COVID-19 Cytokine Testing Solutions

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COVID-19 Cytokine Testing Solutions

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COVID-19 Risk Stratification & Treatment Monitoring

Randox Cytokine Testing Solutions

COVID-19 Risk Stratification and Treatment Monitoring

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    Simultaneous detection of up to 12 cytokines and growth factors from a single patient sample
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    Suitable for use with serum and plasma samples
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    Fully automated and semi-automated solutions available to suit all laboratory throughputs
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    Excellent analytical performance
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    Comprehensive test menu comprising 26 cytokines, cytokine receptors and growth factors
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    Availability of complementary quality controls for a complete testing package

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.

 

 

 

Biochip

Cytokine Array I (12-plex)

  • IL-1α
  • IL-1β
  • IL-2
  • IL-4
  • IL-6
  • IL-8
  • IL-10
  • IFNγ
  • EGF
  • MCP-1
  • TNFα
  • VEGF

Interleukin-1 (IL-1) is a regulatory and inflammatory cytokine, which exists in two forms, (IL-1α) and (IL-1β), which share 25% homology at amino acid level. IL-1α is produced as a biologically active 31 kDa precursor, which undergoes proteolytic cleavage yielding a 17 kDa protein of 159 amino acids.

There are two forms of IL-1, IL-1α and IL-1β ,which share 25% homology at amino acid level. IL-1β is synthesised as a biologically inactive precursor of 269 amino acids with a molecular mass of 31 kDa , which undergoes proteolytic cleavage by IL1 converting enzyme (ICE), which yields a 17kDa protein of 153 amino acids.

Interleukin-2 (IL-2) is an interleukin, a type of cytokine signaling molecule in the immune system. It is a 15 – 18 kDa protein which has varying degrees of glycosylation accounting for the observed molecular weight range. IL-2 regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity.

IL-4 is a glycoprotein synthesised as a precursor protein of 153 amino acids. The first 24 amino acid residue signal peptide is cleaved to produce a 129 amino acid 15-19 kDa protein.

IL-6 is synthesised as a precursor protein of 212 amino acids. The N-terminal 28 amino acid residue signal peptide is cleaved to produce a 21kDa protein. It has two potential N-glycosylation sites which have no effect on bioactivity. Different post-translational alterations such as glycosylation and phosphorylation give various forms of IL-6 with molecular masses of 21.5-28 kDa. The IL-6 receptor is a strongly glycosylated 80 kDa protein of 449 amino acids. Two different forms of the receptor have been described that bind IL-6 with differing affinities, a soluble form of the IL-6 receptor has also been described. The IL-6 receptor is expressed on T cells, mitogen activated B cells, peripheral monocytes and some macrophage and B cell derived tumour cell types. IL-6 also influences antigen-specific immune responses and inflammatory reactions.

IL-8 is a member of a structurally similar family of cytokines called chemokines, which demonstrate chemotactic activity for neutrophils. IL-8 is a non-glycosylated protein of 8 kDa and consists of 99 amino acids with a 22 residue signal peptide that is cleaved to generate a 77 amino acid sequence. IL-8 is produced in response to proinflammatory stimuli. It is produced by monocytes, macrophages, fibroblasts, endothelial cells, keratinocytes, melanocytes, hepatocytes, chondrocytes, T-cells, neutrophils, and astrocytes.

Interleukin-10 (IL-10), alternatively known as B-cell-derived T-cell growth factor (B-TCGF), cytokine synthesis inhibitory factor (CSIF) or T-cell growth inhibitory factor is a homodimeric protein with a molecular weight of 18 kDa. It is produced as a 178 amino acid residue precursor, which is cleaved to give a mature protein of 160 amino acids. IL-10’s primary function is as an anti-inflammatory agent, which inhibits cytokine production by T cells and natural killer cells caused by activation of monocytes/macrophages.

IFN-γ is a cytokine critical to both innate and adaptive immunity, and functions as the primary activator of macrophages, in addition to stimulating natural killer cells and neutrophils. Biologically active interferon gamma is a 20 or 25 kDa glycoprotein depending on its glycosylation state. This lymphokine is synthesised as a 166 amino acid sequence but is cleaved to give a 143 amino acid residue.

Human EGF is produced as a long precursor protein of 1207 amino acids which is released by proteolytic cleavage to give a globular protein of 6.4 kDa consisting of 53 amino acids. EGF is a common mitogenic factor that stimulates the proliferation of different types of cells, especially fibroblasts and epithelial cells. EGF activates the EGF receptor (EGFR/ErbB), which initiates, in turn, intracellular signaling.

Monocyte chemoattractant protein (MCP-1) is part of the chemotactic family of cytokines called chemokines. ). It is a 76 amino acid peptide and has a molecular weight of 8.6 kDa. MCP-1 in particular chondrocytes confirming its role in inflammatory responses. MCP-1 has been implicated in a wide variety of inflammatory diseases such as artherosclerosis, delayed hypersensitivity reactions, rheumatoid arthritis, alveotitis and idiopathic pulmonary fibrosis.

Tumour necrosis factor alpha (TNFα) is a 157 amino acid 26 kDa transmembrane protein which is secreted as a soluble mature 233 amino acid homotrimer of 17 kDa by proteolytic cleavage. TNF-α is secreted by macrophages in response to stimuli for the induction of systemic inflammation. The binding of the ligand TNF-α to the TNF receptor (TNFR1) initiates the pro-inflammatory and pro-apoptotic signaling cascades.

Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is secreted as a glycosylated homodimeric protein of 46 kDa that is made up of two 24 kDa subunits linked by disulphide bonds. VEGF is expressed by vascularised tissue such as pituitary, brain, lungs, kidneys, heart and adrenal glands, although it is assumed that all tissues have the potential to produce the growth factor. VEGF is stimulated when cells become deficient in oxygen or glucose or under inflammatory conditions.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3508Cytokine Array I Evidence360 Biochips
EV3544Cytokine Array I Evidence180 Biochips
EV3513Cytokine Array I Evidence Investigator54 Biochips
EV3623Cytokine Array I High Sensitivity Evidence Investigator54 Biochips

Cytokine Array III (4-plex)

  • IL-5
  • IL-15
  • GM-CSF
  • MIP-1 α

Interleukin-5 (IL-5) is a disulphide linked homodimer and belongs to a family of structurally related proteins that includes: interleukin-2, interleukin-4, macrophage colony-stimulating factor, granulocyte macrophage colony-stimulating factor and growth hormone. It is a glycoprotein with the apparent molecular weight of recombinant IL-5 produced by mammalian cells in the range 45 to 60 kDa. The large variation in the molecular weight caused predominantly by the addition of heterogeneous carbohydrate chains.

Interleukin-15 (IL-15) is a 14 to 15 kDa protein of 114 amino acids. It contains 2 disulphide bonds and 2 N-linked glycosylation sites at the C-terminus1. IL-15 is expressed at the mRNA level in numerous normal human tissues in a broad range of cell types, including activated monocytes, dendritic cells, osteoclasts and fibroblasts. IL-15 has an essential role in natural killer (NK) cell development. It activates NK cell proliferation, cytotoxicity, and cytokine production and regulates NK cell/macrophage interaction. Studies have suggested that IL-15 may have a role in establishing innate immune responses and maintaining neutrophil-mediated inflammatory processes.

Granulocyte-macrophage colony stimulating factor (GMCSF) isolated from human sources is glycosylated with an apparent molecular mass of 23 kDa. The mature protein has 127 amino acids and is preceded by a hydrophobic leader sequence of 25 amino acids.

Macrophage inflammatory protein-1α (MIP-1α, CCL3) is a member of the CC chemokine subfamily whose members are known for chemotactic and proinflammatory effects and also for the promotion of homeostasis. MIP-1α is synthesised as a 92 amino acid precursor that is proteolytically processed to a mature protein of about 70 amino acids. MIP-1α has roles in inflammatory responses at sites of injury or infection by recruiting proinflammatory cells.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3680Cytokine Array III Evidence180 Biochips
EV3678Cytokine Array III Evidence Investigator54 Biochips

Cytokine Array IV (5-plex)

  • MMP-9
  • sIL-2Rα
  • sIL-6R
  • sTNFR I
  • sTNFR II

Matrix metalloproteinase-9 (MMP-9) (gelatinase B) (92 kDa) is a member of the matrix metalloproteinase (MMP) family. MMP-9, one of the most widely investigated MMPs, regulates pathological remodeling processes that involve inflammation and fibrosis.

Soluble IL-2 receptor α (sIL-2Rα) results from the proteolytic cleavage of IL-2Rα at the cell surface by a membrane metalloproteinase; which is encoded by IL2RA on human chromosome. It’s widely noted in research that sIL-2Rα has been found in diseases caused by infections, autoimmune disease and organ transplantation.

Interleukin-6 (IL-6) is a multifunctional cytokine that regulates pleiotropic roles in immune regulation, inflammation, hematopoiesis, and oncogenesis. The IL-6 receptor complex belongs to the haematopoietic receptor superfamily and mediates the biological activities of IL-6. It consists of two distinct membrane bound glycoproteins, an 80 kDa cognate receptor subunit (IL-6R) and a 130 kDa signal-transducing element (gp130). The gp130 subunit is expressed in almost all organs including heart, kidney, spleen, liver, lung, placenta and brain.

Tumour necrosis factor receptor I is one of two specific, high affinity cell surface receptors that function as transducing elements, providing the intracellular signal for cell responses to tumour necrosis factor (TNF). TNF is a proinflammatory cytokine mainly produced by stimulated monocytes, macrophages and T-lymphocyte subsets. It has a key role in host defence and immunosurveillance, mediating complex cellular responses of a different, even contrasting nature. TNFRI has a molecular mass of 55 kDa1 and is expressed by almost all cell types2 especially those cells that are susceptible to the cytotoxic action of TNFI. TNFRs are detectable in normal serum, but their concentration increases significantly in inflammatory and non-inflammatory diseases.

Tumour necrosis factor receptor II (TNFRII) is one of two specific, high affinity cell surface receptors that function as transducing elements, providing the intracellular signal for cell responses to tumour necrosis factor (TNF). TNF is a proinflammatory cytokine mainly produced by stimulated monocytes, macrophages and T-lymphocyte subsets. It has a key role in host defence and immunosurveillance, mediating complex cellular responses of a different, even contrasting nature. TNFRII has a molecular mass of 75 kDa1. Although TNFRII is expressed by almost all cell types, it is expressed primarily by cells of the immune system, cells of myeloid origin and endothelial cells.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3659Cytokine Array IV Evidence180 Biochips
EV3661Cytokine Array IV Evidence Investigator54 Biochips

Cytokine Array V (5-plex)

  • IL-3
  • IL-7
  • IL-12p70
  • IL-13
  • IL-23

Interleukin-3 (IL-3) possesses diverse biological activities and was discovered independently in studies on its biological activities. IL-3 is a heavily glycosylated protein with a polypeptide chain of 133 amino acids. It occurs naturally in a diversity of glycoforms generated by the addition of carbohydrate groups which results in size heterogeneity from 28 to 45 kDa. The function of the extensive carbohydrate modifications of the IL-3 polypeptide is not known however IL-3 has been linked with various diseases including colorectal and pancreatic cancers.

Interleukin-7 (IL-7) is classified as a type 1 short-chain cytokine of the haematopoietin family, a group that also includes IL-2, IL-3, IL-4, IL-5, GM-CSF, IL-9, IL-13, IL-15, M-CSF, and stem cell factor. The human gene for IL-7 is located on chromosome 8q12-13. The amino acid sequence of IL-7 predicts a molecular weight of 17.4 kDa, but glycosylation results in an active protein of 25 kDa. IL-7 appears to be involved in the development of an effective immune system and also in the generation and maintenance of strong and effective cellular immune responses directed against cancer cells, or infectious diseases.

Interleukin-12 (IL-12) is a 75 kDa heterodimeric glycoprotein cytokine composed of disulphide linked p40 (40 kDa) and p35 (35 kDa) subunits that are derived from separate genes1. p35 is expressed in a limiting and tightly regulated fashion by many different cell types, however the expression of p40, though in greater quantities than required for p70 formation, appears to be restricted to antigen presenting cells. IL-12 stimulates IFN production, which is essential in resistance to intracellular protozoan, fungal and bacterial infections and, in addition, tumours. Traditionally, IL-12 is accepted as an important mediator of autoimmunity and is involved in a number of autoimmune diseases including rheumatoid arthritis, psoriasis, inflammatory bowel disease and insulin-dependent diabetes mellitus.

Interleukin-13 (IL-13) is a 12 kDa protein that folds into four I-helical bundles. It contains four potential N-glycosylation sites and four cysteine residues that form two intramolecular disulphide bonds. IL-13 shares a number of structural features and functional characteristics with IL-4. The IL-13 protein is approximately 25% homologous1 with IL-4 and belongs to the same I-helix protein family. IL-13 plays a dominant role in resistance to most gastrointestinal nematodes and also modulates resistance to intracellular organisms by regulating cell mediated immunity. IL-13 is the central mediator of allergic asthma, where it regulates eosinophilic inflammation, mucus secretion, and airway hyperresponsiveness. Although IL-13 is associated primarily with the induction of airway disease, it also has anti-inflammatory properties.

Interleukin 23 (IL-23) is member of the IL-12 family. The IL-12 family consists of cytokines IL-12(p40p35), IL-23(p40p19) and IL-27(EBI13p28), and monomeric and homodimeric p401. IL-23 is a heterodimeric cytokine composed of disulphide linked p19 and p40 subunits. IL-23 plays a role in a signaling pathway that triggers inflammation.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3666Cytokine Array V Evidence Investigator54 Biochips

Immunoassay Platforms

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Contact us or visit our COVID-19 Monitoring & Management page

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Randox Discovery

Randox Discovery | The Benchtop Lab

Discover The Future Of Molecular & Immunoassay Diagnostics

Why Choose the Discovery?

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    The Discovery is an exciting and disruptive analyser capable of molecular and immunoassay testing
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    Simultaneous detection of hundreds of targets from a single patient sample via patented biochip technology
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    Flexible test menu comprising immunoassay and genetic tests for infectious diseases & oncology
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    Rapid turnaround time. Three hours to first batch of results with results for subsequent batches every hour after
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    Fully automated platform increasing operator walkaway time.  A single operator is all that’s required to run up to 3 Discovery analysers
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    Simple and easy to use. Intuitive user interface guides the operator through the entire testing process

Discover The Power Of Automation

Randox Discovery is comprised of three interconnected modules which each  operate independently performing different aspects of the diagnostic testing process. Each module is separated by a physical barrier to prevent contamination and is accessible via a door. The workflow process runs from right to left and is compatible with lean working principles.

  • Module I
  • Module II
  • Module III

Nucleic Acid Extraction

Module I is responsible for DNA/RNA extraction. After extraction the sample is automatically transferred to Module II. Before transfer, Module I detects the presence of Module II cartridges using a unique vision system.

Multiplex PCR

Module II is responsible for amplification of the extracted nucleic acid by End-Point PCR. UV light is used to sterilise the module and reduce the risk of crossover contamination.

Biochip Hybridisation & Detection

Module III is used in both immunoassay & molecular workflows and is responsible for hybridisation and subsequent detection using patented biochip technology. The detection camera uniquely moves between sample cartridges to detect biochip chemiluminescence.

Discover the Power of Randox Biochip Technology

 

The Randox Discovery is an exciting and disruptive molecular & immunoassay diagnostic analyser capable of consolidating the normal workload of multiple laboratories, into one compact benchtop platform. Randox patented Biochip Technology allows simultaneous detection of hundreds of targets from a single patient sample.  The benefits of multiplexing in this way are endless; allows complete patient profiling, reduces the amount of time spent on individual tests, identifies co-infections, differentiates between pathogens that exhibit similar symptoms and eliminates the need to run multiple time consuming and sample intensive assays. The biochip detection system is based on a chemiluminescent signal, this is the emission of light, without heat, as a result of a chemical reaction.

Discover Our Comprehensive Test Menu

 

  • SARS-CoV-2 Array (COVID-19)
  • Extended Coronavirus Array
  • Molecular Test Menu
  • Immunoassay Test Menu
  • Toxicology Test Menu
VIRUSES
SARS-CoV-2 (COVID-19)Sarbecovirus
(SARS, SARS like, SARS-CoV-2)
VIRUSES
SARS-CoV-2 (COVID-19)Sarbecovirus
(SARS, SARS like, SARS-CoV-2)
Influenza A
Coronavirus 229E/NL63Adenovirus A/B/C/D/EInfluenza B
Coronavirus OC43/HKUIEnterovirus A/B/CRhinovirus A/B
Middle East Respiratory
Syndrome Coronavirus (MERS-CoV)

*In Development – Respiratory Tract Infections Array, Chronic Lung Infections Array, Sexually Transmitted Infections Array & Urinary Tract Infections Array, KRAS, BRAF & PIK3CA Array, Familial Hypercholesterolemia Array & Cardiac Risk Array.

*In Development – A number of clinical immunoassay arrays covering a range of disease markers including adhesion molecules, alzheimers, anaemia, bone disease, cancer, cardiac, cytokines, diabetes, endocrines, fibrinolysis, fertility, gastrointestinal, metabolic, renal, stroke, thyroid & tissue damage.

*In Development – A number of clinical toxicology arrays are in development covering a wide range of Drugs of Abuse (DoA) & New Psychoactive Substances (NPS) detecting over 500 drug and drug metabolites using innovative Biochip Technology.

Product availability may vary from country to country. Some product may be for Research use Only. For more information on product application and availability, please contact your local Randox Representative.

Discover Randox’s Molecular Platforms

All In One Point Of Care Molecular Platform

Compact, Semi-Automated Benchtop Analyser

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QCMD

Vivalytic

Evidence Investigator


The world’s most extensive Drugs of Abuse Test Menu

Randox Toxicology offers the most comprehensive Drugs of Abuse (DoA) test menu across multiple forensic matrices. Our level of expertise in toxicology research and development allows us to adapt quickly to the ever-changing market influences and develop assays for current and novel drugs trends. Excellent assay precision and performance eliminates false reporting, therefore reducing unnecessary confirmatory tests and time lost in the laboratory as a result. Our Biochip Arrays offer CVs typically less than 10%, producing an accurate drug profile to ensure confidence in results.

DoA II
BuprenorphineKetamineOxycodone I
CreatinineLSDOxycodone II
FentanylMDMAPropoxyphene
Generic OpioidsMethaqualone

The Evidence Series of immunoassay analysers are powered by Biochip Array Technology and combine the latest technological advances for drug residue detection using immunoassay principles. The Drugs of Abuse II panel is available for both the Evidence and the Evidence Investigator analysers. The Evidence has a throughput of 90 samples per hour, testing up to 44 tests per sample.  The Evidence is a fully automated batch immunoanalyser, allowing for 3960 tests per hour, while the Evidence Investigator is a semi-automated, bench top analyser with testing capabilities of 2376 tests in 70 minutes.

 

 

To find out more about our Biochip Array Technology and our Evidence Series analysers, visit www.randoxtoxicology.com, or email us at info@randoxtoxicology.com


Product Spotlight: HbA1c Quality Controls

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Product Spotlight

HbA1c Quality Controls

Diabetes

Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.

Type 1 Diabetes

Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.

Type 2 Diabetes

A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.

HbA1c

HbA1c is the average blood glucose level for the past two to tthree months. A high HbA1c means there is too much sugar in the bloodstream. This means the patient is more likely to develop complications associated with diabetes, like problems with feet and eyes [1].

HbA1c in Diagnostics

In 2011, the WHO accepted the use of glycated haemoglobin (HbA1c) testing in the diagnosis of diabetes, Diabetes UK also supports this decsion [2].

HbA1c can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement.”
World Health Organisation (2011)

Clinically Significant Levels

A HbA1c level of 6.5% is recomended as the cut off for diabetes diagnosis [3], this can be seen in Fig. 1.

HbA1c Levels

Fig. 1. Clinically relevant levels for Diabetes diagnosis.

Acusera HbA1c Controls

Acusera HbA1c Quality Control

The Randox Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a minimum and helps to reduce costs.

View HbA1c Control

Acusera Liquid HbA1c Quality Control

Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.

View Liquid HbA1c Control
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  • References

    [1] “What is HbA1c?”, Diabetes UK, 2018. [Online] Availabel: https://www.diabetes.org.uk/guide-to-diabetes/managing-you-diabetes/hba1c.

    [2] Diabetes UK, “Diagnostics criteria for deabetes”, Diabetes UK, 2018. [Online]. Available: https://www.diabetes.org.uk/professionals/position-statements-reports/diagnosis-ongoing-management-monitoring/new_diagnostic_criteria_for_diabetes.

    [3] WHO, “Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus”, World Health Organisation, 2011.


sTfR Quality Control

Therapeutic Drug Quality Control

Providing a true third party solution for the measurement of Soluble Transferrin Receptor (sTfR), the Acusera sTfR Control  will deliver an unbiased, independent assessment of analytical performance.

Designed for used with sTfR assays, this handy single analyte control saves money on wasted material.

Features & Benefits

  • Lyophilised control
  • Human based material
  • Assayed target values available
  • Stable to expiry date at 2°C to 8°C
  • Reconstituted stability of 30 days at 2°C to 8°C
DescriptionSizeAnalytesCat No 
sTfR Control (Bi-level)3 x 2 x 1 ml1TF10162
sTfR Calibrator6 x 1 ml1TF10161

Analytes

  • Soluble Transferrin Receptor (sTfR)

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Product Spotlight: Respiratory Controls – Molecular Infectious Disease Testing

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Product Spotlight

Molecular Controls for Respiratory Infection Testing

Respiratory Infections

Flu is a contagious respiratory illness cause by influenza viruses that infect the throat, nose, and sometimes lungs. It can cause illness and sometimes death. Getting vaccinated is the best way to prevent catching flu [1].

There are four types of seasonal flu, A, B, C, and D. Types A and B cause seasonal epidemics of disease. Illnesses range from severe to mild and can even result in death in high risk groups. High risk groups include, pregnant women, children under 5 years of age, the elderly, and people with chronic or immunosuppressive medical conditions [2].

Flu season begins as early as October, reaches its peak in February, and ends in March. In the southern hemisphere, flu season falls between June and September. Wherever it’s cold, it’s flu season.

Diagnosing Flu

A test to detect Influenza viruses can be used to determine whether a patient has the flu. A swab is taken from either the nose or back of the throat and sent for testing. Molecular assays can be used to detect genetic material of the virus [3]. Molecular methods play an important role in the diagnosis and surveillance of influenza viruses. Molecular diagnostics allow timely and accurate detection of influenza and are already implemented in many laboratories. The combination of automated purification of nucleic acids with real-time PCR should enable even more rapid identification of viral pathogens such as influenza viruses in clinical material [4].

Learn more about Flu Season
Qnostics - Molecular Controls for Infectious Disease Testing

The Qnostics range of complete molecular controls for infectious disease testing can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training. As whole pathogen controls, the range is designed to mimic the performance of patient samples and can be used to effectively monitor the entire testing process including extraction, amplification and detection.

Qnostics offers a range of solutions for molecular respiratory testing:

Q Controls

Independently manufactured, these positive and externally run controls are designed to be treated as a patient sample within an assay run. Helping to support a laboratory’s accreditation requirements in line with ISO 15189:2012, Q Controls are supplied in an unassayed, liquid frozen format delivering accurate and reliable test results.

Analytical Q Panels

Each Analytical Q Panel consists of five or more individual samples including a negative and is designed to cover the dynamic range of individual infectious disease assays, in a linear progression. Analytical Q Panels are intended for use in the validation and verification of new assays with the main purpose of helping to ensure assays are linear throughout the dynamic range. In addition, Analytical Q Panels will support a laboratory’s accreditation requirements, in line with ISO 15189:2012.

Evaluation Panels

Evaluation Panels may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of clinical assays and the development of diagnostic tests.

Learn more about Qnostics Respiratory Testing
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Molecular Respiratory Testing

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  • References

    [1] “Key Facts About Influenza (Flu) | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/keyfacts.htm. [Accessed: 25- Sep- 2018].

    [2] “Influenza (Seasonal)”, World Health Organization, 2018. [Online]. Available: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). [Accessed: 27- Sep- 2018].

    [3] “Diagnosing Flu | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/about/qa/testing.htm. [Accessed: 25- Sep- 2018].

    [4] J. Ellis and M. Zambon, “Molecular diagnosis of influenza”, Reviews in Medical Virology, vol. 12, no. 6, pp. 375-389, 2002.


Product Spotlight: Acusera Cardiac Quality Control

Product spotlight - Cardiac Quality Control Solutions
Cardiac Quality Control Solutions

For this month’s product spotlight, we have chosen our whole range of cardiac quality control solutions. Randox offers options for both Internal Quality Control (IQC) and External Quality Assessment (EQA).

29th September is World Heart Day. World Heart Day is a global campaign during which individuals, families, communities and governments around the world participate in activities to take charge of their heart health and that of others.

Cardiovascular disease (CVD) is a term to describe conditions that affect the heart and blood vessels. It is normally associated with a build up of fatty deposits in the arteries and an increased risk of blood clots. CVD is the leading casues of death globally, representing around 30% of all deaths. A healthy lifestyle can help prevent CVD; however, increasingly busy lifestyles mean that it is difficult to avoid CVD. This means it is vitally important that individuals are tested for CVD and to ensure that diagnoses are acurate.

Acusera Internal Quality Controls

The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid misdiagnosis and/or incorrect treatment. The Acusera Cardiac Quality Controls have been designed to cover a wide range of cardiac markers at clinical decision levels eliminating the need for additional low level controls at extra expense. Available in a choice of both liquid ready-to-use and lyophilised formats, they are ideal for use at the point-of-care and in the laboratory. Manufactured from 100% human serum a matrix similar to that of the patient is guaranteed.

  • Liquid Controls

    Control Vial

    Liquid Cardiac Control

    Liquid, Assayed, 100% Human serum
    8 Analytes

    Control Vial

    BNP Control

    Liquid, Assayed, 100% Human serum
    1 Analyte

  • Lyophilised Controls

    Control Vial

    Cardiac Control

    Lyophilised, Assayed, 100% Human serum
    7 Analytes

    CK-MB Control

    Lyophilised, Assayed, 100% Human serum
    2 Analytes

    Control Vial

    H-FABP Control

    Lyophilised, Assayed, 100% Human serum
    1 Analyte

    hsTnT Control

    Lyophilised, Assayed, 100% Human serum
    1 Analyte

RIQAS External Quality Assessment

The RIQAS Cardiac EQA programme is designed to monitor the performance of up to 7 clinically significant cardiac markers. Two flexible reporting options are available to suit the needs of all laboratory sizes.

Accredited to ISO/IEC 17043

•  Lyophilised for enhanced stability
•  100% human serum
•  Bi-weekly reporting
•  Submit results and view reports online via RIQAS.Net
•  Register up to five instruments at no extra cost

Parameters

CK, Total | CK-MB activity units | CK-MB mass units | Homocysteine | Myoglobin | Troponin I | Troponin T

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Cardiac Controls

Cardiac EQA

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The Evidence Series

Having developed the patented Biochip Array Technology following £250 million investment in research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series.

The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.

Have a read below of the overview of each analyser in the Evidence Series

Evidence Evolution

The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.

Evidence

As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.

Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.

Evidence MultiSTAT

The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.

 

 

 

About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.

For more information on any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

 

 

 


Product Spotlight: Acusera Immunoassay Premium Plus Control

Product spotlight - immunoassay premium plus
Acusera Immunoassay Premium Plus Control

The Randox Acusera Immunoassay Premium Plus quality control covers an impressive 54 analytes with assayed instrument specific target values and ranges provided for up to 51 analytes. The unique combination of routine tumour markers, therapeutic drugs and Vitamin D allows laboratories to dramatically reduce the number of controls required while ultimately keeping costs to a minimum. Three levels of control are available with analytes present at clinically significant levels.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Assayed, instrument specific target values provided for up to 51 parameters
  • Ferritin and Vitamin B12 levels suitable for anaemia monitoring
  • Ultra low TSH levels in the level 1 control
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C
  • Contains routinely run tumour markers: AFP/CA15-3/CA19-9/CA-125/CEA/PSA/Free-PSA

Flexible options are available with a low, normal and high level, as well as a combined tri-level.

Description
Size
Analytes
Cat No.
Immunoassay Premium Plus Level 112 x 5 ml54IA3109
Immunoassay Premium Plus Level 212 x 5 ml54IA3110
Immunoassay Premium Plus Level 312 x 5 ml54IA3111
Immunoassay Premium Plus Tri-Level4 x 3 x 5 ml54IA3112
Clinical Significance

The clinical significance of some selected analytes.

  • Androstenedione

    Androstenedione is an androgen, which are hormones responsible for the induction of sexual differentiation and produce secondary male physical characteristics such as a deep voice and facial hair. Another example is testosterone. They are also present in females as precursors to female hormones (such as estrogen).

    This test measures the amount of androstenedione in the blood. Because AD has its origins in the adrenal glands, it is useful as a marker of adrenal gland function, of the function of the ovaries or testicles, and androgen production.

    An androstenedione level may be used to [1]:

    Evaluate adrenal gland function and distinguish between androgen-secreting conditions that are caused by the adrenal glands from those that originate in the ovaries or testicles, if results of DHEAS and testosterone testing are abnormal
    Help diagnose tumours in the outer layer (cortex) of the adrenal gland or tumours outside of the adrenal gland that secrete ACTH (ectopic) and separate these conditions from ovarian or testicular tumours and cancers
    Diagnose congenital adrenal hyperplasia (CAH) and monitor CAH treatment, in addition to tests for testosterone and 17-hydroxyprogesterone
    Help diagnose polycystic ovarian syndrome (PCOS) and help rule out other causes of infertility, no monthly menstrual periods (amenorrhea), and excess body and facial hair (hirsutism) in women who have abnormal results on tests for DHEAS, testosterone, and other hormones such as FSH, LH, prolactin, and estrogen
    Help determine the cause of delayed puberty and investigate suspected ovarian or testicular failure
    Investigate and diagnose the cause of male physical characteristics (virilisation) in young girls and early (precocious) puberty in young boys
  • Digoxin

    Digoxin is a therapeutic drug used to treat abnormal heart rhythms and failure. Heart failure causes the heart to become less effective at circulating blood, resulting in blood backing up in the hands, legs, liver, and lungs, causing swelling.

    This test measures the level of digoxin in the blood. Digoxin is prescribed to patients to alleviate symptoms of heart failure by strengthening contractions, helping the heart pump blood more effectively. Digoxin can also be used to treat arrhythmias. It cannot be used to cure heart failure or arrhythmias but can help to manage the symptoms along with other medication, exercise and diet.

    Digoxin levels are monitored due to the drug’s narrow safety range. If the level is too high, toxicity may occur, if too low, symptoms may recur.

    A Digoxin level may be used to [2][3]:

    Monitor the concentration of the drug in the patient's blood
    Determine if a patient's symptoms are due to insufficient levels of Digoxin or due to digoxin toxicity
    Increase the strength and efficiency of heart contractions, helping control the rate and rhythm of the heart
    Slows electrical conduction between the atria and the ventricles, which is useful in treating abnormally rapid atrial rhythms that can cause heart attacks
  • Luteinizing Hormone (LH)

    Luteinizing Hormone (LH) is associated with the reproductive cycle and the release of an egg from the ovary in women and testosterone production in men. LH production is a complex system controlled by the hypothalamus in the brain, hormones produced in the testes and ovaries, and the pituitary gland.

    This test measures the amount of luteinizing hormone in the blood or urine. It is used alongside other tests such as FSH, estradiol, progesterone, and testosterone to investigate reproductive irregularities.

    A luteinizing hormone level may be used [4]:

    In both men and women:

    In the workup of infertility
    To aid in the diagnosis of pituitary disorders that can affect LH production
    To help diagnose conditions associated with dysfunction of the ovaries or testicles

    In women:

    In the investigation of menstrual irregularities
    To detect a surge in LH levels during the menstrual cycle, helping determine when a woman is likely to be the most fertile

    In children:

    To diagnose delayed and precocious (early) puberty. Irregular timing of puberty may be an indication of a more serious problem involving the hypothalamus, the pituitary gland, the ovaries or testicles, or other systems
  • Insulin

    Insulin is a hormone produced and stored in the beta cells of the pancreas. It is secreted as a response to an elevated glucose level following a meal and is vital in the transportation and storage of glucose, the body’s primary source of energy. Insulin regulates blood glucose by helping transport it from blood to cells.

    This test measures the amount of insulin in the blood. After a meal, carbohydrates are broken down into glucose, this is then absorbed into the blood causing the blood glucose level to rise, this then falls as it moves into cells. If an individual cannot produce enough insulin, or if they are insulin resistant (cells are resistant to insulin’s effects), glucose does not reach the body’s cells and they starve. The blood glucose level will rise to an unhealthy level, which can cause various complications, including Diabetes.

    An insulin level may be used to [5]:

    Diagnose an insulinoma, verify that removal of the tumor has been successful, and/or to monitor for recurrence
    Diagnose the cause of hypoglycemia in an individual with signs and symptoms
    Identify insulin resistance
    Monitor the amount of insulin produced by the beta cells in the pancreas (endogenous); in this case, a C-peptide test may also be done. Insulin and C-peptide are produced by the body at the same rate as part of the conversion of proinsulin to insulin in the pancreas
    Determine when a type 2 diabetic might need to start taking insulin to supplement oral medications
    Determine and monitor the success of an islet cell transplant intended to restore the ability to make insulin, by measuring the insulin-producing capacity of the transplant

    What test results mean [5]:

    Disorder
    Fasting Insulin Level
    Fasting Glucose Level
    Insulin resistanceHighNormal or somewhat elevated
    Not enough insulin produced in beta cells (diabetes, pancreatitis)LowHigh
    Hypoglycemia due to excess insulin (insulinomas, cushing syndrome)Normal or HighLow
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  • References

    [1] “Androstenedione”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/androstenedione. [Accessed: 07- Aug- 2018].

    [2] “Digoxin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/digoxin. [Accessed: 08- Aug- 2018].

    [3] O. Ogbru and J. Marks, “digoxin, Lanoxin: Drug Facts, Side Effects and Dosing”, MedicineNet. [Online]. Available: https://www.medicinenet.com/digoxin/article.htm#which_drugs_or_supplements_interact_with_digoxin?. [Accessed: 08- Aug- 2018].

    [4] “Luteinizing Hormone (LH)”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/luteinizing-hormone-lh. [Accessed: 08- Aug- 2018].

    [5] “Insulin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/insulin. [Accessed: 08- Aug- 2018].

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