Diagnostics
it may lead to incorrect results. According to specimen collection company
Forte Medical, 58,275 UK patients are misdiagnosed every day due to problems with urine samples. Its Peezy Midstream device makes it easier for users to obtain an uncontaminated clean catch sample without needing to pause urination or hold a separate tube and funnel. When the device was trialled at the Barts Health NHS Trust, Royal London Hospital site, Professor Chinegwundoh reported that: “Up until this point, our contamination rates were running at
17.4%...The trial is ongoing, but so far we have found contamination significantly reduced to 1.5%. The Microbiology Department are convinced that the device delivers a higher quality specimen.” 9
Improving sample collection Sample collection holds a huge amount of untapped innovation potential. Obtaining specimens can be difficult for various emotional and technical reasons, and this appears to be particularly true of blood, urine, and stool samples. Exploration of this area should be firmly on the agenda of diagnostic companies looking to enter or expand in the PoC space. Some of the challenges could be addressed using a combination of existing, readily available technologies and empathy-led design. With urine collection, the first step in
overcoming limiting factors is to acknowledge that it is not always easy to obtain a high-quality sample. A human centred mindset plays a critical role here, ensuring various user needs, experiences, and scenarios are accounted for. The aforementioned British Journal of General
Practice study on stool sample provision concluded that small changes could make a big difference to patients. Suggestions included ensuring that GPs, rather than receptionists, distribute collection kits to make it easier for patients to raise any questions. In terms of blood collection, wearable
devices enable the self-collection of larger volumes than the finger prick technique in
a less invasive manner. Collection devices can also be designed to enable simple direct transfer to the test device to reduce the risk of sample contamination or infection of the person handling the sample. The protection of healthcare workers and
clinical staff is an important aspect of infection prevention, and it should be a core consideration of sample collection innovation. Self-collection of samples for PoC analysis helps, and this can be taken further with the development of processes or devices that immediately inactivate or isolate the specimen. In some cases, at-home diagnostic testing may be the best approach. This would avoid the need for the infected individual to attend in person, reducing the risk of person-to-person transmission on the journey and in the hospital or clinic.
From PoC to point of need Addressing issues with sample collection could help extend and enhance the role PoC diagnosis plays in infection prevention. It could also enable further decentralisation, and increased accessibility, of diagnosis at point of need, for instance in community, workplace, or home settings.
During the COVID-19 pandemic, at-home diagnostic testing took off in a big way, helping to reduce the spread of SARS-CoV-2 and introducing many people to the convenience of this model. Scientific progress in diagnostics combined with social factors such as patient acceptance creates a fertile environment for at-home diagnostic devices. In the coming months and years, we anticipate increased over the counter (OTC) device innovation for infectious diseases. Indeed, while this market is less mature than that for PoC diagnostics, it is forecast to grow at a compound annual rate of 5.3 percent to reach USD 9.87 billion by 2032.10 Clearly, there are many complex factors
involved in the development of diagnostic devices for use at point of need. As well as being simple and straightforward enough for layperson use, they must be cheap to produce. Attention must also be paid to the risk of false negative or false positive results, as well as the potential for undetected co-infections. Sample collection should be considered alongside these matters as a critical element of effective diagnostic testing.
Whether it is performed at point of care or point of need, fast, cheap, and effective diagnostic testing facilitates earlier treatment and aids infection prevention. Extending the scope of these diagnostic methods would be hugely beneficial to global health. Sample collection can be the Achilles heel or the hidden strength of innovation in this space.
References 1. Point of Care Diagnostics Market, Markets and Markets, December 2022
2. Our Work / Communicable and Non- communicable diseases, World Health Organization
3. Tuberculosis deaths and disease increase during the COVID-19 pandemic, World Health Organization, 27 October, 2022
4. Nandlal, L., et al, Rapid molecular assays for the diagnosis of drug-resistant tuberculosis, Infect Drug Resist, 29 August, 2022
5. Khan, Z., et al, Evaluation of reliability of self-collected vaginal swabs over physician- collected samples for diagnosis of bacterial vaginosis, candidiasis and trichomoniasis, in a resource-limited setting: a cross-sectional study in India, BMJ Open, 2018
6. Lecky, D., et al, Patients’ perspectives on providing a stool sample to their GP: a qualitative study, British Journal of General Practice, November 2014
7. Palmer, C.K., et al, Reasons for non-uptake and subsequent participation in the NHS Bowel Cancer Screening Programme: a qualitative study, British Journal of Cancer, 11 March 2014
8. Chinegwundoh, F., Urine sample collection: issues and a solution, Urology, January/ February 2018
9. Forte Medical, Peezy Midstream UK 10. Home Diagnostics Market, Precedence Research, June 2023
About the author
Nick Collier PhD is the Chief Technology Officer at Sagentia Innovation. Nick supports organisations as they translate new technologies from the research lab bench to commercial products. He has been responsible for numerous breakthrough products and innovations including technologies for diagnostic imaging; and in vitro diagnostics using molecular assays, NGS, flow cytometry and immunoassays.
https://www.sagentiainnovation.com/
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