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Assay Design & Validation

Your desire, our mission

We are the 'DNA Excellence Center' in the Eurofins Group and have many years of experience in handling hundreds of customized projects successfully (from academia, biotech, hospital and the pharma industry).

We can offer almost all genomic analyses based on DNA or RNA in the fields of biotechnology, pharma, food, agrogenomics, basic and applied Research.

Therefore, please send us requests for any project you can imagine. Be aware, with the largest genomic service provider worldwide as your partner, you will receive the best solution for your project every time. 

Our service ranges from single assay design for your analyses in your own lab to full-service assay performance.

All analyses are carried out by our ISO 9001:2008 certified and ISO 17025:2005 (D-PL-13372-01-00) accredited laboratories, also possible in compliance with GxP regulations.

What quality demands your data?

For evaluating available procedures to determine which are best for your intended use, the most important aspect of any analytical method is the quality of the data it produces.

Eurofins offers all possibilties and conditions for both short assay validations and complete validations according to ICH guidelines (e.g. quality testing of industrial products according to GxP guidelines).

As a fee of service provider, Eurofins offers the validated method itself or the subsequent routine analysis of your samples in addition.

Full assay validation at Eurofins includes the following questions that have to be answered according to the ICH guidelines:

Evaluation of critical process steps
Identification of potential method specific risks that can occur.
Definition of the working range
Determination of the final project goal, the method used and the acceptance criteria of the method.

The analytical procedure refers to the way of performing the analysis. All steps necessary to perform the analytical test should be described in detail.
Evaluation of specificity
Securing of specific and exclusive detection the target for target identification, purity tests or quantification purposes.
Determination of the Limit of Detection (LOD)
The LOD gives the smallest DNA amount that can be qualitatively detected but not quantitatively measured.
Determination of the Limit of Quantification (LOQ)
If DNA amounts in a specific range would be detected in a sample, how valid is the determination of the concentration of this amount of DNA?
Trueness / Accuracy
How precise can the amount of DNA present in a product be determined by DNA extraction followed by Real-Time PCR with the assay?
Precision / Uncertainty of Measurement
How precise can the amount of DNA present in a distinguished volume be repeatedly determined under inter laboratory conditions (different days, different staff)?
Robustness
Is it possible to retrieve comparable results from repeated extractions from the same samples?
Documentation
A validation plan describes the scope of the validation. And finally, all results of the validation study are summarized in an official validation report.

All analyses are carried out by our ISO 9001:2008 certified and ISO 17025:2005 (D-PL-13372-01-00) accredited laboratories, also possible in compliance with GxP regulations.

Mission completed

In the past 15 years we completed hundreds of customer's projects in various fields, with satisfied and recurrent clients from university to big players in pharma industry.

Please find a short overview about previous project fields where assay design, validation and performance was done by Eurofins:

  • Gene expression analyses for all thinkable purposes
  • Genotyping by SNPs or microsatellites, e.g. human, mouse, seed, plant (tomatoes, cherrys, rice, etc.), livestock animal, flies, bats, honeybees etc. -  from small sample numbers to high-throughput
  • Clincal genotyping
  • Residual DNA testing
  • Bacterial strain determination
  • Plant species determination
  • Meat and fish species determination
  • Cell line authenticity testing
  • FFPE sample analysis


All analyses were carried out by our ISO 9001:2008 certified and ISO 17025:2005 (D-PL-13372-01-00) accredited laboratories, partly also in compliance with GxP regulations.