The handheld device has been developed as a simple to use system, that requires minimum operator intervention to run assays and can easily be integrated into existing workflows where rapid diagnostics can add value to clinicians.
The reader has been developed to fully control the running of the assay and its analysis. Once the sample has been added to the assay cartridge and inserted into the reader, the reader takes over the running of the assay. This includes the actuation of the fluids for the wash step and the ammonium thiocyanate for the reduction of the silver nanoparticles. No user intervention is required until the assay has been completed, where all that is required is the removal of the assay cartridge from the reader for disposal.
The system is fully communication enabled with built in WiFi, Bluetooth and USB connectivity for results transfer. The reader has on board information storage and can store up to 30000 test results.
Assay results are all associated with a User ID, Patient ID and are time and date stamped for traceability. The reader has a built in barcode scanner that is used for identification of the assay for analysis and can also be used for scanning user and patient ID’s for ease of information capture.
The reader and software is being developed to allow for customisation to end user requirements to ensure maximum flexibility in its use.
The AgPlus system is being developed in line with required ISO standards and complies with medical device directives to ensure development partners can easily integrate into their regulatory compliance systems for approval of use.