CE marking granted to Quality Control for newborn infectious disease tests
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
Cytokine Testing Solutions
COVID-19 Risk Stratification and Treatment Monitoring
Randox offer testing solutions for a comprehensive range of cytokines, cytokine receptors and growth factors designed to assist with COVID-19 risk stratification, monitoring of treatment efficacy and recovery. Utilising patented Biochip technology up to 12 cytokines and growth factors may be detected simultaneously from a single patient sample.
Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of inflammatory and infectious diseases. The over stimulation of these cytokines in response to infection is referred to as a ‘cytokine storm’ and strongly correlates with poor disease outcomes.
Cytokine storms are a common complication of SARS-CoV-2 (COVID-19) infection triggering viral sepsis, where viral replication and excessive, uncontrolled systemic inflammation may lead to pneumonitis, Acute Respiratory Distress Syndrome (ARDS), respiratory failure, shock, multiple organ failure, secondary bacterial pneumonia, and potentially death.
Why Choose Randox Cytokine Arrays?
- Simultaneous detection of up to 12 cytokines and growth factors from a single patient sample
- Fully automated and semi-automated solutions available to suit all laboratory throughputs
- Comprehensive test menu comprising 26 cytokines, cytokine receptors and growth factors
- Suitable for use with serum and plasma samples
- Excellent analytical performance
- Availability of complementary quality controls for a complete testing package
Cytokine Array I
Analytes
- Interleukin-1 Alpha (IL-1α)
- Interleukin-1 Beta (IL-1β)
- Interleukin-2 (IL-2)
- Interleukin-4 (IL-4)
- Interleukin-6 (IL-6)
- Interleukin-8 (IL-8)
- Interleukin-10 (IL-10)
- Interferon Gamma (IFNγ)
- Epidermal Growth Factor (EGF)
- Monocyte Chemotactic Protein (MCP-1)
- Tumour Necrosis Factor Alpha (TNFα)
- Vascular Endothelial Growth Factor (VEGF)
Ordering Information
| Cat. Number | Description | Kit Size |
|---|---|---|
| EV3508 | Cytokine Array I Evidence | 360 Biochips |
| EV3544 | Cytokine Array I Evidence | 180 Biochips |
| EV3513 | Cytokine Array I Evidence Investigator | 54 Biochips |
| EV3623 | Cytokine Array I High Sensitivity Evidence Investigator | 54 Biochips |
Cytokine Array III
Analytes
- Interleukin-5 (IL-5)
- Interleukin-15 (IL-15)
- Granulocyte Macrophage
- Colony Stimulating Factor (GM-CSF)
- Macrophage Inflammatory Protein-1 Alpha (MIP-1 α)
| Cat. Number | Description | Kit Size |
|---|---|---|
| EV3680 | Cytokine Array III Evidence | 180 Biochips |
| EV3678 | Cytokine Array III Evidence Investigator | 54 Biochips |
Cytokine Array IV
Analytes
- Matrix Metalloproteinase-9 (MMP-9)
- Soluble Interleukin-2 Receptor Alpha (sIL-2Rα)
- Soluble Interleukin-6 Receptor (sIL-6R)
- Soluble Tumour Necrosis Factor I (sTNFR I)
- Soluble Tumour Necrosis Factor II (sTNFR II)
| Cat. Number | Description | Kit Size |
|---|---|---|
| EV3659 | Cytokine Array IV Evidence | 180 Biochips |
| EV3661 | Cytokine Array IV Evidence Investigator | 54 Biochips |
Cytokine Array IV
Analytes
- Interleukin -3 (IL-3)
- Interleukin-7 (IL-7)
- Interleukin-12 p70 (IL-12p70)
- Interleukin-13 (IL-13)
- Interleukin-23 (IL-23)
| Cat. Number | Description | Kit Size |
|---|---|---|
| EV3666 | Cytokine Array V Evidence Investigator | 54 Biochips |
Evidence Investigator
The Evidence Investigator is a benchtop, semi-automated analyser capable of screening 54 patient samples and up to 44 analytes simultaneously using Randox Biochip technology. Ideal for medium to high throughput testing, the Evidence Investigator test menu comprises immunoassay testing and molecular diagnostics on a single platform. Find out More
Evidence
Evidence is a fully automated analyser utilising Randox Biochip technology to screen up to 88 patient samples and up to 44 analytes simultaneously for complete patient profiling. Our comprehensive test menu comprises cytokines, endocrines, tumour markers, thyroid hormones, adhesion molecules and drugs of abuse. Find out More
Quality Control – Qnostics
Qnostics
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 Controls – Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays. As whole pathogen controls they target the whole viral genome including CDC and WHO consensus sequences.
- Full Process Control – Whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Highly Characterised – When the use of time and resources are critical like in COVID-19 testing, the use of highly characterised controls enables laboratories to meet their daily QC needs and accreditation requirements. Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
- True Third Party – An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Superior Manufacturing – Qnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
- Liquid for Ease-of-use – Conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
- Negative Control Available – Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.
- Complete QC Solution – Products available for new assay validation as well as routine performance monitoring.
Complete QC Solutions
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.
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).
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.
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
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
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
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2AQP | SARS-CoV-2 Molecular Q Panel | 4 x 0.5 ml |
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
Bilirubin Linearity Verifier
Our Bilirubin verifier contains both Direct Bilirubin and Total Bilirubin so testing is fully covered. Dedicated for use on Roche
Cobas systems, this verifier spans five levels ensuring the instruments entire reportable range is measured.
Features & Benefits
- Lyophilised for enhanced stability
- 5 levels provided
- Open vial stability of 10 days at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Enzyme Linearity Verifier | 5 x 3mL | 10 | LV10366 | |
Analytes
- Direct Bilirubin
- Total Bilirubin
Enzyme Linearity Verifier
Our Enzyme Linearity Verifier contains 10 commonly tested enzymes in one unique multi-marker verifier allowing you to
consolidate testing. Spanning 5 clinical levels, this verifier ensures the systems entire reportable range is measured. Designed
specifically for use with Roche Cobas systems, our Verifier is available in a convenient liquid frozen format.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Enzyme Linearity Verifier | 5 x 3mL | 10 | LV10366 | |
Analytes
- ALT
- ALP
- a-Amylase
- Pancreatic Anylase
- AST
- CK
- CKMB
- yGT
- LDH
- Lipase
Clinical Chemistry Linearity Verifier
Our Clinical Chemistry Linearity Verifier comprises 17 common chemistry assays, supplied in a liquid frozen format. Designed specifically for use on Roche Cobus analysers, this verifier spans five levels ensuring the instruments entire reportable range is measured.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 7 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Verify Clinical Chemistry Linearity Verifier | 5 x 5mL | 17 | LV10390 | |
Analytes
- Albumin
- BUN
- Calcium
- Chloride
- Creatinine
- Glucose
- Iron
- Lactate
- Lithium
- Magnesium
- Phosphate
- Potassium
- Sodium
- Total Protein
- Triglycerides
- Uric Acid
- Total Cholesterol
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
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Acusera 24•7 | Update Features
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