Diagnosing diabetes with the RX series
Diabetes is a lifelong condition that causes a person’s blood sugar level to become too high.
If you have diabetes, your body is unable to break down glucose into energy. This is because there’s either not enough insulin to move the glucose, or the insulin produced doesn’t work properly  which can lead to serious health complications.
The RX series range of analysers have one of the largest test menus available on the market which includes an extensive diabetes testing panel. Tests within the RX series diabetes panel allow for Diagnosis, Monitoring and Risk Assessment of Diabetes.
An adiponectin test system is a device intended for the quantitative in vitro determination of adiponectin concentration in human serum or plasma.
Adiponectin is a protein hormone, produced and secreted by fat cells (adipocytes), which is normally found in reasonably high concentrations within the blood. Adiponectin regulates the metabolism of lipids and glucose and influences the body’s response to insulin and inflammation.
Adiponectin levels are inversely correlated with abdominal visceral fat (AVF) levels, which have proven to be a strong predictor of several pathologies including metabolic syndrome, type 2 diabetes mellitus (T2DM), cancers and cardiovascular disease (CVD). It is widely recognised that people who are overweight are at a higher risk of developing T2DM, however measure waist circumference and Body Mass Index (BMI) are not enough. As such adiponectin levels are a much more reliable indicator of at-risk patients.
A number of key publications have advocated the testing of adiponectin in clinical settings and concluded that higher adiponectin levels are associated with a lower risk of T2DM across diverse populations.
A fructosamine test system is a device intended for the quantitative in vitro determination of glycated protein (fructosamine) concentration in human serum or plasma.
Fructosamine is a mid-term indicator of diabetic control as it can provide information on a person’s averge blood glucose levels over the preceding 14-21 days.
Due to the shorter time span of fructosamine, it is often used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes.
A Haemoglobin A1c test system is a device intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
In a diabetic patient, where blood glucose levels are abnormally elevated, the level of HbA1c also increases proportionally to the level of glucose in the blood and has been widely accepted as an indicator of the mean daily blood glucose concentration over the preceding 6-8 weeks. It is therefore, a long term indicator of diabetic control.
Read our poster on Randox’s development of a new latex enhanced immunoturbidimetric assay for the rapid direct measurement of glycated haemoglobin (HbA1c) applicable to RX series analysers by clicking here.
Diagnosing diabetes with the RX series
The RX series range of clinical chemistry analysers have many benefits when testing patients for diabetes. With analysers ranging from the RX misano semi-automated analyser to the RX modena which can perform up to 1200 tests per hour the RX series analysers offer a suitable platform for your laboratory, ensuring results are received in a time efficient manner. Windows based software and easily recognisable icons ensure that the RX series analysers are easy to use and allows for an enhanced laboratory productivity. Laboratory cost savings can also be achieved with a low water consumption available on each RX series analyser.
Other RX series analyser features include:
Diabetes Test Menu:
Consolidate your testing with a comprehensive diabetes testing panel available on the RX series analysers. A large number of tests can be carried out on one platform, including direct HbA1c testing, providing consolidation opportunities and real cost savings.
High quality results are achieved first time, every time. This saves operator time and avoids unnecessary additional costs of repeat testing and reduces the possibility of patient misdiagnosis.
Built in inventory management system automatically calculates remaining reagent volume and the number of tests available. Superior performance means minimal downtime and swift reporting of results.
In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.
Read on as we take a summarised look at our favourite bits.
Setting control Limits
Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.
Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.
The types of Controls used by labs
More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.
Frequency of QC
The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.
The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.
The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.
“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard
QC Frequency Influences
Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.
Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.
Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.
A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.
More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.
Managing QC Costs
Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.
Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.
How Randox Can Help
Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits – this is where Randox comes in.
Acusera Third Party Controls offer the highest quality solution for any lab – regardless of size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189 recommendations. Unrivaled consolidation allows for significant cost savings.
Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.
Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results