Qnostics is a leading provider of molecular quality reagents and custom manufacture solutions.
Qnostics specialises in the development, manufacture and distribution of Infectious Diseases Molecular Controls for use within the standard procedures of today’s molecular laboratory and Nucleic Acid Testing (NAT) assays. In addition to product supply, Qnostics has for more than a decade been a service provider to molecular diagnostics IVD assay manufacturers, EQA providers, Pharmaceutical and CRO organisations. This particular customer base has been established through supply of custom manufactured materials in support of all stages of the assay’s product life cycle from R&D to on-market customer support. Primary focus for the company is on infectious diseases, including the availability of hundreds of molecular characterised viral, bacterial and fungal targets.
Quality
Qnostics maintain and offer the highest quality procedures at our purpose built facility where state of the art laboratories are run by an experienced group of highly qualifed and trained scientists.
This enables Qnostics to offer our customers numerous molecular control targets in a variety of different formats to the highest possible quality standards.
Qnostics offers:
- Product manufacture, packaging, shipment and documentation meeting ISO 13485:2016 requirements.
- Scalable cGMP and custom manufacturing to client specific requirements.
- QC Reagents calibrated in compliance with ISO 17511.
Products:
Evaluation Panels
Verification and Validation panels* are designed to evaluate and establish the assay parameters of the molecular method and determine its fitness for purpose.
- Evaluate molecular assay characteristics: Sensitivity, Specificity, Linearity, Precision, Accuracy, and Reportable Range.
- Used for verification and validation of clinical assays, development of diagnostic tests and training of laboratory personnel.
- Designed to confirm any performance claims and suitability for the laboratories testing requirements.
- Where appropriate, calibrated against a WHO International Standard or Internal Reference Material, all quantified by digital PCR.
Analytical ‘Q’ Panels
Analytical ‘Q’ Panels are designed to cover the dynamic range of an assay allowing the laboratory to assess the linearity, LOD and LOQ of their assay. Each panel contains samples covering the dynamic range of most assays, in a linear progression, all of which should be treated as a patient sample within an assay run.
Molecular ‘Q’ Panels
Qnostics’ Molecular ‘Q’ Panels are intended to help laboratories evaluate their assays’ analytical measurement parameters and monitor their molecular diagnostic assay procedures. The panels can also be used to support laboratory training and in the assessment and development of molecular diagnostic assays from extraction phase through amplification to detection.
‘Q’ Controls
Qnostics’ ‘Q’ Controls are positive run controls intended to help laboratories monitor their molecular diagnostic assay on a run to run basis within customer derived limits. These third-party independent external controls will ensure that assay drift is detected, monitored and managed allowing the laboratory to continue to provide accurate and reliable results. They also help support a laboratory’s regulatory requirements under the standard ISO 15189:2012.
QCMD Past Panels
QCMD past panels are highly characterised Quality Assessment materials that have been used within previous QCMD International EQA / PT schemes. They are extremely helpful in post EQA evaluations and provide an additional source of quality material. Qnostics as a distribution partner of QCMD, is able to provide the EQA panel materials and accompanying EQA reports to customers outside of the active QCMD EQA programmes once the EQA programmes have closed.
