Mycoplasma Detection Proficiency Testing: Ensuring Quality, Benchmarking Methods, Enhancing Safety

Why Proficiency Testing for Mycoplasma PCR is More Important Than Ever Before

Interlaboratory comparisons, commonly known as proficiency tests, are a proven way to verify the reproducibility of molecular biological methods across different laboratories. They are widely accepted and recommended as a tool for quality assurance. This is especially relevant when methods are used in multiple labs, newly developed, or submitted for regulatory approval.

Reliable test results are essential. They ensure that timely action can be taken when pharmaceutical products are contaminated. This is critical to protect patients. Mycoplasma testing plays a key role in this context. It helps safeguard the quality of ATMPs, cell cultures, and biopharmaceuticals. Equally important is the comparability of results between laboratories. This includes research institutions and industrial partners. Proficiency tests offer a structured platform for that. They help confirm the strengths of testing methods and identify areas for improvement.

How the Minerva Biolabs Proficiency Test Works

Participating laboratories receive anonymized samples spiked with defined quantities of inactivated mycoplasma or other inactivated microorganisms. These are analyzed using the lab’s own established methods. Results are submitted to Minerva Biolabs GmbH and compiled in an anonymized report, providing each lab with individualized performance feedback.

Since its foundation, Minerva Biolabs’ international proficiency testing program has provided not only a solid foundation for method validation but also continuous insights into methodological quality. It is ideal for onboarding new staff and ongoing internal training.

A Look Back at Six Years of Mycoplasma Detection Proficiency Testing: Data, Trends, and Insights

Looking back over the past six years the results of the PCR-based mycoplasma detection proficiency test reveal high overall test quality and underline the value of interlaboratory comparison for method development and improvement.

Diverse international participation

Participants from 12 countries and various sectors highlight the global relevance and diversity of the program:

Consistently high success rates

In nearly all years, the vast majority of participants achieved at least four out of five correct results, with many delivering flawless analyses. This consistency underscores the reliability of established test systems and the expertise of specialist labs worldwide.

Challenges as a driver of quality

A core component of the proficiency tests has always been the deliberate inclusion of methodological stress tests using inhibitory matrices like PVSA, cell debris, or low-GC mycoplasma standards with extremely low GC:CFU ratios. These challenges reveal improvement opportunities in extraction protocols, rehydration steps, or sample handling even for experienced laboratories.

Gaining knowledge, ensuring quality

Beyond demonstrating laboratory competence, the program serves as a tool for continuous methodological refinement. It promotes transparency, supports standardization, and enhances recognition in regulatory processes.

Key Learnings and Implications

Validated methods deliver more stable results:

Labs using commercial kits with validated, optimized protocols consistently perform better. These kits offer harmonized workflows for sample prep and PCR reagents especially beneficial for complex matrices or low target concentrations. Internal controls and effective DNA extraction are recurring success factors.

Matrix effects remain a challenge:

In-house methods often face limitations, particularly when samples contain inhibitors such as high protein content, cell debris, high cell density, excipients, or paraffin embedding. The optimisation of sample preparation, especially the extraction process, is crucial for reliable results.

Ongoing training is essential:

The tests show that even well-established labs benefit from regular training and method review. This not only improves accuracy but also enhances cross-site comparability.

Why These Results Matter

PCR-based detection workflows involve several sensitive steps - from cell lysis to DNA extraction and amplification. Minor deviations can have major consequences. This is where proficiency testing proves its value: by exposing weak points, improving comparability between labs, and strengthening acceptance with regulatory bodies - especially in global approval procedures.

Proficiency testing is much more than a performance check. It’s a key instrument for continuous quality improvement, test validation, and ultimately, patient safety. Participating labs gain a powerful proof of quality - internally and externally, for customers, partners, and regulators alike.

Proficiency testing doesn’t just measure performance it drives progress and lays the foundation for methodological excellence and regulatory compliance.

Outlook: Where are we headed?

Minerva Biolabs is continuously expanding the program with:

Our mission: To not only keep pace with science, but to actively shape the standard.

Join Now – Shape Quality With Us

Show that your lab stands for quality, precision, and safety.
Take the opportunity to benchmark your PCR method - realistically, data-driven, and anonymously.

Information on registration and deadlines can be found on our webpage.