Product Spotlight: Molecular QC and EQA for Infectious Disease Testing

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Product Spotlight: Molecular QC and EQA for Infectious Disease Testing

Molecular QC and EQA for Infectious Disease Testing

Earlier in the year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.

Background

The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.

According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.

Qnostics - Molecular Controls

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.

Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

There are five main product areas for Qnostics:

  • Product Groups (click to expand)

    Q Controls
    Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.

    Analytical Q Panels
    Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.

    Molecular Q Panels
    Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range.  Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.

    Evaluation Panels
    Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.

    QCMD Past Panels
    Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.

    Custom Manufacture

    Qnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.

    • Choose from hundreds of molecular characterised targets
    • Targets can be custom made into numerous different formats
    • The whole pathogen format accurately mimics clinical samples
    • All materials can be provided in a “ready-to-use” or liquid frozen format

    Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.

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

EQA participants 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.

  • Features & Benefits (click to expand)

    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.

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Qnostics

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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.

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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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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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Measurement Uncertainty Vs Total Error

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

Where do errors and uncertainty come from?

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

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

Random and systematic errors

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

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

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

TE is calculated using the below formula:

TE = %BIAS + (1.96 * %CV)

Measurement Uncertainty (MU)

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

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

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

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

The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”

Uncertainty is calculated using the below formula:


u = √A2+B2          

                                           U = 2 x u               

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

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

Conclusion

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

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

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

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

How Randox can help

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

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

Fig. A

Measurement Uncertainty

Fig. B

Total Error vs Measurement Uncertainty

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

Measurement Uncertainty vs Total Error
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The Importance of ISO 15189

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References

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

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

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

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


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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The Importance of Meeting ISO 15189 Requirements

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

Some key benefits include:

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

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

Impact on healthcare

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

ISO 15189

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

Meeting ISO Requirements

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

The Importance of Meeting ISO 15189 Requirements

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

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

Fig. A

ISO 15189 requirements - non-conformances

Fig. B

ISO 15189 requirements - non-conformances
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References

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

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

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

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


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

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

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

Case Study - Royal Wolverhampton NHS Trust

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

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

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

What it means

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

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


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