The Evidence Series of Immunoassay analysers consists of four revolutionary Biochip Array Technology platforms including the Evidence, Evolution, MulitSTAT and Investigator. These analysers can be used in multiple applications including; Clinical Diagnostics, Drug Development, Forensic Toxicology, Food Diagnostics, Academic Research and Veterinary Testing.

Powered by Biochip Array Technology (BAT), the Evidence series is a precise multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.

It provides a unique platform for assessment of biological samples in a rapid, accurate and easy to use format.

Based on ELISA principles, the biochip is a solid-state device with discrete test sites onto which antibodies specific to different targets are immobilised and stabilised. Competitive chemiluminescent immunoassays are then employed, offering a highly sensitive screen.

Biochip Array Technology uniquely offers immunoassay diagnostic testing for simultaneous multi-analyte biomarker detection. After addition of a single patient sample to the biochip, analytes present in the sample bind to the specific biochip bound ligands. The degree of binding is determined using a chemiluminescent light source and quantified using a Charge Coupled Device (CCD) camera and imaging system.

Each biochip has up to 49 Discrete Test Regions (DTR’s) each detecting a different biomarker. This means that up to 44 tests can be carried out simultaneously. The additional DTR’s are reserved for internal quality control and visual reference, a unique Biochip Array Technology feature.

Drug Toxicity

Our Acute Kidney Injury (AKI) panel can help in the application of patient safety monitoring in the detection of drug toxicity during the clinical trial phases. The detection of drug toxicity in the early stages of a clinical trial is critical to ensure not only patient safety but also saves valuable time and resources in drug development. This is also important in saving valuable research funding with phase I, II & III costing upwards of $30-40 Million¹.

Acute Kidney Injury

• Osteopontin – OPN
• Serum creatinine – Creatinine
• Serum cystatin-C – Cystatin-C
• Kidney injury Molecule-I – KIM-I
• Urinary neutrophil gelatinase associated lipocalin – NGAL

Randox’s AKI panel is available as a single sample test on our Biochip Array Technology on our Evidence Investigator Immunoassay Analyser. With a throughput of up to 2376 test per hour, the Evidence Investigator is the perfect platform to detect Acute Kidney Injury, a strong indicator of early stage drug toxicity.

The importance of Renal testing has become ever more prevalent due to the increase of several factors that can lead to chronic kidney disease (CKD) with more evidence demonstrating that AKI can initiate the development or accelerate the progression of CKD². CKD affects 1 in 10 people worldwide and is incurable, causing patients to need lifelong care³. According to the National Kidney Foundation, the two main causes of CKD are Diabetes and high blood pressure^.4. The World Health Organisation estimated that 8.5% of adults aged 18 years and older had diabetes in 2014 and of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also known as diabetic kidney disease – the leading cause of renal failure in the world⁵. With this in mind it is vitally important to get tested right away especially if you suffer from diabetes, hypertension or have a family history of kidney failure. Our CKD 7-plex and 4-plex arrays developed in collaboration with National University of Galway demonstrate that a multi-marker approach holds promise for early CKD detection, discrimination of progressive CKD stages and prediction of renal decline.

Chronic Kidney Disease I:

• Fatty Acid Binding Protein I – FABPI
• Soluble Tumour Necrosis Factor Receptor I – sTNFR I
• Soluble Tumour Necrosis Factor Receptor II – sTNFR II
• Macrophage Inflammatory Protein Iα – MIP-Iα
• Interleukin-8 – IL-8
• Epidermal Growth Factor – EGF
• D-Dimer

Chronic Kidney Disease II:

• Complement C3a Des Arginine – C3a des Arg
• C-Reactive Protein – CRP
• Neutrophil Gelatinase Associated Lipocalin – NGAL
• Cystatin C

References

1. (2018). How much do clinical trials for drugs cost?. [online] Available at: https://www.quora.com/How-much-do-clinical-trials-for-drugs-cost [Accessed 10 Jul. 2018].
2. Hartung, T. (2018). Food for Thought Look Back in Anger – What Clinical Studies Tell Us About Preclinical Work. [online] PubMed Central (PMC). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3790571/ [Accessed 10 Jul. 2018].
3. com. (2018). Chronic Kidney Disease: The Silent Killer – Path Medical. [online] Available at: https://pathmedical.com/ckd-the-silent-killer/ [Accessed 10 Jul. 2018].
4. National Kidney Foundation. (2018). About Chronic Kidney Disease. [Online] Avaiable at: https://www.kidney.org/atoz/content/about-chronic-kidney-disease [Accessed 10 Jul. 2018]
5. World Health Organisation. (2018) Diabetes. [Online] Available at: http://www.who.int/en/news-room/fact-sheets/detail/diabetes [Accessed 10 Jul. 2018]

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