Product Focus: Randox HbA1c
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
Product Focus: Calibrators
Calibrators
The importance of accurate instrument calibration in the laboratory is often overlooked. At Randox Quality Control we believe that accurate calibration is the foundation for producing reliable patient results. In fact, we believe that this should be your first step in ensuring accurate instrument performance and something you should consider carefully.
Effective instrument calibration will provide you with a baseline for your analysers from which accurate results can be produced. This baseline is then used to adjust readings to match the computed value and ensure accurate patient results are reported.
Calibrator features you should consider;
As well as frequent recalibration, according to the instructions provided by the instrument / reagent manufacturer, Randox Quality Control recommends;
- Utilising a third party calibrator, such as those available from our Acusera range, which have independently assigned values and have not been optimized for use with any specific instrument or reagent system
- Ensuring the calibrator you employ has the same matrix as a patient sample
- Choosing a calibrator that is 100% commutable, ensuring it mimics the behaviour of a patient sample
- A multi-analyte calibrator with a long shelf life
Clinical Chemistry Calibration Serum
Third party calibrator covering 42 commonly used clinical chemistry tests. Method and instrument specific target values and ranges are provided for most chemistry analysers. Two clinically significant levels are available.
Features & Benefits
- Lyophilised for enhanced stability
- Human based serum
- Instrument specific target values provided for 42 parameters
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C
What is Measurement of Uncertainty?
Measurement Uncertainty (MU) relates to the margin of doubt that exists for the result of any measurement, as well as how significant the doubt is. For example, a piece of string may measure 20 cm plus or minus 1 cm, at the 95% confidence level. As a result, this could be written: 20 cm ±1 cm, with a confidence of 95%. Therefore, we are 95% sure that the piece of string is between 19 cm and 21 cm long.
Standards such as ISO 15189 require that the laboratory must determine uncertainty for each test. However, they have not specified how this should be done.
How do we calculate Measurement Uncertainty using QC data?
Employing your QC data to calculate uncertainty makes several assumptions; your test system is under control, the patient samples are treated in the same manner as your controls and gross outliers have been removed. If you choose to use your QC data to calculate this you should ensure that you use a commutable control with a matrix similar to that of a patient sample, with analytes present at clinically relevant levels
To calculate MU, labs must look at the intra-assay precision and inter-assay precision of their test.
Intra-assay precision: Sometimes known as ‘within run’ precision, is where 20 or more replicates of the same sample are run at the same time, under the same conditions (calculated from a single experiment). Intra-assay precision helps to assess systematic uncertainties
Inter-assay precision: Sometimes known as ‘between run’ precision, is where 20 or more replicates are run at different times – e.g. 1 replicate every day for 20 days (can be calculated from routine IQC data). Inter-assay precision can help identify random uncertainties within the test system.
*The Australian Association of Clinical Biochemists (AACB) recommends that at least 6 months’ worth of QC data are used when calculating the inter-assay precision1.
Once the data is collected, you must calculate the standard error of the mean (SEM) of the intra-assay precision (A) and the SD of the inter-assay precision (B) in order to measure the uncertainty (u). Once A and B have been calculated, they need to be squared, added together and the square root of the sum found:
As uncertainty is calculated as SD and 1SD is equal to 68% confidence on a standard Gaussian curve, we can conclude that if we multiply using a coverage factor of 2, we can attain 2SD confidence of 95%. This is known as the Expanded Uncertainty (U):
What is the Advantage of Measurement Uncertainty for a lab?
Labs need to carry out MU as it is a requirement of ISO 15189. It states: “The laboratory shall determine measurement uncertainty for each measurement procedure, in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty”.
MU also helps determine whether the difference between two results is negligible due to uncertainty or significant due to a genuine change in condition of the patient; giving labs a greater confidence in reported results.
How can Randox help?
Our new Acusera 24.7 Live Online software provides automatic calculation of MU, saving valuable time and helping labs meet ISO 15189 requirements with ease.
Contact marketing@randox.com to find out how your lab can benefit from Acusera 24.7 Live Online
Take steps to prevent incorrect patient results by making one simple change
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 5.6.2.2 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
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. In order to make sure a laboratory instrument is performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.
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)
Liquid CSF Quality Control
Providing a true third party solution for the measurement of Cerebrospinal Fluid (CSF), the Acusera Liquid CSF Control is designed to deliver an unbiased, independent assessment of analytical performance for 14 analytes, helping to ensure the results clinical laboratories release are accurate and reliable.
With an extended open vial stability of 30 days at 2oC – 8oC, the Acusera Liquid CSF Control will reduce waste, while remaining easy and convenient to use.
Features & Benefits
- Liquid ready-to-use samples requiring no preparation
- Human based material
- True third party control providing unbiased performance assessment
- Assayed target values available
- Shelf life of 2 years from the date of manufacture
- Open vial stability of 30 days for all analytes when stored at 2oC to 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Liquid CSF Control Level 1 | 10 x 3ml | 14 | CF10138 | |
| Liquid CSF Control Level 2 | 10 x 3ml | 14 | CF10139 | |
Analytes
- Albumin
- Albumin (electrophoresis)*
- Alpha – 1- globulin (electrophoresis)*
- Alpha – 2- globulin (electrophoresis)*
- Beta- globulin (electrophoresis)*
- Chloride
- Gamma – globulin (electrophoresis)*
- Glucose
- hsIgA*
- hsIgG
- hsIgM*
- Lactate
- Protein (Total)
- Sodium
*No claims are made regarding values and stability.
PTH Quality Control
Providing a true third party solution for the measurement of Intact PTH, the new Acusera PTH Control will deliver an unbiased,
independent assessment of analytical performance with any instrument or method.
This notoriously unstable marker, present in a number of immunoassay controls, is now available in a liquid frozen format with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use.
Features & Benefits
- Liquid Frozen
- 100% human serum
- Assayed target values available for many immunoassay platforms
- Stable to expiry date at -20°C to 70°C
- Open vial stability of 30 days at 2°C to 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| PTH Control Level 1 | 3 x 3 ml | 1 | PTH10110 | |
| PTH Control Level 2 | 3 x 3 ml | 1 | PTH10111 | |
| PTH Control Level 3 | 3 x 3 ml | 1 | PTH10112 | |
Analytes
- Intact PTH (Parathyroid Hormone)
Related Products
Evidence Immunoassay Control
Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Reconstituted stability of 7 days at 2oC – 8oC or 4 weeks at -20oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Evidence Immunoassay Control | 4 x 3 x 5ml | 14 | EV3570 | |
Analytes
- CEA
- Estradiol
- FSH
- Free T4
- Free T3
- Leutinising Hormone
- Prolactin
- Progesterone
- PSA (Total)
- PSA (Free)
- Testosterone
- Total T4
- Total T3
- TSH
Cardiac Array Quality Control
Multi-analyte cardiac control designed for use in the routine monitoring of accuracy and precision on clinical chemistry and immunoassay systems. This is the only control of its type to include the novel marker heart type fatty acid binding protein (H-FAP). Three levels of control are supplied spanning the complete clinical range.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry at 2oC – 8oC
- Reconstituted stability of 16 hours at 2oC – 8oC or 7 weeks at -80oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Cardiac Array Control | 3 x 3 x 1ml | 4 | EV3691 | |
Analytes
- Heart-type acid binding protein (H-FABP)
- Myoglobin (MYO)
- Troponin I (cTnI)
- Creatine-Kinase Muscle Brain (CK-MB)
Not for sale in the USA
Canine CRP Quality Control
A dedicated control designed for the use in the quality control of the Randox Canine CRP assay.
Features & Benefits
- Liquid ready-to-use
- Human CRP in a stabilised protein matrix
- Stable to expiry date at 2oC – 8oC
- Once open stable to expiry date at 2oC – 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Canine CRP Control Level 2 | 3 x 1ml | 1 | CP2803 | |
| Canine CRP Control Level 3 | 3 x 1ml | 1 | CP2804 | |
Analytes
- Canine CRP
