Introduction

Qnostics is a leading provider of Quality Control solutions for Molecular Infectious Disease testing. Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), our 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.

As a provider of complete QC solutions, our products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

In addition to clinical and molecular laboratories, Qnostics has, for more than a decade, delivered custom QC products and services to IVD assay manufacturers, EQA providers, Pharmaceutical and CRO organisations with the overall aim of supporting them at all stages of the assay’s product life cycle from R&D to in-market customer support.

Q Controls

Our range of positive run, whole pathogen, third party controls are designed to monitor assay performance on a daily 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 regulatory requirements.

Molecular Q Panels

Molecular Q Panels consist of four individual levels, including a negative, and are intended to evaluate the assays’ analytical measuring 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 Detection (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

Evaluation Panels cover a range of genotypes and/or levels, and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of clinical assays and the development of new diagnostic tests.

QCMD Past Panels

Samples from previous QCMD EQA challenges may be available for use in assay evaluation and staff training.

The following table is designed to help you choose the most appropriate solution for your needs:

© 2019 Aksamedical.net