Don’t Get Tricked This Halloween
Don’t Get Tricked This Halloween
Don’t Get Tricked This Halloween – Treat Your Lab to Randox True Third Party Controls Today!
Halloween – a celebration observed by many countries around the world on a yearly basis. Falling on October 31st this holiday is a chance for people to dress up, carve pumpkins, bob for apples, attend costume parties, trick-or-treat and tell scary stories.
It just so happens that we have a scary story for you – and what makes this story even scarier is that it’s a true story!
Our story starts off in a medical laboratory. This laboratory was running QC on their machine as they would do every day. Getting accurate results with no faults or problems arising from their machine, this laboratory was happy with how things were going – until one day when it all went wrong!
Having run their EQA/PT samples, the laboratory found themselves reviewing their report with shock –they noticed a large negative bias. To their horror the perceived ‘accuracy’ they had once achieved was now no longer the case. Right away the laboratory professional’s thoughts turned to the fact that approx. 70% of all clinical decisions are based on laboratory test results, meaning it is essential that the results provided are accurate and reliable in order to prevent potential misdiagnosis or inappropriate treatment. Had they sent incorrect patient results to the clinicians? Had a patient been misdiagnosed? Many thoughts fluttered around in their heads.
The laboratory repeated their QC and found that the results obtained were almost identical to the previous run. The laboratory knew there must be a problem with their QC or their instrument, so they began the troubleshooting process. Nothing. Nada. Zilch. “What was going on?” was the question on the lips of the laboratory professionals.
One of the laboratory professionals then stumbled across a case study that took place in the University of Verona and Academic Hospital of Parma, Italy. The study was related to a field recall of Intact PTH, the reagent was recalled after falsely elevated patient results were discovered. The alarming thing was that the same elevated performance was not identified by the instrument manufacturer’s control. The study reported that due to this issue there was potential for 40,000 inaccurate patient results from just 18 labs in the Lombardy region of Italy. The study also concluded that the issue could have been prevented if a third-party control, independent from calibrator materials had been used.
This PTH case study got the laboratory thinking that maybe they should source a true third party manufacturer… Having sampled a third party QC, the lab found their results now mirrored that of their EQA and patient samples and as such proceeded to make the switch from first party to third party.
The moral of this story is that first party controls can sometimes “trick” the lab into thinking their performance is acceptable. Quite often target values provided with first party quality controls are in the middle of the analytical range thus masking the issues at the low and high ends of the assay range. Laboratory professionals should “treat” their labs to the best QC material. ISO 15189 highlights that the “use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”. So this Halloween don’t randomly choose your QC supplier, treat your laboratory to the best, Randox QC.
All Randox controls are manufactured independently of any instrument or reagent, and designed for use with multiple instruments and methods ensuring, unbiased performance assessment.
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)
Does Your QC Cover Clinically Relevant Ranges?
Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. 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’.
Measuring the Complete Clinical Range
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 working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
| Analyte | Medical Decision Level | Diagnostic Status |
| Glucose (fasting) | <100 mg/dL | Non-Diabetic |
| 100–125 mg/dL | Pre-Diabetic | |
| >125 mg/dL | Diabetic |
Competitor QC
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Randox QC
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
| Analyte | Medical Decision Level | Randox Level 1 IA Control | Competitor Level 1 IA Control |
| TSH | 0.1 or 0.27 uU/mL | 0.15uU/mL | 0.37 uU/mL |
| Vitamin B12 | 190 pmol/L | 174 pmol/L | 327 pmol/L |
| Ferritin | 12 ng/mL | 11.1 ng/mL | 49.6 ng/mL |
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
Liquid Controls vs Lyophilised Controls
Results of our Liquid vs Lyophilised Poll
Having conducted a recent poll on our Social Media platforms (Facebook, LinkedIn & Twitter) asking our customers what format they preferred their quality control material in – liquid or lyophilised – we saw a large preference for liquid controls.
What does this poll result really tell us?
That most people prefer Liquid controls? Yes.
Lyophilised controls are not as popular amongst our social following? Yes.
However, it also tells us that even though most people chose a liquid format there was still almost a quarter of people who prefer to use lyophilised controls. Liquid and lyophilised controls both have their advantages and disadvantages, this blog is designed to help you decide which is the best fit for your lab.
Liquid Controls
Firstly, it is important to note that there are two distinct types of liquid control available on the market;Liquid ready-to-use and Liquid for ease-of-use, better known as Liquid Frozen. Both types of liquid controls reduce the potential for reconstitution errors and prevent contamination from poor quality water.
Liquid frozen controls must be thawed in a refrigerator before use, making them a little less convenient than the liquid ready-to-use alternative. They require no reconstitution so associated errors are removed. Due to the frozen nature of these controls, they are often shipped on dry ice to prevent thawing in transit, as such transportation costs can be significant.
Liquid ready-to-use controls are arguably the most favoured of the three formats and it is easy to understand why. The controls are simple to use, they require no preparation and there is no need to thaw before use.– With zero preparation required, these controls can be removed from the packaging and used right away! What’s more, they can be conveniently stored at 2-8oC minimising expensive shipping costs.
Another major benefit of using a liquid ready-to-use control is the fact that they are ideal for POCT (Point of Care Testing). The ability to use these controls on the spot is extremely beneficial to POC providers.
Lyophilised Controls
Lastly, the choice of 22% of respondents – lyophilised. This is freeze dried material which requires the laboratory professional to reconstitute the sample using sterilised water and mixing before use. Although this format is not as easy to use as either liquid control it does come with benefits. The enhanced stability of this control sees a shelf life of almost double the two years that is normal with a liquid control, however, the potential for reconstitution errors and the fact it is not as simple to use lead to the majority of people opting for a more convenient liquid control.
Randox Quality Control Range
With Randox QC there are a vast array of controls available in liquid ready-to-use and liquid frozen formats. Areas we have liquid frozen formats available in, include; Clinical Chemistry and Immunoassay.
Liquid ready-to-use controls can be found in the following; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c and Liquid Tumour Markers.
Lyophilised controls available with Randox QC can be found within; Chemistry, Immunoassay, Cardiac, Coagulation, HbA1c, Lipids and Therapeutic Drug Monitoring.
To register an interest in any of our controls simply contact us at acusera@Randox.com and let us know how we can help and support you or alternatively click here – where you will be redirected to our contact page.
Now featuring Sigma Metrics, Measurement Uncertainty & Total Error
We are delighted to announce the launch of Acusera 24.7 Live Online Version 1.6, now featuring automatic calculation of Measurement of Uncertainty, Total Error and Sigma Metrics.
Automatic Uncertainty of Measurement calculation; helping to meet ISO 15189:2012 requirements
The new Uncertainty of Measurement report automatically generates and displays the Measurement Uncertainty (UM) of all QC tests currently in use helping you to easily meet ISO 15189:2012 requirements.
To calculate UM, users must first enter the SEM of their intra assay precision (A) for each individual test and each level of control. This is based on a minimum of 20 replicates performed within the same run. Based on performance history, the Acusera 24.7 software will then automatically calculate the SD of the inter assay precision (B). The software then uses the following formula to automatically calculate the UM.
Since UM is calculated using SD and one SD is equal to 68% confidence on the Gaussian curve the software multiplies the UM by 1.96 to attain the Expanded UM and a confidence level of 95%.
The report can be filtered by date to display data from a specific date range and may also be exported to CSV or printed.
Improve QC strategy design with our new Statistical Metrics Report
The Statistical Metrics Report facilitates enhanced performance assessment by incorporating several new metrics including; Measurement Uncertainty, Total Error (TE) and Sigma.
%Bias provides an indication of your laboratories performance compared to the peer group mean, while TE gives an indication of the overall error within a test system taking into account both imprecision and inaccuracy (bias). The availability of a Sigma Metric for each test is useful for designing an appropriate QC strategy. For example methods with a high Sigma score generally require less stringent QC strategies than those with a low Sigma value.
Sigma is a measure of the number of Standard Deviations (SDs) that fit within the total allowable limits. It is generated automatically by the software using the following formula:
- TEa – Total Allowable Error
- %Bias – Deviation from the target
- %CV – Imprecision of the data
ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
ISO 22870:2006
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.
Microalbumin shifts when changing reagent batch
A laboratory running a competitors 3rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.
They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.
| Competitor Control – Microalbumin | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 19.9 | 81.0 |
| 2 | 29.7 | 90.5 |
| 3 | 50.4 | 122.4 |
As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.
The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.
Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.
| Randox Control – Microalbumin | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 33.5 | 158.8 |
| 2 | 34.9 | 164.9 |
| 3 | 34.8 | 168.0 |
The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.
This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.
Serving Up Accurate Test Results
Today, June 27th, sees the beginning of one of the four tennis majors – Wimbledon. Basking in the summer sun while lying on ‘Henman Hill’, this yearly tournament attracts spectators from all over the globe who want to watch the world’s best tennis players ply their skills on the revered centre court over the course of a two week period. But what exactly is the most important skill a tennis player can utilise? Well, many players have different strengths but the one skill that all of them must possess is the ability to serve – and accurately.
The ability to serve is vitally important as it allows the point to begin, serving accurately however allows the player to set the pace and ensure they are on the front foot. By making sure they serve more accurately, the player can be confident in their ability to win the point and the match.
Just like tennis, laboratories will aim to be accurate when ‘serving’ up their test results. Achieving accurate test results is what every lab strives for. With patient results on the line it is important for labs to use QC material that will assist them in obtaining the correct results, therefore keeping them clear of causing a ‘racquet’.
Randox Acusera is world renowned for delivering unbiased performance assessment. Our range of true third party controls are manufactured to the highest standard ensuring commutable samples that react to the test system in the same manner as a patient sample, ultimately allowing labs to be confident in the results they produce. Much like the serve in tennis that needs to fall within a target area, QC results should be as close as possible to the target and ideally should fall within +/- 2 SD from the mean. By falling within these limits a lab can be sure of accurate results and an acceptable performance.
Employ Acusera quality controls in your laboratory today and experience unrivaled confidence in your test results.
Get your slice of our control range here by contacting us at acusera@randox.com. We guarantee you will love us!
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)
