Randox Unveils Whole Pathogen Molecular Controls for SARS-CoV-2 (COVID-19)

Randox Laboratories (Crumlin, UK) has developed whole pathogen quality controls to support accurate coronavirus testing. The molecular controls are currently being used as part of a nationwide testing program for frontline NHS workers. Alongside its pioneering Coronavirus Biochip, which includes tests for SARS-CoV-2, the virus which causes COVID-19, and nine other respiratory viruses, Randox is using these third-party quality controls to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.

Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens, as a result of which they mimic the patient sample, providing the best sample matrix for laboratories. 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. Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.

Performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories. Randox SARS-CoV-2 Qnostics controls are conveniently supplied in a liquid frozen format, meaning there is no additional preparation or handling required, and negative controls are available, thus creating a complete testing package.

“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls 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,” said Lynsey Adams, Randox Quality Control Manager. 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.”