Randox QC unveils brand new multi-analyte commutable Acusera Infectious Disease Controls
Randox Quality Control is set to introduce its brand new Acusera Infectious Disease (Serology) Controls at the American Association for Clinical Chemistry 2019, designed to deliver a cost-effective, high quality solution for the analysis of infectious diseases whilst producing trustworthy results.
The Infectious Disease Serology Internal Quality Controls will include quality control material for Lyme Disease, ToRCH, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).
Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements while also reducing inconvenient shifts in QC results when reagent batches are changed.
Lynsey Adams, Randox Quality Control Manager, commented;
“These controls are the first of their kind on the market to be used on a wide range of immunoassay analysers. Unlike the current practice of analyser-specific tests, these controls can be used across a wide range of laboratory technologies and, with a working stability of 60 days at 2°c to 8°c, waste and costs are kept to a minimum.”
Acusera Infectious Disease (Serology) Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials, saving laboratories valuable space and time. A single control can be used to assess performance across a range of analytes.
Key benefits of the Acusera Infectious Disease Controls;
- All samples are provided in a user-friendly, liquid, ready-to-use format
- Manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
- Designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
- Working stability of 60 days ensures waste and costs are kept to a minimum
- Multi-marker controls help reduce the number of individual controls required
- Designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance
Ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing, Randox QC’s Acusera Infectious Disease (Serology) Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.
A ground-breaking new test which improves the accuracy of stroke diagnosis has been developed by Randox scientists.
The Randox Stroke Biochip is a rapid and highly sensitive blood test that will complement and enhance existing CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.
With a unique ability to differentiate between ischaemic and haemorrhagic stroke, the Randox Stroke Biochip takes less than 30 minutes to complete – making sure patients get the right diagnosis as fast as possible.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, whose team developed the test, commented;
“There is great tragedy in the fact that the majority of stroke damage can be minimised if intervention is delivered on time, yet too often the window closes before a diagnosis is made. For doctors, nothing is more frustrating.
“Excellent work has been undertaken to assist the public in recognising the signs of a stroke so people can get to hospital as quickly as possible. Our stroke test is the vital next step – assisting clinicians in making a rapid diagnosis and differentiation between haemorrhagic and ischaemic stroke, so their patients get the right treatment at the right time.”
Using Randox revolutionary patented Biochips, the Randox Stroke Biochip provides a unique solution for simultaneous detection of multiple stroke biomarkers from a single sample, facilitating fast and accurate classification of stroke patients in an emergency setting.
Benefits of the Randox Stroke Biochip
- Results in 30 minutes on the Evidence MultiSTAT
- Unique solution for stroke classification
- Differentiation of ischaemic and haemorrhagic stroke
- Guarantees rapid thrombolytic therapy ensuring better patient outcomes
John Lamont, R&D Director for Randox Laboratories, explained the benefits of the Stroke Biochip;
“While patients undergo a CT scan to confirm either the presence or lack of a haemorrhagic stroke, a blood test on the Randox Biochip can be run on our innovative point-of-care analyser, the Evidence MultiSTAT, to identify the same for an ischaemic stroke.
“For the almost 90% of stroke patients who are ruled out for haemorrhagic stroke1, the Randox Biochip will then accelerate decision making for clinicians with regards to thrombolytic therapy.
“Any treatment is most effective if started as soon as possible after the stroke occurs, and so every minute that passes without a diagnosis is likely to leave a permanent mark on a stroke patient’s future health and lifestyle. The vitally important diagnostic information from the Randox Stroke Biochip facilitates accurate stroke classification, directs the appropriate patient care pathway, and enables rapid thrombolytic therapy, ensuring a better patient outcome for ischaemic stroke sufferers, for whom time is of the essence.”
Whilst the Randox Stroke Biochip is currently being used as complementary testing in parallel with CT scanning, Mr Lamont is confident of a more prominent role for the test in the future patient pathway;
“The Biochip has the potential to really revolutionise the stroke diagnosis pathway as we currently know it. The accessibility of this type of blood testing could potentially extend its use beyond the A&E department, to ambulances and even the home, in the form of a hand-held testing device.”
For further information about our pioneering Stroke Biochip please visit us at stand 1101 at this year’s AACC or follow the links below.
Whole pathogen Blood Borne Virus (BBV) controls have been brought to market by global diagnostics company Randox Laboratories.
The molecular controls, available under the brand name Qnostics, are versatile in monitoring the presence of BBVs, including HIV, Hepatitis B and Hepatitis C.
For use with molecular methods, the controls are manufactured using whole pathogens and therefore mimic the patient sample, providing the best sample matrix for laboratories.
Lynsey Adams, Randox Quality Control Manager, explained;
“We’re delighted to be able to bring to market these whole pathogen Blood Borne Virus Controls, which are designed to help molecular laboratories effectively manage assay performance.
“Using whole pathogens in the development of the controls ensures we meet the demands of today’s molecular diagnostics laboratories by monitoring the entire testing process.”
The Molecular BBV controls from Randox, which are liquid frozen for user convenience and ease of use, will aid microbiology and virology laboratories to monitor assay drift and ultimately will help to ensure accurate test system performance. Each control is designed to be medium positive and are suitable for use with a variety of molecular workflows.
“These versatile Blood Borne Virus controls can be used in the daily monitoring of assay performance, but are equally applicable for use in the validation/verification of new assays, and may also be used for troubleshooting after poor EQA performance.”
Randox Blood Borne Virus Molecular Controls are manufactured to ISO 13485 standards and calibrated against an independent Internal Reference Material. Also included within the Qnostics BBV range are Molecular Q panels. Each molecular Q panel includes a negative, low, medium and high positive sample designed to cover more of the assays measuring range.
Key Features and Benefits of Randox Blood Borne Virus Qnostics Controls:
- Third party controls as recommended by ISO 15189:2012
- Specifically designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT)
- Suitable for use across a wide range of molecular assays to monitor the entire molecular workflow from extraction to amplification and detection
- Flexible and suitable for use with the majority of commercial and in-house molecular methods
- Traceable to the current relevant WHO International Standards and characterised by digital PCR
- Liquid frozen for user convenience and ease of use, with no additional preparation required
- Calibrated against an independent Internal Reference Material (IRM)
- Quality products manufactured to ISO 13485: 2016 standards
- Manufactured using whole pathogens and therefore mimic the patient sample providing the best possible sample matrix for laboratories
- New controls available include Hepatitis B (HBV) Medium Q Control, Hepatitis C (HCV) Medium Q Control and HIV Medium Q Control
- US-IVD labelled for clinical use
For further information please visit https://www.randox.com/molecular-infectious-disease-controls/blood-borne-virus-testing/, visit us at stand 1101 at this year’s AACC or email firstname.lastname@example.org
Randox Quality Control is set to launch new Acusera Verify linearity sets at the American Association for Clinical Chemistry 2019.
Randox Linearity sets are designed to challenge a larger segment of an instrument’s reportable range, and test validity of system calibration. The Acusera Verify materials will cover testing of C-reactive Protein, Rheumatoid Factor, Lipids, Therapeutic Drugs, and Esoterics, amongst others and are compatible for use with Roche Cobas and Beckman systems.
Materials also include a unique combination of analytes, meaning laboratories do not need multiple products for testing, which reduces both costs and need for storage space.
Lynsey Adams, Randox Quality Control Manager, commented;
“Acusera Verify’s range of instrument-dedicated calibration verifiers are designed to challenge the entire Analytical Measuring Range, whilst remaining convenient to use and helping to meet Clinical Laboratory Improvement Amendments (CLIA) requirements.”
According to CLIA, a laboratory should perform and document calibration verification procedures at least once every 6 months and/or whenever one of the following occur;
- A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range.
- There is a major preventive maintenance or replacement of critical parts that may influence test performance.
- Control material reflects an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
- Laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
- New instrument validation.
CLIA also recommends that a minimum of 3 levels are tested covering the low end, mid-point and high end of the reportable range. The Clinical and Laboratory Standards Institute (CLSI) however, recommend at least 5 levels are tested. It is also considered best practice that laboratories run at least 3 replicates of each level in the same way they would a patient or control sample.
Acusera Verify from Randox QC will ensure that laboratories meet the recommended CLIA and CLSI guidelines in both a timely and costly manner.
Randox Linearity sets available:
- C-Reactive Protein (CRP) Linearity Verifiers
- High Sensitivity C-Reactive Protein (hsCRP) Linearity Verifier
- Esoterics Linearity Verifier
- Rheumatoid Factor (RF) Linearity Verifier
- Lipids Linearity Verifier
- Apolipoprotein A1 (Apo A1) & Apolipoprotein B (Apo B) Linearity Verifier
- Therapeutic Drug Monitoring (TDM) Linearity Verifier
- CO2 and Electrolytes Linearity Verifier
Acusera Verify also allows users to access real-time peer group data and automatically-generated statistics through a cloud-based data reduction software package which is supplied with all linearity sets. This provides laboratories with comprehensive graphs of results and at-a-glance performance assessment.
Global diagnostics firm Randox will next month showcase its unique life science capabilities in areas including Stroke differentiation and quality control for a range of infectious diseases, at the world’s largest laboratory medicine conference – the AACC Annual Scientific Meeting & Clinical Lab Expo – in California.
The 71st event from the American Association for Clinical Chemistry (AACC) is set to highlight the best in the industry on the world stage once again as clinicians, companies and customers from all over the world flock to the Californian Anaheim Convention Centre from Sunday 4th to Thursday 8th August 2019.
“We look forward to AACC every year as we exhibit our constantly-evolving revolutionary technologies,” said Randox Managing Director, Dr. Peter FitzGerald.
“This year we will once again highlight Randox’s ground-breaking diagnostic products and services which help to save and extend lives across the world.”
Launching at this year’s AACC event are a number of exciting new innovations from Randox, including a new offering of Infectious Disease Serology Internal Quality Controls which includes quality control material vital for the testing of HIV, Hepatitis A, Congenital infections and even Lyme Disease.
Dr. FitzGerald continued;
“We are delighted to bring our Infectious Disease Serology Internal Quality Control portfolio to market for the first time. There are approximately 1 million people in the US living with HIV and around 15% unaware they are infected.
“The impact of all infectious diseases, including HIV, is increasing and, therefore, laboratories play an increasingly larger role in providing accurate results. This is a key component in controlling the spread of infection.”
At AACC Randox will also be unveiling its brand new Randox Stroke Biochip, an advancement of its Biochip Array Technology in which an investment of £305 million has been invested to date. This disruptive technology is set to enhance CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.
Dr FitzGerald added;
“We are pleased to highlight our brand new Randox Stroke Biochip which is set to revolutionise stroke differentiation when time is of the essence. There is great tragedy in the fact that the majority of stroke damage can be minimised if intervention is delivered on time.
“Our stroke test is the vital next step – assisting clinicians in making a rapid diagnosis and differentiation between haemorrhagic and ischaemic stroke, so their patients get the right treatment at the right time.”
Randox look forward to showcasing the latest innovations in diagnostic capabilities at AACC 2019 as they strive to attain earlier diagnoses and, subsequently, earlier treatment and intervention which will directly impact on positive outcomes and reduce the burden on healthcare services. From Stroke and HIV to Lyme Disease and Hepatitis A virus, the company’s innovative technologies facilitate improved prognosis for patients when it matters most.
AACC runs from the 4th to the 8th of August 2019 at Anaheim Convention Centre, Anaheim, California. Randox can be found at booth #1101.
World-leading medical diagnostics manufacturer Randox Laboratories is this week showcasing advancements in biotechnology at the world’s largest diagnostics conference, being held in Chicago, Illinois.
The American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, known as the leading event for laboratory medicine worldwide, offers Randox the opportunity to showcase their capabilities to more than 20,000 healthcare professionals and decision makers from around the globe.
“Our pioneering diagnostic technologies are leading the way in innovation and have real potential to transform healthcare around the world,” said Randox Managing Director, Dr Peter FitzGerald.
“At AACC we will be hosting demonstrations of a wide range of our intuitive multiplex analysers, including the revolutionary Randox Evidence Evolution, the world’s first fully automated random-access testing platform, capable of delivering 2640 results in one hour, with the first delivered in just 37 minutes.”
The unique and unrivalled capabilities of the Randox Evidence Evolution are made possible thanks to Randox’s patented Biochip Array Technology, which can currently run 49 different tests simultaneously – ensuring an accurate and reliable diagnosis as fast as possible.
Launching at this year’s AACC event are a number of exciting new tests on the Randox Biochip, the result of a £280 million investment in research and development. Including but not exclusive to a diagnostic test for the differentiation of hemorrhagic and ischemic strokes, an algorithm capable of generating a patient’s Type 1 Diabetes Genetic Risk Score, and a test to diagnose Acute Kidney Injury (AKI) in the participants of pharmaceutical drug trials, these new tests all share the common goal of much earlier and effective diagnosis, to greatly improve healthcare outcomes and reduce the burden on healthcare services.
Dr. FitzGerald continued;
“We remain committed to developing new health diagnostic technologies for a range of the world’s most pressing health issues in need of the most urgent address, and to expanding the business in our key markets, such as the US.
“Our very significant investment in research and development means that we have more new tests in development than any other healthcare company in the world and are able each year to bring a wealth of exciting new technologies to the American market.
“We look forward to showcasing our latest innovations at this year’s AACC conference, and how they can be utilised to save, improve and extend lives through the earliest possible diagnosis. Randox technology can truly revolutionise the future of healthcare.”
AACC runs from the 29th July – 2nd August at McCormick Place in Chicago, Illinois. Randox can be found at booth #3624.
For further information visit aacc.randox.com
Randox are delighted to announce that at this week’s American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia, we have been presented with a NACB / AACC Distinguished Abstract Award for a new Randox Biochip Blood Test to identify Alzheimer’s Disease risk.
Or more specifically, an award for our “Development of a New Biochip Array for ApoE4 Classification from Plasma Samples using Immunoassay Based Methods!”
Out of 1024 posters presented at the diagnostics conference, which is the largest of its kind globally, the poster for our new ApoE4 test, presented by our R&D Scientist Dr. Emma Harte, was one of only 29 to receive this prestigious award.
Emma is one of a team of Randox scientists at our Teoranta site in Dungloe, Co. Donegal, Ireland who carried out this pioneering Alzheimer’s research.
The ApoE4 poster demonstrated the work involved in the development of our ApoE4 blood test, performed on our patented Randox Biochip Array Technology. This blood test is an affordable method of identifying patients at risk of developing Alzheimer’s Disease, and provides a faster alternative to standard testing which analyses a patient’s DNA. Standard molecular testing can be both time-consuming and expensive.
The Randox ApoE4 Biochip Array can conduct multiple diagnostic tests on a single blood sample, which has both cost and time-saving benefits, in addition to a rapid diagnosis for the patient.
The Randox Biochip analyses the Apolipoprotein E (ApoE), a gene which is recognised as one of the most significant genetic risk factors for dementia and other neurodegenerative diseases.
There are three versions of the ApoE gene: E2, E3 and E4. The E4 version increases a person’s risk of developing late-onset Alzheimer’s disease, and it may also be associated with an earlier onset of memory loss.
Each parent passes on one ApoE gene to their child. Around 25% of the population inherit one copy of the ApoE4 gene. Inheriting two copies of the E4 variant increases a person’s disease risk by 10 times or more.
Our research into the identification of this gene was conducted in conjunction with our colleagues at the Medical University of Vienna, and verified the accuracy of the Randox Biochip Blood Test by analysing 384 samples and comparing the results to that of a standard molecular diagnostic test. Both tests provided the same accurate results, however the Biochip test results were available in a significantly faster 3 hours.
In combination with information on medical and family history, medication, and lifestyle, an individual’s ApoE4 status, as obtained from the Randox Biochip test, can go a long way in advising personalised medicine for the patient.
“This type of testing is important in our quest to understand and diagnose Alzheimer’s and empower patients to understand risks, consider medication, and even make early lifestyle changes,” said Emma, our R&D Scientist.
“Pairing this test with medical and family history for risk of Alzheimer’s disease has the real potential to advance personalised medicine. This fast, accurate testing will allow doctors and patients to make more informed choices earlier to potentially slow the possible progress of Alzheimer’s.”
Following its recent £1 billion sales announcement, Randox Laboratories is maintaining its focus on international markets, as a group of 30 representatives from the diagnostics company, which has headquarters in County Antrim, have travelled to the US this week, to take part in the world’s largest diagnostics conference – in Philadelphia, Pennsylvania.
The American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, known as the leading event for laboratory medicine worldwide, is attended by over 20,000 delegates from across the globe, and offers Randox the opportunity to showcase their capabilities and to network with leading healthcare professionals and key decision makers.
Managing Director of Randox, Dr. Peter FitzGerald, explained the company’s focus on business with the US;
“The USA is one of our most important markets and we have been exporting our diagnostic products there since the early 1980s. For example, we have Randox Clinical Chemistry Analysers in key Ivy League Institutions, such as Yale University School of Medicine, and Harvard University. It is vital to nurture and develop these key relationships, as well as endeavor to establish new ones.”
Randox’s expertise in diagnostics means that the company has been able to diversify beyond healthcare, into the veterinary, research, forensic, and food safety sectors in the US. For example, a number of countries have implemented strict regulations on their meat imports in recent years, meaning that US exports have had to source new ways of demonstrating the quality of their products. Randox Food Diagnostics technology have enabled US exporters to demonstrate residue-free products, by screening for the growth promoter Ractopamine.
Randox’s Toxicology division is also at the forefront of one of the world’s key health challenges; ‘legal highs.’ Key state level agencies for forensic investigations, such as The Alabama Department of Forensic Sciences, are able to stay on top of this growing public health threat by custom ordering Randox biochips to test the most relevant drugs of abuse within their state.
Dr. FitzGerald continued;
“Following the Brexit decision there will of course be particular business challenges, but at Randox we will maintain our commitment to research and development, and seek new opportunities in international markets such as the US. A growing demand for Randox innovations in the US has supported a $10m investment in our new facility Kearneysville, in West Virginia, which will be officially opened later this year, and will enable us to strengthen our position in that market.”
AACC runs from the 31st July – 4th August at the Pennsylvania Convention Center Philadelphia, Pennsylvania. Randox can be found at booth #2927.
Global biotechnology firm, Randox Laboratories, is taking a leading role in the world’s largest medical conference which is currently under way in Atlanta, Georgia.
The Northern Ireland medical diagnostics company is a major sponsor of the American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, which is attended by over 20,000 delegates and 784 exhibitors from across the globe.
As the leading event for laboratory medicine worldwide, the conference provides an opportunity for breakthrough innovations in clinical testing and patient care to be introduced to the healthcare world.
A group of 32 members of Randox staff are attending the event, exhibiting Randox’s wide range of products and capabilities, which are exported to 145 countries. AACC provides a valuable opportunity to develop new business and clinical partnerships, as well as to consolidate and strengthen current relationships.
Managing Director of Randox, Dr. Peter FitzGerald, is attending the conference and says that the company is proud to be promoting Northern Ireland business to an international audience:
“The global laboratory diagnostics market, is currently valued at around US$55 billion, and is growing at 5.3% per year. With ambitious plans for growth over the next few years, we are committed to improving healthcare worldwide through our investment in our people and the world’s most revolutionary diagnostic technology. Our presence at the AACC annual meeting is fundamental to achieving our strategic aims in promoting our brand, and in strengthening Northern Ireland trade links across the world.”
AACC runs from the 28th – 30th July at the Georgia World Congress Center in Atlanta, Georgia.