25 May 2020

Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking

CE marking has been granted to whole pathogen quality controls for SARS-CoV-2 (COVID-19), from global diagnostics company Randox Laboratories.

The molecular controls are currently being used alongside the firm’s pioneering COVID-19 tests, performed on its proprietary Biochip, as part of a nationwide UK testing programme.

Randox is using these third-party quality controls, which include a Positive Control, Negative Control, Analytical Q Panel and Molecular Q Panel, to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.

Lynsey Adams, Randox Quality Control Manager, explained;     

“Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.

“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls, which have been CE marked, help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”

Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They therefore mimic the patient sample, providing the best sample matrix for laboratories.

Lynsey continued;

“The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by CDC and WHO, are compatible for use with both commercial and in-house testing methods, and are quantified by digital PCR to ensure batch to batch reproducibility.

Lynsey added;

“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our Coronavirus Biochips but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.

 “The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new CE-marked controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”

Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.

Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:

• Whole pathogen – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
• Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
• Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
• Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
• Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
• High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
• Liquid for Ease-of-Use – conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
• Complete QC package – Analytical and Molecular Q Panels available for new assay validation as well as routine performance monitoring.

For more information visit www.randox.com/coronavirus-randox