RIQAS Point of Care EQA
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.
Why RIQAS Point of Care?
Programme Offering
Tests
Role
Matrix
Learn More
Lipids (Total Cholesterol & HDL Cholesterol)*
- Risk Factor for heart Disease
- Monitoring lipid lowering therapy
Whole Blood
HbA1c (Glycated Hemoglobin)*
- Diagnosing diabetes mellitus
- Monitoring treatment
- Encouraging self-management
Whole Blood
CRP (C Reactive Protein)*
- Early detection of infectious disease
- Identifying need for antibiotic treatment
Whole Blood
Glucose / Ketones
- Diagnose and monitor diabetes
- Monitor the presence of hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose)
- To determine whether excessive ketones are present in the blood, to detect diabetic ketoacidosis (DKA)
Serum
Key Cycle Dates
RQ9181 Distribution Month Sample Distributed Result Submission Deadline January 2024 8th January 17th January February 2024 5th February 14th February March 2024 4th March 13th March April 2024 2nd April 10th April May 2024 6th May 15th May June 2024 3rd June 12th June July 2024 1st July 10th July August 2024 5th August 14th August September 2024 2nd September 11th September October 2024 7th October 16th October November 2024 4th November 13th November December 2024 2nd December 11th December What Participants Say
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”
The Importance of Quality Assurance
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?
Contact us or download the RIQAS Point of Care catalogue to learn more.
Continue Reading
Frequently Asked Questions
RIQAS
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VeraSTAT-Sports Performance
Best in the Field
Eliminate delays in sending samples to labs and receive rapid results for rapid recovery in 6 minutes.
Requires just a few drops of whole blood or serum, ideal for use at the point of care.
Lightweight, portable and convenient, the Randox VeraSTAT delivers diagnostic results where and when they are required.
The Randox VeraSTAT allows for results to be exported via bluetooth connectivity.
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.
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
GET IN TOUCH
VERASTAT BROCHURE
Qnostics SARS-CoV-2 Controls
Qnostics
Respiratory Target Multiplex (RTX) 1 Control
This multiplex control has been designed in response to the current Coronavirus pandemic. The control can be used to support the validation, verification and performance monitoring of molecular assays used in SARS-CoV-2 testing and other respiratory pathogens.
Meeting the requirements of various testing strategies, this 4-plex control covers multiple viral pathogens that cause respiratory diseases in various patient cohorts, in line with public health testing and the test menu of most syndromic assays.
Having a multiplex control, like the Qnostics RTX1, gives great flexibility to laboratories and allows them to meet laboratory requirements in terms of respiratory pathogens covered whilst keeping QC tests to a minimum.
Features & Benefits
- Whole Pathogen Control
Containing the entire SARS-CoV-2 genome, the RTX1 Control is compatible with the majority of commercial and in-house assays. As a whole pathogen control, it targets the whole viral genome.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Highly Characterised
Using highly characterised controls enable labs to meet their daily QC needs and accreditation requirements. Qnostic controls are quantified by digital PCR to ensure batch-to-batch reproducibility.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Liquid for Ease-of-Use
Conveniently supplied in liquid frozen format meaning there is no additional preparation or handling required.
Specification
Target Pathogen – Influenza A (H1N1), Influenza B (Victoria), Respiratory Syncytial Virus (A), Coronavirus (SARS-CoV-2)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – RUO
Ordering Information
| Catalogue Number | Product Description | Pack Size | Package Insert |
|---|---|---|---|
| RTX1QC | RTX1 Q Control | 5 x 0.6 ml | Kit Insert |
SARS-CoV-2 (COVID-19) Control
In response to the current Coronavirus outbreak, Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19). Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control. The use of third-party controls will allow laboratories to effectively monitor the performance of diagnostic methods. For more information on Qnostics click here
Features & Benefits
- Whole Pathogen Control
Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Negative Control Available
Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Complete QC Solution
Products available for new assay validation as well as routine performance monitoring.
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Q Controls
Whole pathogen controls designed to monitor assay performance on a run to run basis. As true third party controls, assay drift is detected, monitored and managed helping to ensure accurate and reliable results.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2QC | SARS-CoV-2 Q Control | 5 x 0.5 ml |
| TMNQC | Negative Q Control | 5 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Analytical Q Panels
Designed to span the analytical measuring range of an assay, allowing assessment of linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ).
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2AQP | SARS-CoV-2 Analytical Q Panel | 9 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Molecular Q Panels
Four individual levels including a negative are provided spanning the assays’ clinical range. Molecular Q Panels may be used to support laboratory training and in the performance assessment and validation of molecular diagnostic assays.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2MQP | SARS-CoV-2 Molecular Q Panel | 4 x 0.5 ml |
Specification
Target Pathogen – Novel Coronavirus SARS-CoV-2, SARS-CoV-2 (Delta, Alpha, Beta, Gamma, Eta, Alpha N variant, Omicron)
Matrix – Transport Medium (TM)
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately
Regulatory Status – Research Use Only (RUO)
Evaluation Panel
Intended for research use only, this evaluation panel is designed to help laboratories develop their molecular procedures.
Suitable for use with most commercial and in-house molecular methods, this panel is characterised using real-time PCR and NGS. The panel contains variants of whole pathogen inactivated SARS-CoV-2 and is supplied in a liquid-frozen format.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2TEP | SARS-CoV-2 Typing Evaluation Panel | 8 x 1.0 ml |
Related Products
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 2024 8th January 17th January February 2024 5th February 14th February March 2024 4th March 13th March April 2024 2nd April 10th April May 2024 6th May 15th May June 2024 3rd June 12th June July 2024 1st July 10th July August 2024 5th August 14th August September 2024 2nd September 11th September October 2024 7th October 16th October November 2024 4th November 13th November December 2024 2nd December 11th 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.
Continue Reading
Frequently Asked Questions
RIQAS
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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.
RIQAS Point of Care – FAQs
RIQAS Point of Care
RIQAS
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ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
ISO 22870:2006
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.
Blood Gas Quality Controls
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.
Features & Benefits
- Liquid ready-to-use
- Aqueous material
- Method specific target values provided for the most common blood gas analysers
- Suitable for use in POC testing
- Stable to expiry date at 2°C – 8°C
- Once opened controls should be analysed immediately for pH and blood gas parameters, for electrolyte measurements the control should be analysed within 1 hour of opening
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Blood Gas Control Level 1 | 30 x 1.8ml | 10 | BG5001 | |
| Blood Gas Control Level 2 | 30 x 1.8ml | 10 | BG5002 | |
| Blood Gas Control Level 3 | 30 x 1.8ml | 10 | BG5003 | |
Analytes
- pCO2
- pO2
- Calcium
- Glucose
- Potassium
- pH
- Bicarbonate
- Chloride
- Lactate
- Sodium