Quality Control solutions for Molecular Infectious Disease Testing
The Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Infections and Central Nervous System Diseases.
Usage of Qnostics controls
- Daily monitoring of assay performance
- Linearity assessment
- Assay evaluation
- Validation/verification of new assays and staff training
Positive run, whole pathogen, third party controls are designed to monitor assay performance on a routine basis. As true third party controls, assay drift is detected, monitored and managed, helping to ensure accurate and reliable results. The use of third party controls will also help to support ISO 15189:2012 regula- tory requirements.
Molecular Q Panels
Molecular Q Panels consist of four individual levels, including a negative, and are intended to evaluate the assays’ clinical range. Molecular Q Panels can also be used to support laboratory training and in the assessment and development of molecular diagnostic assays from extraction phase through amplification and finally detection.
Analytical Q Panels
Analytical Q Panels are designed to cover the dynamic range of an assay allowing assessment of the linearity, Limit of Detec- tion (LOD) and Limit of Quantitation (LOQ). Each panel contains a minimum of five samples spanning the dynamic range of the assay in a linear progression.
Evaluation Panels cover a range of genotypes and/or levels, and may be used to evaluate assay characteristics, con- firm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the valida- tion of clinical assays and the development of new diagnostic tests.