Vivalytic | Strep A
Vivalytic | Strep A
Vivalytic | Strep A
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Detection of Streptococcus pyogenes
*Currently under development. Not available for sale.
Qualitative RT-PCR detection of Streptococcus pyogenes
- Quick turnaround time of less than 30 minutes, beneficial for both the patient and for the containment of Strep A reducing aerogenic transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms Streptococcus pyogenes.
Clinical Significance
Group A Streptococcus (GAS) is the primary culprit behind bacterial pharyngitis in school-aged children. Typically resulting in a mild illness characterised by symptoms such as a sore throat, headache,
and fever, GAS infections may also manifest as scarlet fever, presenting with a fine, red rash. Although often manageable, severe cases warrant antibiotic treatment for effective resolution.
An automated, qualitative in vitro diagnostic test employing real-time polymerase chain reaction (PCR) is utilised to detect nucleic acids from Streptococcus pyogenes in human oropharyngeal swabs. This advanced test serves as a valuable aid in diagnosing streptococcal pharyngitis in symptomatic individuals.
Features
Sample Type: Oropharyngeal swabs
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: Less than 30 minutes
| Detectable Pathogen |
|---|
| Streptococcus pyogenes |
Vivalytic Group B Streptococcus (GBS) (In Development)
Real-time PCR for the detection of Streptococcus agalactiae – More information to follow
| Detectable Pathogen |
|---|
| Streptococcus agalactiae (B-Streptococci) |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | Candida auris
Vivalytic | Candida auris
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Detection of Candida auris
*Currently under development. Not available for sale.
Qualitative RT-PCR detection of Candida auris
- Quick turnaround time of 30 minutes, beneficial for both the patient and for the containment of Candia auris and reducing transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms of the multidrug-resistant fungal Candia auris.
Clinical Significance
Candida auris is an emerging and often multidrug-resistant fungal species that poses a significant threat to public health. This yeast-like fungus can cause severe infections, primarily affecting individuals with compromised immune systems, those in healthcare facilities, or those with underlying medical conditions. Candida auris is particularly concerning due to its ability to persist on surfaces, leading to healthcare-associated outbreaks. Diagnosis can be challenging as it is often misidentified with other Candida species. Effective management involves prompt identification, strict infection control measures followed by treatment. The Vivalytic Candida auris test is an automated, qualitative in vitro diagnostic employing real-time PCR to detect Candida auris DNA from swabs taken from the human axilla, groin, nasal, and rectal areas.
This test serves to screen individuals at risk for colonisation, playing a crucial role in the prevention and control of Candida auris outbreaks and infections within healthcare settings.
Features
Sample Type: Swab
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 30 minutes
| Detectable Pathogens |
|---|
| Candida auris |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | riTA CT/NG
Vivalytic | riTA CT/NG
–
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
*Currently under development. Not available for sale.
Qualitative RT-PCR detection of STI causative Species
- Quick turnaround time of less than 30 minutes, beneficial for both the patient and for the containment of STIs and reducing transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Isothermal amplification enables rapid and targeted detection up to 4 weeks after the onset of symptoms and differentiate the STI pathogenic species.
Clinical Significance
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are bacterial sexually transmitted infections (STIs). Chlamydia, primarily transmitted through sexual contact, is often asymptomatic, necessitating testing for diagnosis. Symptoms may include painful urination, and if untreated, it can lead to complications like pelvic inflammatory disease. Gonorrhoeae, also transmitted sexually, presents symptoms such as painful urination and genital discharge. Early detection is crucial for both infections to prevent complications and further transmission.
Utilising isothermal nucleic amplification technology, our system qualitatively detects nucleic acids from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
Features
Sample Type: Swab or Urine
Sample Volume: 300 μl
Detection Method: Isothermal amplification
Time to result: Less than 30 minutes
| Detectable Pathogens | |
|---|---|
| Chlamydia trachomatis | Neisseria gonorrhoeae |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Our Technology
Genomic Laboratory Technologies
Relatively new to the Randox Group is our Randox Genomics Services department, having been hugely successful in aiding the COVID testing programme, our established sequencing laboratory has been specifically designed and set up to fulfil a unique range of testing from our specialised laboratory in Northern Ireland.
Nucleic Acid Extraction and Isolation
Thermo Scientific KingFisher Flex
Automated nucleic acid extraction instruction that provides high throughput purification of up to 96 samples per run within 40 minutes.
Sample Quality Control
ThermoFisher Scientific Qubit 3.0 & Qubit Flex
Capable of fast and specific nucleic acid quantification using fluorescence-based dye application, suitable for a lower throughput. More sensitive and accurate protocol than UV absorbance.
ThermoFisher Scientific Varioskan LUX
Capable of rapid fluorescence-based UV absorbance nucleic acid analysis, suitable for high throughput of processing samples.
Agilent 4200 TapeStation System
An automated electrophoresis solution that with a scalable throughput (1-96 samples) can provide results in 1-2 minutes per plate with excellent reproducibility for sizing, concentration and integrity assessment.
Liquid Handling
Tecans
Freedom EVO 150 base unit tecans, are automated liquid handling machines, enabling fully traceable, scalable (1-96 samples) automated library preparation including QC and library pooling.
Integra Viaflo 384
Viaflo 384 enables transfers of 24, 96 and 384 samples in a single step, thus increasing pipetting throughput and reproducibility significantly.
Integra Assist Plus
Pipette adapter: accommodates all Integra electronic multichannel pipettes- with fixed and adjustable tip spacing and the D-One single channel pipetting module.
Sequencing
Applied Biosystems SeqStudio Genetic Analyser
Low-throughput benchtop system that delivers gold-standard Sanger sequencing technology and fragment analysis, easily used across a broad range of applications.
Next Generation Sequencing
MiSeq
The MiSeq System is capable of automated paired-end reads and up to 15 Gb per run, delivering over 600 bases of sequence data per read.
NextSeq 2000
NextSeq 2000 System supports emerging and mid-throughput sequencing applications as well as a broad range of methods such as exome sequencing, target enrichment, single-cell profiling, transcriptome sequencing, and more. It offers an intuitive workflow with load-and-go ease and visual cues about run status. The NextSeq 2000 allows whole-exome sequencing of up to 48 samples in 33 hours.
NovaSeq6000
The most powerful sequencing instrument Illumina produce with the ability to provide scalable throughput for efficient whole-genome, whole exome and whole-transcriptome sequencing through sequencing by synthesis and patterned flow cell technology.
Genotyping
Illumina iScan
An innovative array scanner that supports rapid, sensitive, and accurate imaging of Illumina BeadChips for exceptional genetic analysis results. The iScan System can scan thousands of array samples per day, without sacrificing data quality or reproducibility. It supports an expansive portfolio of genetic analysis assays, from high-throughput genotyping to DNA methylation analysis.
Useful Resources
CDx & Biopharma Services
Next Generation Sequencing (NGS)
Next Generation Sequencing
Next-generation sequencing (NGS) is a sequencing technology that offers speed, scalability and ultra-high throughput. The technology can be used to determine the order of nucleotides in entire genomes or targeted regions of DNA or RNA. NGS has applications in environmental, agricultural and forensic science as well as genomic and clinical research.
NGS Capabilities
Whole Exome Sequencing (WES) is a wildly used NGS method that involves sequencing every protein coding region (approximately 21,000 genes) to identify any variants that may increase the risk of developing certain conditions or impact health/lifestyle. WES can be used across a broad range of applications including genetic disease, population genetics and cancer studies.
Advantages
- Attains widespread coverage of coding regions
- Cost effective alternative to Whole-Genome Sequencing (WGS)
- Smaller data set provides faster and easy data analysis compared to WGS approaches
Human Whole Genome Sequencing (hWGS) involves sequencing very single base in your DNA (approximately 3.2 billion) to identify any variants that may increase the risk of developing certain conditions or impact health/lifestyle. This sequencing method has many applications including identifying genetic disorders, mutations responsible for cancer progression, as well as monitoring disease outbreaks.
Advantages
- High-resolution view of the genome
- Detection of all variant types
- Low cost, fast library preparation
16s rRNA gene sequencing involves the analysis of the prokaryotic 16s ribosomal RNA gene which is found in all bacteria and archaea. This sequencing approach is extremely useful for microbiome research studies. 16s rRNA gene sequencing has a number of applications including, environmental, clinical and food
Advantages
- Identification and taxonomic classification of bacterial species
- Fast speed and cost efficient
- Discovery of novel pathogens
Shotgun sequencing reads all the genomic DNA in the sample, rather than just one specific region. This sequencing method provides a vast amount of genetic information as it can identify archaea, bacteria, fungi and viruses.
Advantages
- Less labour intensive than other sequencing methods.
- Faster process than clone-clone sequencing
- Requires less DNA
qPCR
qPCR allows for the analysis of particular variants of specific locations. It is a good choice when interrogating a small region of DNA on a limited number of samples. Real-time PCR can be used for both qualitative and quantitative analysis.
Advantages and Applications of qPCR
Next Generation Sequencing (NGS) Advantages
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High sample throughput
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High sensitivity
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Comprehensive genomic coverage
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Can sequence thousands of genes simultaneously
- Low sample input required
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Fast turnaround time for high sample volumes
Related Services
CDx & Biopharma Services
Genotyping Services
Genotyping Services
The Randox Genomics Services Department currently has target genotyping solutions in multiple areas. Genotyping is the process of analysing DNA to detect SNPs of interest. These SNPs are compared to reference SNPs, available from years of genetic research, to determine differences in genetic makeup.
Genotyping Advantages and Applications
Clinical Diagnostics
Clinical Research
Food & Agriculture
Pharmacogenomics
Pharmacogenomics (PGx) is the study of how a person’s DNA effects their drug response. This is a relatively new field in science but it is expected to be the future of medicine as it focuses on personalised medicine and treating every patient individually.
Microarray Technology for PGx
At Randox we use Illumina’s Infinium Global Diversity Array with Enhanced PGx microarray to test for pharmacogenomic markers. This is the most comprehensive genotyping microarray on the market for pharmacogenomic research. The microarray features over 44,000 genome-wide PGx markers which span more than 20000 pharmacogenomic targets and gives 100% coverage of priority level A and B CPIC genes.
Related Services
CDx & Biopharma Services
Genomics Services
Genomics Services
An End-to-End Genomics Solution
Randox Genomics Services department is fitted with specialised, fully equipped, state of the art testing facilities, designed and set up to fulfil a unique range of end-to-end sequencing solutions inclusive of in-house bioinformaticians and data analysts.
Why Randox?
Randox Laboratories is a global market leader within the in vitro diagnostics industry. Utilising a multitude of platforms, our sequencing and genotyping facility is suited to a wide range of areas of genome sequencing.
Our team of genetic scientists and bioinformaticians provide customisable sequencing and genotyping services for research, development, validation and running of different genomic tests to generate high quality data in line with modern healthcare and future disease insights.
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A dedicated team of genetic scientists including automation specialists, enabling adaption to testing throughputs changes from call small projects to large scale testing.
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Huge capacity for storage and accessioning of multiple sample types with fast turnaround times.
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Specific customised project planning and validation of services, tailored to the needs of each Randox customer.
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Multiple options for variable throughput from low throughput instruments, to the largest sequencer on the market with targeted solutions in multiple areas.
- Targeted genotyping solutions in multiple areas
Our Services
Related Services
CDx & Biopharma Services
OLINK
OLINK® | Comprehensive Biomarker Discovery
Let Experts at Randox Run Your Samples
As one of the UK’s first commercial partners of Olink® Proximity Extension Assay (PEA) technology, Randox offer scientists involved in drug development, clinical, or basic life science research, the service they need to run large-scale discovery proteomics.
Randox offer customers access to the entire Olink® protein library of ~3000 protein assays for exploratory proteomics and multiomics.
Olink® Technology- How it Works
Olink Proximity Extension Assay (PEA) technology offers a new method for measuring & detecting proteins of interest in a wide variety of sample types.
Using real-time PCR amplification, Olink platforms such as the Explore 3072 uses dual recognition with antibody- protein pairs in high multiplex to create 96 unique DNA reporter sequences. Using this approach, researchers can incorporate Olink’s kits into their workflow to measure and detect low abundance proteins whilst ensuring exceptional specificity and accuracy in serum or plasma samples.
The platform uses PEA technology combined with Next Generation Sequencing (NGS) readout methods to measure the relative concentration of proteins in liquid samples.
Workflow
Olink®- Driving the Future of Healthcare
Driven by precision medicine, the future of healthcare relies on a new generation of therapies to deliver the right treatment to the right patients at the right time. Proteomics is set to be at the forefront of this movement.
Technological limitations previously restricted comprehensive investigations of proteomics. Inhibiting large scale studies examining broad ranges of proteins in large numbers of human samples.
Olink® PEA technology provides an example as to how technological developments have eradicated past issues involving:
-Poor sensitivity
-Low throughput
-Large sample volume needed
-Lack of specificity
Features and Benefits
- Covers all major biological pathways with ~3000 validated protein assays
- High sample throughput for large scale proteomic studies and research
- Minimal sample volume with just 60uL for the complete library
- Exceptional specificity in comparison to mass spec utilising PEA technology
- Compatible with a wide variety of sample types
Randox Successfully Completed Olink® Concordance Testing
Randox successfully completed the Explore Concordance challenge as beta testers of the Concordance program, certifying the ability to operate the PEA with the same level of competency as the Olink® Analysis Service.
| Randox Summary Report | Acceptance Criteria | Result | |
|---|---|---|---|
| QC Warnings | 0% | Max 16% allowed | Passed the QC warning criteria |
| Detectability | 97.2% | Min 85% allowed | Passed the detectability criteria |
| Intra CV | 9% | Max 15% allowed | Passed the CV criteria |
| Median correlation coefficient (r) | 0.98 | Min 0.9 allowed | Passed the correlation criteria. |
| Coefficient of determination (R2) | 0.96 | Min 0.9 allowed | Passed the correlation criteria. |
Overall, Randox passed all QC criteria, successfully passing the Olink Concordance Test on Explore 3072.
Related Services
CDx & Biopharma Services
World’s first Xylazine assay
Randox’s newly established ELISA for xylazine is the first immunoassay test in the world for this drug
Xylazine is an analgesic drug primarily used within the veterinary industry as a tranquilizer.
It has not been approved for human use, however, in recent years it has been linked to the USAs illicit drug supply. The United States Drug Enforcement Authority (DEA) recently published a Public Safety alert about xylazine. Its primary use is as a sedative and analgesic in veterinary medicine for horses, cattle, and other large animals. However, xylazine has been reported as an adulterant in an increasing number of illicit drugs mixtures and detected in a growing number of overdose deaths in the USA, according to the DEA.
A report released by the US Centers for Disease Control and Prevention (CDC) on June 30th 2023 found that “Among 21 jurisdictions, the monthly percentage of illicitly manufactured fentanyl-involved deaths with xylazine detected increased 276% from January 2019 (2.9%) to June 2022 (10.9%).” However, they note that because of inconsistent testing, detection is still likely underestimated.
According to the CDC researchers “Medical Examiners and Coroners might differ regarding whether they consider xylazine to increase fatal overdose risk, or they might be unfamiliar with xylazine and therefore not list it on death certificates. This variation highlights the importance of collecting postmortem toxicology data on all drugs detected in overdose deaths, rather than just those listed on the death certificate.”
The CDC advises that “Expanded postmortem testing for xylazine is needed to clarify prevalence in drug supplies” and that “Routine toxicology testing for xylazine in suspected overdose cases is critical for accurate surveillance”.
Studies continue to see the drug reported as an adulterant in an increasing number of illicit drug mixtures. Commonly encountered in combination with fentanyl but xylazine has also been detected in mixtures containing cocaine, heroin, and a variety of other drugs.
Unlike fentanyl, xylazine is not an opioid, naloxone (Narcan) does not reverse its effects. As such this dangerous combination of toxic drugs can lead to fatal accidental overdoses in users.
The severity of its side effects remain a concern: depressed breathing, blood pressure, heart rate and body temperature to critical levels.
Available now on the Evidence MultiSTAT!
Randox Toxicology continue to lead in new test development within the ever-changing drugs of abuse market. Our newly established test for xylazine is the first immunoassay test in the world for this drug of abuse.
Simultaneously screen two samples for up to 29 drugs of abuse, including xylazine, on our ToxPlex Array in just 31 minutes!
About Randox Toxicology
With over 40 years’ experience in the diagnostic market, Randox Toxicology is dedicated to advancing forensic, clinical and workplace toxicology.
Placing a heavy focus on new product R&D has led to the development of technology at the forefront of advanced global diagnostics.
A market leader in the development of new assays and technology in the field of toxicology, Randox aim to minimise laboratory workflow constraints whilst maximising the scope of quality drug detection.
With the world’s largest toxicology test menu, screening for over 600 drugs and drug metabolites, our range of versatile analysers provide toxicology solutions for both high and low throughput laboratories.
For more information, contact Randox Toxicology at info@randoxoxicology.com.
Differentiating Type 1 and Type 2 Diabetes Mellitus
An estimated 422 million people across the world are living with diabetes1. Diabetes Mellitus (DM) encompasses a collection of chronic diseases characterised by absent or ineffective insulin activity. Insulin is a hormone produced by the pancreas responsible for a host of essential physiological processes related to glucose metabolism and protein synthesis.
There are two main forms of DM, named type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which result from different mechanisms and more importantly, require different therapeutic approaches. It is estimated that up to 40% of those diagnosed with T1DM after the age of 30 may have been misdiagnosed with T2DM2. This misdiagnosis of T1DM as T2DM will result in poor glycaemic control, frequent healthcare contact for increased treatment, inappropriate insulin regimes and risk of life-threatening ketoacidosis.
In this article, we’ll look at the similarities and differences between these two forms of DM and investigate the mechanisms by which these common diseases arise.
Insulin Pathway
The normal insulin signalling pathway, shown below, is responsible for the processing and transport of glucose in the body. Briefly, insulin binds to the insulin receptor and activates PI3K and, subsequently, serine-threonine kinase (AKT). AKT is responsible for the phosphorylation of glycogen synthase kinase 3-β (GSK-3β), inhibiting its activity and promoting the synthesis of glycogen leading to a reduction in blood glucose concentration. Failing to inhibit GSK-3β will result in hyperglycaemia and eventually T2DM.
Type 1 Diabetes Mellitus
T1DM is most commonly diagnosed at a young age. This form of DM is the result of an autoimmune reaction to proteins produced by the pancreas which results in a lack of insulin secretion. The antibodies responsible for this autoimmunity are detailed in the table below:
A key factor in T1DM pathogenesis is changes in the T cell-mediated immunoregulation, notably in the CD4+ T cell compartment. The activation of the CD4+ T cells is responsible for inflammation of the pancreatic cells which produce insulin, known as insulitis.
Changes in the expression of IL-1 and TNFα cause structural alterations in pancreatic β-cells which result in the suppression of insulin secretion. This insulin deficiency has subsequent effects on glucose metabolism and protein synthesis.
T1DM causes an increase in hepatic glucose levels when gluconeogenesis converts glycogen to glucose. A lack of insulin means the subsequent hepatic uptake of this glucose does not occur.
Insulin is also responsible for regulating the synthesis of many proteins. This regulation can be positive or negative but ultimately results in an increase in protein synthesis and a decrease in protein degradation. Therefore, when hypoinsulinemia occurs, decreasing insulin concentration in the blood, protein catabolism is increased leading to increased plasma amino acid concentration.
Type 2 Diabetes Mellitus
The pathogenesis of T2DM, detailed in the diagram below, is multi-factorial. It arises from a combination of genetic and environmental factors which affect insulin activity.
In T2DM, the regulatory mechanisms related to glucose metabolism fail resulting in impaired insulin activity or insulin resistance.
Mutations in genes involved in insulin production can cause the secretion of abnormal insulin molecules, known as insulinopathies. Insulinopathies are unable to effectively metabolise glucose which results in the accumulation of this sugar. Additionally, obesity is considered to be a causal factor in the development of T2DM.
Unlike those with T1DM, patients with T2DM can maintain circulating insulin levels. T2DM is characterised by glucose intolerance, impaired glucose tolerance, diabetes with minimal fasting hyperglycaemia, and DM in association with overt fasting hyperglycaemia.
Individuals with impaired glucose tolerance have hyperglycaemia despite preserving high levels of plasma insulin. These levels of insulin decline from impaired glucose tolerance to DM. It is insulin resistance is considered the primary cause of T2DM.
Misdiagnosis
The misdiagnosis of these types of DM is common, due to similar symptoms. The simplest differentiating factor is when these symptoms manifest. T1DM is an autoimmune disorder and therefore, symptoms generally occur much earlier in one’s life. T2DM is typically diagnosed in later life. The common symptoms of DM are:
- Frequent urination, particularly throughout the night.
- Polydipsia (excessive thirst)
- Polyphagia (excessive hunger)
- Lethargy
- Sudden weight loss
- Genital itching or thrush
- Blurred vision
The misdiagnosis of T2DM as T1DM results in unnecessary initial insulin therapy, higher drug and monitoring costs and often, an increase in the number and severity of symptoms. Conversely, the incorrect classification of T1DM as T2DM causes poor glycaemic control, frequent visits to healthcare services for treatment, inappropriate insulin regimes and risk of Diabetic Ketoacidosis.
Diabetic Ketoacidosis (DKA)
DKA is a potentially life-threatening condition caused by an accumulation of ketones in the body due to insulin deficiency, which is common in patients with T1DM, however, an increasing number of cases have been reported in patients with T2DM. Diagnosis of DKA consists of a high anion gap metabolic acidosis, ketone bodies present in serum and/or urine, and high blood glucose concentration. The symptoms of DKA include:
- Polyuria (excessive urination) and polydipsia (thirst)
- Weight loss
- Fatigue
- Dyspnoea (shortness of breath)
- Vomiting
- Fever
- Abdominal pain
- Polyphagia (excess hunger)
- Fruity-smelling breath caused by acetone accumulation.
Randox Type 1 Diabetes Mellitus Genetic Risk Array
T1DM is largely genetic and is associated with over 50 distinct genetic signatures, many of which are single nucleotide polymorphisms (SNPs). This is of great advantage in testing as unlike traditional biomarkers, genetic markers don’t change throughout one’s life, providing a robust method for diagnosis and risk stratification. Genetic data gathered can then be used to develop a genetic risk score, allowing an individual’s probability of developing the disease to be quantified.
Using this principle, together with our patented Biochip array technology, Randox have developed a T1DM GRS array. Using a combination of 10 SNPs from the HLA region and the non-HLA region commonly detected in T1DM patients, and a selection of other risk factors and biomarkers, this molecular array can accurately discriminate between T1DM and T2DM.
Conclusions
Misdiagnosis of DM can have life-threatening consequences. Both types of DM are very common and distinguishing between T1DM and T2DM is crucial.
T1DM is an autoimmune disorder with a lack of insulin secretion, while T2DM is primarily due to insulin resistance. Understanding their mechanisms is vital for accurate diagnosis and treatment. Genetic testing, like the Randox Type 1 Diabetes Mellitus Genetic Risk Array, can differentiate between T1DM and T2DM by analysing genetic markers and providing personalized treatment insights.
Accurate diabetes diagnosis is crucial for proper management, prevention of complications, and improving the lives of millions. Together, we can make a difference in the lives of those affected by diabetes!
If you’d like to learn more about the different types of DM, including the pathogenesis, pathophysiology, associated risk factors, and more, please take a look at our educational guide Diabetes Solutions.
Alternatively, feel free to reach out to our marketing team at marketing@randox.com who will be happy to help you with any queries you may have.
References
- World Health Organization. Diabetes. World Health Organisation. Published April 5, 2023. Accessed April 25, 2023. https://www.who.int/news-room/fact-sheets/detail/diabetes
- The Misdiagnosis of type 1 and type 2 diabetes in adults. The Lancet Regional Health. 2023;29:100661-100661. doi:https://doi.org/10.1016/j.lanepe.2023.100661
