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Randox Laboratories

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Randox Unveils Whole Pathogen Multiplex Controls to Support Testing for Cold, Cough and COVID-19

By LabMedica International staff writers
Posted on 02 Nov 2020
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Randox Laboratories (Crumlin, UK) has unveiled a range of whole pathogen multiplex controls that cover multiple viral and bacterial pathogens which cause respiratory disease.

Inclusive of SARS-CoV-2, Influenza A & B, and Respiratory Syncytial Virus (RSV), the Qnostics Multiplex Respiratory Pathogen Controls (RTX) facilitate diagnosis of the likes of cold and flu, and importantly, the differentiation of these respiratory 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 QC, and ultimately save time, money and resource. 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 new RTX controls contain the entire genome, meaning they are compatible with the majority of commercial and in-house assays. Whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories. Additionally, 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. An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements. Qnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability. Moreover, the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.

“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,” said 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.”

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