Custom and Service Provision

Qnostics offers custom made Molecular Controls to Fit All Stages of YOUR Assay’s Product Life Cycle:

Assay Life Cycle

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-lot testing
  • stability testing

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

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

HIV | HCV | HBV | Parvovirus B19 | HAV | HEV

Fungal

Aspergillus spp. | Pneumocystis jirovecii (PCP) | Candida albicans

Gastro

Norovirus | Adenovirus 40, 41 | Clostridium difficile | Coronavirus | Hepatitis A virus | Hepatitis E virus | Parechovirus | Campylobacter spp. | Salmonella spp. | Shigella spp. | Yersinia enterocolitica | Rotavirus | Astrovirus | Sapovirus | Giardia lamblia | Cryptosporidium parvum | Entamoeba sp. | Dientamoeba fragilis

HAI & Drug Resistance

Methicillin Resistant S. aureus | Vancomycin Resistant Enterococci | Extended Spectrum ?-lactamase

Parasitic

Toxoplasma gondii | Giardia lamblia | Cryptosporidium parvum | Entamoeba spp. | Dientamoeba fragilis

Respiratory

Influenza A | Influenza B | RSV A, B | Rhinovirus | Enterovirus | Adenovirus 7, 14 | Coronavirus | Parainfluenza | Bordatella Pertussis | Bordatella Parapertussis | C. pneumoniae | M. pneumoniae | Legionella pneumophila | M. tuberculosis

Sexually Transmitted Diseases

Chlamydia trachomatis | Neisseria gonorrhoea | Human Papilloma Virus

Transplant

Cytomegalovirus | HHV6 | BKV | JCV | Epstein-Barr Virus | HSV1 | HSV2 | Varicella-Zoster Virus

Vector Borne Diseases

West Nile Viruses | Dengue Virus | Borrelia burgdorferi (Lyme Disease)

And many more targets available on request.

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

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