During Flu season, great demand is placed on hospitals and Point-of-Care health professionals - time to result is critical and waiting for a diagnostic test to come back from a lab is not ideal. With early-detection results available in as little as 3 minutes, Sofia 2 can provide a full result in 15 minutes. By providing rapid diagnosis and certainty, patients to commence treatment as soon as possible, rather than having to wait days. The Sofia 2 instrument also provides two modes of operation to improve throughput. For occasional use the Walk-Away mode provides fully automatic sample developing and analysis. The Read-Now mode suits busy clinics where multiple tests need to be analyzed consecutively.
By simplifying the user-experience, Sofia 2 takes diagnostic testing out of the lab and into the hands of Doctors and Pharmacists, reducing the burden on hospitals and labs. The designers undertook extensive consultation and usability testing with clinical staff to develop an easy-to-follow workflow. The user-interface has been purposely developed to aid use by non-clinical operators, and features a full-color touchscreen with animated step-by-step guidance on how to process a test. To avoid language barriers, a unique icon set was developed. Considerable effort was undertaken to develop and test these custom icons with real users, to ensure they were concise and unambiguous.
To start the process, a patient sample is dispensed onto the a single-use test Cassette. Upon insertion into the Sofia 2 instrument, the Cassette barcode is scanned to determine the appropriate test sequence. After incubation, the optical sensor inside the instrument scans and collects data from the test strip, before applying proprietary algorithms to interpret the data and provide an objective result. Significant engineering effort eliminated moving parts from the optics design, creating a robust and reliable system with reduced footprint. The inbuilt rechargeable battery adds to the instruments portability; allow potential deployment into remote Point-of-Care clinics or developing countries.
The Sofia 2 design pushes the boundaries of what a medical device can look like. The aesthetic is approachable and contemporary with a color scheme that indicates its technical advantages and moves away from the ubiquitous “white box”. The soft curved form of the instrument is enhanced by strong bold use of color, and the subtle textures of the instrument contrast with the gloss touchscreen. Color is also used to identify key user access areas, with the Cassette tray, carry handle and removable battery color-coded to match.
The built-in wireless connectivity of Sofia 2 offers significant benefits beyond the immediate environment of use. De-identified patient results can be automatically sent from Sofia 2 to Virena - a global wireless Surveillance and Remote Data Management system that provides a near-real-time database. Results are mapped and forwarded to public health, providing data for actionable community response to an epidemic. The information can also be accessed by authorized personnel within a healthcare provider to collate, report and analyze daily, de-identified test, QC, calibration and operator data from multiple clinic sites.
Specific design development activities ensured that the Sofia 2 instrument could be manufactured to the strictest of quality required for medical instrumentation, at a price point that kept the instrument accessible. The casing design was optimized to just 3 major components. Tabbed assembly and snap fits were incorporated to the design to reduce the reliance on fasteners, and simplify disassembly for service and end-of-life recycling. A bespoke manufacturing facility has been setup in Melbourne to produce the instruments under the strictest of quality controls. Here best practice manufacturing principles have been employed to ensure the instruments are assembled with efficient use of labor.