Measurement Uncertainty Vs Total Error

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Measurement Uncertainty Vs Total Error

In a recent article, Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred, James Westgard comments on the latest developments in the debate on the use of analytical total error (TE) and measurement uncertainty (MU), a debate which has been regularly revisited for the last twenty years. This blog aims to briefly explore the benefits of MU and TE and attempt to draw a conclusion on which is most beneficial in the clinical laboratory.

Where do errors and uncertainty come from?

Many things can undermine a measurement. Measurements are never made under perfect conditions and in a laboratory, errors and uncertainties can come from (Good Practice Guide No. 11, 2012):

  • The measuring instrument – instruments can suffer from errors including bias, changes due to ageing, wear, poor readability, and noise.
  • The item being measured – the sample may be unstable.
  • The measurement process – the analyte may be difficult to measure
  • ‘Imported’ uncertainties – calibration of the instrument.
  • User error – skill and judgement of the operator can affect the accuracy of a measurement.
  • Sampling issues – the measurements you make must be properly representative of the process you are trying to assess. I.e. not using fully commutable controls will mean your quality control process is not reflective of a true patient sample.

Random and systematic errors

The effects that give rise to uncertainty in a measurement can be either random or systematic, below are some examples of these in a laboratory.

  • Random – bubbles in reagent, temperature fluctuation, poor operator technique.
  • Systematic – sample handling, reagent change, instrument calibration (bias), inappropriate method.
Total Error (TE)

Total Error (TE) or Total Analytical Error (TAE) represents the overall error in a test result that is attributed to imprecision (%CV) and inaccuracy (%Bias), it is the combination of both random and systematic errors. The concept of error assumes that the difference between the measured result and the ‘true value’, or reference quantity value, can be calculated (Oosterhuis et al., 2017).

TE is calculated using the below formula:

TE = %BIAS + (1.96 * %CV)

Measurement Uncertainty (MU)

Measurement Uncertainty is the margin of uncertainty, or doubt, that exists about the result of any measurement.

There is always margin of doubt associated with any measurement as well as the confidence in that doubt, which states how sure we are that the ‘true value’ is within that margin. Both the significance, or interval, and the confidence level are needed to quantify an uncertainty.

For example, a piece of string may measure 20 cm plus or minus 1 cm with a 95% confidence level, so we are 95% sure that the piece of string is between 19 cm and 21 cm in length (Good Practice Guide No. 11, 2012).

Standards such as ISO 15189 require that laboratories must determine uncertainty for each test. Measurement Uncertainty is specifically mentioned in section 5.5.8.3:

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.”

Uncertainty is calculated using the below formula:


u = √A2+B2          

                                           U = 2 x u               

Where:
A = SD of the Intra-assay precision
B = SD of the Inter-assay precision
u = Standard Uncertainty
U = Uncertainty of Measurement

Error methods, compared with uncertainty methods, offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine (Oosterhuis et al., 2018).

Conclusion

It is important not to confuse the terms ‘error’ and ‘uncertainty’.

  • Error is the difference between the measured value and the ‘true value’.
  • Uncertainty is a quantification of the doubt about the measurement result.

Whenever possible we try to correct for any known errors: for example, by applying corrections from calibration certificates. But any error whose value we do not know is a source of uncertainty (Good Practice Guide No. 11, 2012).

While Total Error methods are firmly rooted in laboratory medicine, a transition to the Measurement Uncertainty methods has taken place in other fields of metrology. TE methods are commonly intertwined with quality assurance, analytical performance specifications and Six Sigma methods. However, Total Error and Measurement Uncertainty are different but very closely related and can be complementary when evaluating measurement data.

How Randox can help

Whether you prefer Measurement Uncertainty, Total Error, or believe that they should be used together, Randox can help. Our interlaboratory QC data management software, Acusera 24•7, automatically calculates both Total Error and Measurement Uncertainty. This makes it easier for you to meet the requirements of ISO:15189 and other regulatory bodies.

This is an example of the type of report generated by the 247 software. MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets.

Fig. A

Measurement Uncertainty

Fig. B

Total Error vs Measurement Uncertainty

Fig. A and Fig. B above are examples of report generated by the 24•7 software. Fig.A shows how MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets. Fig. B shows TE displayed for each test.

Measurement Uncertainty vs Total Error
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References

Good Practice Guide No. 11. (2012). Retrieved from http://publications.npl.co.uk/npl_web/pdf/mgpg11.pdf

Hill, E. (2017). Improving Laboratory Performance Through Quality Control.

Oosterhuis, W., Bayat, H., Armbruster, D., Coskun, A., Freeman, K., & Kallner, A. et al. (2017). The use of error and uncertainty methods in the medical laboratory. Clinical Chemistry and Laboratory Medicine (CCLM)56(2). http://dx.doi.org/10.1515/cclm-2017-0341

Westgard, J. (2018). Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred. Clinical Chemistry64(4), 636-638. http://dx.doi.org/10.1373/clinchem.2017.284406


The Importance of Meeting ISO 15189 Requirements

Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.

Some key benefits include:

  • Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
  • Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
  • Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.

To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).

Impact on healthcare

In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).

ISO 15189

ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.

Meeting ISO Requirements

Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.

The Importance of Meeting ISO 15189 Requirements

At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.

Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.

Fig. A

ISO 15189 requirements - non-conformances

Fig. B

ISO 15189 requirements - non-conformances
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References

CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf

Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014

Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf

Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856


Benefits of High-Sensitivity Troponin I (hs-TnI)

Benefits of High-Sensitivity Troponin I (hs-TnI)

Chest pain is a common symptom; 20% to 40% of the population will experience chest pain during their lifetime. There are many causes of chest pain, some of which are benign, while others are potentially life threatening. Importantly, in patients with chest pain caused by an acute coronary syndrome (ACS) or angina, there are effective treatments to improve symptoms and prolong life, emphasising the importance of early diagnosis in patients where chest pain may be of cardiac origin (Skinner et al, 2010). Chest pain is one of the most common reasons for emergency admission to hospital and is a heavy burden on health-care resources. A strategy to identify low-risk patients suitable for immediate discharge would have major benefits (Shah et al., 2015).

Case Study - Royal Wolverhampton NHS Trust

In 2012, all patients attending Royal Wolverhampton NHS Trust (RWT) with potential cardiac chest pain were admitted to the acute medical unit where a blood sample was collected, 12 hours post pain onset, for cardiac troponin T testing to aid in the exclusion or confirmation of acute myocardial infarction. A review of the trust’s chest pain pathway, by a consultant acute care physician, was conducted following a need to increase patient discharge rates and reduce hospital admissions.

The introduction of high-sensitivity troponin I (hs-TnI) allowed clinical practitioners in the UK to implement a novel and radically different chest pain pathway. The new pathway uses an admission hs-TnI of <1.9ng/L to discharge patients with suspected acute coronary syndrome (ACS).

The percentage of chest pain patients admitted to the hospital declined from 60.9% to 38.4% and the mean length of stay reduced from 23 hours 2 minutes to 9 hours 36 minutes. (Ford, 2017)

What it means

The adoption of high-sensitivity Troponin I (hsTnI) has allowed RWT to relieve pressure on their emergency department by discharging patients with a hs-TnI level below 1.9ng/L, the limit of detection for the assay.

Randox Liquid Cardiac Control

Accurate test results are vitally important in diagnosis of chest pain and effective quality control is crucial to achieving this.  The Randox Liquid Cardiac Control Level 1 features ultra-low levels of Troponin I, enabling it to challenge the sensitivity of analysers, ensuring confidence in vital clinical decisions.

Features & Benefits

Liquid ready-to-use – enables ultimate ease-of-use, saving time and money. Suitable for both clinical laboratories and point-of-care testing (POCT), where important clinical decisions are made.

100% human serum – ensures complete commutability whereby the control mimics a real human sample, reducing annoying shifts with a change in reagent batch.

Consolidation – comprising an impressive 8 cardiac markers, featuring ultra-low levels of Troponin I meaning a separate high-sensitivity control is not required.

Open vial stability of 20 days at 2°C – 8°C for all analytes – enables less wastage, saving money.

Related Products

RIQAS Liquid Cardiac Programme

Interlaboratory data Management

Benefits of High-Sensitivity Troponin I (hs-TnI)
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References

Ford, C. (2017). Benefits of High Sensitivity Cardiac Troponin I at Admission. Clinical Laboratory Management Association, (July/August 2017), 22-24.

Shah, A., Anand, A., Sandoval, Y., Lee, K., Smith, S., & Adamson, P. et al. (2015). High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. The Lancet386(10012), 2481-2488. http://dx.doi.org/10.1016/s0140-6736(15)00391-8

Skinner, J., Smeeth, L., Kendall, J., Adams, P., & Timmis, A. (2010). NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart96(12), 974-978. http://dx.doi.org/10.1136/hrt.2009.190066


Meeting ISO 15189:2012 Requirements for Multiple Instruments

Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.

About ISO 15189:2012

ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.

Gaining Accreditation

ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.

A particular requirement of ISO 15189:2012 is:

“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”

How Randox can help labs with multiple instruments?

Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.

RIQAS

Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.

Multi-Instrument Reports

All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.

The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.

Acusera 24.7 Live Online

Our stress free QC analysis software is designed to assist in the management of daily QC activities.

Support for multiple instruments

Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.

Helping you get accredited

Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.

To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.

Meet ISO 15189 Requirements for Multiple Instruments

Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’

Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.

It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.

IQC and EQA in Laboratory Quality Management

IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.

EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.

Is there any disadvantage to using IQC and EQA material from the same provider?

The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.

For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.

However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.

Conclusion

ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).

No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.

Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.

How can we help?

To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.

References

Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.

Mythbusting QC Bias
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Westgard’s Great Global QC Survey 2017

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.

Respondent Map - Westgard QC Survey

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.

Managing QC

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.

Conclusion

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

To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.


Randox showcases future-proofing diagnostic technology at MEDICA 2017

Randox Laboratories, the world-leading medical diagnostics manufacturer, is showcasing advancements in laboratory technology at the 2017 MEDICA – World Conference for Medicine conference, being held November 13-16 in Dusseldorf, Germany.

Unveiling its state-of-the-art interactive exhibition stand, Randox will host a series of demonstrations of its innovative analysers including the Evidence Evolution and Rx modena, and a number of exciting advances in laboratory medicine, involving  increasing the test menu available to clinicians and improving the connectivity of laboratories across the world to improve overall quality.

“Through our advancements in laboratory innovation, we’re driving an industry-wide evolution” said Randox CEO, Dr Peter FitzGerald.

“Our products are leading the way in innovation and enabling laboratories to transform the way they operate. We will be hosting demonstrations of a wide range of our fully-automated analysers, which are packed with cutting-edge technology and intuitive software. The goal is to provide future-proof diagnostic technology that will create the most efficient and effective laboratories.”

Paving the way is Randox’s patented Biochip Array Technology (BAT). This multi-analyte testing platform is the product of a £250 million research and development project. The ceramic tile measuring 9×9 mm can currently run up to 49 assays simultaneously,100 assays in the near future.   This innovation allows the simultaneous quantitative or qualitative detection from a wide range of analytes from a single sample. It is suitable for use in a wide range of laboratories including clinical, research, hospital, veterinary and forensic and clinical toxicology.

To enhance the benefits of BAT, Randox introduced the Evidence Evolution to its stable of immunoassay analyser platforms. The Evidence Evolution is the world’s first fully automated random-access biochip testing platform, capable of delivering 2640 results in one hour, with the first delivered in just 37 minutes.

Joining the Evolution in Hall 3 stand A08 is the RX modena. This highly reliable, precise, fully automated clinical chemistry analyser can run 1200 tests per hour including ISE. When combined with its unrivalled RX series test menu, it offers a winning combination for all large, multi-disciplinary laboratories.

“We develop more new tests than any other diagnostics manufacturer, and one of the products that we’re showcasing at this year’s MEDICA is Adiponectin,” added Susan Hammond, Global Sales Manager at Randox.

“This novel biomarker is a powerful new weapon in the fight against some of the biggest health issues faced throughout the world including diabetes, cancers and cardiovascular disease. As it’s World Diabetes Day on Tuesday 14th November, it’s a great opportunity to draw attention to this array which labs can run as part of their routine testing panel.”

MEDICA attendees will also be among the first to experience the advancements delivered by the latest update for Randox’s Acusera 24.7. This online interlaboratory data management and peer reporting package is now smarter, faster and more powerful than ever before.

Acusera 24.7 is designed to help laboratories efficiently review QC data from all their lab instruments on one central platform, thereby allowing quick and easy identification of QC failures and emerging trends. Unique access to peer group data updated instantly in real-time from our global network of laboratory participants will speed up troubleshooting and help pinpoint the root cause of any QC failures by easily identifying if an issue is isolated or widespread.

 

The Randox team will be on hand throughout MEDICA 2017 at stand #3A08. To make an appointment in advance, contact them through the Randox MEDICA webpage.

Click here for more information on Randox, or to get in touch, phone the Randox PR Team on 028 9442 2413, or email randoxpr@randox.com 


Committed to meeting customers’ needs

At Randox Quality Control, we strive to meet and exceed customer expectations ensuring high quality products and superior customer service are at the top of our priority list.

How can Randox Quality Control help you?

High Quality QC

The Acusera range of true third party controls boasts an impressive range of benefits ultimately designed to help laboratories reduce costs and time while also ensuring an accurate and reliable test system.

The extended shelf life of our controls allows the same lot of control to be used for a period of up to 2 years keeping costly new lot validation studies to a minimum.  We may also be able to sequester lots on your behalf.

The availability of commutable controls designed to react to the test system in the same manner as a patient sample and controls targeted at clinical decision levels will not only help you to meet ISO 15189:2012 requirements but will effectively challenge instrument performance.

Click here to find out more about our QC range.

Customer support

The Randox global support network are on hand with expert advice to ensure timely, accurate and helpful resolution of any issues or queries you may have. The added benefit of quick delivery of product orders further highlights how we work with and for our customers to provide the best service available.

Customer Reviews

Don’t believe us? Read a few of the reviews we have received from laboratories around the world;

“I would like to thank the Randox team for the excellent service when helping to reserve and manage our IQC orders, lot numbers and stock.” – Chief Biomedical Scientist, London, 2017.

Request your free QC consultation by contacting us today! Get in touch and we can arrange for your laboratory to have a consultation with one of our Randox QC specialists. Alternatively, if you would like to leave us a review you can do so by emailing acusera@randox.com.


Centralised QC Data Management Platform

Busy laboratories are not uncommon, in fact, many laboratories are expanding and their workload is increasing as a result. In labs like this, time is limited therefore ease of use and accessibility are valuable traits when it comes to the technology used to monitor daily QC activities.

With this in mind, Randox Quality Control are pleased to announce the launch of a new centralised platform for the management of both daily QC activities and calibration verification.

Convenience is key and that is what we have aimed for with the launch of this new platform. With laboratory professionals at the front of our minds, the platform delivers access to QC data at the click of a button ensuring the review process is as simple as possible.

What is available on the new QC platform?

With the new QC platform users have access to both;

By encompassing these two programs onto one easy to use platform, laboratories can save precious time allowing them to focus on other important tasks with the reassurance that their data is easily accessible.

Further information on Acusera 24.7 Live Online and Acusera Verify can be seen below;

Keep your instrument in check with Acusera Verify

Designed with convenience in mind the Acusera Verify range of linearity sets will help you to easily meet CLIA requirements for calibration verification. The availability of instrument dedicated, liquid ready-to-use materials covering a wide range of cardiac markers, specific proteins and therapeutic drugs enables specific instrument requirements to be met, while challenging the complete reportable range. Complimentary data reduction software is provided with all linearity sets delivering access to:

  • Easy-to-interpret charts for at-a-glance performance assessment
  • Unique traffic light system indicating pass or fail
  • Automatically generated statistics
  • Peer group data updated live in real-time

Stress free QC analysis with Acusera 24.7

Acusera 24.7 Live Online is an interlaboratory data management package complementing our Acusera range of true third party controls. With the recent launch of version 2.0, the software is smarter, faster and more powerful than ever before.

Designed to help laboratories efficiently review QC data from all of their laboratory instruments, the software generates a wide range of charts and reports enabling quick & easy identification of QC failures and emerging trends.  Unique access to peer group data updated instantly in real-time facilitates comparative performance assessment and helps speed up the troubleshooting process, easily identifying if a problem is unique to your lab or a widespread issue.

Contact us today and register your interest in Acusera Verify & Acusera 24.7 Live Online.


A week dedicated to unsung heroes! – Medical Laboratory Professionals Week 2017

From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.

Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care.  They perform and interpret billions of laboratory tests every year.

Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory QC for the in vitro diagnostics market, we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.

Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.


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Clinical Laboratory Survey