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
- Sexually Transmitted Diseases
- Drug Resistance
- 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:
- 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
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.