The INDICATE device is a single-use disposable device inspired by nature and influenced by next generation mass-market IVDs such as the ClearBlue™ ovulation test. It requires no prior manipulation of the blood, no expensive equipment, readers, or specialised personnel, has no external power requirements, it is handheld, small and rapid generating a simple visible yes/no answer. The device is a hybrid microfluidics-lateral flow device, the microfluidics section is powered by Degas flow via specially designed micropumps as a result of the device being packaged under negative pressure, whilst the lateral flow test signal region is powered by capillary force. Button-batteries power the on-device electronics.
The specificity of the INDICATE device comes from specific binding of the mutated DNA sequence to specially designed probe sequences. The trigger mechanism is caused by the agglomeration of nanoparticles attached to these probes. The sensitivity of the device comes from the selective release of tens of millions of signal molecules only in the presence of the trigger; this amplification process is analogous to signalling cascades in living cells.