QCMD – Molecular External Quality Control

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QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 15,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Features & Benefits
Reports & Feedback

After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.

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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


Product Spotlight: Liquid Assayed Chemistry Premium Plus

product spotlight - Liquid Assayed Chemistry Premium Plus - Chemistry Control

Routine clinical chemistry is the basis of a laboratory’s daily testing, it is, therefore, important to choose a chemistry control which offers the greatest consolidation, accuracy, and stability.

Acusera Liquid Assayed Chemistry Premium Plus Control

The Acusera Liquid Assayed Chemistry Premium Plus control is one of the most comprehensive chemistry controls on the market, with instrument specific values provided for 99 analytes. A unique combination of proteins, lipids, cardiac markers, therapeutic drugs, immunoassay, and routine chemistry parameters enables effective consolidation, as well as time and cost savings. As a true third party control, it is manufactured independently from any analyser, with values assigned using our unique value assignment process, target values are available for several common analyser platforms. Containing an impressive array of lipids and Immunoassay parameters, this Acusera Chemistry control offers unrivaled consolidation.

Key Features & Benefits

  • Liquid for ease of use
  • Human based serum
  • Assayed instrument specific target values and ranges
  • High levels of CRP and other proteins eliminate the need for multiple controls
  • Stable to expiry when stored at -20°C to -70°C
  • Open vial stability of up to 7 days at 2°C – 8°C
  • Analytes (click to expand)

    Albumin (Electrophoresis)
    Alpha-1-Globulin (Electrophoresis)
    Alpha-2-Globulin (Electrophoresis)
    Beta-Globulin (Electrophoresis)
    Gamma-Globulin (Electrophoresis)
    Alpha-HBDH
    α-1- Acid Glycoprotein
    α-1-Antitrypsin
    Β-2-Microglobulin
    Acid Phosphatase (Total)
    AFP
    Albumin
    Alkaline Phosphatase
    Amikacin
    ALT
    Amylase
    Amylase (Pancreatic)
    Apo A-1
    Apo B
    AST
    Bicarbonate
    Bile Acids
    Bilirubin Direct
    Bilirubin Total
    C-Reactive Protein
    Caffeine
    Calcium
    Carbamazepine
    CEA
    Ceruloplasmin
    Chloride
    Cholesterol
    Cholinesterase

    CK Total
    Complement C3
    Complement C4
    Copper
    Cortisol
    Creatinine
    D-3-Hydroxybutyrate
    DHEA Sulphate
    Digoxin
    Ethanol
    Ferritin
    Folate
    FSH
    Free T3
    Free T4
    Gamma GT
    Gentamicin
    GLDH
    Glucose
    Haptoglobin
    hCG
    HDL Cholesterol
    IgA
    IgE
    IgG
    IgM
    Iron
    Lactate
    LAP
    LDH
    LDL Cholesterol
    Leutinising Hormone
    Lipase

    LP(a)
    Lithium
    Magnesium
    Myoglobin
    Osmolality
    Paracetamol
    Phenobarbital
    Phenytoin
    Phosphate Inorganic
    Potassium
    Prealbumin
    Progesterone
    Prolactin
    Protein Total
    PSA Total
    Salicylate
    Sodium
    Testosterone
    Theophylline
    Total T3
    Total T4
    TSH
    TIBC
    Transferrin
    Triglycerides
    Troponin T
    T Uptake
    Urea
    Uric Acid
    Valproic Acid
    Vancomycin
    Vitamin B12
    Zinc

Featured Analytes

C-Reactive Protein (CRP)

CRP is a protein made by the liver and released into the blood within a few hours after tissue injury, the start of an infection, or other cause of inflammation. It is tested to detect the presence of inflammation and can be used to monitor the response to treatment for inflammatory disorders. CRP is included in the Liquid Assayed Chemistry Premium Plus control, ensuring accurate instrument performance at key decision levels and further reduces the number of individual controls required. CRP is available at elevated levels in the level three control.

Troponin T (TnT)

A troponin test measures the levels of troponin proteins in blood and is used when a patient is suspected to have suffered a heart attack. These proteins are released when the heart muscle has been damaged, such as with a heart attack. More damage to the heart would result in a higher level of Troponin T. As a highly consolidated contorol, the Liquid Assayed Chemistry Premium Plus includes Troponin T, meaning a separate control is not required.

Related Products

Interlaboratory Data Management

RIQAS Chemistry EQA

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Download some of our related brochures below and broaden your understanding.

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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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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.

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


Product Spotlight: Liquid Lipid Control

product spotlight - liquid lipid control

Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is usually associated with a build-up of fatty deposits inside the arteries and increased risk of blood clots. It can be associated with damage to arteries in organs such as the brain, heart, kidney and eyes. Some types of CVD include coronary heart disease, strokes and aortic disease. Some of the main causes of CVD are smoking, high cholesterol, diabetes and high blood pressure (NHS, 2016).

These diseases can be extremely dangerous and lead to permanent damage or even death, therefore, it is vitally important for laboratories to be confident in their analyser’s ability to accurately diagnose and monitor the risk of these diseases.

Randox Liquid Lipid Control

The Randox Acusera Liquid Lipid quality control includes assayed target values and ranges for 8 analytes covering the complete lipid profile. With a 30 day open vial stability the Acusera Liquid Lipid control will reduce waste, whilst remaining easy and convenient to use. Three distinct levels are available covering low risk, borderline risk, and high risk concentrations of HDL and LDL cholesterol, ensuring the clinically relevant decision levels are tested, eliminating the need to purchase additional high and low level controls. Containing no Sodium Azide, which can interfere with direct clearance methods for  detecting HDL and LDL cholesterol, ensuring ultimate accuracy and confidence in results.

Key Features & Benefits

  • Liquid for ease of use
  • 100% human serum
  • Assayed target values provided
  • True third party control
  • Stable to expiry date at -20°C to -80°
  • Open vial stability of 30 days at 2°C to 8°C

Analytes

Apolipoprotein A  |  Apolipoprotein B  |  Cholesterol (HDL)  |  Cholesterol (LDL)
Cholesterol (Total)  |  C-Reactive Protein (CRP)  |  Lipoprotein (a)  |  Triglycerides

Featured Analytes

HDL Cholesterol

High-Density Lipoproteins (HDL) are one of the major classes of plasma lipoproteins. HDL is often referred to as ‘good cholesterol’ because it transports cholesterol from the tissues of the liver for removal from the body. High levels of HDL can indicate a lower risk of developing heart disease.

Apolipoprotein A-1

Apolipoprotein A-1 is one of the main protein forms found in High Density Lipoproteins (HDL). The chief role of Apolipoprotein A-1 is in the activation of lecithin cholesterol acyltransferase (LCAT) and the capture and removal of free cholesterol from extra hepatic tissue. Studies have shown that there is an inverse relationship between Apolipoprotein A-1 and coronary artery disease (CAD).

Related Products

Acusera Lipid Control

RIQAS Lipid EQA

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References

NHS. (2016). Heart attack. nhs.uk. Retrieved 15 February 2018, from https://www.nhs.uk/conditions/heart-attack/

National Institute for Health and Care Excellence. (2014). Myocardial infarction (acute) Early rule out using high-sensitivity troponin testsNice.org.uk. Retrieved 15 February 2018, from https://www.nice.org.uk/guidance/dg15/chapter/3-clinical-need-and-practice


Product Spotlight: RIQAS CO-Oximetry EQA

Product Spotlight - RIQAS CO-Oximetry EQA Programme

RIQAS CO-Oximetry EQA

The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).

Background

CO-Oximetry is a methodology that measures the levels of the oxygen-carrying protein haemoglobin, which is the chief component of red blood cells. CO-Oximetry is a useful tool in that it helps determine the levels of various forms of haemoglobin.

Key Benefits & Features

  • Liquid ready-to-use
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

Liquid ready-to-use

The liquid stable formulation requires no preparation making the samples extremely easy and convenient to use.

Consolidation

Covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.

RIQAS

RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories.

Analytes

  • Carboxyhaemoglobin (COHb / HbCO)
  • Methaemoglobin (MetHb)
  • Oxygen Content (O₂CT)
  • Oxygen Saturation (sO / Vol O)
  • Oxyhaemoglobin (OHb / HbO)
  • Total Haemoglobin (tHb)
  • Reduced / Deoxyhaemoglobin (RHb / HHb)

Related Products

RIQAS Blood Gas EQA

Suitable for monitoring the performance of 10 blood gas parameters.

  • Accredited to ISO/IEC 17043
  • Liquid ready-to-use
  • Aqueous material
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

Download some of our related brochures below and broaden your understanding.

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References

Chatburn, R. (2014). To co-ox or not to co-oxAcutecaretesting.org. Retrieved 19 February 2018, from https://acutecaretesting.org/en/articles/to-coox-or-not-to-coox


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

Product Spotlight: Liquid Urinalysis Control

Product Spotlight - Jan - Liquid Urinalysis Quality Control

Liquid Urinalysis Quality Control

The Randox Acusera Urinalysis Quality Control is designed primarily to ensure accurate test system performance however offer the laboratory additional benefits that will help them to meet regulatory requirements whilst also reducing costs and time.

Background

It is estimated that 1 in 2 people will be affected by a urological condition at some point in their lifetime. Conditions and diseases related to kidneys, bladder and prostate, among others, are commonplace and can be devastating for millions of men, women and children across the globe.

Urological conditions can be common, such as urinary tract infections, or they can be much more serious, for example, prostate or testicular cancer.

Urinalysis is used as a screening or diagnostic tool because it can detect kidney and metabolic disorders. Often, substances such as glucose or protein will appear in the urine before a patient is aware that they have a problem. In some conditions, urinalysis also provides an easy and economical test to track patient progress, for example, if you want to know if a condition is improving.

Key Benefits & Features

  • Liquid ready-to-use
  • 100% human urine
  • Assayed ranges provided for 13 parameters
  • Suitable for use in POC testing
  • Stable to expiry date at 2°C – 8°C
  • Open vial stability of 30 days at 2°C – 25°C (20 immersions for UC5033/5034)

Consolidation

As a leading provider of multi-analyte, third party controls, Randox helps busy laboratories significantly reduce the number of controls needed to cover their test menu. The Randox Liquid Urinalysis Control combines multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality. Analytes at key decision levels will ensure test system performance across the clinical range. It can also be used in monitoring the performance of both automated and manual methods of urine test strip analysis.

Liquid Stable

Samples are conveniently supplied ready-to-use requiring no preparation as such they can save valuable laboratory time. The Acusera Liquid Urinalysis Control can be used for POCT as well as laboratory based testing.

True third party quality control

The Acusera Liquid Urinalysis Quality Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

Analytes

  • Albumin
  • Bilirubin
  • Blood
  • Creatinine
  • Glucose
  • hCG
  • Ketones
  • Leukocytes
  • Nitrate
  • pH
  • Protein
  • Specific Gravity
  • Urobilinogen

Complete QC solution

The combining of the Acusera Liquid Urinalysis Quality Control, RIQAS Urinalysis EQA programme, and our Acusera 24•7 software will provide a complete QC solution for laboratories of all sizes.

Download some of our related brochures below and broaden your understanding.

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