Whole pathogen quality controls to support accurate coronavirus testing have been developed by scientists in the UK. The molecular controls, available from global diagnostics company Randox Laboratories, are currently being used as part of a nationwide testing programme for front-line NHS workers. Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. Therefore, they mimic the patient sample, providing the best sample matrix for laboratories.
Alongside its pioneering Coronavirus Biochip, which includes tests for SARS-CoV-2 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.
Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards, with key features and benefits including:
- Whole pathogen controls – containing 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-irradiated enabling safe handling of material.
- Highly characterised – the controls are quantified by digital PCR to ensure batch-to-batch reproducibility.
- Clinically relevant – performance data are 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 – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
- Negative controls available – delivering a complete testing package.
More information is available on the Randox website.