Qnostics offers custom made Quality Controls to Fit All Stages of Molecular Assays Life Cycle

Choose from our large range of molecular characterised targets: viral, bacterial, fungal and parasitic targets available for many different infectious disease groups:

  • Blood Borne Viruses
  • Gastro
  • Respiratory
  • Fungal
  • Transplant
  • Sexually Transmitted Diseases
  • HAI
  • Drug Resistance
  • Parasitic
  • Vector Borne Diseases

The Qnostics Verification & Validation pack (QnV&V)

The Qnostics Verification & Validation pack (V&V pack) is intended to support the internal evaluation of your molecular diagnostic assay prior to undertaking a formal verification & validation exercise for regulatory purposes.

Composition of the V&V pack

The Qnostics V&V pack consists of highly characterised molecular control reagents which have been calibrated against a digital PCR Internal Reference Material. Each V&V pack is tailored to the specific requirements of the customer and enables them to evaluate the following molecular assay characteristics:

  • Linearity
  • Accuracy
  • Reproducibility (precision)
  • Analytical Sensitivity
  • Analytical Specificity

Do not hesitate to contact us if you need further information on these V&V packs.

Qnostics has custom solutions with a short turnaround time (TAT) for:

  • Operator and training panels
  • Genotype panels
  • Species-related panels
  • Controls for QC and batch release of reagent lots
  • Dynamic range and LOD determination panels

Services

Qnostics R&D department and manufacturing facility has a track record in providing services to assay manufacturers regarding a variety of study types and molecular control production services.

Some study examples are:

  • Inter-platform comparison studies
  • Inter-extraction comparison studies
  • dPCR quantitation
  • LOD/LOQ determination
  • Full analytical validations
  • Lot-to-lot testing
  • Stability testing

To learn more about our services and opportunities please contact us.


And many more targets available on request.

  • Targets can be prepared into numerous different formats and matrices
  • Whole pathogen accurately mimics clinical samples
  • Ready to use formats

Qnostics – The reference point and blueprint for high quality contract manufacturing.