CE marking has been granted to whole-pathogen quality controls for SARS-CoV-2, from global diagnostics company Randox Laboratories. The molecular controls are currently being used alongside the firm’s coronavirus 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 coronavirus 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 the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), are compatible for use both with commercial and in-house testing methods, and are quantified by digital polymerase chain reaction (PCR) to ensure batch-to-batch reproducibility.