uneven distribution and risk of undetected contamination.
• Use only after equilibrating to room temperature and avoid repeated freeze–thaw cycles.
• Appropriate sample DNA extraction is strongly recommended prior to PCR to reduce inhibition and maximize assay sensitivity.
• Include at least one negative control using the same sample matrix for each test sample; PCR inhibition may be caused by the sample matrix.
• This product is intended for research use only and should not be used for clinical diagnosis or treatment; follow appropriate laboratory safety practices (lab coat, disposable gloves).
• Any operational deviations from the user guide may affect results.
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 the MycoSHENTEK® Mycoplasma Sensitivity Standards?
They are intended as non-infectious reference standards to validate and verify the sensitivity and robustness of NAT/qPCR mycoplasma detection workflows, and as positive controls or spike-in materials for assay performance assessment.
Q2: How do I prepare a test solution at 10 CFU/mL?
Thaw the strain at 2–8 °C. Based on the volume indicated on the tube label, add appropriate sample matrix to each tube to a final volume of 1 mL to achieve 10 CFU/mL. Vortex 10 seconds, centrifuge 30 minutes at 16,000 × g at 2–8 °C, carefully remove 500 µL supernatant (avoid disturbing pellet), and use the remaining 500 µL for DNA extraction and subsequent qPCR.
Q3: How should the standards and buffer be stored?
Store mycoplasma strain tubes at -65 °C and DNA Dilution Buffer (DDB, NND001) at -20 °C. Do not repeat freeze–thaw cycles and use within the kit shelf life (6 months).
Q4: Can these standards be used for culture-based mycoplasma testing?
No. The standards are non-infectious and not intended for culture. They are designed for NAT/qPCR validation and verification only.
Research Use Only
✔
Research Use Only (RUO). Non-infectious standards; not for clinical diagnosis or treatment; not for culture. – 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.
