Qnostics offers custom made Molecular Controls to Fit All Stages of YOUR Assay’s Product 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:
- 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-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 | Hepatitis A Virus | Hepatitis B Virus | Hepatitis C Virus | Hepatitis D Virus | Hepatitis E Virus | Parvovirus B19
Aspergillus spp. | Pneumocystis jirovecii (PCP) | Candida albicans
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 beta-lactamase
Toxoplasma gondii | Giardia lamblia | Cryptosporidium parvum | Entamoeba spp. | Dientamoeba fragilis
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 | Trichomonas vaginalis | Mycoplasma genitalium | Mycoplasma hominis | Ureaplasma urealyticum | Gardnerella vaginalis
Cytomegalovirus | HHV6 | BK Virus | JC Virus | 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.