Device for the qualitative detection of nucleic acid from the coronavirus SARS-CoV-2 that causes COVID-19
Diassess Inc. (now Lucira Health Inc.) developed a compact rapid diagnostic tester of Flu and STDs. The original design provided a visual color change at the end of the test and was intended to be read out by a trained professional. Early trials demonstrated that it was difficult to create a definitive reading. Gener8 was asked to investigate if a low-cost electronic reader could be developed for either a disposable handheld device or for a higher throughput benchtop unit. The initial aim of this work was to investigate available technologies and propose solutions that could be implemented within a tight budget.
This test, originally developed for the Flu virus, later became the first FDA approved sample to result in-home test for Covid-19.
Challenges
- Add an electronic output reading compact enough for a disposable handheld device or for a higher throughput benchtop unit.
- Provide a high quality product while maintaining a low cost.
Solutions
- A serpentine wire heater replaced the inefficient resistive heaters.
- The chamber array was changed from a linear lab slide based design to a radial pattern with a 3D fluidic path.
- We employed a novel light source, light pipe, and optical detector to provide a very high quality, low-cost device.