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Out of the Lab – UK
The threat from biological agents has led to production of a technology which can also be used as a rapid diagnostic tool to identify diseases without sending samples to a laboratory. It can be operated on-site by practitioners in the field, and so vital treatment can be administered in a more timely and effective way. The portable mini-lab is being put to use to test both humans and animals for diseases.
Development of the Technology
The technology was initially developed at the UK Defence Science and Technology Laboratory (Dstl) to rapidly detect biological threat agents in the field without the need for scientific personnel or a laboratory. It is vital that results are ready as soon as possible, so a novel technology using ultra-rapid chemistry was developed. The scientists invented and patented instruments and technologies to speed up the detection of DNA sequences using the Polymerase Chain Reaction (PCR) method.
| PCR (polymerase chain reaction) is a laboratory technique that can increase the amount of DNA from a tiny sample to a large amount within a short period of time. The PCR process heats and cools samples using an enzyme to generate billions of copies of DNA segments. It is normally a laboratory-based technique but the portable systems developed by Enigma Diagnostics Ltd automate all steps in the PCR process, including sample preparation, allowing operation by non-scientists in the field. |
The wider potential applications of PCR in both human and veterinary healthcare were soon recognised. Enigma Diagnostics was established in 2004 as an extension of the Defence Science Technology Laboratory (Dstl) at Porton Down, and funding was raised from Porton Capital and Partnerships UK. The company was formed to commercialise technology and intellectual property generated by a decade of Ministry of Defence funded research on the detection of biological threat agents.
Its aim is to produce equipment that would generate medical test results by a patient’s side, rather than having to wait days or weeks for a laboratory to return a result. On-site tools will enable General Practitioners (GPs), specialist clinics and vets to benefit from rapid analysis of samples. This will assist them in confirming diagnoses to aid decisions on therapy or to control disease outbreaks.
How the Technology Works
There are three stages in the PCR process: sample preparation, amplification of the target DNA, and reporting. Traditionally, preparation and reporting have been carried out manually or, more recently, by separate machines in a total PCR process using a heating block to heat and cool samples in a test tube. This process can take from a few hours up to a full day. Enigma’s portable system, Enigma-FL , has it own heating system which directs heat to each test tube individually. It combines all three steps automatically and completes the whole process in less than half an hour. These, and other unique factors, greatly simplify the whole process, so it can be used by anyone, anywhere and at any time. When a raw sample is taken, the instrument does the rest automatically.
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| Enigma-FL takes real time PCR out of the laboratory for the detection of biological agents at a time and place where the result can deliver immediate on-site benefit |
Using PCR technology, sequences of DNA present only in the target agents are purified from the sample and rapidly replicated, generating billions of identical copies. The instrument detects the amplified DNA and results are quickly displayed in an easily readable format with a yes/no response.
Enigma has developed several products to exploit this technology. Near Patient PCR using Enigma-FL will provide clinical diagnostics with detection times as low as 30 minutes from sampling. Uses include the diagnosis of sexually transmitted infections and genetic testing. For the first time, a clinician will be able to obtain DNA data at a time and place where the result can deliver maximum benefit to the patient. For Chlamydia testing Enigma-FL has several features for patient screening, such as:
- Testing urine which avoids the need to swab
- A real-time result which eliminates the need to recall patients
- Can be used by a semi-skilled operator
- No requirement for laboratory equipment or refrigeration
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| Ruggedised version of Enigma-FL used for in-field testing |
Another product has been developed for ultra-rapid, in-field detection of bio-threat agents, particularly useful for military applications. However, there is scope to use it in a range of industries:
- In v eterinary diagnostics to test for diseases such as foot and mouth or avian flu
- At crime scenes for forensic detection
- For environmental monitoring and food safety – it could detect genetically modified foods.
The system uses a rugged portable real-time platform and has detection times as low as 20 minutes from sampling. There are several features that make it unique:
- Can be used by a semi-skilled operator without the use of laboratory equipment
- Self-contained in a closed-cap process to eliminate contamination
- Raw sample to result in as little as 20 minutes
- Ability to process a wide range of environmental samples.
These products can be used by non-specialists outside the normal laboratory setting, for example in the GP's surgery, at the scene of crime, on the farm, or along the food production line. They have the accuracy and sensitivity of laboratory-based instruments and can provide results from raw samples in about 20 minutes. The technology is robust enough to be used in the field, either powered by batteries or through a mains supply.
Future Developments
Enigma’s technology is currently being tested in the military field and veterinary fields. Production of the instruments will begin in early 2006 for the defence and veterinary markets with clinical diagnostic products following later in the year.
Acknowledgements
Hands On would like to thank Dr Ian George of Enigma Diagnostics for help and advice in putting together this case study.
Further Information
Enigma Diagnostics Ltd
Building 224, Tetricus Science Park
Porton Down
Wiltshire SP4 0JQ
UK
E-mail: ian.george@enigmadiagnostics.com
Website: www.enigmadiagnostics.com
Resources
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