We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Randox Laboratories

Provides global diagnostic solutions for hospital laboratories, forensic laboratories, research laboratories, pharmac... read more Featured Products: More products

Download Mobile App





Randox Whole Pathogen Molecular Controls for SARS-CoV-2 (COVID-19) Receive CE Marking

By LabMedica International staff writers
Posted on 26 May 2020
Randox Laboratories (Crumlin, UK) has been granted CE marking for its whole pathogen quality controls for SARS-CoV-2 (COVID-19).

The molecular controls are currently being used alongside the firm’s pioneering COVID-19 tests, performed on its proprietary Biochip, as part of a nationwide UK testing program. More...
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.

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. Randox Qnostics SARS-CoV-2 Controls are heat-inactivated and gamma-irradiation to enable safe handling of material and make them non-infectious, and are manufactured to ISO 13485 standards. 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. They are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.

“Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control. 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.”

“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our Coronavirus Biochips but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results,” added Adams. “The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new CE-marked controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”



Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Serological Pipet Controller
PIPETBOY GENIUS
New
Gold Member
Blood Gas Analyzer
Stat Profile pHOx
New
Staining Management Software
DakoLink
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: An “evolutionary” approach to treating metastatic breast cancer could allow therapy choices to be adapted as patients’ cancer changes (Photo courtesy of 123RF)

Evolutionary Clinical Trial to Identify Novel Biomarker-Driven Therapies for Metastatic Breast Cancer

Metastatic breast cancer, which occurs when cancer spreads from the breast to other parts of the body, is one of the most difficult cancers to treat. Nearly 90% of patients with metastatic cancer will... Read more

Pathology

view channel
Image: A real-time trial has shown that AI could speed cancer care (Photo courtesy of Campanella, et al., Nature Medicine)

AI Accurately Predicts Genetic Mutations from Routine Pathology Slides for Faster Cancer Care

Current cancer treatment decisions are often guided by genetic testing, which can be expensive, time-consuming, and not always available at leading hospitals. For patients with lung adenocarcinoma, a critical... Read more

Technology

view channel
Image: Researchers Dr. Lee Eun Sook and Dr. Lee Jinhyung examine the imprinting equipment used for nanodisk synthesis (Photo courtesy of KRISS)

Multifunctional Nanomaterial Simultaneously Performs Cancer Diagnosis, Treatment, and Immune Activation

Cancer treatments, including surgery, radiation therapy, and chemotherapy, have significant limitations. These treatments not only target cancerous areas but also damage healthy tissues, causing side effects... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.