Abstract

Sequentially Linked Integrated Cassette for Molecular Diagnostics – SLIC MDx

Wamadeva Balachandran, Director, Brunel University London

Current molecular diagnostic methodologies use laboratory-based nucleic acid tests (NATs), but these routinely require specialised infrastructure, a reliable power supply and trained personnel. At present, a cost-effective, accurate sample-in-to-answer-out NAT requiring minimal user input on a disposable platform is not available. To this end, a self-use sample collection and preparation device capable of collecting a 2 ml volume of urine with an integrated swab and paper-based molecular diagnostic platform to perform DNA extraction, amplification and detection has been developed. This system can deliver a sample-in-to-answer-out low-cost, equipment-free, power free NAT in about one hour and is completely disposable in an environmentally friendly manner. The novel design enables a lay user to collect and prepare a sample following simple, on- pack instructions and place it into the integrated, paper-based diagnostic device. The diagnostic device enables a novice user to perform molecular diagnostics through execution of sequential operations that mimic swiping and pressing on a smartphone. The design prevents accidental or erroneous operations, has reagent storage and does not require precise metering of fluids or refrigeration. The system can be linked to an e-clinical pathway via a smartphone app to deliver immediate treatment and collection of data for public health surveillance. The e-clinical pathway will be implemented using the in-house developed wireless architecture which includes healthcare data security protocols.