Troponin T Quality Control
Troponin T Quality Control
Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.
Features & Benefits
- Liquid frozen for enhanced stability
- Aqueous based material
- Ultra low levels of Troponin T
- Stable to expiry date at -18-24ºC storage
- Thawed stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Troponin T Control | 6 x 3 ml | 1 | CQ10450 | |
Analytes
- Ultra low Troponin T
Protected: Analysis of results from the QCMD Coronavirus Preparedness EQA Pilot Study
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).
Lynsey continued;
“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/
QUALITY CONTROL
REAGENTS
RX SERIES
Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking
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.
Lynsey continued;
“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.
Lynsey added;
“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
QNOSTICS
QCMD
CORONAVIRUS
Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
16 April 2020
Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
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 frontline NHS workers.
Alongside its pioneering COVID-19 tests, performed on its proprietary Biochip, Randox is using these third-party quality controls 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 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.
Lynsey continued;
“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.
Lynsey added;
“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 COVID-19 tests on the Randox Biochip, 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 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 controls – 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 – 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.
For more information visit www.randox.com/coronavirus-randox
QNOSTICS
QCMD
CORONAVIRUS
Ethanol Calibrator/Control Set
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.
Features & Benefits
- Liquid ready-to-use
- Human urine
- Stable to expiry date when capped and stored at 2oC – 8oC
- Open vial stability of 28 days at 2oC – 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Ethanol Calibrator/Control Set | 4 x 10ml | 1 | DA2703 | |
Analytes
Ethanol
Related Products
Randox QC unveils brand new multi-analyte commutable Acusera Infectious Disease Controls
Randox Quality Control is set to introduce its brand new Acusera Infectious Disease (Serology) Controls at the American Association for Clinical Chemistry 2019, designed to deliver a cost-effective, high quality solution for the analysis of infectious diseases whilst producing trustworthy results.
The Infectious Disease Serology Internal Quality Controls will include quality control material for Lyme Disease, ToRCH, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).
Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements while also reducing inconvenient shifts in QC results when reagent batches are changed.
Lynsey Adams, Randox Quality Control Manager, commented;
“These controls are the first of their kind on the market to be used on a wide range of immunoassay analysers. Unlike the current practice of analyser-specific tests, these controls can be used across a wide range of laboratory technologies and, with a working stability of 60 days at 2°c to 8°c, waste and costs are kept to a minimum.”
Acusera Infectious Disease (Serology) Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials, saving laboratories valuable space and time. A single control can be used to assess performance across a range of analytes.
Key benefits of the Acusera Infectious Disease Controls;
- All samples are provided in a user-friendly, liquid, ready-to-use format
- Manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
- Designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
- Working stability of 60 days ensures waste and costs are kept to a minimum
- Multi-marker controls help reduce the number of individual controls required
- Designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance
Ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing, Randox QC’s Acusera Infectious Disease (Serology) Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.
For further information please email acusera@randox.com, visit www.randoxqc.com or tel: +44 (0) 28 9442 2413 / fax: +44 (0) 28 9445 2912
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
For further information please visit https://www.randox.com/molecular-infectious-disease-controls/blood-borne-virus-testing/, visit us at stand 1101 at this year’s AACC or email market@randox.com
Tackling Worldwide Drugs of Abuse
Throughout November, we’ve been highlighting how the Randox clinical teams – Randox Rx series, Randox Reagents and Randox QC – are aiding the fight against drugs of abuse.
Drugs of Abuse are a growing problem worldwide and represent a significant burden to healthcare systems as well as creating problems in an individual’s lifestyle. It has been estimated by the WHO (World Health Organisation) that 31 million people globally suffer from drug use disorders and 3.3 million deaths each year are linked to the abuse of both drugs and alcohol.
The abuse of drugs is one of the most pressing issues in the United States of America. Drug abuse not only affects the individual, but also can have far-reaching consequences that affect family, employment, personal health, health care systems, local communities, and society as a whole.
- Misuse of illicit drugs affects society through secondary costs incurred such as crime, reduced productivity at work, and health care expenses.
- Substance abuse costs the US health care system about $11 billion, with overall costs reaching $193 billion.
- Substance abuse and addiction also affects other areas of life and can cause broken families, destroyed careers, death due to negligence or accident, domestic violence, physical abuse and child abuse.
- Drug abuse and addiction changes the chemistry of your brain. The longer you use your drug of choice, the more damage is caused and it becomes more difficult to return to ‘normal’ during drug rehabilitation.
- In 2013, 22.7 million Americans needed treatment for a substance use disorder – almost 9% of the population over the age of 12. Only about 2.5 million received treatment as a specialist facility with 20% of admissions for opiate addication treatment and 17% for the treatment of marijuana abuse.
To find out more about how Randox is helping in the fight against Drugs of Abuse, please visit https://www.randox.com/drugs-of-abuse/ or for more information about Randox RX, Randox Reagents or Randox QC, please email marketing@randox.com.
November focus: Drugs of Abuse
Throughout November, the Randox clinical teams – Randox Reagents, Randox Rx series and Randox QC – will be highlighting how the Randox product range can be utilised to allow for the most accurate analysis of Drugs of Abuse, with a particular focus placed with the Evidence MultiSTAT. The Evidence MultiSTAT is a fast, fully automated and versatile immunoanalyser that enables on-site detection of up to 21 Drugs of Abuse from a single sample of oral fluid, urine or blood.
Drugs of Abuse are a growing problem worldwide and represent a significant burden to healthcare systems as well as creating problems in an individual’s lifestyle. It has been estimated by the WHO (World Health Organisation) that 31 million people globally suffer from drug use disorders and 3.3 million deaths each year are linked to the abuse of both drugs and alcohol.
Randox have reacted to this growing concern and are now a world leader in the Drugs of Abuse testing field. Our product range currently comprises classical, prescription and synthetic drugs.
The Evidence MultiSTAT offers a simple drug screening solution to those who have little or no knowledge of laboratory procedures. As an extremely versatile desktop analyser, it is ideally suited to a variety of settings including both the clinical laboratory and the emergency room.
Randox Reagents – Drugs of Abuse Assays
In order to assist in dealing with the ongoing burden of substance abuse, Randox Reagents offer a comprehensive range of ten assays to test for some of the top most commonly-abused substances including alcohol, methamphetamines, cocaine, methadone, cannabis, benzodiazepines, barbiturates, EDDP and ecstasy and opiates. The Randox Drugs of Abuse assays are liquid, ready-to-use for increased efficiency and applications are available for over 30 different analysers.
RX Series – Toxicology testing
Renowned for quality and reliability, the RX series range of clinical chemistry analysers boasts a world-leading test menu comprising of both therapeutic drugs and Drugs of Abuse. Our toxicology range comprises amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolite, ecstasy, EDDP, ethanol, methadone and opiates. The RX series range of clinical chemistry analysers ensures a high degree of accuracy with a wide range of testing throughputs to suit all laboratories, big or small.
RIQAS Urine Toxicology Programme
Designed to monitor the performance of 20 Drugs of Abuse tests in urine, our RIQAS urine toxicology EQA program is suitable for both qualitative and quantitative methods of analysis. As the largest EQA scheme in the world, access to large peer groups is guaranteed. Additional benefits include; monthly analysis, user-friendly reports allowing at-a-glance performance assessment, ability to register up to five instruments per programme and cost savings via our unrivalled consolidation.
For more information about Randox RX, Randox Reagents or Randox QC, please email marketing@randox.com.
