The Ireland-based Randox Laboratories, world's largest manufacturer of clinical diagnostic equipment, has commissioned its latest generation analyzer, the protein biochip array analyzer, branded Evidence, at Apollo Hospitals, Hyderabad, last week.
Talking to Pharmabiz.com, Dr Lorna Lawrance, Business Development Manager of the company, said, "Evidence is the only instrument that can do more than one test on a chip at a time. Biochip test panels have been developed to enable simultaneous testing of up to 25 analytes with a single drop of patient sample, making available comprehensive information and accurate diagnosis." The test results will be known in minutes instead of several hours as is the practice till now.
The Protein Array Technology has been developed after 10 years of research at Randox Laboratories. The technology enables 'multi-analyte' testing to be carried out on very small volumes of bodily fluid including blood, urine and spinal fluid.
Explaining the Evidence technology, Dr Lawrence said it was based on a novel concept to use a biochip as a reaction platform, with multiple specific ligands (antibodies or antigens) attached at pre-defined sited on the surface. After the addition of a patient sample to the biochip, analytes present in the sample would bind the specific ligands. The degree of binding was determined using a chemiluminescent endpoint and quantified using a charge-coupled camera (CCD) and imaging system.
Stating that barcoding allowed full traceability of samples and eliminated pre-analytical error and the results stored in electronic format enabling easy retrieval, she said Evidence had become the world's highest throughput immunoassay system. "With only 20 tests on a chip, the throughput of tests can be as high as 3,600 tests per hour, while the nearest rival in the market has only 240 tests per hour. Since Evidence technology uses minimal sample volumes, from 7 to 100 microlitres per chip, it was also considered highly useful for pediatric testing, where babies cannot provide large samples of blood for testing."
Evidence offers complete process automation for biochip assays with minimal operator intervention and maximum sample throughput capacity. Each system component has been developed to facilitate the automation process. Apart from having special chips for diagnosis of coronary heart disease and various forms of cancer, Evidence also generates accurate and timely diagnosis for diseases such as thyroid and fertility abnormalities, inflammation, allergies and drugs abuse.
Launched in November 2002, seven Evidence machines had been sold so far. The Apollo facility is the first in India and second in Asia after China. The equipment costs around Rs 1 crore and has a life span of 20 years. However, Dr Lawrence said since it was a platform technology, it could be used for several years by changing or adding new software and devices.
With the commissioning of Evidence, Apollo Hospitals was also planning to make the Hyderabad facility the hub of clinical laboratory services for all the group hospitals across the country. Utilising the facility, Apollo is also planning to extend phase-III multi-centric clinical trials of new drugs. At present the hospital is carrying out 19 clinical trials in various areas, including cardiology and oncology. Dr Lawrence said her company was very much pleased to be associated with Apollo Hospitals in its endeavour to develop a world-class healthcare service.
Established in the year 1982 by Dr Peter Fitzgerald, Randox diagnostic kits are used in over 30,000 laboratories in 128 countries on a variety of automated clinical analysers. All products and services are ISO 9001 accredited which signifies Randox's commitment to maintaining high quality standards, says Dr Lawrence. The company has 21 international sales offices, including Randox India, Mumbai. The company was planning to set up its network throughout India to provide adequate support to its customers.
Asked about some of the company's other products, Dr Lawrence said Randox manufactured diagnostic kits to suit the needs of all clinical chemistry laboratories. Routine assays were combined with specialist tests in probably the most comprehensive product range available from any manufacturer of diagnostics in the world. The assay methodologies covered a range of techniques including routine colorimetric assays, Elisa, and immunoturbidimetric methods.
The company launched a Benchtop Analyser in January 2003 for medium-sized labs for clinical chemistry tests. This equipment has been installed in Kolkata, Pune and Chennai.
Leading the field in biochip analysers, the 'Rx daytona' has a throughput of a test result every 20 seconds. With reusable glass cuvettes, on board reagent refrigeration and barcoding of samples and reagents, this random access analyzer can accommodate up to 40 reagent bottles, 40 patient sample tubes and results can be transferred directly to a host computer using the software interface.
Randox has also introduced a range of control products in new, easy-to-use colour-coded packaging to help distinguish different analyte levels. Bottles, caps, labels and packaging are all colour-coded for ease of use in the laboratory.
Riqas is an external quality assurance scheme, helping clinical laboratories to monitor their own analytical performance in comparison with laboratories all over the world. Riqas is a dynamic customer focused scheme that responds rapidly to the needs of 4,330 laboratories currently registered. Eight programmes are currently available that include general clinical chemistry, specific proteins, therapeutic drugs, human urine, Lipids, immunoassay, cardiac and haematology.
Randox Twenty-four Seven (24-7) is the new Internet driven software with peer group values from laboratories worldwide. Twenty-four Seven operates 24 hours a day, 7 days a week. This software allows rapid data entry by user-defined panels, serum groups or tests, data validation and onscreen display of lab results and peer group values. This package is offered together with Randox's Quality Control Sera.
Food analysis test packs from Randox include Acetic acid, Glucose / Fructose, L-lactic acid and Malic acid. The kits are designed to be used for single tests in a manual mode or to be automated for larger throughput laboratories.
Dr Lawrence said Randox used to be solely a reagent manufacturing company. "Now we have reagents as well as analysers for clinical chemistry and immunoassays. We want to expand our business based on our own instrumentation. India is going to be our major target in expanding our business," she said.