Randox Laboratories, Crumlin, United Kingdom, has unveiled a range of whole pathogen multiplex controls that cover multiple viral and bacterial respiratory pathogens—including SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV). The Qnostics Multiplex Respiratory Pathogen Controls (RTX) facilitate diagnosis of respiratory illnesses such as colds and flu and differentiation of these diseases from covid-19.
Using a control line that covers a range of respiratory pathogens in this way will allow laboratories to streamline their testing, consolidate quality control, and ultimately save time, money, and resources.
“When the use of time and resources are critical such as in covid-19 testing, the use of highly characterized controls enables laboratories to meet their daily QC needs and accreditation requirements, says Lynsey Adams, Randox Quality Control Manager. “Accurate and reliable laboratory testing is an essential aspect of the management of COVID-19 and other respiratory diseases, so we are pleased to be able to offer these new controls which will crucially support the validation, verification and performance monitoring of molecular respiratory assays.”
The new RTX controls, which are whole pathogen for compatibility with the majority of commercial and in-house assays, are used to monitor the full testing process, from extraction to amplification and detection.
The Multiplex Respiratory Controls will support public health testing strategies during the incoming flu season and are suited for the test menus of most syndromic assays.
“The Randox Qnostics Multiplex Respiratory Pathogen Controls are clinically relevant for full-process validation,” says Lynsey. “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.”
Randox Qnostics Multiplex Respiratory Pathogen Controls are manufactured to ISO 13485 standards and are in line with ISO 15189:2012 regulatory requirements.
- Whole pathogen controls. The controls contain the entire genome meaning they are compatible with the majority of commercial and in-house assays.
- Full process control. Whole pathogen controls are the ideal material for full-processvalidation, monitoring the testing process from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
- Highly characterized.Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
- True Third Party. An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Superior Manufacturing. Qnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
- Liquid for Ease-of-Use.The controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
For more information visit Randox.
Featured image: This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2 is the virus that causes COVID-19. Courtesy NIAID.