Global technology specialist Smiths Detection is developing clinical point-of-care diagnostic technology in a bid to rapidly detect infections such as MRSA and Clostridium difficile and send the results direct to hospital databases.
Bio-Seeq (pictured below) is based on a veterinary system that is undergoing trials. Dr Jay Lewington, chief technical officer of Smiths Detection Diagnostics, said very little had to be changed technically for the clinical version.
‘It uses most of the technology in the veterinary device,’ he said. ‘We left a few things out as it doesn’t need a GPS, it’s not so portable as it’s used in a hospital, and it’s not as rugged.’
The tests use the LATE PCR (Linear After The Exponential Polymerase Chain Reaction) technique developed at Massachusetts’ Brandeis University in the US six years ago and patented last April.
It is based on a special type of polymerised chain reaction, a process for analysing nucleic acids and DNA. The version Smiths uses amplifies just one side of the DNA double helix, producing a single-strand product. This has significant advantages, principally that it can easily have parallel tests carried out so more characteristics can be examined.
The platform comes in three parts. The main instrument that carries out the analysis sits on a desk. A consumable called a sample preparation unit (SPU) receives any sample type using a universal preparation method. The third component is an assay-specific reagent pack, which contains the various chemicals to detect the specific organism.
‘The user takes an SPU, adds the reagents to turn it into a specific assay, puts the lid down to seal the sample in, then places it on the machine which can read a unique barcode and automatically carry out the analysis,’ said Lewington. The barcode contains all the information about the sample, the method of how to run the test, and the analytical procedure to carry out.
Lewington said a key challenge is getting the device to automatically communicate with the different versions of patient information management software hospitals use, and retain confidentiality levels.
Smiths started work on the device three months ago, and clinical trials — at two UK and two US hospitals — start in January. Depending upon the results Lewington said in could be available in Europe early next year.