Rapid Mycoplasma Testing Designed for fast, reliable & compliant mycoplasma testing using real-time PCR
Viable but non-culturable (VBNC) Mycoplasma can go undetected when using the traditional method of mycoplasma culturing, risking false-negative results. Our qPCR kits offer a method for early detection of mycoplasma contamination. These kits are fast, highly specific, sensitive, and compliant with international guidelines.
Mycoplasma qPCR detection kits: a rapid and guideline-compliant solution for Mycoplasma detection.
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Mycoplasma Testing Product Highlights
Cyclus® RT-qPCR Mycoplasma
Rapid Mycoplasma Detection in only a few hours
Cyclus® RT-qPCR Mycoplasma is designed to rapidly detect total mycoplasma in cell cultures, cell culture-derived biologicals, and ATMPs. The technology is based on real-time polymerase chain reaction (PCR).
Why choose Cyclus® RT-qPCR Mycoplasma?
- Reliable Results in only a few hours — Replace 28-day cultivation protocols with Cyclus® RT-qPCR Mycoplasma. TaqMan® probe chemistry maximizes qPCR specificity, while internal control reactions help rule out false negatives.
- The only non-infectious, digital PCR quantified sensitivity standards — Cyclus® 10 CFU and 100 GC standards for all EP/USP relevant mycoplasma species. We provide step-by-step, matrix-specific validation guidance from Sartorius PCR experts.
- Compliance with international standards — Cyclus® Mycoplasma Test Kits are validated according to EP 2.6.7 (12.2) and meet the criteria of international authorities, including USP and JP.
- Ease of use — Cyclus® RT-qPCR Mycoplasma is compatible with any qPCR cycler that detects FAM® and HEX® (or VIC™/JOE™). Clear, color-coded reagents guide users through a short, simple protocol. Lyophilized components ensure consistent stability and quality without freezer storage.
- Superior sensitivity — Detect as low as ≤ 10 CFU/mL and < 100 GC/mL, capturing both DNA and RNA with RT-qPCR.
- Flexibility — Broad sample matrix compatibility and optional automation enabled by Cyclus® Bead Extraction sample preparation.
Cyclus® Bead Extraction
Magnetic Bead Based Mycoplasma Nucleic Acid extraction
Cyclus® Bead Extraction is a magnetic bead-based nucleic acid extraction kit developed for the efficient and automated isolation of Mycoplasma nucleic acids from various sample matrices, such as cell cultures, cell culture supernatants, and biopharmaceuticals.
Why Choose Cyclus® Bead Extraction ?
- Flexible Extraction Methods — Extraction can be performed manually using a magnetic rack or automatically using the KingFisher™ Flex.
- Designed for Sartorius qPCR Kits — Cyclus® Bead Extraction is designed for use with Cyclus® RT-qPCR Mycoplasma, Cyclus® 10 CFU Mycoplasma and Cyclus® 100 GC Mycoplasma Sensitivity Standards.
- Fast Results — Extraction time is approximately 1.5 hours.
- Regulatory-Compliant Preparation — Sample preparation for Mycoplasma release testing is in accordance with EP 2.6.7 Edition 12.2
- Convenient & Stable Kit — The kit includes 100 extractions, has a shelf life of 2 years, and is stable at room temperature.
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Mycoplasma Versions
Choose the right product for your needs
| Application | Use this Cyclus® product | Product Details |
|---|---|---|
| Sample preparation/Nucleic acid extraction | Cyclus® Bead Extraction | Shop Now |
| 10 CFU Sensitivity Standard for method validation & routine external positive control | Cyclus® RT-qPCR Mycoplasma | Shop Now |
| 10 CFU Sensitivity Standard for method validation & routine external positive control (all relevant EP/USP species) | Cyclus® 10 CFU Mycoplasma | Shop Now |
| 10 CFU Sensitivity Standard for method validation & routine external positive control (all relevant EP/USP species) | Cyclus® 100 GC | Shop Now |
Mycoplasma Detection Video
The Dangers of Mycoplasma Contamination
Mycoplasma contamination can quietly compromise experiments, change cell behavior, and invalidate results without any obvious signs. More than 95% of contaminations arise from just six species and can spread through water baths, pipettes, or even lab personnel. Traditional testing methods can take weeks. Cylus® Mycoplasma offers reliable detection in only a few hours, allowing you to respond quickly and safeguard your work.
Resources for Clean and Reliable Cell Cultures
Featured Resources
Mycoplasma Testing Product Documentation & Literature
Cyclus® 10 CFU - Validation Standard and External Positive Control - Instructions for Use
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Mycoplasma FAQ
Both guidelines introduce 100 genome copies (GC)/mL as a PCR-appropriate sensitivity unit and require defined controls for assay performance, including a positive extraction control (PEC) and verification of validated method sensitivity.
Yes, Cyclus® Bead Extraction and Cyclus® RT-qPCR are validated according to EP 2.6.7 (Issue 12.2), USP <63>, USP <77> Draft, JP18, and ICH Q2(R2).
Yes, the kit fully meets the current EP 2.6.7 requirements and can already be implemented to ensure a smooth transition to the new guideline in 2026.
All Cyclus® Mycoplasma products are designed for use in GMP-compliant quality control laboratories and supports rapid batch release of biopharmaceuticals and ATMPs.
The validated Cyclus® Bead Extraction and Cyclus® RT-qPCR assay achieve sensitivities of ≤ 10 CFU/ml and < 100 GC/ml, covering both culturable and non-culturable mycoplasmas.
The internal positive control (synthetic DNA) is included in the kit and monitors the full assay including the DNA extraction and each subsequent PCR run.
The external positive control (EPC) is a separate reference standard required by EP 2.6.7 (12.2) to confirm the validated sensitivity; we recommend our ready-to-use and dPCR quantified Cyclus® 100 GC - and Cyclus®10 CFU Standards.
Cyclus® Bead Extraction and Cyclus®RT-qPCR Mycoplasma were intensively validated according to EP 2.6.7 (12.2) hence, only a product-specific “test for inhibitory substances” with your own matrix is required.
For any new, yet unvalidated product you should use the EP 2.6.7 (12.2) validated assay consisting of Cyclus® Bead Extraction, Cyclus® RT-qPCR Mycoplasma and the Cyclus® Sensitivity Standards to perform a product-specific validation to confirm that the validated LOD is maintained in your specific matrix.