Complete QC Solutions for Results you can Trust

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Complete QC Solutions for Results you can Trust

Randox is one of the largest manufacturers of true third party quality control solutions.  With over 35 years’ experience delivering reliable, high quality products designed to effectively challenge instrument performance you can be confident in the accuracy of patient test results, whilst reducing time and costs. With more than 390 analytes available across the Acusera range and a wide range of formats providing flexibility & choice, we have a solution to suit you.

Our diverse range of multi-analyte, third party controls offer industry leading opportunities for consolidation, ultimately delivering cost savings, reduced preparation time and increased efficiency all without compromising on quality. Manufactured using the highest quality raw materials, lot to lot consistency and unrivalled commutability is guaranteed, ensuring performance mirrors that of the patient sample and costly shifts in QC results are reduced.

  • Benefits

    acusera-consolidation

    Consolidation
    Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number of individual controls required to cover your test menu, ultimately reducing costs, preparation time and storage space.

    acusera-commutability

    Commutability
    All Acusera controls are designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements whilst reducing inconvenient and costly shifts in QC results when reagent batch is changed.

    Clinically-relevant-decision-levels

    Clinically Relevant Levels
    The presence of analytes at key decision levels not only helps to ensure accurate instrument performance but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra expense.

    acusera-reduce-waste

    Reduced Waste
    The unrivalled working stability of the Acusera control range helps to keep waste and costs to a minimum.

    acusera-flexible-options

    Flexibility
    With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.

    acusera-third-party

    True Third Party Controls
    Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.

Did you know?

Our controls are used in over 50,000 labs, hospitals and universities across the world.

Choose below to find a control that suits you.

Interlaboratory Data Management

Complementing our Internal Quality Control range is Acusera 24•7, a powerful data management tool designed to help even the most demanding laboratories manage their daily QC activities. Delivering unique access to real-time peer group statistics, a variety of fully interactive charts and automatic calculation of performance metrics such as Measurement Uncertainty, Acusera 24•7 will speed up data review and troubleshooting.

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Acusera Third Party Controls

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RX series (Concept 3)

clinical chemistry analyser

The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.

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Why Choose the RX series?

Consolidation of Routine & Specialised Testing on One Single Platform 

With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.

Low Reagents & Sample Volumes

Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering  accurate, reliable and precise results each time, every time.

Robust Hardware & Intuitive Software 

The RX series boasts many features including user-friendly Windows based software, an in-built inventory management system and multiple levels of password protection ensuring optimum performance, flexibility and excellent functionality.

Unrivalled Customer Support

Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.

View Our Test Menus

Fully Automated
Test Menu

Semi-Automated
Test Menu

Niche
Test Menu


QCMD – Molecular External Quality Control

QCMD - Molecular EQA for Infectious Disease Testing

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 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Features & Benefits

Frequency

A variety of programme options are available.  Choose the number of challenges that best suit your laboratory’s  requirements.

Online EQA Management System

ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

High level of participation

Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

Comprehensive reports

Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

International accreditation

Programmes are accredited to ISO 17043.

EQA Programmes
  • Blood Borne Viruses
  • Central Nervous System Diseases
  • Drug Resistance
  • Exotic / Emerging Diseases
  • Gastrointestinal Diseases
  • Immunocompromised Associated Diseases
  • Multiple Pathogen / Syndromic Infections
  • Respiratory Diseases
  • Serology
  • Sexually Transmitted Infections
  • Transplant Associated diseases
  • Typing
  • New Pilot Studies
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.

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QCMD Website

RIQAS EQA

*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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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

Continue Reading

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

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from past months


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


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

Continue Reading

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

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from past months

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


RIQAS Serology Report

The Serology report is available within ten days of the final submission date. The results for each parameter are displayed on a single page report. There are two types of Serology report – one for qualitative reporting and one for quantitative reporting. Each of these report ensure quick and easy performance assessment.

RIQAS EQA Reports

The Qualitative report comprises three subsections including a text section, Histogram and method summary. The text section conveniently displays your laboratory’s result to the correct result for your method. The Histogram visually displays your laboratory’s result in relation to all of the results submitted for your method group and the all method group. Finally, the method summary provides a breakdown of the results for all methods registered with RIQAS.

(Click to enlarge)

The Quantitative report comprises four subsections including a text section, Histogram, Levey-Jennings chart and method summary. The text section conveniently displays your laboratory’s result to the mean for comparison, the histogram visually displays your laboratory’s result to the mean for comparison, the Levey-Jennings chart displays the SD for the last 20 samples ensuring instant identification of performance over time and finally the method summary provides a breakdown of the results submitted for all methods registered with RIQAS.

(Click to enlarge)


RIQAS Urinalysis Report

RIQAS Urinalysis reports have been designed specifically for participants of the RIQAS Urinalysis programme (RQ9138). Report features include;

  • Scoring system
  • Ability to rate performance and visualise historical performance data
  • Visual representation of performance
  • Peer group comparison levels

To find out more on the range of features available with the report, see the table below.

RIQAS EQA Reports

The Urinalysis Report scoring system, scores participants based on a spread of results over each category and how far a participant is away from the consensus, which is referred to as the Target Category.

The score calculated is based on how close to the target category a participant’s result falls. A score of 0 refers to a result which falls within the target category and therefore, the comment “acceptable” will be given. A laboratory’s performance is described as being acceptable or unacceptable based on this calculated score.

A laboratory must achieve a score of between -6 and +6 for their performance to be deemed acceptable. Scores can fall between the values of -10 and +8.

  1. If a participant’s result matches the target category then they will receive the score of 0 and the comment “acceptable” given.
  2. Where a participant returns a negative result and the target category is positive (category 9), the participant score will be -10. The comment “unacceptable” will be given.
  3. Where a participant returns a positive result (category 9) and the target category is negative, the participant score will be +8 and the comment “unacceptable” given.

(Click to enlarge)

Current Sample

The score achieved for the current reported sample together with the associated comment of acceptable, unacceptable or borderline will be listed in the comments box located towards the top of the results page for each registered parameter. The percentage (%) of results from the selected peer group which fall within the target category are also stated.

Potential Historical Information

The number of correct scores (i.e. scores of 0) that have been submitted in the last “n” samples, up to a maximum of 6 previous samples. The number of acceptable assessments that have been submitted in the last “n” samples, up to a maximum of 6 previous samples.

(Click to enlarge)

Charting of Current & Historical Information

Results of scoring for each sample are displayed on a Levey-Jennings style chart with “0” score in the middle and scoring categories positioned on either side for 2, 4, 6, 8 and 10. The chart is shaded into bands depending on the scores.

Acceptable scores (0-6) have no shading, Borderline scores (6-8) have light red shading and unacceptable scores (8-10) are shaded a darker red.

Scores for each of the last 12 samples are plotted against the appropriate sample number and the chart also indicates whether the participant’s reported result category is higher or lower than the target category.

The target categories are stated along the top of the chart and if there are no target categories due to a lack of numbers then an “X” is plotted to show that a result has been submitted but could not be scored.

(Click to enlarge)

Reporting – Summary Page

The summary page at the end of the report lists all of the parameters that a participant has registered for.

For each parameter the following information is stated:

  1. Target Category, which is dependent on the unit registered
  2. The result which has returned by the participant
  3. The score achieved for the current sample
  4. The comment of Acceptable / Unacceptable / Borderline
  5. Where the comment is “Unacceptable” it is highlighted in bold italics and underlined
  6. The number of “Acceptable” assessments that have been achieved over the previous 6 samples

(Click to enlarge)


RIQAS Urine Toxicology Report

A dedicated report is provided for the Urine Toxicology programme. The report is divided into two subsections; the screening (qualitative) and the quantitative section, allowing for visual performance assessment at-a-glance.

RIQAS EQA Reports

Your laboratory’s result is displayed along with the correct response. A visual chart is also provided displaying performance of the last 20 samples. A breakdown of the screening results submitted by other laboratories in your method group and all method groups for the current sample is also provided at a variety of cut-offs. A further breakdown is provided for various methods at your specific cut-off.

(Click to enlarge)

The Quantitative section of the Urine Toxicology report is further broken down into a text section comparing your laboratory’s performance to the mean for comparison, a Histogram chart indicating your laboratory’s performance in relation to the method group and the all method group and a multi-method section highlighting the performance of other methods.

(Click to enlarge)


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