⚡ Detection Method

qPCR

🕒 Assay Time

Refer to manual

🎯 Storage Temperature

-65 °C (strains); -20 °C (DDB) (shelf life 6 months)

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), specifically qPCR/real-time PCR, for mycoplasma detection. These standards contain defined nominal amounts of mycoplasma (10 CFU per tube) and are intended to be mixed with sample matrix to produce a test solution (e.g., 10 CFU/mL) for downstream DNA extraction and qPCR detection. The standards support method validation and performance verification in accordance with pharmacopeial guidance (EP/USP/JP), where NAT sensitivity targets include 10 CFU/mL to replace culture methods and 100 CFU/mL to replace indicator cell culture methods. The product is not for culture and is intended for research use only. Compatible with MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit for complete workflow validation.

Technical Specifications

Parameter	Details
Nominal concentration	10 CFU per vial (when reconstituted to 1 mL final volume → 10 CFU/mL)
Available strains / catalog	Mycoplasma orale (Product No. 1501501), Mycoplasma pneumoniae (Product No. 1501503), Mycoplasma hyorhinis (Product No. 1501505)
Kit format / quantity	Each strain: 10 CFU × 5 tubes; DNA Dilution Buffer (DDB): 1.5 mL × 5 tubes
Storage conditions	Strains: -65 °C; DNA Dilution Buffer: -20 °C
Shelf life	6 months (check expiration date on labels)
Preparation guidance	Thaw at 2–8 °C. Add sample matrix to bring tube volume to 1 mL to achieve 10 CFU/mL. Vortex 10 s and centrifuge 30 min at 16,000 × g, 2–8 °C. Remove 500 µL supernatant carefully and mix remaining 500 µL for DNA extraction.
Intended analytical sensitivity (pharmacopeial target)	Per EP/USP/JP guidance: demonstrate method sensitivity to 10 CFU/mL to replace culture methods; 100 CFU/mL to replace indicator cell culture methods

Features

Non-infectious reference standards: Standards are non-infectious and not intended for culture—safer and convenient for laboratory use.
Defined nominal CFU: Each vial contains a nominal 10 CFU to enable validation of low-level assay sensitivity.
Prepared for NAT/qPCR validation: Specifically designed to validate nucleic acid amplification techniques such as qPCR/real-time PCR according to pharmacopeial guidance.
Simple preparation workflow: Add sample matrix to 1 mL, vortex, centrifuge, remove supernatant and extract DNA for downstream qPCR.
Compatible with extraction and detection kits: Recommended use with MycoSHENTEK® Mycoplasma DNA Extraction Kit and MycoSHENTEK® Mycoplasma DNA Detection Kit for complete workflow verification.

Applications

Validation of qPCR/NAT mycoplasma detection assays
Method sensitivity verification to meet EP/USP/JP requirements
Quality control and assay performance checks in cell therapy and biologics manufacturing
Workflow verification for DNA extraction and qPCR detection kits
Laboratory training and proficiency testing for low-level mycoplasma detection

Kit Contents

Mycoplasma orale Sensitivity Standard (10 CFU × 5 tubes) (Product No. 1501501)-65 °C

Mycoplasma pneumoniae Sensitivity Standard (10 CFU × 5 tubes) (Product No. 1501503)-65 °C

Mycoplasma hyorhinis Sensitivity Standard (10 CFU × 5 tubes) (Product No. 1501505)-65 °C

DNA Dilution Buffer (DDB) (1.5 mL × 5 tubes) (Part No. NND001)-20 °C

* Total: Not applicable (standards: 10 CFU × 5 tubes per strain) | Method: qPCR (real-time PCR) for downstream detection after DNA extraction

Attention

• Do not mix reagents from different batches.

• Do not use reagents beyond their expiration date.

• Do not dilute the strain vials; dilution may cause uneven distribution and undetected contamination risk.

• Equilibrate to room temperature before use and avoid repeated freeze–thaw cycles.

• Perform appropriate sample DNA extraction prior to PCR to reduce inhibition and maximize assay sensitivity.

• PCR inhibition may be caused by sample matrix—include a negative control prepared in the same sample matrix.

• Include at least one negative control for each test run/sample set.

• This product is intended for research use only and must not be used for clinical diagnosis or treatment.

• Wear appropriate lab clothing and disposable gloves for safety.

Quality Management & Certifications

Quality System

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QMS (ISO, GMP)

Download Certificate

Quality Advantages

View Report

Quality Control Process

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📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What is the intended use of the MycoSHENTEK® Mycoplasma Sensitivity Standards?

These standards are intended for research use only to validate and verify the sensitivity and robustness of NAT/qPCR mycoplasma detection workflows. They are non-infectious and not for clinical diagnosis or culture.

Q2: How do I prepare a test solution from the standard vial?

Thaw the vial at 2–8 °C. Add sample matrix to bring the tube volume to 1 mL to achieve a final concentration of 10 CFU/mL. Vortex 10 seconds, centrifuge 30 minutes at 16,000 × g (2–8 °C), carefully remove 500 µL supernatant, and mix the remaining 500 µL for DNA extraction.

Q3: What are the storage conditions and shelf life?

Strain vials should be stored at -65 °C, DNA Dilution Buffer (DDB) at -20 °C. The kit has a shelf life of 6 months—check the expiration date on the label.

Q4: Can these standards be used for culture or as infectious controls?

No. The standards are non-infectious and are not intended for culture; they are designed solely as molecular sensitivity standards for NAT/qPCR validation.

Research Use Only

✔

Research Use Only (RUO). Not for clinical diagnosis or treatment. Non-infectious standards; not intended 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.

Mycoplasma pneumoniae Sensitivity Standard (10 CFU) MycoSHENTEK®