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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The Importance of ISO 15189

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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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Interlaboratory Data Management

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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


Randox Quality Control Celebrate British Science Week 2018!

This British Science Week 2018, Randox Quality Control are celebrating the hard work our team puts in every day, to help bring the best Quality Control products to the market. 

We caught up with Edward Hill, QC Product Specialist, to explain a bit about what his role involves and how Randox QC are impacting on global healthcare!

What is your position and what does it involve?

I am a QC Product Specialist at Randox Laboratories. This is a hugely varied role, and some of my general duties involve; creating educational material for laboratory professionals, conducting competitor comparisons to ensure we are always one step ahead of the competition, staying up-to-date with the latest industry trends and thinking of new and innovative ways to interact with our customer-base.

For those of us who aren’t in the industry, can you give us a brief snapshot of what Quality Control is and why we use it?

When a patient has their blood/urine/serum etc. taken, it must be sent to the laboratory for analysis. Laboratory professionals run the patient sample on a clinical instrument, which gives a quantitative result for each analyte. However, the laboratory professional does not know whether the value given by the instrument is correct or not. For this reason, the laboratory professional must use a Quality Control – which is a material designed to mimic the patient sample, and has a known concentration of each analyte.

When the laboratory professional runs the QC material on their instrument, they can compare the obtained result with the expected result. If these values are comparable, then the laboratory professional can be confident that their instrument is reporting accurately. Essentially, QC is a ‘practice run’ to ensure the testing system is working correctly.

How does your teams’ work impact on global healthcare?

Quality Control is a hugely important part of laboratory quality. Around 70% of clinical decisions are made based on laboratory results, so it is plain to see how significant Quality Control practices can be in relation to global health care. My work, as well as the work of the wider Quality Control team, is focused on making end-users aware of the importance of Quality Control. We aim to provide advice and recommendations to optimise accuracy and efficiency.

As a company, Randox prioritizes quality above all else, and this ethos is perfectly reflected by the Quality Control team. We work tirelessly to provide quality products and simplify the entire testing process – giving the laboratory professionals more time to do what they do best; provide accurate results time and time again.

What is your favourite Randox QC product and why?

My favourite QC product is the Acusera Liquid Cardiac Control. It’s my favourite control because it perfectly displays all the advantages of Acusera in a single product:

  • Highly consolidated analyte list without any unnecessary extras, keeping costs low
  • True third party
  • Manufactured with 100% human serum, giving full commutability
  • Liquid ready-to-use and suitable for POC testing
  • Clinically relevant ranges, with ultra-low levels of Troponin I
  • Long open vial stability of 30 days

Competitors often offer additional low level Troponin I controls. The thing I like most about the Acusera Liquid Cardiac Control is that the Troponin I levels are still lower than the ‘ultra-low level’ competitor controls – showing that Acusera gets it right the first time, rather than supplementing weak QC products with additional products at an extra cost.

Listen to our 24.7 podcast with QC Product Specialist, Edward Hill.
Find out more about British Science Week 2018.
If you would like further information on our Quality Control Products, contact acusera@randox.com.

British Science Week
British Science Week
British Science Week
British Science Week
British Science Week

Our commitment to Research and Development at Randox

With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. Over 16% of turnover is reinvested in R&D, and therefore, we have more new tests in development than any other diagnostic company.

Of our 1400-strong workforce, almost 400 are research scientists and engineers. Over the past year alone these highly-skilled specialists have developed a new test for Alzheimer’s disease, a bladder cancer test and a test with the ability to stratify Acute Myeloid Leukemia (AML) patients, to determine patient response before chemotherapeutic treatment.

We were also the first company in the world to bring to market a test to detect ‘Flakka’, a dangerous and highly addictive new psychoactive substance.

Most recently we announced the official opening of our new research and testing laboratory, Randox Clinical Laboratory Services (RCLS), at the Randox Science Park in Antrim, Northern Ireland.

Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations.

Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.

Our R&D projects are known across the world for their ingenuity and relevance to current health issues.

Both our Bladder Cancer project and our Acute Myeloid Leukemia projects were awarded Innovate UK Research Awards, which enabled economic studies to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative.  These DECs will investigate the economic benefits of the new diagnostic tests for The National Health Service, and their role in the current patient care pathway.

Our revolutionary Alzheimer’s disease test was presented with a NACB / AACC Distinguished Abstract Award at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia.

We have also recently established a collaborative agreement with Dr. Carl Novina at the Dana-Farber Cancer Institute and Harvard Medical School. The goal of this collaboration is to develop therapeutic antibodies that will be incorporated into a platform technology that can reprogram patients’ immune systems to attack cancers.

Our research and development programme at Randox is continuously evolving to address the most pressing health issues.  We are committed to improving health worldwide and as such will continue to focus our R&D efforts where they are most needed.

Please see below for some examples of our latest research and development news stories.

New Randox blood test detects Alzheimer's disease in 3 hours
Randox Clinical Laboratory Services officially opens at Randox Science Park
Randox R&D Centres of Excellence with support from Invest NI
New Randox project committed to helping bladder cancer patients

Our commitment to Research and Development at Randox

With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. Over 16% of turnover is reinvested in R&D, and therefore, we have more new tests in development than any other diagnostic company.

Of our 1400-strong workforce, almost 400 are research scientists and engineers. Over the past year alone these highly-skilled specialists have developed a new test for Alzheimer’s disease, a bladder cancer test and a test with the ability to stratify Acute Myeloid Leukemia (AML) patients, to determine patient response before chemotherapeutic treatment.

We were also the first company in the world to bring to market a test to detect ‘Flakka’, a dangerous and highly addictive new psychoactive substance.

Most recently we announced the official opening of our new research and testing laboratory, Randox Clinical Laboratory Services (RCLS), at the Randox Science Park in Antrim, Northern Ireland.

Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations.

Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.

Our R&D projects are known across the world for their ingenuity and relevance to current health issues.

Both our Bladder Cancer project and our Acute Myeloid Leukemia projects were awarded Innovate UK Research Awards, which enabled economic studies to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative.  These DECs will investigate the economic benefits of the new diagnostic tests for The National Health Service, and their role in the current patient care pathway.

Our revolutionary Alzheimer’s disease test was presented with a NACB / AACC Distinguished Abstract Award at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia.

We have also recently established a collaborative agreement with Dr. Carl Novina at the Dana-Farber Cancer Institute and Harvard Medical School. The goal of this collaboration is to develop therapeutic antibodies that will be incorporated into a platform technology that can reprogram patients’ immune systems to attack cancers.

Our research and development programme at Randox is continuously evolving to address the most pressing health issues.  We are committed to improving health worldwide and as such will continue to focus our R&D efforts where they are most needed.

Please see below for some examples of our latest research and development news stories.

New Randox blood test detects Alzheimer's disease in 3 hours
Randox Clinical Laboratory Services officially opens at Randox Science Park
Randox R&D Centres of Excellence with support from Invest NI
New Randox project committed to helping bladder cancer patients

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