Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations
Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations
We are thrilled to present two educational guides that delve into the newly updated minimum performance specifications for Proficiency Testing by CLIA (Clinical Laboratory Improvement Amendments). These regulations, set to be implemented by 2024, aim to enhance the accuracy and reliability of test results in clinical laboratories. Here, we introduce these invaluable resources designed to assist laboratories in navigating the evolving landscape of proficiency testing.
1. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology):
Our first guide focuses on the specific regulations and requirements pertaining to microbiology proficiency testing. With a comprehensive exploration of these guidelines, this guide is a useful resource for microbiology labs striving to ensure precision and integrity in their testing procedures. From the required categories of testing to maintaining optimal testing conditions, the guide details the updates that promote adherence to the highest standards of quality and safety.
2. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):
For non-microbiology laboratories, our second guide delves into the updated proficiency testing regulations concerning various analytes. From chemistry to haematology, molecular diagnostics to immunology, this guide offers a comprehensive overview of the new requirements and minimum performance specifications. By embracing these regulations, medical laboratories can uphold the utmost accuracy and reliability in their test results, ensuring optimal patient care and clinical decision-making.
Elevating Laboratory Practices:
These educational guides are indispensable tools that empower laboratories to navigate the changing landscape of proficiency testing regulations. By staying informed and adopting the updated minimum performance specifications, laboratories can maintain compliance, demonstrate excellence, and ultimately deliver the highest quality of care to their patients.
Accessing the Guides:
We invite you to access these comprehensive educational guides by following the link provided below. They offer a wealth of knowledge and practical insights, serving as essential references for laboratory professionals, quality managers, and anyone involved in clinical diagnostics.
With the implementation of updated CLIA proficiency testing regulations on the horizon, these educational guides come at a crucial time. By embracing the knowledge and guidance they provide, laboratories can navigate the changing landscape with confidence and ensure their adherence to the highest standards of proficiency testing. Together, let’s strive for excellence, precision, and patient-centric care in clinical laboratory practices.
#CLIARegulations #ProficiencyTesting #ClinicalLaboratories #QualityAssurance #PatientCare
Microbiology
Non-Microbiology
Internal Quality Control and ISO 15189
As a major contributor to the IVD industry, like many of you, the trials and tribulations of quality control are an everyday consideration. It is for this reason we strive to make the process of IQC as straightforward as possible. We recognise how busy life in the laboratory can get and believe it is our duty to simplify your QC process as much as possible.
The Acusera range has been designed with this in mind. Our true third-party control range boasts unrivalled levels of consolidation, supplied at clinically relevant concentrations in a suitable, commutable matrix. When used in combination with Acusera 24.7, our interlaboratory management software, the Acusera range will help to reduce analytical errors and maximise precision in your laboratory.
With the recent updates to ISO 15189:2022, we understand that there will be added pressure on many laboratories who are trying to maintain their accreditation. To assist you with your gap analysis and transition to these updated standards, we have produced this accreditation guide, detailing all of the key points relating to this new version of the highly sought after accreditation.
If you’d like to find out more about what we can do to help your laboratory or view our range of Internal Quality Controls, don’t hesitate to contact us at marketing@randox.com or feel free to browse the range on our website https://www.randox.com/laboratory-quality-control-acusera/.
D-3-Hydroxybutyrate & Diabetic Ketoacidosis
Diabetic Ketoacidosis is characterised by an accumulation of ketone bodies in response to insulin deficiency, most commonly occurring in T1DM patients, but is becoming increasingly prevalent among sufferers of T2DM.
Diabetic ketoacidosis is associated with symptoms such as polyuria, polydipsia, fever, vomiting, abdominal pain and fatigue with the most severe cases resulting in disastrous consequences such as cerebral oedema and death.
D-3-Hydroxybutyrate is considered to be the predominant ketone bodies associated with diabetic ketoacidosis and novel methods of detection utilise this biomarker to provide robust and accurate quantification of ketone bodies and aid in confident diagnosis of diabetic ketoacidosis.
This guide discusses the physiological and pathological processes associated with diabetic ketoacidosis and the relevant biomarkers, the complications associated with this condition and classic and novel detection methods.
To download this guide, simply click the image at the top of this post!
For more information on this assay visit https://www.randox.com/d-3-hydroxybutyrate-ranbut/
To read about some of our other superior performance reagents visit https://www.randox.com/superior-performance-and-unique-
Or, to view our wide range of diagnostic solutions visit https://www.randox.com/
Determining bilirubin concentration in paediatric facilities – Vanadate Oxidation Method
The quantification of bilirubin has a wide range of diagnostic utility. In paediatric settings, bilirubin concentrations are commonly used to identify cases of bilirubin encephalopathy or kernicterus.
Historically, bilirubin quantification has been achieved through various techniques derived from the diazo method, first described by Van der Bergh and Muller in 1918. New technologies and novel methods, like the Vanadate Oxidation method, have emerged and have been shown to display superior diagnostic power, driven by its lower sensitivity to interference caused by haemolysis and lipemia when compared with other methods.
This week, we present our educational guide, ‘Determining bilirubin concentrations in paediatric facilities’ which details the key points relating to bilirubin quantification, along with descriptions and comparisons of the methods mentioned above.
To download this guide, simply click the image at the top of this post!
For more information on our Vanadate Oxidation Bilirubin assay visit: www.randox.com/bilirubin
To view our wide range of diagnostic solutions visit: www.randox.com/
Or, if you’d like to discuss this assay, or any of our other products, please contact us at: marketing@randox.com
The Importance of Maintaining Regular Dietary Patterns to reduce CVD risk
Cardiovascular disease (CVD) is the leading cause of mortality worldwide. An estimated 17.9 million people died from some form of CVD in 2019, accounting for 32% of all-cause mortality that year1. Associations between diet and risk of cardiovascular complications have long been established, largely relating to alterations in lipid profiles.
For as long as anyone can remember, breakfast has been considered the most important meal of the day. Previous studies2 have shown an association between skipping breakfast and increased CVD risk prompting recommendations that up to 30% of one’s daily energy intake should be consumed during the first meal of the day. It has been reported that over 25% of adults skip breakfast. These individuals are often socioeconomically disadvantaged, shift workers, individuals who work particularly long hours, those who suffer from depression or those with poor health literacy2. Another study3 showed that skipping breakfast, when compared with consuming a high-energy breakfast, was associated with a 1.6x and 2.6x higher probability of non-coronary and general atherosclerosis respectively, when all other CVD risk factor had been controlled. This suggests a close relationship between eating breakfast and reducing CVD risk, however, the mechanisms and magnitude of this relationship are poorly understood.
Small, dense low-density lipoprotein cholesterol (sdLDL-C) is a smaller form of LDL-C which boasts greater propensity for uptake by arterial tissue, increased proteoglycan binding, and increased susceptibility for oxidation4. sdLDL-C concentration is strongly associated with CVD risk, yet once again, the mechanisms of this association remain enigmatic. It is thought that all of the metabolic changes associated with alterations in sdLDL-C concentration collectively contribute to the increased risk of CVD, with the main drivers being its propensity for uptake by arterial tissues and its long circulatory stability4
Skipping breakfast and sdLDL-C
A recent study investigated the relationship between skipping breakfast and the effects on lipid parameters5. In a cohort of around 28’000 people from the Japanese population, this study looked at the several markers, including sdLDL-C, to develop an understanding of the importance of regular dietary patterns for reducing the risk of CVD.
The study participants were divided into two main categories: breakfast eaters and breakfast skippers. These categories were further subdivided to differentiate men and women, over and under 55 years old, and those who eat staple products (rice, pasta, bread, etc.) and those who did not. The participants contributed blood samples which were tested for several cardiovascular biomarkers: Creatinine, Liver ALT, Total Cholesterol, Triglycerides, direct LDL-C, HDL-C and sdLDL-C.
They found that around 26% of men and 16.9% of women skipped breakfast regularly. Of these, most were considered young and had significant increases in concentration of triglycerides, LDL-C and sdLDL-C compared with those who ate breakfast almost every day.
Table 1. Median concentration of triglycerides, LDL-C, and sdLDL-C for breakfast skippers and eaters5
| Analyte | Breakfast Skippers (mg/dL) | Breakfast Eaters (mg/dL) |
| Triglycerides | 103 | 93 |
| LDL-C | 124 | 122 |
| sdLDL-C | 34.7 | 32 |
This investigation also revealed that in this cohort, 20% of men and 27.3% of women did not regularly consume staple foods as part of their diet and had higher median sdLDL-C concentration.
Table 2. Median concentration of sdLDL-C in men and women who eat or skip staple food products in their diet5
| Gender | Staple Skippers (mg/dL) | Staple Eaters (mg/dL) |
| Men | 34.1 | 31.6 |
| Women | 25.8 | 24.7 |
The data from this study supports the finding that individuals who skipped breakfast had higher sdLDL-C concentrations than those who ate breakfast consistently. Skipping breakfast can therefore be associated with troublesome lipid parameters in both genders and all age groups in the Japanese population. This study suggests that eating breakfast every day is crucial to maintain beneficial lipid parameters and reduce the risk of developing CVD.
The data also show that individuals who skipped staple foods in their meals presented with higher concentrations of sdLDL-C and a higher sdLDL-C/LDL-C ratio, in men and postmenopausal women, when compared with those who included staple foods in their meals. It is becoming increasingly common to remove staple foods from one’s diet due to their high carbohydrate content and the prevalence of low-carbohydrate diets. This data exhibits the importance of maintaining a nutritionally balanced diet to help reduce the risk of developing CVD.
As the first large scale study of its kind, this analysis provides clear insight into the increased risk of CVD associated with not only skipping breakfast, but failing to maintain a nutritionally balanced diet. The major limitation of this analysis is that it only includes individuals from the Japanese population and the same affects may not be seen in populations from other ethnicities. Therefore, further in-depth analysis is required to confirm these findings in other ethnicities
Randox sdLDL-C Assay
The Randox sdLDL-C assay employs the clearance method which displays good correlation with the gold standard in sdLDL-C quantification, giving laboratories increased confidence in their results first time, every time. Supplied as liquid ready-to-use reagents, this this test can be applied to a wide range of clinical chemistry analysers, producing results in as little as 10 minutes. Relevant controls and calibrators are also available from Randox as part of the Acusera range.
Randox sdLDL-C Assay Key Features
- Direct, automated test for convenience and efficiency.
- Rapid analysis results can be produced in as little as ten minutes, facilitating faster patient diagnosis and treatment plan implementation.
- Liquid ready-to-use reagents for convenience and ease of use.
- Applications available detailing instrument specific settings for a wide range of clinical chemistry analysers.
- sdLDL-C controls and calibrator available.
References
- World Health Organization. Cardiovascular Diseases. World Health Organization. Published June 11, 2021. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
- Ofori-Asenso R, Owen AJ, Liew D. Skipping Breakfast and the Risk of Cardiovascular Disease and Death: A Systematic Review of Prospective Cohort Studies in Primary Prevention Settings. Journal of Cardiovascular Development and Disease. 2019;6(3):30. doi:https://doi.org/10.3390/jcdd6030030
- Uzhova I, Fuster V, Fernández-Ortiz A, et al. The Importance of Breakfast in Atherosclerosis Disease. Journal of the American College of Cardiology. 2017;70(15):1833-1842. doi:https://doi.org/10.1016/j.jacc.2017.08.027
- Rizvi AA, Stoian AP, Janez A, Rizzo M. Lipoproteins and cardiovascular disease: An update on the clinical significance of atherogenic small, dense LDL and new therapeutical options. Biomedicines. 2021;9:1579. doi:https://doi.org/10.3390/biomedicines9111579
- Arimoto M, Yamamoto Y, Imaoka W, et al. Small dense low-density lipoprotein cholesterol levels in breakfast skippers and staple food skippers. Journal of Atherosclerosis and Thrombosis. 2023;30. doi:https://doi.org/10.5551/jat.64024
For more information on our sdLDL-C assay or any of our other products, please contact us at: marketing@randox.com