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For Research Use Only (RUO)
$1,236.00
Sku: 1501501
Product Description
The MycoSHENTEK® Mycoplasma Sensitivity Standards are non-infectious controls designed to validate the robustness and sensitivity of nucleic acid amplification techniques (NAT), such as real-time qPCR, for mycoplasma detection. They provide defined mycoplasma target loads to support method validation and replacement of traditional culture-based assays. Prepared by adding the specified volume of sample matrix to the provided standards to produce a test solution (final concentration 10 CFU/mL when filled to 1 mL). Intended for use with appropriate DNA extraction procedures and compatible MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit. Not intended for culture; research use only.
Technical Specifications
| Parameter | Details |
|---|---|
| Nominal concentration per tube | 10 CFU per tube (when prepared to 1 mL final volume yields 10 CFU/mL) |
| Intended detection sensitivity (regulatory guidance) | Per EP/USP/JP guidance, NAT methods should reach 10 CFU/mL to replace culture methods and 100 CFU/mL to replace indicator cell culture methods |
| Storage conditions | Mycoplasma strains: -65 °C; DNA Dilution Buffer (DDB): -20 °C |
| Shelf life | 6 months (check expiration date on labels) |
| Sample preparation | Add sample matrix to each tube to 1 mL final volume to achieve 10 CFU/mL; vortex 10 s; centrifuge 30 min at 16,000 × g, 2–8 °C; carefully remove 500 µL supernatant leaving pellet-containing 500 µL for DNA extraction |
| Recommended workflow | Equilibrate to room temperature, perform appropriate DNA extraction, then real-time PCR (qPCR) |
| Handling warnings | Do not dilute strains; avoid repeated freeze–thaw; do not mix reagents from different batches |
| Compatibility | Designed to be used with MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit |
Features
- Defined low-level sensitivity standards: Each tube contains a defined 10 CFU nominal mycoplasma amount to validate assay sensitivity down to regulatory targets.
- Non-infectious, non-culture standards: Standards are non-infectious and not intended for culture-based assays — optimized for NAT/qPCR workflows.
- Ready-to-use format: Supplied in pre-aliquoted tubes; prepare test solution by adding sample matrix to the labeled volume to obtain the target concentration.
- Regulatory-aligned: Prepared to support method validation according to EP/USP/JP recommendations for replacing culture methods with NAT.
Applications
- Validation of nucleic acid amplification tests (qPCR) for mycoplasma detection
- Method sensitivity verification during assay development and qualification
- Quality control and lot release testing workflows for cell therapy and biologics
- Training and proficiency testing for laboratory staff performing mycoplasma NAT assays
Kit Contents
Mycoplasma orale Sensitivity Standard (10 CFU)-65 °C (10 CFU × 5 tubes)
Mycoplasma pneumoniae Sensitivity Standard (10 CFU)-65 °C (10 CFU × 5 tubes)
Mycoplasma hyorhinis Sensitivity Standard (10 CFU)-65 °C (10 CFU × 5 tubes)
DNA Dilution Buffer (DDB)-20 °C (1.5 mL × 5 tubes)
* Total: 15 tubes total (3 species × 5 tubes); each tube contains 10 CFU (prepare to 1 mL to yield 10 CFU/mL) | Method: qPCR (real-time PCR) after DNA extraction
Attention
• Do not mix reagents from different batches.
• Do not use reagents beyond their expiration date; check labels.
• Each strain must not be diluted — dilution may cause uneven distribution and risk undetected contamination.
• Equilibrate reagents to room temperature and avoid repeated freeze–thaw cycles.
• Include at least one negative control per test sample; include a negative control using the sample matrix to monitor inhibition.
• Appropriate sample DNA extraction is strongly recommended before PCR to reduce inhibition and maximize sensitivity.
• This product is for research use only; not for clinical diagnosis or treatment.
• Wear appropriate laboratory clothing and disposable gloves for safety.
Quality Management & Certifications
Quality System
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Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the nominal mycoplasma concentration in each tube and how do I prepare the test sample?
Each tube contains a nominal 10 CFU. To prepare the test solution, add the indicated volume of sample matrix to each tube to bring the final volume to 1 mL (resulting in 10 CFU/mL). Vortex 10 seconds, centrifuge 30 minutes at 16,000 × g (2–8 °C), carefully remove 500 µL supernatant, and use the remaining 500 µL for DNA extraction followed by qPCR.
Q2: How should the standards be stored and what is the shelf life?
Store mycoplasma strain tubes at -65 °C and DNA Dilution Buffer (DDB) at -20 °C. The kit shelf life is 6 months — always check the expiration date on the labels.
Q3: Can these standards be cultured or are they safe to handle without BSL precautions?
The standards are non-infectious and are not intended for culture. They are intended for use as NAT/qPCR controls. Follow standard laboratory safety practices (gloves, lab coat) when handling.
Q4: What controls should I include in my PCR assay?
Include at least one negative control for each test sample and a negative control using the sample matrix to monitor for inhibition. Follow your assay validation protocol and manufacturer recommendations for positive and internal controls.
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.
