Smiths Detection's pen-side veterinary test starts global validation

Smiths Detection Diagnostics today announces that its Bio-Seeq Portable Veterinary Diagnostics Laboratory is now being tested at an international reference laboratory and will shortly enter field trials with the Food and Agriculture Organisation (FAO).

The first assay to be launched on Bio-Seeq will be for Foot-and-Mouth Disease virus which has been provided to the World Reference Laboratory for the disease at the Institute for Animal Health (IAH), Pirbright, UK along with the instrument, for validation testing.

Intended for use in the field by non-specialists, Bio-Seeq simplifies complex sample-handling and is specifically designed to allow the analysis of a wide variety of samples for a range of viral and bacterial infectious agents.

It works by introducing a sample into a disposable Sample Preparation Unit which is then placed on the instrument. No manual preparation is needed and the unit can process a variety of solid and liquid samples.

A Reagent Pack, inserted into the Sample Preparation Unit, contains all the components for the specific test and includes a bar code used to set up the instrument, further reducing the need for operator input.

Bill Mawer, President of Smith Detection Diagnostics, said: "This is a major milestone in developing the Bio-Seeq. Field testing for animal diseases is a relatively new concept and we recognise the importance of winning a vote of confidence from globally recognised experts. The international nature of this validation programme is critical in ensuring the consistency in standards and acceptance of field testing."

Dr Donald King, Group Leader of Molecular Characterisation and Diagnostics at the IAH, said: "Smiths Detection Diagnostics has been actively collaborating with us to evaluate a pen-side diagnostics system for the rapid detection of FMD-infected animals in the field. We are very excited to have one of the first instruments in our lab and are looking forward to evaluating it. Previous work has included the validation of the assay in the lab and we now hope to demonstrate that similar performance can be achieved on a unit designed for field use."

Units will shortly be available for early adopter customers such as the EUFMD Commission, a specialist organisation on FMD control within the United Nations Food and Agriculture Organisation, which will run field trials in countries with endemic FMD in the first half of this year.

Dr Keith Sumption, Secretary of the EUFMD Commission, said: "Bio-Seeq has great potential to meet the need for a rapid and sensitive FMD test suitable for areas normally free from the infection. It can also fill a gap in laboratory capacity in regularly affected areas, since many endemic countries lack a national laboratory equipped to undertake highly sensitive molecular tests for virus confirmation, and could be used at the frontline in the management of epidemics when they occur. Speed in confirming FMD is vital as any delay potentially increases the impact of the disease."

Reagent packs for a wider range of tests will be developed, either by Smiths Detection or selected development partners and tests for Avian Flu will shortly begin a similar validation programme. Tests run on the Bio-Seeq use the LATE PCR technique licensed from Brandeis University in Waltham, MA. to amplify and analyse the genetic material of the infectious agent. The power of LATE PCR will be used to detect multiple diseases in each test, and to provide diagnostic information which would be important in determining the veterinarians' actions.