Welcome to Vivasuite!
Welcome to Vivasuite!
Running within the Bosch IoT cloud maintaining the highest standard of IT security and data privacy. Connectivity ensures that devices are always available and fully updated.
Advantages of Vivasuite:
– Schedule remote software updates
– Know when your devices were last synchronised
– View all devices in one dashboard
– View device information and general device data
– View testing history from one system
– Mobile device monitoring
– Vivalytic user management
– Save time with less “on-device” work
Vivalytic Overview
Discover more about the Vivalytic
VeraSTAT-Sports Performance
Best in the Field
Eliminate delays in sending samples to labs and receive rapid results for rapid recovery in 6 minutes.
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Requires just a few drops of whole blood or serum, ideal for use at the point of care.
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Lightweight, portable and convenient, the Randox VeraSTAT delivers diagnostic results where and when they are required.
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The Randox VeraSTAT allows for results to be exported via bluetooth connectivity.
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Intuitive user interface guides the operator through the entire testing process.
VeraSTAT-Improve your performance
As the best it’s field, the Randox VeraSTAT device allows athletes to overcome the limitations of other generation tests, providing accurate, cost effective and reliable results that will help users receive the care necessary to get them back on their feet and back to their best.
Monitoring response to exercise is vitally important to an athlete and trainer. While a heavy training schedule can lead to chronic immunosuppression in athletes, it is essential that they receive the appropriate care in the case of a dip in health state. Eliminating the risk of inflammation and infection is essential to preventing disruptions to practice and performance.
VeraSTAT Test Menu
The VeraSTAT testing menu is designed to monitor an athletes immune response to exercise. C-Reactive Protein (CRP) levels are used to guide the treatment of bacterial infections or inflammation associated with tissue injury and other inflammatory disorders. On the other hand, Mxyovirus Resistance Protein 1 (MxA) is used as a key indicator of viral infections. These tests used in combination, can allow healthcare clinicians to determine the best course of treatment and get the athlete back to full health
C-Reactive Protein (CRP)
CRP is a Key indicator of inflammation and stress, often resulting from the breakdown in tissues. Overtraining can lead to elevated levels of CRP in the body.
Myxovirus Resistance Protein I (MxA)
MxA is a key indicator of a viral infection which may impact physical performance and activity levels. Unexplained failures are often attributed to recent or current infections.
Vivalytic Resource Hub
Vivalytic Overview
Discover more about the Vivalytic
Rapid PCR MRSA/SA testing now available on Vivalytic
Rapid PCR MRSA/SA testing now available on Vivalytic
Providing a quick diagnosis of methicillin resistant at the point of the care, the latest addition to the Vivalytic portfolio of tests, not only provides rapid RT-PCR results in 53 minutes but differentiates whether the bacterial strain is methicillin-resistant (MRSA) or methicillin-sensitive (MSAA) which promotes targeted therapy.
MRSA is a major multi-resistant nosocomial pathogen worldwide with the WHO estimating that the mortality rate of patient infection rates is around 50% higher compared with patients who have been infected by non-resistant Staphylococcus aureus strains.1 Moreover, the extensive period of hospitalisation, morbidity, and the associated medical costs increase significantly with an MRSA infection.2
Introducing MRSA to the vivalytic portfolio can provide high quality answers, anywhere and anytime improving patient pathways and the need for care. Significantly, introducing rapid MRSA screening at both ward level, emergency settings and before hospital elective surgery procedures allow for an effective response to identifying whether the bacteria strain is methicillin-sensitive (MSSA) or -resistant.
Making a point to care, the rapid essence and speed of Vivalytic not only showcase technology but the ability to contribute to current health risks by preventing contamination, breaking the chain of infection, and again fighting the silent pandemic of antimicrobial resistance (AMR) & superbugs.
The treatment on the front line today looks at increasing empirical antibiotic prescribing and increasing drug-resistant outbreaks. AMR is growing rapidly, with superbugs threatening the ability to treat common infectious diseases appropriately. The COVID-19 pandemic has elevated concerns over AMR and antibiotic-associated adverse events, with surges in antibiotic prescribing, hospitalisations, and drug-resistant bacterial transmissions.
Speed is key here – since the result of diagnostics with culture sampling, which is the current traditional method for MRSA testing is only available after one to three days, this PCR test for the point of care is ideal as an additional tool when speed is of the essence.
Few points to note about the current Vivalytic panel for MRSA/SA detection:
- By using one single cartridge, the Vivalytic MRSA/SA test detects and differentiates between MRSA and MSSA DNA to aid in the diagnosis of MRSA infection in a speedy manner so that appropriate antibiotic treatment can be applied, and complications prevented.
- Detection Method: Real-Time PCR
- Result Time: 53 minutes
- Sample Volume: 600 μl
- Sample Type: Nasal- or oropharyngeal swab sample
| DETECTABLE DNA PATHOGENS: | SPECIFIC GENE TARGETS: |
|---|---|
| Methicillin-resistant Staphylococcus aureus (MRSA) | SCCmec/orfX junction |
| Methicillin-sensitive Staphylococcus aureus (MSSA) | mecA/ mecC, SA422 |
Making this happen, The MRSA/SA rapid test on Vivalytic by Bosch, a point of care platform brought to the market by Randox Laboratories. The Vivalytic system is a fully automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex infectious disease testing. Each easy-to-use cartridge contains all necessary reagents, is fully-sealed to minimise risk and can be conveniently stored at room temperature.
The Vivalytic consolidates the full molecular workflow into a small benchtop platform, capable of extraction, PCR amplification and detection. It follows an easy 4 step process from sample entry to results and with the gold standard PCR testing. With most up to date technology, the Vivalytic has wireless connectivity, with no peripherals required, making a unique space saving and hygienic solution. Handling and utilisation are simple and medical professionals require only minimal training.
For more information on the Vivalytic, why not visit our webpage- https://www.randox.com/vivalytic-molecular-point-of-care/
For more information on our new MRSA test, please contact market@randox.com
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Identification and Differentiation of Viral and Bacterial Respiratory Infection to Guide Antibiotic Stewardship
Identification and Differentiation of Viral and Bacterial Respiratory Infection to Guide Antibiotic Stewardship
The development of point-of-care testing is critical in the identification and differentiation between bacterial and viral respiratory infections. Defining the indications of infection to improve antibiotic stewardship, ensures that patients are protected from unnecessary antibiotic use and antibiotic resistance. It has been shown that particular protein biomarkers, such as myxovirus resistance protein (MxA) and C-reactive protein (CRP), differentiate infections between bacterial and viral. Using point-of-care platforms, such as Randox’s VeraSTAT, for detection of these protein biomarkers may provide more rapid and cost-effective discriminating tools.
The treatment of bacterial and viral infections can differ significantly, however people are often treated with empirical antibiotics due to a lack of paid and accurate testing. Although early intervention of infection is urgent, current diagnostic methods are either time intensive or inaccurate. The challenges clinicians are faced with in the differentiation of viral or bacterial respiratory infection can lead to delayed diagnosis, misappropriation of antibiotics and increased healthcare costs.
MxA protein has the potential to greatly enhance the rapid detection of viral respiratory infections as it increases significantly when there is actuate viral infection. CRP is the dominant acute phase protein often used to guide treatment of a bacterial infection or inflammation associated with tissue injury, inflammatory disorders, and associated diseases.
CRP & MxA together, allow clinicians to make appropriate decisions in supporting antimicrobial stewardship and guide the appropriate use of antibiotics, saving time performing unnecessary tests, providing unnecessary treatment which missing the opportunity to provide the right treatment in a timely manner.
The Randox VeraSTAT is a simple, accurate, portable point of care device which delivers rapid results via the use of patented cathodic electrochemiluminescence technology (C-ECL). Designed with the aim of offering users the next generation of rapid diagnosis, the VeraSTAT eliminates the requirement to send samples to a laboratory and instead returns results in as little as 6 minutes.
- Eliminates delays in sending samples to the lab and facilitate immediate decision making at the point of care.
- Lightweight, portable and convenient, the Randox VeraSTAT can be used in a variety of locations to deliver results as required, such as a GP surgery or Emergency Department.
- Intuitive user interface guides the operator through the entire testing process.
- All necessary reagents are conveniently included in each single use, sealed cassette with no preparation required. All necessary consumables are supplied with the kit.
- The Randox VeraSTAT allows for results to be exported via Bluetooth connectivity.
- Flexible test menu comprising of a range of immunoassay, protein, inflammatory, diabetes & infectious disease markers.
Novel testing approaches identifying the type of infection at the point of care are essential in accurately guiding appropriate antibiotic treatment. Although these tests can’t determine what type of viral or bacterial infection a patient has, it will determine whether the infection is viral or bacterial, further testing is then carried out to determine what type of pathogen the patient has via PCR – the gold standard. The ability to distinguish between viral and bacterial infections is the most effective guide for clinical decision making and is an innovative tool for antibiotic stewardship.
References
1 – Fleming-Dutra K.E., Hersh A.L., Shapiro D.J. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA. 2016;315:1864–1873. doi: 10.1001/jama.2016.4151.
2 – Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial. BMC Fam Pract. 2007;8:15.
3- New report calls for urgent action to avert antimicrobial resistance crisis [Internet]. World Health Organization. World Health Organization; 2019
4 – Hutchings MI, Truman AW, Wilkinson B. Antibiotics: past, present and future. Curr Opin Microbiol. (2019) 51:72–80. doi: 10.1016/j.mib.2019.10.008
For more enquiries please contact the Marketing team: market@randox.com
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NEWS
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CRP & MxA VeraSTAT
VeraSTAT | CRP & MxA
Rapid Differentiation of Viral & Bacterial Respiratory Infections
MxA protein has the potential to greatly enhance the rapid detection of viral respiratory infections and increases significantly when there is actuate viral infection.
CRP is the dominant acute phase protein often used to guide treatment of a bacterial infection or inflammation associated with tissue injury, inflammatory disorders, and associated diseases.
Together, allow clinicians to make appropriate decision in supporting antimicrobial stewardship and guide thappropriate use of antibiotics.
MxA
VeraSTAT MxA kit is an in vitro near-patient diagnostic test for the quantitative determination of Myxovirus resistance protein A (MxA) from whole blood. The MxA Kit is used for detection of acute respiratory tract viral infections from symptomatic patients.
CRP
VeraSTAT CRP kit is an in vitro near-patient diagnostic test for the quantitative determination of C-reactive protein (CRP) from whole blood to assess the inflammatory status of the body.
Sample Volume- 7 μL
Sample Type- Whole Blood
Measuring Time- 11 minutes
Ordering Information: VS1004
Sample Volume- 5 μL
Sample Type- Whole Blood
Measuring Time- 6 minutes
Ordering Information: VS1003
Useful Resources
VERASTAT-V
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VERASTAT BROCHURE
VeraSTAT
VeraSTAT | Excellence at the Point of Care
Accurate & Reliable Results in Minutes
Why Choose the VeraSTAT?
- Eliminate delays in sending samples to the lab and facilitate immediate decision making at the point of care.
- All necessary reagents are conveniently included in each single use, sealed cassette with no preparation required. All necessary consumables are supplied with the kit.
- Lightweight, portable and convenient, the Randox VeraSTAT can be used in a variety of locations to deliver results as required.
- The Randox VeraSTAT allows for results to be exported via bluetooth connectivity.
- Intuitive user interface guides the operator through the entire testing process.
- Flexible test menu comprising of a range of immunoassay, protein, inflammatory, diabetes & infectious disease markers.
The Randox VeraSTAT is a simple, accurate, portable point of care device which delivers rapid results via the use of patented cathodic electrochemiluminescence technology (C-ECL).
Through this technology, the target analyte in the patient sample reacts with the labelled antibody and captured antibody. After the reaction, unbound or excess labelled antibody is washed away and the labelled antibody complex is excited with electricity, with the electrochemiuminescence being measured and an accurate result produced.
Designed with the aim of offering users the next generation of rapid diagnosis, the VeraSTAT eliminates the requirement to send samples to a laboratory and instead returns results in as little as 6 minutes when and where required.
The superiority of the VeraSTAT allows for users to overcome performance limitations of previous generation tests relating to sensitivity, accuracy, ease of use and cost efficiency. This, combined with a versatile test menu, means that the Randox VeraSTAT is built to outshine and enhance detection in any setting.
Click here to download Windows App:
- Download VeraSTAT Analyzer windows application to your computer.
- Extract the zipped file and double click VeraSTATsetup
- Follow the application install instruction to install the application on device
VeraSTAT User Guide
VeraSTAT Test Menu
C-Reactive Protein (CRP)
CRP is the dominant acute phase protein often used to guide treatment of a bacterial infection or inflammation associated with tissue injury, inflammatory disorders and associated diseases.
Myxovirus Resistance Protein I (MxA)
An informative general marker for the most common acute viral infections. MxA protein has the potential to greatly enhance the rapid distinction between viral and bacterial respiratory infections.
Useful Resources
VERASTAT-V
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VERASTAT BROCHURE
RIQAS Point of Care EQA
Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres, RIQAS Point of Care EQA provides independent evidence of the accuracy and reliability of test results. Randox International Quality Assessment Scheme (RIQAS) is the world’s largest EQA scheme with over 55,000 participants in more than 134 countries.
Why RIQAS Point of Care?
About RIQAS Point of Care
How it Works
Tests and Analysers
Test Role Matrix Lipids (Total Cholesterol & HDL Cholesterol) • Risk factors for heart disease
• Monitoring lipid lowering therapy
Whole Blood HbA1c (Glycated Haemoglobin) • Diagnosing diabetes mellitus
• Monitoring treatment
• Encouraging self-management
Whole Blood C-Reactive Protein (CRP) • Early detection of infectious disease
• Identifying need for antibiotic treatment
Whole Blood Glucose/Ketones • Diagnose and monitor diabetes
• Monitor for the presence of hypoglycaemia
(low blood glucose) and hyperglycaemia (high blood glucose)
• To determine whether excessive ketones are present in the blood, to detect diabetic ketoacidosis (DKA)
Serum International Normalised Ratio (INR) • Used to measure the effect of anticoagulant
drugs such as warfarin
• Help diagnose a bleeding disorder; to help
estimate the severity of liver disease
Plasma Note – The RIQAS Point of Care range is constantly expanding to include new tests and analysers. Please contact us if your desired analyser or test is not currently displayed.Ordering Information
Panel Catalogue Number Lipids RQ9181/A Lipids + 1 panel RQ9181/B Lipids + 2 panels RQ9181/C Additional Sample RQ9181/D Glucose and Ketones RQ9188 INR RQ9189 Pipette Tips RQ9182 Bulbous pipette RQ9183 What Participants Say
Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:
“All in all a quick and efficient service”
“Good online system”
“Very helpful team”
“Excellent training”
“They are an experienced team”
“Very satisfied with the service that we receive”
“Very good value for money”
“The website is great”Key Cycle Dates
RQ9181 Distribution Month Sample Distributed Result Submission Deadline January 2023 9th January 18th January February 2023 6th February 15th February March 2023 6th March 15th March April 2023 3rd April 12th April May 2023 2nd May 10th May June 2023 5th June 14th June July 2023 3rd July 12th July August 2023 7th August 16th August September 2023 4th September 13th September October 2023 2nd October 13th October November 2023 6th November 15th November December 2023 4th December 13th December Importance of Quality Assurance
Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:Internal Quality Control
Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.External Quality Assessment
External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.
EQA provides assurance to both staff and customers that testing provides accurate and reliable results.Want to know more?Visit our Importance of EQA page to learn more.
Want to know more?
Contact us or download the RIQAS Point of Care catalogue to learn more.
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Frequently Asked Questions
RIQAS
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Randox Sepsis innovation hailed by Health Secretary Matt Hancock
An innovative new tool for quickly diagnosing the often deadly infection Sepsis, will save lives, the Health Secretary has said.
The bedside test, being developed by healthcare diagnostics company Randox, will slash the 24 hours usually taken to identify the correct antibiotic for sepsis treatment. Currently, more than a third of those with sepsis die. Every hour that patients are not diagnosed increases the chance of death by 8%.
Health Secretary Matt Hancock said: “Instead of having to give people huge amounts of antibiotics across the board, which causes other problems, both medical and problems with resistance and super bugs, instead we will be able to work out exactly what the right treatment is for that individual person and do it fast enough to get the treatment in to save lives.”
He paid a visit to Randox’s new headquarters, the Randox Science Park, in Antrim, Northern Ireland on Thursday 21st March.
He added: “I can see a very clear application across the health service for how we can use the technology that is being developed here in Northern Ireland, both across the UK and indeed around the world.”
Sepsis can develop from infections caused by a simple cut or minor medical procedure. The body’s white blood cells fight the infection but the reaction can escalate and also damage healthy tissue.
Many who survive face amputations because of this tissue damage, Randox’s Molecular Diagnostics Manager Dr Martin Crockard said.
Dr Crockard highlighted that the traditional sepsis testing method, which involves sending blood samples to laboratories, takes too long. The problem is worsened by the fact that doctors are then forced to initially prescribe broad spectrum antibiotics which are not specific enough for individual patients. This encourages resistant strains.
To speed up the process, the new technology from Randox’s Biosciences division will allow clinicians in hospital emergency departments to check multiple samples simultaneously, at the press of a few buttons on a smart pad.
Dr Crockard said it is imperative that appropriate antibiotic treatment is administered as quickly as possible.
He said: “We can deal with the exact organism causing the problem in less than four hours, allowing you to tailor the treatment for that individual patient very quickly.”
The UK Sepsis Trust’s Chief Executive Ron Daniels said: “Randox is leading the way around molecular technologies.
“No other system brings this so close to the clinician on the shop floor.”
For further information please contact the Randox PR team by emailing randoxpr@randox.com or phoning 028 9442 2413
Point of Care Testing (POCT) Explained
Point of Care Testing (POCT) is the delivery of a test at the point in time at which the result will be used to make a decision and taking appropriate action resulting in an improved health outcome. It is also known as near patient, bed-side, extra-laboratory, decentralised, and ancillary testing [1]. It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment [2].
Point of care testing is not a recent practice; many early diagnostic tests were administered at the bedside. However, analytical technology has progressed and multiple tests can be performed within minutes in a laboratory. Recently, this technology has been put into the hands of the staff near the patients [2]. There are two types of technology, benchtop analysers and hand held devices. Bench top systems are just smaller versions of laboratory analysers but some steps are automated. Hand held devices are simple in appearance but complex internally, they can manage several tasks including, adding reagents, separating cells from plasma, and reading colour or other measures.
Results can be obtained faster, allowing for more immediate decisions meaning treatment can begin sooner. Patients can live a longer and higher quality life, helped by a reduction in the length of hospital stays.
Some benefits of POCT [2]:
Key objective
The main objective of Point of Care Testing is to generate results more quickly so that appropriate treatment can be provided, resulting in an improved patient outcome.
Management
Accurate and reliable results can only be obtained if the patient and sample are treated correctly. Point of care testing is likely to be performed by staff with a limited technical background, so training and quality control are vital.
Outcomes
Proper analysis technique alone is not enough to ensure an accurate decision; any test will only be beneficial if the appropriate action is taken based on the result. The effectiveness of POCT is assessed in terms of the overall outcome of the patient.
There are three phases in the POCT cycle: pre-analytical phase, analytical phase, and post-analytical phase. About 90% of quality issues are attributed to the pre-analytical and post-analytical phases [3]. These errors are mainly attributed to user error and can be caused by a number of issues including, selecting the wrong POCT device, not following manufacturer instructions, inadequate training, not adhering to appropriate QC practices, and many more.
The errors can usually be mitigated by implementing an action plan and ensuring it is executed exactly as designed, deviation from the action plan will lead to errors. Errors in POCT diagnostics can lead to misdiagnosis, improper treatment, costly follow-up procedures, and death.
Some strategies for improvement:
Internal Quality Control and External Quality Assessment is conducted to monitor the stability of the analytical measurement system and to alert the operator to a change that may lead to a medically significant error [6].
A study by Price, Smith and Bruel [8] was conducted on a number of labs over a period of time of up to 15 years. They discovered that test result performance improved with time and was associated with regular participation in External Quality Assessment (EQA) schemes and with the use of internal quality control (IQC) procedures.
Internal Quality Control
Internal Quality Control (IQC) is used to assess the day-to-day consistency of assay performance, providing quality assurance for patient results. IQC activities are among the ten most common POCT deficiencies. These may include performing and documenting quality control testing and taking the correct action for outliers [4]. This poor performance could be attributed to how IQC is viewed in POCT; users may lack appreciation of the potential for errors and may see the analyser as infallible, they likely see IQC as an additional workload as opposed to part of their testing routine.
CLSI regulations require risk assessment for each stage of patient testing alongside an implementation of a quality control plan. Below are some suggestions for how IQC should be conducted for POCT.
Conduct
IQC should be conducted when: a new lot of consumable is used; a patient result is queried; after maintenance; the device has been physically insulted. IQC should be conducted by the usual device operator so assurance can be provided for the whole testing process.
Training
ISO 22870 requires POCT users should be trained in the theory and practice of IQC [5]. Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.
Material
QC material for POCT should be obtained from a third party provider and not rely on material provided by the device manufacturer, the benefits of which are well documented. It should also contain analytes at clinically relevant concentrations, be provided ready-to-use, and be stable at ambient temperatures.
Results
All IQC results must be recorded with the date, time, user, decision to accept or reject, and any actions taken as appropriate. Locally assigned ranges alongside analyte-specific rules should be used to maximise error detection. An example of how IQC could be recorded and an action flowchart can be seen in Fig. A below.
Troubleshooting
There should be a protocol for required actions following a failed IQC. Any troubleshooting should be developed with knowledge of the most common errors and user capability.
Review
A monthly review should be conducted to identify persistent failures and trends.
The cost of IQC may also be a factor in resistance to IQC, however, while it is difficult to quantify, the cost of not conducting it may be greater in terms of human harm. A whitepaper is available detailing IQC in POCT (download).
![Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]](https://www.randox.com/wp-content/uploads/2018/08/Fig.-A.jpg "Fig. A")
Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]. (Click to expand)
External Quality Assessment
External Quality Assessment (EQA) or Proficiency Testing (PT) involves running blind patient-like samples and comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results. (Learn more about EQA)
Benefits of participation in an EQA programme include assessment of result accuracy, assessment over time, comparisons with instruments, methods and peers, and providing confidence in test results.
EQA for POCT is, in theory, similar to EQA in a large laboratory. There is a significant difference however, the POCT participants are usually health care professionals with little knowledge of laboratory medicine. A lack of understanding of the importance of EQA had led to a smaller percentage of sites participating than large laboratories.
A Good EQA Scheme
A good EQA scheme should offer:
Conducting EQA in POCT
Below are some suggestions for how EQA should be conducted for POCT.
Conduct
EQA should be conducted by the operator who normally conducts patient testing to ensure the true workflow is assessed [6].
Material
EQA samples should be commutable, meaning they have the same numeric relationship between measurements procedures as is observed for a panel of patient samples (reacts the same as a real patient sample).
Report Frequency
Challenges / surveys should be frequent enough to identify systematic errors in a timely manner, affecting the fewest patient results [10].
Report Turnaround
A fast turnaround time allows test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab.
Review
A regular review of past EQA results should be part of the cycle of quality.
Guidance
A POCT EQA provider should be able to provide assistance when the user is having difficulties.
Results
Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.
Internal Quality Control
Randox offer a number of controls suitable for Point of Care Testing applications:
Acusera Blood Gas Control
The Randox Acusera Blood Gas Quality Controls contain assayed target values for ten parameters, covering pH, pCO2, pO2, electrolytes, glucose and lactate. The material is provided in easy to open ampoules for added convenience and ease-of-use. The liquid ready-to-use nature of the control makes it ideal for use in point-of-care testing and on a wide range of blood gas instruments.
Acusera Liquid Cardiac Control
The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore, an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.
Acusera Liquid HbA1c Control
Liquid Urine Control
The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2℃ – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.
External Quality Assessment
Randox offers RIQAS Point of Care, a simple EQA scheme designed for use in point of care settings. It is a single sample, single scheme programme featuring whole blood samples for authentic patient sample assessment.
RIQAS
RIQAS Point of Care
Acusera
[1] C. Price, A. St john and J. Hicks, “Point-of-care testing”, 2004. [Online]. Available: http://mldt.hu/upload/labor/document/PRICEP.pdf. [Accessed: 23- Jul- 2018].
[2] C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.
[3] A. Okorodudu, “Optimizing accuracy and precision for point-of-care tests”, Acutecaretesting.org, 2011. [Online]. Available: https://acutecaretesting.org/en/articles/optimizing-accuracy-and-precision-for-point-of-care-tests. [Accessed: 24- Jul- 2018].
[4] H. Holt and D. Freedman, “Internal quality control in point-of-care testing: where’s the evidence?”, Annals of Clinical Biochemistry, vol. 53, no. 2, pp. 233-239, 2016.
[5] “ISO 22870:2016 – Point-of-care testing (POCT) — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/71119.html. [Accessed: 25- Jul- 2018].
[6] J. Gill and M. Shephard, “The Conduct of Quality Control and Quality Assurance Testing for PoCT Outside the Laboratory”, Clin Biochem Rev., vol. 31, no. 3, pp. 85-88, 2010.
[7] A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.
[8] C. Price, I. Smith and A. Van den Bruel, “Improving the quality of point-of-care testing”, Family Practice, vol. 35, no. 4, pp. 358-364, 2017.
[9] “ISO 15189:2012 – Medical laboratories — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/56115.html. [Accessed: 31- Jul- 2018].
[10] J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.
[11] G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.