Complete Product Description

Randox EVIDENCE Biochip Array Technology the best multi-analyte Biochip Array Technology on the market today. This integrated analyzer performs simultaneous quantitative detection of a wide range of protein analytes in a multi-analyte format. The system may be used for clinical analysis in laboratory medicine, cutting-edge investigative research laboratories or in clinical trails. Evidence performs multiple immunoassays on each patient sample. The technology platform supports multiple different protein results, per person, on each biochip.

The Randox EVIDENCE Biochip Array Technology system won the UK?s most prestigious award for innovation in engineering, the MacRobert award. Presented each year by the Royal Academy of Engineering, the MacRobert Award recognizes that Evidence will make a significant contribution to society, is innovative and will be a significant commercial success.

Randox EVIDENCE Biochip Array Technology Features

• This system that has the capacity to perform a test output in excess of 2,700 tests per hour*
• The imaging system that can read multiple analytes simultaneously
• Biochip technology, a 9mm_ solid substrate containing an array of discrete test regions located on the surface of the biochip

* Based on twenty tests per chip

Randox EVIDENCE Biochip Array Technology Software

All operational functions of evidence are managed and controlled by the dedicated Windows based system software. System sensors enable regular updates of onboard inventory details, which are displayed on the user screen.

The Graphic User Interface (GUI) comprises a main access screen, three easiview inventory screens and a menu options section. Easiview screens are used to provide the user with reliable on screen information on inventory status. The three screens provide information on the active sample ring, panel-specific reagents and waste and signal reagents.

• Retrospective reporting facility to enable the retrieval of previously unreported tests.
• User-defined cut-off values for qualitative assays without the need to recalibrate
• QC graphs and report function
• Access to analyser software for remote maintenance and trouble shooting.
• The software restricts access to onboard units and reagent access is also controlled by the software to ensure safe handling

Introduction to Randox EVIDENCE Biochip Array Technology

Several immunoassay based multi-analyte panels have been developed for use on evidence. The assays can be of a competitive or sandwich format, or in the case of allergens an antibody capture format.

The method employed is dependent on the molecular weight and the nature of the analyte. In a competitive assay such as Drugs of Abuse, the light intensity of the signal produced is inversely proportional to the concentration of the analyte present due to competition between the analyte and the conjugated enzyme labelled derivative for free antibody binding sites.

Alternatively in a sandwich assay such as the cytokine panel the light signal is directly proportional to the analyte concentration due to the conjugated enzyme labelled antibody attaching to the analyte present.

Evidence utilizes conventional immunoassay techniques for the measurement of analytes on the surface of the biochip. The greatest advantage of this technology is the specific and simultaneous profiling of biological markers.

After substrate activation, the biochip manufacturing process requires very accurate and specific placement at discrete test regions (DTRs) on the biochip surface for the immobilization of the biological ligand. The number of test sites per biochip is dependant on the test panel selected and can be up to 100. A chemiluminescent signal is generated and can be easily detected and quantified by the unique imaging system.

Evidence utilizes the basic principles of immunology; supporting sandwich, competitive and antibody capture immunoassay formats. However, instead of the ligands being attached to a microtitre plate, for example in an ELISA test, the capture antibodies/antigens are attached to the surface of the biochip.

After addition of a patient sample to the biochip, analytes present in the sample bind the specific ligands. The degree of binding is determined using a chemiluminesence light source and quantified using a Charge-Coupled Detector (CCD) camera and imaging system.

Randox EVIDENCE Biochip Array Technology TESTS

Drugs of abuse Biochip array technology
Simultaneously detect 10 drugs classes in a single patient sample

• Specific test for 10 drugs of abuse
  • Amphetamine
  • Methamphetamine
  • Cocaine
  • Barbiturates
  • Cannabinoids
  • Opiates
  • Methadone
  • Benzodiazepines
  • Phencyclidine
  • Creatinine
• Excellent for drug screening programs
• Suitable for urine and whole blood analysis
• Small sample volume - measure all 10 analytes using just 7-35 ul of sample
• Fully automated walk away analyzer and semi-automated analyzer available
• Excellent correlation with GC/MS
• Biochips are ready-to-use
• User defined cut-off limits
• Barcoded reagents and samples

Cytokines and growth factors array

• Interleukin-1a (IL-1a)
• Interleukin-1b (IL-1b)
• Interleukin-2 (IL-2)
• Interleukin-4 (IL-4)
• Interleukin-6 (IL-6)
• Interleukin-8 (IL-8)
• Interleukin-10 (IL-10)
• Interleukin-12 (IL-12)*
• Vascular endothelial growth factor (VEGF)
• Tumor necrosis factor-a (TNF-a)
• Interferon-g (IFN-g)
• Epidermal growth factor (EGF)
• Monocyte chemotactic protein-1 (MCP-1)

* under development

Free thyroid array

• Thyroid stimulating hormone (TSH)
• Free tri-idothyronine (FT3)
• Free thyroxine (FT4)

Total thyroid array

• Thyroid stimulating hormone (TSH)
• Total tri-idothyronine (TT3)
• Total thyroxine (TT4)

Fertility array

• Follicle stimulating hormone (FSH)
• Prolactin (PRL)
• Lutenising hormone (LH)
• Progesterone
• Testosterone
• Estradiol*

* under development

Tumor monitoring array

• Carcinoembryonic antigen (CEA)
• a-fetoprotein (AFP)
• Human chorionic gonadotrophin (hCG)
• Gastrointestinal tumor antigen (CA 19-9)
• Ovarian tumor antigen (CA 125)
• Breast cancer antigen (CA 15-3)

Tumor PSA array

• Carcinoembryonic antigen (CEA)
• Total prostate specific antigen (tPSA)
• Free prostate specific antigen (fPSA)

Cardiac array

• Troponin I
• Myoglobin
• Creatinine kinase isoform (CK-MB)
• Carbonic anhydrase III (CAIII)
• Glycogen phosphorylase BB (GPBB)
• Fatty acid binding protein (FABP)

Adhesion molecule array

• I-CAM
• V-CAM
• E-selectin
• P-selectin
• L-selectin

Randox EVIDENCE Biochip Array Technology Configuration

Cassette Loading Tower
Cassette contain vertically stacked biochip carriers in an easy-load bar-coded cassette. Cassettes are inserted directly and move downward into a storage compartment

Refrigerated Reagent Storage Unit
The refrigerated reagent storage unit comprises two separate internal units for panel-specific reagents and chemiluminescent signal reagents. Bar-coded reagents for the test array enable rapid identification

Sample Unit
Sample tubes or cups can be continuously loaded onto two removable sample carousels (180 capacity) each with a barcode reader for rapid sample identification

Bulk Solutions Unit
Universal wash buffer and displacement fluids are required for routine operation

Cassette Collection Unit
Cassettes are released into an onboard collection unit when empty or when the test panel changes

Biohazard Waste Unit
An onboard waste container for used biochip carriers minimizes the risk of biological contamination and contains an interlocked door for enhanced safety