Randox launches whole pathogen Blood Borne Virus Controls at AACC

Whole pathogen Blood Borne Virus (BBV) controls have been brought to market by global diagnostics company Randox Laboratories.

The molecular controls, available under the brand name Qnostics, are versatile in monitoring the presence of BBVs, including HIV, Hepatitis B and Hepatitis C.

For use with molecular methods, the controls are manufactured using whole pathogens and therefore mimic the patient sample, providing the best sample matrix for laboratories.

Lynsey Adams, Randox Quality Control Manager, explained;

“We’re delighted to be able to bring to market these whole pathogen Blood Borne Virus Controls, which are designed to help molecular laboratories effectively manage assay performance.

“Using whole pathogens in the development of the controls ensures we meet the demands of today’s molecular diagnostics laboratories by monitoring the entire testing process.”

The Molecular BBV controls from Randox, which are liquid frozen for user convenience and ease of use, will aid microbiology and virology laboratories to monitor assay drift and ultimately will help to ensure accurate test system performance. Each control is designed to be medium positive and are suitable for use with a variety of molecular workflows.

Lynsey added;

“These versatile Blood Borne Virus controls can be used in the daily monitoring of assay performance, but are equally applicable for use in the validation/verification of new assays, and may also be used for troubleshooting after poor EQA performance.”

Randox Blood Borne Virus Molecular Controls are manufactured to ISO 13485 standards and calibrated against an independent Internal Reference Material. Also included within the Qnostics BBV range are Molecular Q panels. Each molecular Q panel includes a negative, low, medium and high positive sample designed to cover more of the assays measuring range.

Key Features and Benefits of Randox Blood Borne Virus Qnostics Controls:

Third party controls as recommended by ISO 15189:2012
Specifically designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT)
Suitable for use across a wide range of molecular assays to monitor the entire molecular workflow from extraction to amplification and detection
Flexible and suitable for use with the majority of commercial and in-house molecular methods
Traceable to the current relevant WHO International Standards and characterised by digital PCR
Liquid frozen for user convenience and ease of use, with no additional preparation required
Calibrated against an independent Internal Reference Material (IRM)
Quality products manufactured to ISO 13485: 2016 standards
Manufactured using whole pathogens and therefore mimic the patient sample providing the best possible sample matrix for laboratories
New controls available include Hepatitis B (HBV) Medium Q Control, Hepatitis C (HCV) Medium Q Control and HIV Medium Q Control
US-IVD labelled for clinical use