Qnostics SARS-CoV-2 Controls
Qnostics
Respiratory Target Multiplex (RTX) 1 Control
This multiplex control has been designed in response to the current Coronavirus pandemic. The control can be used to support the validation, verification and performance monitoring of molecular assays used in SARS-CoV-2 testing and other respiratory pathogens.
Meeting the requirements of various testing strategies, this 4-plex control covers multiple viral pathogens that cause respiratory diseases in various patient cohorts, in line with public health testing and the test menu of most syndromic assays.
Having a multiplex control, like the Qnostics RTX1, gives great flexibility to laboratories and allows them to meet laboratory requirements in terms of respiratory pathogens covered whilst keeping QC tests to a minimum.
Features & Benefits
- Whole Pathogen Control
Containing the entire SARS-CoV-2 genome, the RTX1 Control is compatible with the majority of commercial and in-house assays. As a whole pathogen control, it targets the whole viral genome.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Highly Characterised
Using highly characterised controls enable labs to meet their daily QC needs and accreditation requirements. Qnostic controls are quantified by digital PCR to ensure batch-to-batch reproducibility.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Liquid for Ease-of-Use
Conveniently supplied in liquid frozen format meaning there is no additional preparation or handling required.
Specification
Target Pathogen – Influenza A (H1N1), Influenza B (Victoria), Respiratory Syncytial Virus (A), Coronavirus (SARS-CoV-2)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – RUO
Ordering Information
| Catalogue Number | Product Description | Pack Size | Package Insert |
|---|---|---|---|
| RTX1QC | RTX1 Q Control | 5 x 0.6 ml | Kit Insert |
SARS-CoV-2 (COVID-19) Control
In response to the current Coronavirus outbreak, Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19). Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control. The use of third-party controls will allow laboratories to effectively monitor the performance of diagnostic methods. For more information on Qnostics click here
Features & Benefits
- Whole Pathogen Control
Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Negative Control Available
Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Complete QC Solution
Products available for new assay validation as well as routine performance monitoring.
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Q Controls
Whole pathogen controls designed to monitor assay performance on a run to run basis. As true third party controls, assay drift is detected, monitored and managed helping to ensure accurate and reliable results.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2QC | SARS-CoV-2 Q Control | 5 x 0.5 ml |
| TMNQC | Negative Q Control | 5 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Analytical Q Panels
Designed to span the analytical measuring range of an assay, allowing assessment of linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ).
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2AQP | SARS-CoV-2 Analytical Q Panel | 9 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Molecular Q Panels
Four individual levels including a negative are provided spanning the assays’ clinical range. Molecular Q Panels may be used to support laboratory training and in the performance assessment and validation of molecular diagnostic assays.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2MQP | SARS-CoV-2 Molecular Q Panel | 4 x 0.5 ml |
Specification
Target Pathogen – Novel Coronavirus SARS-CoV-2, SARS-CoV-2 (Delta, Alpha, Beta, Gamma, Eta, Alpha N variant, Omicron)
Matrix – Transport Medium (TM)
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately
Regulatory Status – Research Use Only (RUO)
Evaluation Panel
Intended for research use only, this evaluation panel is designed to help laboratories develop their molecular procedures.
Suitable for use with most commercial and in-house molecular methods, this panel is characterised using real-time PCR and NGS. The panel contains variants of whole pathogen inactivated SARS-CoV-2 and is supplied in a liquid-frozen format.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2TEP | SARS-CoV-2 Typing Evaluation Panel | 8 x 1.0 ml |
Related Products
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
Official statement from Randox on Covid-19 testing
03 April 2020
OFFICIAL STATEMENT FROM RANDOX
On the emergence of the Covid-19 threat Randox utilised their years of regulated diagnostic experience to quickly develop and robustly validate a test for the Covid-19 virus. Randox had significant confidence in this test and presented them to Public Health England (PHE) for evaluation. PHE were managing this validation process for each of England, Wales, Scotland and Northern Ireland.
The UK Government showed significant confidence in Randox’s capability and conducted full engagement and planning subject to PHE acceptance of the Randox test. When PHE acceptance was granted, the Randox part in the national plan had been prepared and was quickly initiated.
We understand that the national plan for the testing of key workers is exactly that, a national plan, inclusive of Northern Ireland. Initially relatively small numbers of tests were sent to the areas of significant national threat in London.
The planning for the national distribution of test kits is being managed by the various relevant statutory agencies however Randox has made the case that tests should be made available locally. Following that engagement, tests have now been made directly available within Northern Ireland and Randox will continue to support Northern Ireland within the UK national plan.
Randox have acted with speed and initiative throughout this crisis and will continue to ramp up our testing capability to support the national testing plan for key workers in Northern Ireland.
Every part of Randox’s business is focused on doing everything we can to support the Covid-19 testing programme, to both save lives and ensure the speediest possible return to a more normal society.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
QNOSTICS
QCMD
BIOSCIENCES
Randox joins government drive on COVID-19 tests for frontline NHS staff
27 March 2020
Randox Laboratories is partnering with the government to develop a new coronavirus testing programme in which NHS staff will be first in line.
The new service, which will be free, will help to end the uncertainty of whether NHS staff need to stay at home. Those who test negative for coronavirus will be able to return to work – enhancing the capacity of the NHS and social care to treat patients and care for those in community settings, with plans for a full roll-out for health, social care and other frontline workers.
Randox are providing high volume home sample collection kits and laboratory testing.
Randox CEO Dr Peter FitzGerald, said:
“We have an excellent Covid-19 assay and we are committed to supporting the government and this important initiative to test key workers and support vital public services.
“Randox Laboratories is now operational for COVID-19 testing and will be ramping up extensively in the coming weeks. This will provide extensive employment opportunities for laboratory and support staff.
“Our first tests have gone to the London Ambulance Service and we look forward to playing our role in ensuring that this critical capability continues to operate.”
To offer its coronavirus testing capabilities to the new programme, Randox’s COVID-19 test recently underwent evaluation from, and has been accepted by, Public Health England.
In its evaluation of the Randox COVID-19 test, Public Health England’s report noted that the assay correctly identified all positive and negative samples without exception.
As a result the government are proceeding to utilise the Randox COVID-19 test in the new testing programme for NHS staff, with an exceptionally high degree of confidence.
Two simultaneous tests are carried out on the proprietary Randox Biochip, in line with guidelines from the Centres for Disease Control and Prevention, and the World Health Organisation.
Health Secretary Matt Hancock said:
“We want to save lives, protect the most vulnerable, and relieve pressure on our NHS.
“Healthcare staff are key in our fight against the virus and I want to ensure that any frontline NHS or care worker who has symptoms of coronavirus or who has a family member with symptoms can be tested quickly and reliably.
“I pay tribute to the generosity and public spirit of Britain’s universities, research institutes and companies who have lent us their equipment without hesitation.”
Dr Jenny Harries, Deputy Chief Medical Officer, said:
“Laboratory-based testing on this scale is a little like building the medical equivalent of a car factory. We are assembling many different parts, some of them quite specialised and hard to find, then getting them to work accurately together in a highly co-ordinated process. There are bound to be teething problems, so we cannot switch on hundreds of thousands of lab tests overnight. But we hope that soon these hub laboratories will be operating round the clock, allowing us to significantly scale up our testing.”
For more information or to arrange interviews, please contact the Randox PR team by emailing randoxpr@randox.com
QNOSTICS
QCMD
BIOSCIENCES
Point of care coronavirus test from Randox and Bosch will launch in April 2020
26 March 2020
Vivalytic Viral Respiratory Tract Infection Array Detecting SARS-CoV-2 (COVID-19)
A game-changing point of care coronavirus test from global diagnostics company Randox Laboratories and leading technology manufacturer Bosch Healthcare Solutions will launch in April 2020.
The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
This provides a more comprehensive respiratory screening which enables precise and informed treatment decisions to be made.
Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences, commented;
“This array focuses not only on the identification of the novel coronavirus strain that causes COVID-19, but also nine other respiratory infection targets simultaneously, including Influenza A and B, Sarbecovirus and MERS. The aim is to diagnose patients fast and accurately from a single genetic sample, maximising containment of the virus whilst minimising the spread. With the development of this array onto a fully automated platform, patients can be diagnosed rapidly at point of care locations globally such as pharmacies and doctor surgeries.”
The Viral Respiratory Tract Infection Array is one of the world’s first multiplex molecular diagnostic tests meeting the COVID-19 testing recommendations of the World Health Organisation (WHO) and the Centres for Disease Control (CDC).
The target genes for COVID-19 being used on the VRI array represent conserved regions of the genome which have been chosen for their high sensitivity and specificity.
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.”
The new VRI test will be conducted on Vivalytic a point of care platform brought to the market by Randox Laboratories and Bosch. The Vivalytic system is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. The cartridges are fully-sealed which minimises the risk of contamination, require room temperature storage (space-saving), contain all the reagents on-board the cartridge and utilises end point PCR. The test only requires a single nasal swab from the patient and an easy four step process to be carried out by the user to run the patient sample.
Key Benefits of Vivalytic | Point of Care Platform
- Fully-automated
- User friendly
- No laboratory training required
- 4 step work flow
- Minimal contamination risk – fully contained system
- No peripherals required – hygienic
- Touchscreen
- Connects to LIMS (Laboratory Information Management System)
- Sample Type: Nasopharyngeal Swab
- Sample Volume: 300µl clinical sample
For more information or to arrange interviews, please contact info@randoxbiosciences.com
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
Randox Extended Coronavirus Array: Bringing the Best Science to the Forefront
COVID-19 (2019-nCoV) was declared a global emergency of international concern. The WHO’s director-general’s greatest concern is the potential for COVID-19 to spread to countries with weaker health systems. The biggest catch with containing the epidemic of COVD-19 is the detection. It has been recognised that faulty kits have been shipped around America by the Centers for Disease Control and Prevention (CDC) and there simply aren’t enough kits in China 1. Randox can aid in overcoming these challenges.
What is COVID-19?
The COVID-19 is a new strain of coronavirus that has not been previously identified in humans. Consequently, research on this new strain is lacking. Symptoms are similar to that of the common cold or flu, including: fever, cough, difficultly breathing, muscle pain and fatigue. Like other respiratory infections, transmission occurs through respiratory droplets from coughing and sneezing, with an estimated incubation period of 2 to 14 days 2.
Current Situation
Globally, there are 46, 997 confirmed cases of COVID-19, with 46, 550 of these confirmed cases attributed to China. Only 447 of the total number of cases are outside of China, across 24 countries. The total number of deaths attributed to COVID-19 sits at 1, 369 of which all have been observed in China, except one. These statistics are laboratory-confirmed cases only 3. These statistics were reported by WHO on 13 February and is the situation of number, total and new cases, within the past 24hrs from being recorded. Whilst China is at a very high risk, the global risk level is high. These statistics indicate the necessity for COVID-19 diagnosis, especially as the above are only laboratory-confirmed cases combined with the faulty tests distributed in America and the lack of diagnostic tests in China.
The Randox Extended Coronavirus Array
Randox have developed a fast and accurate test for the detection of COVID-19, the new strain of coronavirus. The Randox Extended Coronavirus Array is the only test in the world that can identify the potentially lethal strain and differentiate between other respiratory pathogens with similar symptoms.
The new test utilises the Randox Biochip Technology, with results within 5 hours on the Randox Evidence Investigator, a semi-automated analyser capable of processing 54 patient samples simultaneously.
The Randox Coronavirus Array comprises five coronaviruses strains, including the COVID-19 (2019-nCoV) strain. The table below provides a breakdown of the viruses included in the Randox Extended Coronavirus Array:
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections. We have therefore developed an extended Viral Respiratory Infection Array that tests simultaneously for COVID-19 and nine other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
Want to know more?
Contact us or download our coronavirus flyer
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References
