The Program

Minerva Biolabs GmbH is proud to organize the 7. proficiency test for molecular mycoplasma detection methods for contamination control of cell culture materials and biologicals. This study was strong demanded by customer requests and was requested by the IRPCM Group "Cell Culture" of the International Organisation of Mycoplasmology (IOM).

The aim of the collaborative study is a survey on the quality of mycoplasma testing and long term to establish an external quality assurance programme and thus improving the reliability of NAT-based mycoplasma testing. The study will allow each individual laboratory an assessment of the accuracy and sensitivity of the tests carried out in international comparison. The study is organized on a semi-annual basis.

An identical set of samples will be shipped to all participants and independently analyzed under individual conditions. The results are evaluated statistically. All participants receive the evaluation for information about the correctness of the analysis as well as an individual certificate of success, if 4 of 5 samples were analyzed properly. The evaluation is anonymous. The data might be published in respect of relevance and interest at conferences or in print media but not for commercial use.

The mycoplasmas in the sample set will be titrated applying the culture method (CFU/ml) and using a qPCR method (GU/ml). The sample set may contain different sample matrices, concentrations and bacteria species.

1 sample set = 5 samples

The samples contain the full bacteria particles. Before shipping the samples will be inactivated gently and lyophilized.
For providing the sample material, the logistical effort, the evaluation and preparation of documentation a fee of 130 € plus the statutory VAT and delivery charge will apply.

 


 

Shipping fees:

Germany: 10,50 €
EU: 19,90 €
Outside EU: 42,00 €

 


 

Deadlines

Deadline for Filing: March 13th, 2017
Shipping of Samples: March 27th, 2017
Submission of Results: April 19th, 2017
Release of Certificates and Report: May 1st, 2017

For participation the timely registration is required. Please take advantage of the submission form provided and send the copy by fax to Minerva Biolabs GmbH.

 


 

Terms and Conditions

  1. Minerva Biolabs GmbH organizes the survey for quality control purposes only.
  2. The proficiency test is open to every professional, carrying out laboratory tests.
  3. A participation is only possible by accepting these terms by signing the registration form.
  4. Samples and protocol sheets will be dispatched via courier service. In case of loss or damage of the sample material a replacement might only by possible if an immediate complaint was made.
  5. Only report sheets received in due time can be considered. Additional result reports and certificates can be generated in justified cases, upon payment of a fee.
  6. In case of a failing of the proficiency testing caused by the organization either no invoicing or a replacement of the samples applies. The related costs of reagents, time, etc. cannot be refunded.
  7. The organizers are not liable for the improper use of the set of samples or the analysis results.
  8. Jurisdiction is Berlin.

 


 

Frequently Asked Questions (FAQ)

What does “NAT-Mycoplasma” mean?
Nucleic Acid  Amplification Test

So, does NAT mean PCR?
Not necessarily but including PCR. Any technique which is based on the detection of DNA can be used.

If I understand, the price is 130 € + 19.90 € for shipping charges. Will you supply just 1 sample set? For confirmation or something like that…
The charge of 130 € applies for each set of sample/shipment. In April 2012 we will provide a comparable set of 5 samples for additional participants which missed the October set, failed the test or like to check their system two times a year.

Following the results obtained by end-user, will you supply a kind of “official certificate of external quality assurance”?
Yes. An official certificate for participation and/or results within the range will be issued.

Do you need that all participants declare what method of detection they use?
Yes, as this will give the participants a statistical overview on available test systems and their characteristics.

If I book via our local distributor, who will issue the certificate?
The distributor will receive the test samples and will forward them to the participant. The results will be transferred by the distributor to Minerva Biolabs for evaluation. The certificate will be issued by the distributor with the results supplied by Minerva. In all cases Minerva will not be aware of end customers contact information.

Does an end-user who makes colorimetric detection, or Elisa or another detection method could participate?
No, as the material is inactivated colorimetric assays cannot be used. The inactivation method will disintegrate the protein structure which will not allow proper ELISA.

You say that you will supply a comparable set of 5 samples. But in fact for each participant, the set of 5 will be different? Some of participants will have 5 vials with mycoplasma; some other could have 3 positives and 2 negatives …?
All participants will receive exactly the same material. Material from different proficiency runs will differ in formulation.

Do participants using a home brew method receive some kind of official certificate that their in house test is ok when they participate?
Yes, all participants will receive a certificate which either states “participated” or “completed successfully” if their results are within the statistical range of all other reports.
For statistical reasons the result report form will have a section to address the type of test used. Here they can check “homemade”.

Are those 5 samples enough for a costumer to compare eg 2 or 3 different methods?
Each sample will contain a lyophilized pellet which should be rehydrated with 300 µl of water. This volume should be enough for many PCR reactions even in case a DNA extraction is required.

Is it allowed to compare our in house test  to a commercial test by using this sample set? Is the price the same for using the samples for this purpose?
All participants are treated the same way. All participants who like to use the samples to compare different methods are welcome to do so. Purchase of the sample set does not imply an obligation to provide a result report.