Reference materials for assay validation

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Clinical laboratories require consistent, stable and reliable control materials to validate and monitor the performance of their assays.

With an increasing reliance on the results of different analyses and tests, reference or control samples are essential for any laboratory to be able to implement the best possible quality control programme.

SeraCare uses innovative, patented technology to produce reference materials that are very similar to patient samples, thus facilitating assay optimisation, validation and monitoring processes.


Range of reference materials formulated for use in NGS (Next Generation Sequencing) tests. It guarantees the quality process, minimises costs and saves time in the daily workflow, while ensuring:

  • High customisability according to requirements.
  • Complete monitoring and control of the NGS procedure.
  • Expertly designed panels including clinically relevant variants (all types of variants are included: SNVs, CNVs, Indels and SVs).
  • Access to common, rare and technically challenging variants.
  • Faster test validation with no need for several controls, as each reference material contains multiple variants of interest.
  • Includes positive and negative controls.
  • Provides controls/samples in different matrices adapted to various procedures.
  • Identifies possible variations that may compromise the integrity and reliability of the results.
  • Ensures result sensitivity, robustness, consistency and reproducibility by defining and tracking quality thresholds and detection limits over time.

The reference controls or samples are available in different formats:

  • Purified DNA - gDNA
  • Circulating free DNA - cfDNA
  • Plasma-like synthesised material
  • Formalin-fixed paraffin-embedded tissues – FFPE

The Seraseq® range may be used for:

  • Oncology: Solid tumour profiling/liquid biopsy/haematoma-oncology/tumour mutational burden
  • Reproductive medicine: Non-Invasive Prenatal Testing (NIPT), Pre-Implantation Genetic Testing
  • Hereditary diseases: Hereditary cancer/cardiomyopathies/other (customisable)
  • Infectious diseases: Drug-resistant HIV-1/custom viral sequencing

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Available in Spain and Portugal

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