Randox Laboratories Ltd – from bench to bedside

Randox Laboratories is the leading manufacturer of diagnostic products in the UK and one of the fastest growing clinical diagnostic companies in the world, ranking 23rd in the world for clinical diagnostics.

Randox Laboratories is the leading manufacturer of diagnostic products in the UK and one of the fastest growing clinical diagnostic companies in the world, ranking 23rd in the world for clinical diagnostics. Randox has 25 years experience in the research, development, manufacture and marketing of high quality diagnostic reagents and equipment for the pharmaceutical and biotechnology industry. Randox produce 5% of the world’s clinical chemistry products, and the Randox portfolio also includes revolutionary Biochip Array Technology, environmental diagnostics and in-house recombinant protein and antibody production facilities. The Randox commitment to quality is demonstrated through our compliance with international quality standards such as ISO 13485, FDA 510k clearance and our state-of-the-art facilities. This dedication to quality is reflected in the production of our quality control materials and the Randox International Quality Assessment Scheme (RIQAS), which is available worldwide.

Five times winner of the Queens Award for Export Achievement and awarded Northern Ireland Exporter of the Year, Randox is a significant investor in the development of new healthcare technology solutions for pharmaceutical and biotechnology applications. 

Biochip Array Technology

FDA 510k cleared Biochip Array Technology is used to perform simultaneous quantitative detection of multiple analytes in a single patient sample. Biochip Array Technology is suitable for both protein and DNA analysis; the technology allows a rapid and accurate diagnosis.  Multiple results from a single sample minimise biological variation and offer a more comprehensive patient sample profile - ideal for toxicity trials.  

The core technology is the Randox biochip, a 9mm x 9mm solid-state device based upon ELISA principles of sandwich and competitive immunoassays. The biochip is used as a reaction platform with multiple specific ligands (antibodies or antigens) attached at pre-defined sites on the surface.  Assays are based on chemiluminescence, and increased levels of analyte in a sample will lead to increased binding of antibody labelled with Horseradish Peroxidase (HRP) and thus an increase in the chemiluminescent signal emitted.  The light signal generated from each of the test regions on the biochip is simultaneously detected using digital imaging technology and compared to that from a calibration curve.  The concentration of analyte present in the sample is calculated by the analyser from the calibration curve. Two analysers utilising Biochip Array Technology have been developed.  The fully automated EVIDENCE, ideal for high throughput laboratories and the semi-automated EVIDENCE INVESTIGATOR, designed for research and lower throughput laboratories. 

Biochip Array Technology holds many features that make it ideal for application in the pharmaceutical industry.  These can be divided into time, labour and cost saving features and a wide test menu.  Time and labour savings come from the ability to detect analytes simultaneously and removal of the need to pipette reagents for individual analytes.  Multi-analyte calibrators and controls also save pipetting time.  Small sample volumes mean that fewer patient samples need to be taken, again saving time and reducing patient discomfort.  Biochip Array Technology is ideal for high throughput testing with a test capacity of in excess of 1080 tests per hour. Cost savings come from the ability to detect multiple analytes simultaneously in a single sample.  Up to 23 analytes can be spotted on the surface of the biochip, allowing 23 results from as little as 7µl of sample.  This small sample volume allows the conservation of precious samples, and reduces the need for repeat samples due to insufficient sample volume. Consolidation of test panels onto a common platform diminishes the need to purchase separate analysers for certain analytes.

The range of tests includes novel and routine markers such as cytokines and growth factors, cell adhesion molecules, drugs of abuse, cardiac markers and a DNA chip for point mutations associated with colorectal cancer.  There are currently 220 new analytes in development including protein and DNA biochips for research and clinical trials.  The Randox commitment to continuous research and development is demonstrated through our continuously expanding test menu.  We currently have more analytes in development than any other company in the world.  The combination of routine and novel panels offers flexibility.

RX series of Analysers

Randox also offers a range of clinical analysers that employ an impressive range of time, labour and cost saving features. The RX series of analysers – RX imola, RX daytona and RX monza - are bench top systems that combine outstanding flexibility with a comprehensive test menu, including clinical chemistry, specific proteins, lipids, antioxidants, therapeutic drug monitoring, drug residue, food and wine testing. Over 100 reagents are dedicated to the RX series of analysers. An extensive range of controls and calibrators covers all test analytes. Keeping abreast of new trends in diagnostics, research and clinical trials, our R&D department are constantly developing new markers.

The RX daytona and RX imola fully automated clinical chemistry analysers have several important features in common:

• Wide test menu to include markers for research and clinical trials
• Dedicated reagents and integrated bar code scanner
• An ethos of TLC (time, labour and cost saving features)
• Low sample and reagent volumes
• Permanent cuvettes and low water consumption
• Auto start and shutdown, auto washes
• Easy-to-use software
• Bi-directional LIMS interface

The following features are unique to each analyser:

RX monza
The RX monza is the versatile semi-automated little brother of the RX series. It can run photometric, turbidimetric and coagulation assays for manual testing in clinical laboratories, university research labs, veterinary labs and in food and wine testing. Over 100 channels can be used as open or closed channels, making the analyser very flexible. The analyser has direct access to all channels with one-touch or two-touch access keys for ease of use and comes with integral screen, keyboard and printer. The full range of dedicated reagents, as well as all QC reagents, can be run on the analyser.

Windows® based software with logical displays, great storage capacity and extra features, such as an extensive QC package, make the RX monza one of the best analysers of its class.

Life Science

Another area of excellence is the Randox life science division, devoted to identifying and producing biomarkers that are of interest to researchers in the life science field. To enable detection of these biomarkers, the state-of-the-art department is producing recombinant proteins and polyclonal and monoclonal antibodies, as well as immunogens, haptens and conjugates.

Randox puts a strong emphasis on research and development; over 200 biomarkers are currently in development in addition to an already extensive range of markers. All products are manufactured to the international quality standard ISO 13485.

To meet the demands of sometimes intricate research for clinical trials, the department also offers a customised assay development service.  More details can be found at www.randox-lifesciences.com.

Quality control (QC)
Randox quality controls provide laboratories with the proper tools to assess their analytical performance. Randox QC sera cover an extensive range, reflecting the range of reagents. Randox assayed sera are supplied with target values from independent laboratories worldwide.  Precision sera are supplied with guideline values for most common methods.  Multi-analyte sera include clinical chemistry, cytokine and drugs of abuse immunoassays, specific proteins and lipids and cover a total of 170 analytes. Randox can also customise controls to meet your exact requirements and specifications.
24/7, a peer group reporting QC scheme, offers high-standard internal QC with daily updates through comparison with other labs’ performances.
Randox International Quality Assessment Scheme (RIQAS) is a dynamic customer-focused External Quality Assessment (EQA) scheme for monitoring analytical performance.  It is implemented in laboratories worldwide. Features include flexible programme choice, rapid turnaround time and electronic transfer of results and reports.

Randox has come a long way in the last 25 years, and we will continue to thrive true to our philosophy ‘we exist and expand through our customers’. Continuous changes in modern healthcare constantly challenge us to strive even further and develop to the best of our abilities, to come ever closer to our aim, as expressed in our mission statement: ‘revolutionising healthcare through continuously improving diagnostics solutions’.

Randox Laboratories

Diamond Road
Crumlin
Co. Antrim BT29 4QY
United Kingdom

Tel: +44 (0) 28 9442 2413
Fax: +44 (0) 28 9445 2912
www.randox.com
www.randox-lifesciences.com
marketing@randox.com