Proficiency Testing Program


In response to a growing customer demand, Minerva Biolabs GmbH organizes a periodic international proficiency testing program for contamination diagnostics in cell cultures and biologicals. The aim of the program is the validation of NAT-based detection of mycoplasmas, bacteria, and fungi/yeasts. These inter-laboratory tests should enable the participants to assess the accuracy and sensitivity of the chosen assays in the context of an international comparison.
The proficiency testing program takes place on an annual basis.

An identical set of samples provided by Minerva Biolabs will be tested by all participants independently under comparable conditions. Once the tests are completed, the individual results will be statistically analyzed.

Subsequently, a final evaluation in the form of an anonymous report will be provided.
Each participant will receive information about the outcome of their tests (results correct/incorrect) and a certificate of participation. A successful participation will be certified when 4/5 or 8/10 samples are correctly identified. The certificate will contain the following information: the name of the participant, the location of the laboratory, the selected sample preparation method and detection assay. A simple certificate of participation will be issued in case of a higher error rate.

Importantly, the nature/type of the provided samples can vary. Different sample matrices, concentrations, and species can be included in the set of samples. Each sample will be provided as a freeze-dried matrix (in a vial). This matrix needs to be dissolved in 1 ml of the usual sample material to be tested and used as a sample. The users can deliberately choose to proceed to sample preparation first or to test the samples directly.

All samples will be inactivated by heat-inactivation during the production process. Therefore, special transport conditions for infectious material are not required in these cases. The inactivation procedure is evaluated and certified as part of our quality control procedures. Additionally, the sample material is stable at a broad temperature range.

Sample Set I – Mycoplasma; 5 samples to test with Sartorius Stedim’s Microsart® AMT/ATMP Mycoplasma, Minerva’s Venor®GeM qEP or Venor®GeM Classic.

Sample Set II – Mycoplasma, bacteria, and fungi/yeasts: 10 samples to test with Sartorius Stedim’s Microsart® AMT/ATMP Mycoplasma, Microsart® ATMP Bacteria and Microsart® ATMP Fungi, or alternatively Microsart® ATMP Sterile Release in combination with Microsart® AMT/ATMP Mycoplasma or Minerva’s Venor®GeM qEP/ Venor®GeM Classic.

Attention:

  1. This proficiency testing program is intended exclusively for the users of PCR/qPCR kits commercially available at Sartorius Stedim and Minerva Biolabs. However, extraction methods from other suppliers is can also be applied.
  2. Due to heat-inactivation, methods for sample concentration such as centrifugation cannot be applied with these samples.

Costs


For the production of the sample material, the logistical effort as well as the evaluation and preparation of the documentation, the following costs are due upon delivery. Invoicing takes place upon delivery of the sample material.

Sample set I: €250

Sample set II: €400

Shipping costs and applicable value added tax are not included. For Germany, the shipping costs amount to €14.50. For all other countries, we will be happy to provide an individual calculation of the  shipping costs.

Deadlines


Registration deadline: 15 May

Sample shipment: 30 May

Submission of the results report: 31 August

Dispatch of the results and certificates: 30 September

A timely registration is required for participation. To do so, please download the registration form and send the completed and signed printout to ipt@minerva-biolabs.com.

Terms and Conditions


  1. Minerva Biolabs GmbH organizes the proficiency testing program for quality control purposes, only.
  2. The contractual relationship is established upon acceptance of the legally-binding signed application.
  3. Samples and protocol sheets shall be sent by courier service on the dates specified in the registration form. In case of loss or damage of the sample material, a replacement will be granted if possible, provided that an immediate complaint has been made.
  4. Only protocol sheets sent in due time can be considered.
  5. After an unsuccessful proficiency testing due to the organizing party negligence, neither invoice will be issued nor will additional proficiency testing be carried out. The costs sustained for reagents, time etc. cannot be reimbursed.
  6. The organizers do not assume any liability for the improper use of the sample set or the analysis results
  7. Place of performance and jurisdiction is Berlin.

SDS FAQ