The Evidence Series

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The Evidence Series

Having developed the patented Biochip Array Technology following £250 million investment in research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series.

The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.

Have a read below of the overview of each analyser in the Evidence Series

Evidence Evolution

The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.

Evidence

As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.

Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.

Evidence MultiSTAT

The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.

 

 

 

About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.

For more information on any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

 

 

 


Discussing Companion Diagnostics with Dr Miguel Quesada-González

You may have heard of Companion Diagnostics. This type of diagnostic provides information that is essential for the safe and effective use of a corresponding drug or biological product. It can help to stratify groups of patients which will respond safely to a clinical drug trial, and those who may suffer undesirable side effects.

But why are Companion Diagnostics useful?

Randox Biosciences Pharma Relationship Manager Dr Miguel Quesada-González, PhD has the answer.

“As part of my new role, I’ll be supporting drug development and clinical trials. So as a scientist by background (the nature of the beast) I’ve been reading into and researching this incredibly interesting area of science.

“Since Day 1, Companion Diagnostics (CDx) especially caught my eye.

“When it comes to new drug development, either for Pharma or Biotech, there are many benefits of running a CDx. Based on well-acknowledged scientific papers that I have read, and my own personal perception of the current situation, I’d like to summarise and simplify in just 2 bullet points, what I personally believe to be the most important benefits of running a CDx.

“(a)  Delivering the right treatment to the right patient at the right time.

“We should never forget that our priority is the health and integrity of patients. It’s been proven that patients who have similar diagnoses very often respond differently to the same treatment. This variability presents a risk in both the efficacy of the treatment and the safety of the patient.

“The development of a drug is already a risky, long and costly process, so wouldn’t you like to avoid the initial high risk by having a good defined target initially?

“(b)  Saving time.

“Money is valuable but time even more so. Time is precious and priceless. Once it’s gone, there’s nothing we can do about it!

“The smaller and more targeted the clinical trials are, the less time and resources you’ll be spending. Normally, the CDx is not initiated until a drug has reached the later stages of development, but, actually, if you put the CDx in place at early development stages (preclinical) it presents many advantages because it enables the selected biomarker to be validated and determined before large amounts of resources have been put in place.

“The faster a potential treatment is developed and approved, the more people you can save, cure or simply improve their quality of life.”

For further information on Companion Diagnostics from Randox Biosciences please email us at info@randoxbiosciences.com

Dr Miguel Quesada-González, PhD, Randox Biosciences Pharma Relationship Manager

 

 

 

 

 


The Evidence Series: What is it and how is it changing the diagnostic landscape forever?

Having developed the patented Biochip Array Technology following £250 million investment in diagnostic research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series.

The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.

Have a read below of the overview of each analyser in the Evidence Series

Evidence Evolution

The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.

Evidence

As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.

Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.

Evidence MultiSTAT

The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.

About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.

For more information on any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

 

 

 


The Evidence Evolution: The world’s most advanced immunoassay analyser

What sets the Evidence Series apart from its competitors is its flexibility across the range of immunoassay analysers. No other range of analysers has the capability in terms of throughput in comparison to the Evidence Series. With this established, we are delighted to introduce the latest in the Evidence Series range, the Evidence Evolution.

Join the Evolution

We believe that the Evidence Evolution is the world’s most advanced immunoassay analyser. The Evidence Evolution is the most versatile analyser Randox has ever produced. By utilising the same multiplex technology as the other Evidence Series analysers, the Evidence Evolution can process up to 44 results from a single sample, with a maximum throughput of up to 2640 tests per hour. With such a high volume of potential throughput, you may think that reporting time will be compromised, that is simply not the case. The Evidence Evolution can produce the first set of results in less than 36 minutes, with one sample of up to 44 results reported every minute after. The speed of reporting time distinguishes the Evidence Evolution from its competitors, and allows the analyser to further display its capabilities.

Innovation

By utilising patented Biochip Array Technology, the Evidence Evolution offers batch analysis, true random access and STAT testing capabilities. These, combined with retrospective testing, allows the user to build a more in-depth patient profile.

With such swift reporting times, the Evidence Evolution can boast of a true walkaway time of 2 hours, in a laboratory setting, this can be vital. With multiple daily tasks to be completed, time is of the essence, and the Evidence Evolution has been designed to lessen the workload of laboratory staff. By being able to offer a combination of continuous sample and reagent loading, plus automated on-board sample dilution, the Evidence Evolution will have a positive impact in busy laboratories.

Complete Picture

A fast reporting time and high throughput capabilities is just the tip of what the Evidence Evolution can offer. The analyser has the capability to test across multiple matrices, allowing for more flexibility in sampling. It also comes equipped with state of the art intuitive software and advanced precision bio-drive robotics, meaning the Evidence Evolution is an analyser that has been designed and developed to meet the needs of a modern, high throughput laboratory, by a company that has a deep understanding of laboratory needs.

About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.

For more information on the Evidence Evolution, or any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.  


Committed to meeting customers’ needs

At Randox Quality Control, we strive to meet and exceed customer expectations ensuring high quality products and superior customer service are at the top of our priority list.

How can Randox Quality Control help you?

High Quality QC

The Acusera range of true third party controls boasts an impressive range of benefits ultimately designed to help laboratories reduce costs and time while also ensuring an accurate and reliable test system.

The extended shelf life of our controls allows the same lot of control to be used for a period of up to 2 years keeping costly new lot validation studies to a minimum.  We may also be able to sequester lots on your behalf.

The availability of commutable controls designed to react to the test system in the same manner as a patient sample and controls targeted at clinical decision levels will not only help you to meet ISO 15189:2012 requirements but will effectively challenge instrument performance.

Click here to find out more about our QC range.

Customer support

The Randox global support network are on hand with expert advice to ensure timely, accurate and helpful resolution of any issues or queries you may have. The added benefit of quick delivery of product orders further highlights how we work with and for our customers to provide the best service available.

Customer Reviews

Don’t believe us? Read a few of the reviews we have received from laboratories around the world;

“I would like to thank the Randox team for the excellent service when helping to reserve and manage our IQC orders, lot numbers and stock.” – Chief Biomedical Scientist, London, 2017.

Request your free QC consultation by contacting us today! Get in touch and we can arrange for your laboratory to have a consultation with one of our Randox QC specialists. Alternatively, if you would like to leave us a review you can do so by emailing acusera@randox.com.


Does Your QC Cover Clinically Relevant Ranges?

Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.

Measuring the Complete Clinical Range

It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.

Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”

What are Medical Decision Levels?

Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.

For example, the MDL of Glucose can indicate a certain diabetic status:

Analyte Medical Decision Level Diagnostic Status
Glucose (fasting) <100 mg/dL Non-Diabetic
100–125 mg/dL Pre-Diabetic
>125 mg/dL Diabetic

Competitor QC

Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:

Competitor Chemistry Control Level 1 – 68 mg/dL

Competitor Chemistry Control Level 2 – 134 mg/dL

Competitor Chemistry Control Level 3 – 386 mg/dL

In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).

Randox QC

Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:

Level 1 – 57 mg/dL

Level 2 – 114 mg/dL

Level 3 – 236 mg/dL

The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.

Immunoassay Medical Decision Levels

Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:

Analyte Medical Decision Level Randox Level 1 IA Control Competitor Level 1 IA Control
TSH 0.1 or 0.27 uU/mL 0.15uU/mL 0.37 uU/mL
Vitamin B12 190 pmol/L 174 pmol/L 327 pmol/L
Ferritin 12 ng/mL 11.1 ng/mL 49.6 ng/mL

In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.


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