Research and experimental development services. Research laboratory services. Research and development services on security and defence materials. Military Research & Technology. Dstl require a hand held device for the rapid identification of personnel exposed to ricin and other toxins. Proof of principle for ricin is required initially but subsequent development is likely to be required to deliver a multiplexed capability to enable interrogation of a single sample for the presence of several toxins with a single device.
Although alternative technologies with similar capabilities will be considered, the suggested method is an immunoaffinity chromatography column (IACC), incorporating antibodies for capture of ricin immobilized in 3 dimensions on filter frits which are an integral part of the column matrix. Sample (containing toxin) is mixed with an appropriate buffer and run down the column. Toxin present in the sample is captured on the filter frit. A biotinylated detection antibody is then passed down the column and binds to the toxin. A colour then develops on the frit following subsequent addition of a reagent which is insoluble and resides at the site of reaction. The device must be hand held with a maximum volume of 5ml.
Through this work program, Dstl wishes to develop bespoke devices using our own antibodies. The analytical method/device must satisfy the following criteria:
— Be suitable for reproducibly identifying toxins in complex media with no cross reactivity between toxin types or false positive readings,
— Be hand-held and portable,
— Be rapid to complete, i.e. ≤ 30 minutes,
— Involve minimal sample preparation,
— Require minimal operator expertise and training,
— Positive results should being indicated by eye, enabling correct interpretation of results by a non-expert,
— The ability to utilise portable equipment for qualitative and quantitative assessment of results is also desirable,
— Ideally not be dependent on cold chain storage.
Most importantly, this test for ricin (and other toxins) will require optimisation through the trialling of a number of antibodies supplied by Dstl to capture and detect the toxin. The work will be conducted incrementally on a Task by Task basis and optional follow on tasks will be dependant on successful completion of the previous and continuing Dstl requirements.
To this end, Dstl is seeking an organisation with a proven track record using the identified technology, to develop, optimise, characterise and provide bespoke immuno-affinity columns for assessment at Dstl. Alternative innovative solutions will also be considered. It is business critical that the organisation can demonstrate prior experience using their proposed technology, to reproducibly identify toxins in complex matrices. In particular, previous experience with detection of ricin in complex matrices is desired. Prototype devices produced must be suitable for further development and manufacture to meet the requirement of European Union CE Marking for use as an in vitro diagnostic medical device. Bidders will be expected to indicate how their proposed device could meet these criteria and how the quality systems used would support further development of the device.
There may be a requirement to undertake additional development work if examination of the columns by Dstl indicates that this is required. Stability of the devices and reagents at ambient temperature should also be demonstrated.
Provision of additional batches of columns made to the specifications of the tasks may also be required.
Placement of any contract will be subject to Dstl’s assessment of evidence provided by candidate organisations.
UK Bidders should be aware that ricin is regulated by the Chemical Weapons Convention (CWC) and as such its use will require an Open General Licence (OGL) obtainable from the Department for Business Enterprise and Regulatory Reform (BERR). Registration under Schedule 5 of the Anti-Terrorism, Crime and Security Act 2001 will also be required. Overseas Tenderers will require equivalent national authoritative/regulatory documentation and may require import licences for Dstl antibodies and toxins and shall be responsible for all import/export arrangements.