Automation vs. ELISA

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Automation vs. ELISA

Background

The technological developments and scientific innovations in the field of clinical chemistry from the early 1950’s to date have been vast, enhancing laboratory capabilities and providing the necessary support to clinicians and laboratories to improve patient diagnosis and treatment. (1) Laboratory automation today is a complex integration of robotics, computers, liquid handling and numerous other technologies with a fundamental purpose of saving time and improving performance through the elimination of human error.

Complementing this, in the early 1950’s ready-to-use assay reagent kits, with instructions for use introduced a very significant innovation to the field of automation eliminating the process of manually preparing reagent. (2)

Despite the many advancements in automation many clinical laboratories continue to use manual methods such as ELISA for some specialised tests. (3)

Inefficiencies with ELISA based methods

Manual ELISA based techniques are notoriously inefficient and are particularly draining on time and personnel due to the manual intervention required. The manual nature of the method also means there is greater potential for human error ultimately resulting in lack of sensitivity and potential for cross-reactivity. (4,5)

For many laboratories, the transition from traditional ELISA techniques to an automated method for the detection of the same analyte will significantly improve both costs and time.

Renowned for quality and reliability the RX series range of clinical chemistry analysers ensures confidence in patient testing.

DID YOU KNOW?

The RX Series of analysers allows for automation of specialised tests that previously would have only been possible via traditional ELISA methods e.g. Adiponectin, G-6PDH and Cystatin C.

 

Expanding Capabilities and Performance

With patient care holding a primary focus on clinical chemistry testing, the RX series range of semi-automated and automated analysers offer versatility to suit all laboratory requirements. Expanding your laboratory’s capabilities with our world leading extensive dedicated test menu offers cost savings through consolidation of both routine and specialised tests. By transitioning analytes historically only available as an ELISA based test, laboratories can expand their offering with ease to both patients and clinicians.

Our open system approach to clinical testing offers unique opportunities for consolidation, most of our unique and high-performance assays may be run on any clinical chemistry instrument without the need for specialised equipment.

Outperforming ELISA methodology, the RX series delivers a testing platform that requires limited or no manual preparation. With ELISA, the test is run on a 96 well plate using only a single assay with recommendations to duplicate or triplicate samples to evacuate the extent of errors, therefore increasing time and costs. The RX series of analysers each have different levels of throughput to adapt to the requirements of all laboratories.  Utilising robust hardware and intuitive software the RX series guarantees accurate and precise patient testing.

References:

  1. Olsen K. The first 110 years of laboratory automation: technologies, applications, and the creative scientist. J Lab Autom. 2012; 17:469-80.
  2. Rosenfeld L. A golden age of clinical chemistry: 1948-1960. Clin Chem. 2000; 46:1705.14.
  3. Kricja LJ, Savory J. International year of chemistry 2011. A guide to the history of clinical chemistry. Clin Chem. 2011; 57:1118-26.
  4. Wild D, Sheehan C, Binder S. Introduction to immunoassay product technology in clinical diagnostic testing. In: Wild D, editor. Immunoassay Handbook: Theory and Applications of Ligand Binding, ELISA and Related Techniques. 4th Oxford, UK: Elsevier; 2013.
  5. Hawker CDED. Laboratory automation: total and subtotal. Clin Lab Med. 2007; 27:749-70.

The RX series celebrate Biomedical Science Day

Biomedical Science Day is taking place this year on the 19th of July. This is an annual celebration with the aim of raising public awareness of the importance of biomedical science and the vital role it plays in the world.

To celebrate biomedical science day the RX series interviewed Aidan Murphy, one of our laboratory analysts at Randox to find out more about what his job in the lab entails day-to-day. Aidan works with the RX series of clinical chemistry analysers and Randox QC on a daily basis.

We asked Aidan a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis … 

1. What attracted you to a career in laboratory science?

Science has always interested me in both my academic and personal life, I always aspired to get a science based degree and after achieving this I now hope to improve my laboratory skills to increase my employability.

2. What were your stronger subjects at school?

My strongest subjects in school were biology, chemistry, music and politics. Some of which are more applicable to my current role than others.

3. What does your job in Randox entail?

My job entails a variety of roles ranging from testing Randox diagnostic kits before they’re released to customers as well as maintenance and precision checks of the machines in our lab.

4. What aspects of your job do you enjoy the most?

The independence in my job is great. Knowing what I have to do at the start of each week and the deadlines to do these jobs requires me to organise and prioritise my work accordingly.

5. What are some common preconceived ideas the public have about what laboratory staff do?

From my friends’ ideas of what I do in the lab I have found that a stereotypical image of a lab is one of a dark quiet lab full of strange equipment and even stranger people. However fortunately my lab is a lively one and thankfully with normal people.

6. In your opinion, what are the most important aspects of laboratory work?

Following correct protocols and procedures are imperative in an efficient laboratory. As well as this, good lab practice and good hygiene can have a massive effect on the accuracy of our results.

7. What’s in your lab coat pocket?

My lab coat pockets are quite boring. I have a pair of safety goggles, some post-its and some pens and markers.

8. In what ways does your work make a difference to people’s lives?

Randox is dedicated to improving the quality of diagnostics globally, so knowing that the kits that I have tested are then sent to customers to be used in patient diagnosis gives me a level of job satisfaction that I haven’t got from previous jobs.

Aidan is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through his work. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible. 

To find out more about Randox products contact us at theRXseries@randox.com.

Check out our social media sites for more on Biomedical Science Day.

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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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Acusera Third Party Controls

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 RX series celebrate Medical Laboratory Professionals Week

Medical Laboratory Professionals Week is taking place this year from  22nd28th April 2018. This is an annual celebration of professionals working in the laboratory, highlighting and recognising their contributions to medicine and healthcare.

To celebrate Medical Laboratory Professionals Week the RX series interviewed Aidan Murphy, one of our laboratory analysts at Randox to find out more about what his job in the lab entails day-to-day. Aidan works with the RX series of clinical chemistry analysers and Randox QC on a daily basis.

We asked Aidan a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis … 

1. What attracted you to a career in laboratory science?

Science has always interested me in both my academic and personal life, I always aspired to get a science based degree and after achieving this I now hope to improve my laboratory skills to increase my employability.

2. What were your stronger subjects at school?

My strongest subjects in school were biology, chemistry, music and politics. Some of which are more applicable to my current role than others.

3. What does your job in Randox entail?

My job entails a variety of roles ranging from testing Randox diagnostic kits before they’re released to customers as well as maintenance and precision checks of the machines in our lab.

4. What aspects of your job do you enjoy the most?

The independence in my job is great. Knowing what I have to do at the start of each week and the deadlines to do these jobs requires me to organise and prioritise my work accordingly.

5. What are some common preconceived ideas the public have about what laboratory staff do?

From my friends’ ideas of what I do in the lab I have found that a stereotypical image of a lab is one of a dark quiet lab full of strange equipment and even stranger people. However fortunately my lab is a lively one and thankfully with normal people.

6. In your opinion, what are the most important aspects of laboratory work?

Following correct protocols and procedures are imperative in an efficient laboratory. As well as this, good lab practice and good hygiene can have a massive effect on the accuracy of our results.

7. What’s in your lab coat pocket?

My lab coat pockets are quite boring. I have a pair of safety goggles, some post-its and some pens and markers.

8. In what ways does your work make a difference to people’s lives?

Randox is dedicated to improving the quality of diagnostics globally, so knowing that the kits that I have tested are then sent to customers to be used in patient diagnosis gives me a level of job satisfaction that I haven’t got from previous jobs.

Aidan is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through his work. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible.

To find out more about Randox products contact us at theRXseries@randox.com.

Check out our social media sites for more on Medical Laboratory Professionals Week.

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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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Acusera Third Party Controls

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

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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The Importance of External Quality Assessment in HIV Enzyme Immunoassay Testing

Introduction

Quality Control (QC) is vital for the clinical laboratory in order to ensure the accuracy and precision of patient test results. Without a robust QC strategy, test system errors could go undetected, potentially resulting in misdiagnosis and inappropriate/delayed patient treatment.

QC can be divided into two main components; Internal Quality Control (IQC) and External Quality Assessment (EQA).

What are IQC and EQA?

IQC is used in the daily monitoring of test system precision and reproducibility. IQC essentially compares the internal laboratory’s performance over time, highlighting any deviations from ‘normal’ performance. While IQC is a good method of testing performance, it is not always robust enough to detect calibration errors or issues associated with ‘wide’ acceptable limits.

In an External Quality Assessment (also known as Proficiency Testing, or PT) program the EQA provider will deliver ‘blind’ samples to all EQA participants. The use of such ‘blind’ samples ensures EQA can be used to measure a laboratory’s bias and accuracy. These samples are analysed by the lab and results are returned to the EQA provider for analysis. The data are examined, means and SDs are calculated, and any outliers are highlighted. Reports are then generated and delivered to each participant, giving a summary of performance in comparison to the rest of the participant group.

Why Should Laboratories Carry out EQA Testing?

The World Health Organisation (WHO) recommends that a robust QA program should be implemented in any lab which carries out HIV testing, and Internal and External quality control should be carried out on an ongoing basis1.

Participating in a rigorous and robust EQA scheme is a requirement of ISO 15189. All labs seeking ISO 15189 accreditation need to be part of an EQA scheme which appropriately challenges their test system.

The Importance of External Quality Assessment in HIV Testing - Graphic

The Cost of Poor Quality EQA

The most common method of HIV detection is to utilise Enzyme Immunoassay (EIA) antibody testing2. EIA tests are highly sensitive and can be optimised for automation, facilitating high-volume testing. However, with higher volumes of testing comes a higher probability of error. With EIA assays, the most common error encountered is false positive results2.

False positive results have a number of implications. Any screen-positive results must be verified using a confirmatory test; usually a Western Blot assay. The Western Blot is much more labour intensive and expensive than EIA tests, and is not efficient enough for high volume testing2. Therefore, if a laboratory is producing a higher than average number of false positive results due to poor quality assurance practices, they will ultimately spend significantly more time and money on confirmatory tests.

How can EQA Improve HIV Testing Accuracy?

The main use of EQA is to verify the accuracy of laboratory testing. Accuracy refers to the closeness of the obtained result to the ‘true’ value. As EQA is tested using ‘blind’ samples, operator bias is eliminated and the test system can be appropriately challenged.

EQA can also be used as a means of detecting deficiencies with IQC. For example, some IQC providers supply assayed IQC material with very wide acceptable limits, with 2SD often +/- 20% from target value. For this reason, labs may believe their performance is good, but when scrutinized by EQA with narrow acceptable limits, performance will be identified as substandard.

What to Look for in a Good EQA Scheme

Laboratories can join either Local, National or International EQA schemes. An International EQA scheme would provide the best return on investment due to the higher peer group size and more diverse demographic of participants. Some key factors which typify a good quality EQA scheme include:

  • Accreditation to ISO 17043 – Being accredited to this standard ensures the EQA scheme is fit for purpose
  • Frequent Distribution – Regular EQA analysis allows for rapid identification of errors and any necessary corrective actions can be taken as soon as possible
  • Large Number of Participants – Ensures an extensive database of results for a range of analytical methods and instruments. In addition, larger participant groups increase statistical validity of results
  • Clinically Relevant Ranges – Analytes should be present at both normal and abnormal ranges, as to ensure medical decision limits are adequately tested
  • Comprehensive Reports – Much of the value of participating in an EQA scheme lies in the report generated by the provider. Reports should be comprehensive, providing a range of statistical metrics and charts

How can Randox Help?

The Randox International Quality Assessment Scheme (RIQAS) incorporates all the above features, as well as many others, into the world’s most comprehensive EQA scheme. With more than 45,000 participants worldwide, RIQAS offers unrivalled peer group comparison, and has earned its place as the most popular EQA scheme in the world.

Conclusion

An EQA scheme operates like an early warning system; it can alert the lab and document the need for, stimulate and monitor improvement. However, the improvements themselves must be implemented and maintained by the lab.

Investment in a good EQA scheme can save labs a substantial amount of time and money, so it is worthwhile to invest wisely.

To sign up for RIQAS or to learn more, sign up using the form below!

References

  1. World Health Organisation, Laboratory Methods For Diagnosis Of HIV Infection In Infants And Children. Geneva: World Health Organisation. 2010;5.
  2. Fearon M. The laboratory diagnosis of HIV infections. The Canadian Journal of Infectious Diseases & Medical Microbiology. 2005;16(1):26-30.
The Importance of External Quality Assessment in HIV Testing

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