In the wake of the unprecedented COVID-19 pandemic, the world has witnessed a remarkable shift in the way healthcare is delivered. As countries grappled with the challenges of containing the virus’s spread, medical systems were put to the test, prompting the rise of innovative solutions to meet the growing demand for safer and more accessible diagnostics. One notable outcome of this healthcare revolution has been the surge in popularity of home-based diagnostic testing as a way for people to take personal responsibility for their own health.
Once considered niche, the idea of conducting tests from the comfort of one’s own home without the need to queue up to see a healthcare practitioner has now become an integral part of the healthcare landscape. Powered by advancements in technology, the convenience and efficiency of new innovative home-based testing has captured the attention of health authorities, medical professionals and the general public alike. This paradigm shift has not only redefined healthcare accessibility but has also played a vital role in curbing the spread of infectious diseases and increasingly the ability to regularly monitor wellness biomarkers.
From pregnancy tests and COVID-19 antigen tests to self-screening tests for HIV, the spectrum of home-based testing is expanding to cater to diverse medical needs and increased consumer demand. In this article, we delve into the unprecedented rise of home-based diagnostic testing and its transformative impact on the healthcare industry and community wellness.
Prior to the COVID-19 pandemic, the prevalence of self-testing for various health conditions was relatively low, and there was limited data available on public willingness to conduct diagnostic self-tests at home. While self-testing for certain conditions like pregnancy or blood glucose levels was more common, the broader acceptance of self-testing for infectious diseases or complex health issues remained limited, in large part due to regulatory barriers to approval of ‘bits in a box’ test kits that were fiddly to use and delivered poor usability and performance.
With the outbreak of COVID-19, there was a surge in the use of rapid testing at home. Studies and surveys conducted during the pandemic showed an increased acceptance and readiness among individuals to self-administer COVID-19 tests, especially when traditional testing facilities were overwhelmed and lab results were not being returned quickly enough to be of real use.
While the COVID-19 pandemic undoubtedly accelerated the acceptance and adoption of home-based testing, its benefits now extend far beyond that crisis. The potential to reach remote and underserved communities, support early detection of diseases, and reduce the strain on healthcare facilities are key advantages that make this an emerging trend in the delivery of healthcare.
Despite the concept of self-testing for infectious diseases being relatively new in the consciousness of the general public, it is something that Atomo has been focused on for over a decade. After more than ten years of serving as a senior leader in the medical device industry, John Kelly, Co-Founder and CEO of Atomo Diagnostics, recognised several opportunities for a revolutionary transformation in the field of diagnostics.
The early years of the Atomo saw the company begin to develop its market-leading diagnostic testing solutions, integrating the various moving parts and functionality of traditional multi-component lateral flow rapid diagnostic test kits into one integrated cassette to simplify the testing process and vastly improve usability and accuracy. The successful design, development, and validation of Atomo’s Galileo cassette led to the first finished rapid test being commercialised by the company – the Atomo HIV Self Test. With CE marking secured, inclusion in the Australian Register of Therapeutic Goods (TGA) and WHO prequalification followed with the Atomo HIV Self Test now registered and available in over 40 countries worldwide.
Beyond the HIV Self Test, Atomo has invested heavily in its Pascal cassette which further simplified the testing experience. The handheld device includes a unique integrated buffer delivery mechanism that delivers the required quantity of buffer reagent at the touch of a button to automatically run the test. Interlocked user steps help to mitigate common user errors, making the platform suitable for professional point-of-care and self-test applications. An independent comparative study was recently conducted comparing the Atomo Pascal cassette and a traditional multi-component whole-blood rapid lateral flow diagnostic test kit, demonstrating improved usability and a number of critical performance advantages over traditional test kits.
In order to achieve reliability, improved usability and performance, the selection of plastics for Atomo’s cassettes was rooted in a comprehensive evaluation of key criteria, namely dimensional stability, processing capability, chemical resistance and visual appeal. Each chosen material is exclusively sourced as virgin plastic with their distinction underscored by UL and C-UL approvals. In the creation of the sterile lancet housing, a medium-flow polypropylene homopolymer, renowned for its versatility in general injection moulding applications is used.
For the unique blood collection unit, Atomo reviewed numerous materials and significant efforts in design and prototyping to find a suitable material that would meet requirements with stiffness, critical tolerances, and dielectric properties being key requirements.
A glass-reinforced polymer was selected and delivers hydrophilic properties well in excess of standard polymers typically used in medical devices. This material and special tube geometry improves blood collection from a fingerstick and proprietary design elements remove air bubble formation via venting. The material has great strength, excellent dimensional stability and creep resistance, ensuring reliable and consistent transfer of blood to the test strip.
With the sizable shift in consumer sentiment towards at-home testing, it is increasingly crucial that rapid diagnostic at-home tests are both accurate and easy to use for the layperson. With robust components and a series of interlocked user steps, Atomo’s platforms are tailor-made to provide this solution. Already available in over 40 countries across the world, Atomo’s unique offering is only set to grow, with a strong commercialisation plan in place to expand the world of at-home rapid diagnostic testing.
