VeraSTAT
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
Useful Resources
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VERASTAT BROCHURE
QCMD SARS-CoV-2 Antigen Testing Pilot Study
QCMD
SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study
Randox, in partnership with QCMD, is pleased to announce a new QCMD EQA pilot study for SARS-CoV-2 (COVID-19) Antigen Testing. This new pilot is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 (COVID-19) antigen and will provide an opportunity to assess performance against an international peer group.
QCMD is a world leading EQA / Proficiency Testing (PT) provider, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. With an extensive database of over 10,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the fi eld of infectious disease testing.
Features & Benefits
- Smart-Phone App Results Submission
Results can be returned via a smart-phone app so that participants using lateral flow devices can provide pictures of their device/result with the phone camera.
- Comprehensive Reports
A real-time rapid report will be provided on submission of results. An individual report is received after each challenge, summarising laboratory performance in comparison to an international peer group.
- EQA Management System
IT 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.
- Not infectious
Samples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.
- Suitable for Point of Care
Samples are supplied liquid ready-to-use ensuring they are ideal for use at the point care.
Specification
Target Range – Covers the clinical range
Matrix – Universal p9 virusPHIX sample stabilisation buffer
Sample Format – Eluted swab samples with a buffer
Analysis Type – Qualitative
Shipping Conditions – Ambient
Format – Liquid ready-to-use
Ordering Information
| Catalogue Number | Challenges | Samples per Challenge | Distribution / Testing Period |
|---|---|---|---|
| QAS214224 | 3 | 3 | Q2, Q3, Q4 |
Related Products
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 47,000 participants in more than 139 countries.
Why RIQAS Point of Care?
About RIQAS Point of Care
How it Works
On a monthly basis we will distribute an identical sample of blood to all participating sites. Each participating site will test the sample in the same way they would test a real patient sample, then return their test results to RIQAS within a set time. The scheme is unique in distributing whole blood samples rather than serum based samples, this ensures that samples act identically to real patient samples at the point of care.
An electronic report is then sent to participants, comparing their results with other participants using the same analyser. Satisfactory and unsatisfactory performance is represented using a traffic light system, allowing instant identification of any issues. A more detailed breakdown of performance may be obtained if further information is required. With time, an overall picture will emerge showing whether results are consistently accurate and reliable or whether there may be an underlying analyser and/or operator issue.
Tests and Analysers
Test Role Frequency HbA1c • Diagnosing diabetes mellitus
• Monitoring treatment
• Encouraging self-management
Monthly Total Cholesterol & HDL Cholesterol • Risk factors for heart disease
• Monitoring lipid lowering therapy
Monthly C-Reactive Protein (CRP) • Early detection of infectious disease
• Identifying need for antibiotic treatment
Monthly Glucose • Diagnose and monitor diabetes
• Monitor for the presence of hypoglycaemia
(low blood glucose) and hyperglycaemia (high blood glucose)
Monthly, Bi-monthly and Quarterly 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
Monthly Ketones • To determine whether excessive ketones are
present in the blood, to detect diabetic
ketoacidosis (DKA)
Monthly, Bi-monthly and Quarterly 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 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”Distribution Dates
Distribution Month Sample Distributed Result Submission Deadline January 2022 10th January 19th January February 2022 7th February 16th February March 2022 7th March 16th March April 2022 4th April 13th April May 2022 3rd May 11th May June 2022 6th June 15th June July 2022 4th July 13th July August 2022 1st August 10th August September 2022 5th September 14th September October 2022 3rd October 12th October November 2022 7th November 16th November December 2022 5th December 14th 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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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.
Importance of External Quality Assessment (EQA)
External Quality Assessment (EQA) / Proficiency Testing (PT) allows for a comparison of a laboratory’s testing procedures to other laboratories across the world. Comparisons can be made to a peer group of laboratories or to a reference laboratory.
EQA involves running blind patient-like samples, 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.
Participating in an EQA scheme allows a laboratory to gather valuable data, this data can be used in a variety of ways [1]:
EQA provides assurance to both staff and customers that testing taking place at your laboratory provides accurate and reliable results. Problems can be identified early on and corrective action can be untaken. The reliability of methods, materials, and equipment can be evaluated and training can be developed and its impact monitored.
Large laboratory groups can compare their performance with sites across their group, ensuring accuracy and consistency no matter where testing takes place.
EQA participation is often a requirement for accreditation, gaining accreditation alone has a host of benefits, not least an increased confidence in results from customers, current and potential.
Read more about accreditation: ‘The Importance of Meeting ISO 15189 Requirements’.
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand for POCT has recently seen rapid growth, this comes from the advantages including the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.
EQA is strongly recommended for all point of care devices and is recommended by ISO 22870, which providesspecific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.
There are many External Quality Control schemes that come in different varieties. EQA schemes can be mandatory, required either by accreditation or law. Others are voluntary and carried out by laboratories who want to ensure that they are carrying out accurate testing and improve the quality of the lab’s performance [1].
A good EQA scheme should offer:
EQA is a great tool for comparing against a peer group and maintaining an effective QC strategy, however, it has its limitations.
EQA / PT alone cannot provide a complete evaluation alone; it is important to also run third party controls regularly. You can find out about the importance of third party controls here.
EQA results can also be affected by variables not relating to patient samples, including preparation, clerical functions, matrix effects, and selection of method. The errors can appear to be a downside to EQA but it can be used as a way to evaluate staff performance as well as assay performance.
If possible, every laboratory should participate in an EQA scheme that covers all testing procedures. Laboratories need to develop a management process with the objective to assure that EQA samples are treated appropriately and in the same manner. This includes, sample handling, sample analysis, record keeping, investigating deficiencies, taking corrective actions, and communicating results with laboratory staff and management.
Problems at any stage of sample analysis can cause errors, when an error does happen, all elements of the process need to be checked. Some examples of errors:
Pre Analysis
• Incorrect sample handling during preparation, shipping or storage
• Improper storage
• The material has expired
• An error in manufacturing
Analysis
• Instrument, calibration or reagent defects
• Staff competency
• Matrix effects
• Incorrect analysis method
Post Analysis
• Report misinterpretation
• Clerical or transcription errors
• Failure to take corrective action
• Where possible, all laboratories should participate in an EQA scheme for all tests that they perform.
• EQA samples should be treated in the same way as a patient sample, using the same procedures, instruments, methods, and staff who normally perform the testing.
• EQA provides valuable resources and data to effectively maintain accurate and reliable results and should be seen as educational.
Randox offers RIQAS, the largest EQA scheme in the world with over 45,000 participants across 133 countries, offering 33 consolidated programmes. Randox also offers a range of over 90 molecular programmes for infectious disease testing with Quality Control for Molecular Diseases (QCMD).
Features and Benefits
Fully accredited to ISO/IEC 17043:2010
Consolidated programmes
High frequency reporting
The highest quality material
User-friendly reports
To learn more about RIQAS, visit the RIQAS homepage.
RIQAS
RIQAS Point of Care
QCMD
[1] WHO, Overview of External Quality Assessment (EQA). World Health Organisation, 2009.
[2] ISO 15189:2012 Medical laboratories — Requirements for quality and competence, 3rd ed. ISO, 2014.
[3] ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence, 2nd ed. ISO, 2016.
RIQAS Point of Care – FAQs
RIQAS Point of Care
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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
- Total CO2
- Chloride
- Lactate
- Sodium
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