CE marking granted to Quality Control for newborn infectious disease tests
08 June 2020
CE marking granted to Quality Control for newborn infectious disease tests
ToRCH Quality Controls to support the accuracy and reliability of infectious disease testing in newborns, have been granted CE marking.
The controls for ToRCH, which is a blood test screening to detect infectious diseases including toxoplasmosis, rubella, cytomegalovirus, and herpes simplex, are available from global diagnostics company Randox Laboratories, and are used to ensure accurate ToRCH test and system performance.
Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping laboratories to meet ISO 15189:2012 for quality and competence.
Lynsey Adams, Randox Quality Control Manager, commented;
“The CE marking of the ToRCH controls from Randox will be a game-changer for clinicians and patients alike, by facilitating early, accurate and comprehensive diagnoses of infectious diseases in newborns, that allow for the best possible patient outcomes.
“Ultimately, these ToRCH controls will guarantee quality assurance in laboratories performing ToRCH screening in newborns.”
Randox ToRCH Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials to save laboratories valuable space and time.
In addition to ToRCH, Randox Infectious Disease Quality Controls also include quality control material for Lyme Disease, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).
“Unlike analyser-specific tests, these controls can be used across a wide range of laboratory technologies, and complement our already existing RIQAS Serology EQA programmes to provide laboratories with a complete QC solution from a single supplier.
“With a working stability of 60 days at 2°c to 8°c which keeps waste and costs to a minimum, Randox Infectious Disease Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.”
Randox Infectious Disease Controls are ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing.
Key benefits of the Randox Infectious Disease Controls;
- User-friendly – all samples are provided in a liquid, ready-to-use format
- Commutable – manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
- Versatility – designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
- Stability – working stability of 60 days ensures waste and costs are kept to a minimum
- Multi-marker – helps reduce the number of individual controls required
- Clinical relevance – designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance
For more information visit https://www.randox.com/torch-controls/
25 May 2020
Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking
CE marking has been granted to whole pathogen quality controls for SARS-CoV-2 (COVID-19), from global diagnostics company Randox Laboratories.
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 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 COVID-19 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.
“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 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.
“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.
“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.”
Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.
Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:
- Whole pathogen – the controls contain 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-irradiation enabling safe handling of material.
- Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
- Clinically relevant – performance data is 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 – conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
- Complete QC package – Analytical and Molecular Q Panels available for new assay validation as well as routine performance monitoring.
For more information visit www.randox.com/coronavirus-randox
Multiplex assay for 10 sexually transmitted infections receives CE marking
CE marking has been granted to one of the most comprehensive cartridge-based STI tests.
The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.
Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.
Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
Benefits of the Randox STI assay technology on the Vivalytic system
- Fully automated, cartridge-based molecular diagnostics.
- Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
- Full molecular workflow of extraction, PCR amplification and detection.
- A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
- Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
- Test results can be presented either in summary or in detailed raw data form.
- Instantly available results due to easy integration with popular standard IT systems.
The assay tests simultaneously, from one patient sample, for the STIs below;
- Chlamydia trachomatis (CT)
- Neisseria Gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
- Treponema pallidum (syphilis) (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
- Haemophilus ducreyl (HD)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
For further information please contact the Randox PR team on 028 9442 2413 or email firstname.lastname@example.org