Molecular QC for Infectious Disease Testing

Molecular QC and EQA for Infectious Disease Testing

Earlier in the year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.

Background

The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.

According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.

Qnostics - Molecular Controls

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.

Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

There are five main product areas for Qnostics:

Product Groups (click to expand)
Q Controls
Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.

Analytical Q Panels
Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.

Molecular Q Panels
Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range. Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.

Evaluation Panels
Evaluation Panels cover a range of genotypes 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 molecular assays and development of new molecular diagnostic assays.

QCMD Past Panels
Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.

Custom Manufacture

Qnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.

Choose from hundreds of molecular characterised targets

Targets can be custom made into numerous different formats

The whole pathogen format accurately mimics clinical samples

All materials can be provided in a “ready-to-use” or liquid frozen format

Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.

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QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.

EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

Features & Benefits (click to expand)

Frequency

A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.

Online EQA Management System

ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

High level of participation

Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

Comprehensive reports

Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

International accreditation

Programmes are accredited to ISO 17043.