HbA1c
HbA1c
Reagent | HbA1c
Powered by BiozHbA1c (Indirect)
Key Benefits
Latex Enhanced Immunoturbidimetric method
The Randox assay utilises a latex enhanced immunoturbidimetric method for superior performance
Exceptional correlation to standard methods
A correlation coefficient of 0.98 was obtained with another commercially available method
Excellent precision
The HbA1c assay showed a precision of less than 5% CV
Other Features
- Latex enhanced immunoturbidimetric method
- Liquid ready-to-use reagents
- Stable to expiry when stored at 2-8°C
- Haemoglobin denaturant supplied with the kit
| Cat No | Size | ||||
|---|---|---|---|---|---|
| HA3830 | R1 3 x 14ml (L) R2 3 x 14ml R3 3 x 50ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| HA8321 | R1 4 x 7.8ml (L) R2 4 x 7.8ml R3 4 x 40ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option |
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
HbA1c (Direct)
- Latex enhanced immunoagglutination method
- Liquid ready-to-use reagents
- Stable to expiry when stored at +2 to +8°C
- For use with RX series of clinical chemistry analysers
| Cat Code | Size | ||||
|---|---|---|---|---|---|
| HA8123 | R1 2 x 16.2ml (L) R2 2 x 8.2ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| HA8379 | R1 4 x 12.7ml (L) R2 4 x 6ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| HA4068 | R1 4 x 20ml (L) R2 4 x 8.6ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option | |||||
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
What is HbA1c assay used for?
The concentration of HbA1c in the blood of diabetic patients increases with rising blood glucose levels and is representative of the mean blood glucose level over the preceding six to eight weeks. HbA1c can therefore be described as a long term indicator of diabetic control unlike blood glucose which is only a short term indicator of diabetic control.
It is recommended that HbA1c levels are monitored every three to four months. In patients who have recently changed their therapy or in those who have gestational diabetes it may be beneficial to measure HbA1c levels more frequently, at two to four week intervals.
Diabetes Panel
For more information or to view more reagents within the diabetes panel, please click here
Specific Proteins Panel
For more information or to view more reagents within the specific proteins panel, please click here
Diabetes: The Role of Fructosamine
Diabetes Week is an annual week to raise awareness of diabetes. This year, the aim is to increase the public’s understanding of diabetes 1. Diabetes mellitus (DM) is a global epidemic, increasing at an alarming rate and burdening healthcare systems 2. DM is a life-long condition characterised by the body’s inability to produce / respond to insulin resulting in the abnormal metabolism of carbohydrates and elevated blood glucose levels.
Whilst it is important to increase the public’s understanding of DM, it is imperative that clinicians and physicians are aware of the different in vitro diagnostic tests to diagnose and monitor DM. Not only is this vital, but is also important that clinicians and physicians also understand the different methodologies available when choosing the diagnostic test.
It has been highlighted in numerous clinical studies that diabetic complications may be reduced through the long-term monitoring and tight control of blood glucose levels. Both fasting plasma glucose (FPG) and glycated haemoglobin A1c (HbA1c) tests are universally accepted as reliable measurements of diabetic control. However, studies have emerged highlighting the role of fructosamine in diabetes monitoring. Whilst HbA1c provides an index of glycaemia over 2 to 3 months, fructosamine provides this index over the course of 2 to 3 weeks, enabling closer monitoring of diabetic control 1.
Drawbacks of Traditional Diabetes Tests
The FPG test measures the level of blood sugars which is used to diagnose and monitor diabetes based on insulin function. The main drawback of this test is that a hormone called glucagon, produced in the pancreas, is triggered during prolonged fasting, signalling the liver to release glucose into the bloodstream. In diabetic conditions, either the body is unable to generate enough insulin or cannot appropriately respond to insulin. Consequently, FPG levels remain high 4.
In the 1980’s, HbA1c was incorporated into clinical practice as HbA1c levels correlated well with glycaemic control over a 2 to 3-month period. The main drawback of this test is that any condition that reduces the survival rate of erythrocytes such as haemolytic anaemia will falsely lower the HbA1c test results, regardless of the assay method utilised 5.
Fructosamine Testing
In a diabetic patient where blood glucose levels are abnormally elevated, the concentration levels of fructosamine also increase as fructosamine is formed by a non-enzymatic Maillard reaction between glucose and amino acid residues of proteins. During this glycation process, an intermediate labile Schiff base is produced which is converted to a more stable ketoamine (fructosamine) via an Amadori rearrangement 2.
Fructosamine has been identified as an early indicator of diabetic control compared to other markers such as HbA1c. Red blood cells live for approximately 120 days, HbA1c represents the average blood glucose levels for the previous 2 to 3 months. Conversely fructosamine has a shorter lifespan, about 14 to 21 days, reflecting average blood glucose levels from the previous 2 to 3 weeks. Due to the shorter time span of fructosamine, it is also used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes. The test is also particularly useful in situations where HbA1c cannot be reliably measured e.g. haemolytic anaemia, thalassemia or with genetic haemoglobin variants 5.
Fructosamine Assay Methodology
The most commonly utilised method for fructosamine testing is the colorimetric method. Whilst widely available, automated and inexpensive, the main drawback is the lack of standardisation across the different fructosamine assays 4.
Randox, on the other hand, utilise an enzymatic method, offering improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike existing methods which can also be time consuming and difficult to automate.
The Randox fructosamine assay is also standardised to the highest level as the Randox fructosamine calibrator and control is assigned relative to human serum glycated with 14C-glucose, which directly reflects the nature of the patient sample.
With an excellent stability of 28 days on-board the analyser, the Randox fructosamine assay is developed in a liquid ready-to-use format for convenience and ease-of-use.
Randox offer fully automated applications detailing instrument-specific settings for the convenient use of the Randox fructosamine assay on a wide range of clinical chemistry analysers.
Want to know more?
Contact us or download our diabetes brochure
Related Products
Randox Reagents
Reagents Resource Hub
Diabetes Panel
References
[1] Diabetes UK. Diabetes Week. [Online] 2019. [Cited: May 31, 2019.] https://www.diabetes.org.uk/get_involved/diabetes-week.
[2] Gounden, Verena and Jialal, Ishwarlal. Fructosamine. [Online] January 23, 2019. [Cited: April 11, 2019.] https://www.ncbi.nlm.nih.gov/books/NBK470185/.
[3] World Health Organization (WHO). Diabetes. [Online] October 30, 2018. [Cited: May 2, 2019.] https://www.who.int/news-room/fact-sheets/detail/diabetes.
[4] Manzella, Debra. The Fasting Plasma Glucose Test. very well health. [Online] November 16, 2018. [Cited: April 11, 2019.] https://www.verywellhealth.com/understanding-the-fasting-plasma-glucose-test-1087680.
[5] BMJ. Using haemoglobin A1c to diagnose type 2 diabetes or to identify people at high risk of diabetes. [Online] 2014. [Cited: April 11, 2019.] https://www.bmj.com/content/348/bmj.g2867/rr/695927.
Overcoming the burden of Diabetes and Cardiovascular Disease
The Prevalence
Cardiovascular disease (CVD) is the number one cause of death globally with more people dying annually from CVD than any other disease state. In 2018, according to the American Heart Association, CVD accounted for nearly 836,546 deaths in the USA (1) with over 17 million known deaths recorded worldwide. It is also proclaimed that around 1.5 million people globally die each year because of diabetes and diabetes related complications. (2) Is there a common link? Can this issue be controlled?
Studies have suggested that diabetes is one of the leading related conditions associated with increased risk of CVD death. A recent study undertaken in 2018 examined the association of many risk factors associated with CVD, the study was broken down by disease state with over 17,000 participants involved. The findings highlighted that 17.9% of these patients suffered from diabetes mellitus and death from a cardiovascular event. (3) Many other pilot and research studies discovered similar findings considering further risk factors such as high blood pressure, abnormal cholesterol and high triglycerides, obesity, lack of exercise and lifestyle choices such as smoking, alcohol and drug abuse. All of which are common with patients who suffer from diabetes, placing them at an increased risk of CVD.
Findings highlighted that over 68% of people aged over 65 living with diabetes die from some form of heart disease with 16% of individuals dying from an ischemic stroke. (4) The ability to tackle the prevalence of increased death from CVD and diagnosis of diabetes has become a global burden with the international diabetes federation projecting that 592 million people worldwide will have diabetes by 2035. (5)
Worldwide, the increase of diabetes is becoming an economic burden on the patient and healthcare systems mainly due to the direct costs of medical care and the indirect costs of moderated productivity, tied to diabetes and CVD related morbidity and mortality. Many scholars have highlighted economic burden as a primary attribute to both macrovascular and microvascular complications such as coronary artery disease, myocardial infarction, hypertension, peripheral vascular disease, retinopathy, end-stage renal disease and neuropathy. (6)
Overcoming the Burden
As CVD is the most prevalent cause of mortality and morbidity in patients with diabetes, effective treatment and analysis is required to control and decrease the number of CVD deaths across the globe. Tackling this issue head on, the Randox RX series introduce Direct HbA1c which refers to glycated haemoglobin which is a product of haemoglobin (a protein which can be found in red blood cells) and glucose from the blood making it glycated.
Testing for HbA1c provides an indication of what an individual’s average blood sugar level has been over recent weeks/months and is generally considered as an indicator of how well the patient is managing and controlling their diabetes. This is significant for those who suffer from diabetes because the higher the levels of HbA1c, the higher the chance of an individual suffering from further diabetes related issues, therefore testing for HbA1c improves the predictions of a CVD event occurring.
The Randox RX series have Direct HbA1c testing capabilities on the RX Daytona +, RX imola and RX modena. Our latex enhanced immunoturbidimetric method which the RX series utilises makes the test simple and quick to perform. The removal of the pre-dilution step removes the risk of human error compromising your results without the need for a separate HbA1c analyser.
Offering the world’s largest test menu, the RX series has an extensive range of cardiac, diabetes and lipid tests with excellent correlation to gold standard methodologies designed to allow laboratories to expand their testing capabilities onto one single platform, providing cost savings through consolidation.
References:
- American Heart Association. (2018). Heart Disease and Stroke Statistics 2018 At-a-Glance.Available: https://www.heart.org/-/media/data-import/downloadables/heart-disease-and-stroke-statistics-2018—at-a-glance-ucm_498848.pdf. Last accessed 7th Feb 2019.
- World Heart Federation. (2017). Cardiovascular diseases (CVDs) – Global facts and figures.Available: https://www.world-heart-federation.org/resources/cardiovascular-diseases-cvds-global-facts-figures/. Last accessed 7th Feb 2019.
- Gomadam, P et al, (2018). Blood pressure indices and cardiovascular disease mortality in persons with or without diabetes mellitus. Journal of Hypertension. 36 (1), 1-5.
- Heart attack and stroke symptoms. (2018). Cardiovascular Disease and Diabetes.Available: https://www.heart.org/en/health-topics/diabetes/why-diabetes-matters/cardiovascular-disease–diabetes. Last accessed 7th Feb 2019.
- Aguiree F, Brown A, Cho NH, Dahlquist G, Dodd S, Dunning T, Hirst M, Hwang C, Magliano D, Patterson C. (2013) IDF Diabetes Atlas.
- Bahia LR, Araujo DV, Schaan BD, Dib SA, Negrato CA, Leão MP, Ramos AJ, Forti AC, Gomes MB, Foss MC, Monteiro RA, Sartorelli D, Franco LJ, Value Health. (2011), 137-40.
Why Choose the Randox RX series?
Why Choose the RX series?
Notorious for quality and reliability, the Randox RX series delivers on precision, reliability and accuracy, revolutionising patient testing in a variety of laboratory types including Clinical Laboratories, University & Research Institutes and Veterinary Laboratories.
The RX series is world renowned for delivering superior performance, our comprehensive test menu comprises over 113 clinical chemistry assays – 22 more than our nearest competitor. In addition to this we offer superior methodology for many assays with excellent correlation to gold standard methods. Our test menu is constanty expanding and currently covers routine chemistry, specific proteins, lipids, cardiac markers, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing including direct HbA1c testing capabilities. Designed to meet the needs of your laboratory, our range of novel tests allow laboratories to expand their test menu without expanding their lab ultimately reducing costs, labour and the risk of error without the need for additional / specialised equipment.
With a versatile range of semi-automated and automated analysers, the RX series offers flexibility to suit the needs of all laboratory requirements. Built on the foundations of robust hardware and intuitive software, the RX series will reduce costly test re-runs and potential misdiagnosis. With minimal analyser downtime significant cost and time savings are a reality.
Our prominent reputation of providing laboratories with unrivalled customer and technical support across the globe surpasses that of any of our competitors complementing our extensive and world leading test menu. We pride ourselves in both the delivery and functionality of high quality clinical chemistry analysers, dedicated reagents and support ensuring accuracy and reliability in reporting patient results.
Offering the World’s Largest Clinical Chemistry Test Menu
Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.
Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.
Choose from the RX misano, RX monaco, RX daytona+, RX imola and RX modena to start your journey with the RX series today.
The move from Nephelometry to Immunoturbidimetric Testing
Background
In clinical diagnostics, proteins are part of a wide range of biochemical markers used to identify health and disease in patient samples. Proteins play a key role in the human body, as they are involved in almost every process and can be associated to functions and regulatory pathways that are either signature for disease onset or a target for therapeutic intervention.
There are two main methods used to detect proteins in patient samples; nephelometry and immunoturbidimetry. Nephelometry although traditionally thought to be more sensitive can be expensive due to higher consumable costs. In addition to this nephelometers can be inefficient and are limited by their test menu. Immunoturbidimetric tests are an increasingly accepted alternative to nephelometry for specific protein assays, and studies have shown a close correlation between Randox immunoturbidimetric tests and nephelometry. This particularly lies with the latex enhanced immunoturbidimetry methodology utilised by Randox.
Why the RX series?
Renowned for quality and reliability, the RX series excels in clinical testing combining robust hardware, intuitive software and a world leading test menu featuring routine and novel high performing reagents.
Running specific protein tests on the RX series provides laboratories with a wide range of advantages. The move from nephelometric testing to immunoturbidimetric lowers laboratory costs as nephelometry requires the use of dedicated instruments which are much slower, have higher consumable costs and require highly trained personnel, with the disadvantage of not being able to perform any other type of assay on a single platform.
The RX series improves laboratory efficiencies not just saving costs but also time. Our range of routine clinical chemistry analysers provide users with flexibility and versatility through consolidation of testing onto one single platform.
High Performing and Unique Testing Menu
The RX series of specific protein assays assist in the diagnosis and evaluation of various conditions each with excellent sensitivity and limited inference levels. Randox manufacture immunoturbidimetric kits for the study of a wide range of specific proteins including unique products such as Apolipoprotein C-II, Apolipoprotein C-III, Apolipoprotein E, Cystatin C and Microalbumin.
Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your protein assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.
Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.
Could there be 5 types of diabetes?
A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?
What is diabetes?
Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin. Currently, diabetes is classified into two main forms, type 1 and type 2.
Type 1 diabetes is an autoimmune disease which manifests in childhood. In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas. As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.
Type 1 diabetes affects 10 percent of individuals with diabetes. 96 percent of children diagnosed with diabetes have type 1. Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14. The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).
Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced. As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.
Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden. The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014. It is expected to rise to 592 million by 2035. In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths. 43 percent of these deaths occurred before 70 years of age. Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well. In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).
In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.
The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study
This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.
This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications. The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.
Cluster One – Severe autoimmune diabetes (SAID)
SAID is similar to type 1 diabetes. SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA. 6% of individuals studied in the ANDIS study were identified with having SAID.
Cluster Two – Severe insulin-deficient diabetes (SIDD)
SIDD is similar to SAID, however, GADA is negative. This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present. Patients have a higher risk of diabetic retinopathy. 18% of subjects in the ANDIS study were identified with having SIDD.
Cluster Three – Severe insulin-resistant diabetes (SIRD)
SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI. Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease. 15% of subjects in the ANDIS study were identified as having SIRD.
Cluster Four – Mild obesity-related diabetes (MOD)
MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal. 22% of subjects in the ANDIS study were identified as having MOD.
Cluster Five – Mild age-related diabetes (MARD)
MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters. Patients with MARD have mild problems with glucose regulation, similar to MOD. 39% of subjects in the ANDIS study were identified with having MARD.
This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels. This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).
The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.
Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes. For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.
References
Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].
Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].
Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].
Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].
NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].
The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].
World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.
If you are a clinician, dietitian or laboratory who are interested in running diabetes assays, Randox offer a wide range of high-quality routine and niche assays including: fructosamine, glucose, HbA1c for diagnosing and monitoring diabetes, albumin, beta-2 microglobulin, creatinine, cystatin c, NEFA, microalbumin, and d-3-hydroxybutyrate to monitor associated complications, and adiponectin as a biomarker for diabetes risk assessment. These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/diabetes-reagents or email: reagents@randox.com
Diabetes ā World Diabetes Day (14th Nov 2017)
World Diabetes Day
With World Diabetes Day on Tuesday 14th November 2017, we take a look at what diabetes is and why quality control is so important.
What is 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.
Role of Quality Control
Quality control plays a crucial role in ensuring accurate and reliable diabetes monitoring. 70% of medical decisions are based on a laboratory test result and QC is vital in ensuring the results the laboratory report are both accurate and reliable.
Want to know what makes a good HbA1c control? Read on to find out.
Clinically Relevant Levels
In the diagnosis of diabetes, glycated haemoglobin (HbA1c) in blood provides an indication of average blood glucose levels in the previous three months. HbA1c is the recommended standard of care for type 2 diabetes monitoring. HbA1c is measured using the range below:
HbA1c – Clinically Relevant Levels
| HbA1c | mmol/mol | % |
|---|---|---|
| Normal | Below 42 mmol/mol | Below 6.0% |
| Prediabetes | 42 to 47 mmol/mol | 6.0% to 6.4% |
| Diabetes | 48 mmol/mol or over | 6.5% or over |
It is important to assess the full clinical range of an assay, i.e. the range between the lowest and highest results which can be reliably reported. 48 mmol/mol is the cut-off for diabetes diagnosis, it is crucial that this can be measured accurately because any inaccuracy could mean the difference between being diagnosed and treated and not.
In terms of accreditation, ISO 15189:2012 states, ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
Benefits of Third Party Controls
The importance of third party controls is evident. Third party controls can help identify instrument, reagent, and procedural errors. Unchecked these errors could lead to incorrect patient results, further leading to misdiagnosis.
Third party quality control material has not been designed or optimised for use with any instrument, kit, or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provide an unbiased, independent assessment of analytical performance across multiple platforms.
Again, in terms of accreditation, ISO 15189 states – “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”
Many laboratories perform HbA1c testing on a dedicated machine and as a result, are not always using a third party control.
Controlling Waste
Wastage is a common issue when running HbA1c due to the pre-treatment step required for many HbA1c controls and poor stability of some controls on the market. Look out for controls with an extended open vial stability to help reduce waste and keep costs low.
How can Randox help?
To help you get your QC in check for World Diabetes Day, Randox Acusera HbA1c control contains both HbA1c and Total Haemoglobin, with a reconstituted stability of 4 weeks to reduce waste and reduce costs. To find out more about our HbA1c control visit the page using the button below or fill out the form above.
References
Diabetes: The basics. (2017). Diabetes UK. Retrieved 3 November 2017, from https://www.diabetes.org.uk/diabetes-the-basics
Khan, H et al. (2016). Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights, 95. http://dx.doi.org/10.4137/bmi.s38440
Product Focus: Randox HbA1c
This month’s product spotlight is our new Liquid HbA1c Control. Over the next few weeks, we will be taking a look at some of the QC solutions available from Randox for HbA1c.
Haemoglobin is an oxygen-transporting protein found inside Red Blood Cells (RBC). Glycated Haemoglobin is simply a haemoglobin with a glucose molecule attached. The higher the level of glucose in the blood the more glycated haemoglobin is formed. Red Blood Cells live for around 2-3 months, because of this the HbA1c test is used by clinicians to get an overall picture of average blood sugar levels for the last 2-3 months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. It is suggested that an individual’s HbA1c target should be under 48mmol/mol or below 6.5%. By lowering your HbA1c, you help reduce the risk of long-term health problems.
HbA1c is used to monitor patients with diabetes providing an indication of how well the condition is controlled. A measurement of less than 6% of HbA1c in the sample indicates good glucose control and a lower risk of diabetic complications for the majority of diabetics.
Week 1: 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.
Main Features and Benefits:
Lyophilised for enhanced stability
100% human whole blood
Assayed target values provided for 2 parameters
Convenient bi-level pack containing two clinically significant levels of control
Stable to expiry date at 2°C – 8°C
Reconstituted stability of 4 weeks at 2°C – 8°C
Week 2: Liquid HbA1C Quality Control
The Randox Acusera Liquid HbA1C control is conveniently supplied in a liquid ready-to-use format and 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.
Main Features and Benefits:
Liquid ready-to-use
Human based whole blood
Convenient bi-level pack covering clinically relevant decision levels
Stable to expiry date at 2°C – 8°C
Open vial stability of 30 days at 2°C – 8°C
Week 3: RIQAS HbA1C Programme
RIQAS is the largest international External Quality Assessment Scheme, with more than 40,000 participants in over 124 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 32 flexible multi-parameter programmes. Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.
The RIQAS Glycated Haemoglobin (HbA1c) EQA programme is designed to monitor the performance of HbA1c and Total Haemoglobin assays.
Main Features and Benefits:
Accredited to ISO/IEC 17043 designed to meet ISO 15189 requirements
Lyophilised for enhanced stability
100% whole blood ensuring a matrix similar to the patient sample
Monthly reporting allowing identification of any system errors sooner
Submit results and view reports online via RIQAS.Net
Register up to five instruments at no extra cost
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.
Features & Benefits
- Liquid ready-to-use
- Human based whole blood
- Assayed target values
- Convenient bi-level pack covering clinically relevant decision levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C
Description Size Analytes Cat No
Liquid HbA1c Control 2 x 2 x 0.5 ml 1 HA10155
Liquid HbA1c Control Level 1 6 x 1 ml 1 HA10224
Liquid HbA1c Control Level 2 6 x 1 ml 1 HA10225
Analytes
HbA1c (Haemoglobin A1c)
Diabetes Control Calibrator
Fructosamine Calibrator
Dedicated Fructosamine calibrator specifically designed for use with the Randox Fructosamine assay.
Features & Benefits
- Lyophilised for enhanced stability
- Human based serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 4 weeks at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Fructosamine Calibrator | 3 x 1ml | 1 | FR2993 | |
Analytes
- Fructosamine
HbA1c Calibrator
A human based whole blood calibrator designed for use in the routine calibration of the HbA1c assay.
Features & Benefits
- Liquid ready-to-use
- 100% human whole blood
- Treated in the same manner as a patient sample
- Once opened stable to expiry date at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| HbA1c Calibrator Series | 5 x 2ml 1 x 8ml | 1 | HA3444 | |
Analytes
- HbA1c
HbA1c II Calibrator
A human whole blood calibrator designed for use in the routine calibration of the HbA1c II assay.
Features & Benefits
- Supplied in a lyophilised format
- 100% human whole blood
- Treated in the same manner as a patient sample
- Once opened the calibrator is stable for 14 days at +2°C to +8°C
- Traceable to NGSP
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| HbA1c II Calibrator Series | 5 x 0.5mL | 1 | HA8124 | |
Analytes
- HbA1c II