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About us

Diagenode Diagnostics overview

Since 2003, Diagenode Diagnostics has designed, manufactured and commercialized innovative and trusted CE-IVD kits for the detection of pathogens associated with many infections.

Combining a unique expertise in Nucleic Acid Amplification Technologies (NAAT) and IVD processes, Diagenode Diagnostics provides a wide range of simplex and multiplex real-time PCR kits to detect bacteria, parasites and viruses.

Diagenode Diagnostics develops sustainable partnerships with clinical microbiology laboratories and IVD companies around the world.

Strengths

  • Kits compatible to most IVD platforms
  • Quantitative and qualitative tests allow flexibility
  • Ease of use reduces clinical errors
  • Specific and sensitive kits for reliable results
  • Sample flexibility (swab, blood, sputum, ...)
  • Rapid time-to-results

Research & development

Diagenode’s tests accurately detect infectious pathogens both qualitatively and quantitatively and can produce timely test results allowing a better, cost-effective patient care.

We specifically focus on producing highly sensitive and specific real-time PCR kits as qPCR has rapidly emerged as a standard for clinical molecular laboratories in diagnostic testing.

Quality

Diagenode is ISO13485 and the kits are CE marked for In Vitro Diagnostic use.

Our ISO 13485 certification signifies that we respect procedures and quality controls for health products from the conception to the commercialisation. We answer to many requirements regarding internet website, traceability, marketing and sales procedures, customer satisfaction.

The CE label shows that our products are in conformity with the European Union recommendations from Directive 98/79/EC for IVD medical devices. The CE label guarantees clearly the transparency of products specifications, safety, respect for the environment and consumers protection.

Kit format

Diagenode’s real-time PCR kits consist of primers and use labeled DNA oligonucleotide probes with a fluorophore (TaqMan® probe).

In a multiplex assay these probes are labeled with different fluorophores to distinguish the different pathogens or strains.

Next to the validated primers and probes, the kits also contain a positive control for each specific pathogen, a negative control and a DNA or RNA extraction /inhibition control.

Collaboration

In addition, Diagenode actively collaborates with medical and scientific experts in molecular diagnostics to develop and ensure the highest quality, clinically-validated tests

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