AM Hub case study: Radetec Diagnostics

Additive Manufacturing Hub case study: Radetec Diagnostics

With assistance from the Additive Manufacturing Hub at AMTIL, Melbourne-based Radetec Diagnostics developed an innovative device to facilitate fast and inexpensive testing of various infectious diseases – including COVID-19. Radetec Diagnostics is a Melbourne-based biotechnology company The solution dedicated to developing a world-leading “platform technology” based on quantum dots – advanced luminescent nanoparticles that can be used as labels for imaging and sensing applications. This has a wide range of clinical applications, particularly in the field of pointof-care rapid diagnostics, portable in-vitro diagnostic (IVDs) devices that are used for fast and inexpensive testing of various infectious diseases such as COVID-19, sexually transmitted infections (STIs) or even cancer and Parkinson’s’ disease biomarkers. A first proof of concept of the reader was developed with the help of Professor Dane McCamey (UNSW Sydney and ARC Centre of Excellence in Exciton Science). Cobalt Design was then engaged to improve the design and the sensitivity of the device, as well as manufacturing a series of benchtop reader prototypes to allow extended testing and evaluation of this new device platform. An initial benchtop system prototype was created using an FDMprinted prototype that allowed for variation of position of key Radetec’s IVD product range consist of point-of-care test strips, elements such as the camera. and an electronic reader that is able to generate quantifiable readings in the diagnostic process. The test strips are based on a lateral flow assay test methodology, where a reagent deposited on the test strip generates a reaction to a targeted biomarker. In This prototype included mounting points for each of the electronics components and an OEM USB camera, and allowed for initial function testing of key elements including: this case, this reaction creates a visible florescence response in the • Sample illumination – both with UV and white light sources. reagent when illuminated with a UV light source. • Light tightness of the enclosure. The project entails the design and manufacture of such a reader to • Camera optics selection. initially assist with the manufacture of the test strips, and later form • Camera positioning. a complete set of rapid diagnostic products for clinical use. • OEM hardware including USB camera. The challenge • Electronics – LED and camera power, communication to The aim of this project was to develop a multipurpose benchtop control software. reader device that would facilitate the analysis of the point-of-care • Software development – including camera control, lighting test strips and other type of samples. During the analysis process, control, image capture and image analysis. the test strips are illuminated with a UV light source, while being shielded from ambient light. A camera is used to capture the response and allow further analysis within dedicated software This test unit was a critical step in the development process and allowed a number technical risks to be addressed, while also identifying areas for further optimisation and improvement. Filtering The major challenge for this project was the integration of the main of the LED light sources was identified as a definite requirement elements of the reader that generated results that were of sufficient for the product, which led to a change to the LED configuration accuracy and repeatability. This required successful integration of along with a hardware change. The test unit was also critical in mechanical hardware design, electronics and software, all of which fast-tracking software development as it provided a working device must work seamlessly to create a device that is intuitive and easy to test and debug the custom software that was to use for the operator. being developed concurrently with The reader has also been designed the hardware. to offer flexibility in set-up – to After a series of design allow analysis of a variety of optimisations, a second round sample types and sizes. It was of working prototypes were identified early that offering the manufactured and delivered to ability to analyse samples from Radetec to allow extended testing a single test strip through to a and analysis. Five working units standard 96-sample well plate were manufactured using FDM would provide a significant printing, and along with functional benefit for the product over changes to improve performance, competitor offerings. This a number of additional features demanded more from the were included for better integration camera module, and specifically of components, protection and the relationship of physical isolation of the fragile electronics, position and lens selection. and improved industrial design. Time to market was also identified as a major challenge, and this was a major reason How the Additive Manufacturing Hub helped why additive manufacturing was It was predicated that the project selected as a key part of early would make full use of a $20,000 stage development. Build It Better (BIB) voucher co contribution via the Additive Manufacturing The project allowed Radetec to Hub. The estimated breakdown amounts for develop the reader just in time for the this project were $60,000 to Cobalt Design, with roll-out of its first product – a COVID-19 antigen point-of-care rapid test. $20,000 to be contributed bia BIB voucher.