Experts: Daniel Gygax (SATW), Samantha Paoletti (CSEM)
Point-of-care testing is diagnostic testing carried out near the patient or service recipient in a quick, straightforward and low-cost manner. It can take place in hospitals, general practitioner’s surgeries, pharmacies or at recipients’ homes. This type of monitoring can improve clinical care by enabling more frequent measurements, shortening response times and reducing the frequency of doctor’s visits. In the future, process digitalisation and the integration of services and results into a single platform should lead to more effective medical care and lower healthcare costs. This is contingent on service providers being adequately networked with service recipients, and all players’ responsibilities being clearly defined.
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In medicine, the term ‘point-of-care testing’ (POCT), also known as rapid testing, refers to diagnostic testing that is not performed in central laboratories, but in pharmacies, doctors’ surgeries, ambulances, hospitals or the recipient’s home, the results of which are obtained on the spot without the involvement of a laboratory. Some POCT can be carried out by the recipients themselves. The typical characteristics of POCT are thus as follows: (1) performance and analysis near the service recipient; (2) sample preparation is either unnecessary or technically simple, since testing uses blood, saliva or urine; (3) no medical or technical knowledge is required; and (4) therapeutic consequences are immediately deduced from the results, shortening the interval between diagnosis and therapy. POCT has now also established itself in the food and environmental industries, for example in the detection of salmonella in food or legionella in water samples.
POCT is based on the principle of molecular recognition, meaning the specific interaction between the substance to be tested and a reagent. This interaction takes place on a strip of paper and is made visible by means of a recognition element bound to a dye. The analysis is qualitative, quantitative, visual and unambiguous. The result may be quantified according to requirements and markers. The tests are easy to use, reliable and cheap. The best known are used to measure diabetics’ blood sugar levels, to detect pregnancy or infections (such as coronavirus or sexually transmitted diseases), or to monitor blood clotting. Doctors are increasingly using POCT to detect troponin in tumour diagnostics, or to quickly detect or rule out heart attacks.
In the future, patients will increasingly carry out tests on themselves, thus making an important contribution to the digitalisation of healthcare. Certain biomarkers will be monitored over time, so as to map disease progression, and to ensure timely and uncomplicated therapeutic intervention. This is to be made possible by a medical platform: the Internet of Medical Things (IoMT, see article Internet of Things). Here, service recipients will upload their test results and files so that the relevant service providers at hospitals, practices or health authorities can review them and issue treatment instructions. The platform will thus contribute to patients’ medical care at home.
Digitalisation and the personalisation that it entails can only become a reality if new biomarkers are incorporated into POCT formats, thus opening up new application areas. There is also a link to nutrition here (see article personalised nutrition). In order for POCT to be used more widely for self-testing, it must become increasingly non-invasive or minimally invasive, which means extending it to other body fluids, beyond blood and urine, as samples.
What makes POCT so valuable is that it provides rapid access to medically relevant information. It would thus make sense to incorporate trends like multiplexing (a powerful method of generating quantitative data for many parameters from a limited-volume sample) into point-of-care testing formats. Another trend is towards combining sensors, in the form of electronic patches and medical wearables, with POCT results on the IoMT, thus generating a closed loop. A platform like the IoMT makes it possible to determine biomarkers such as insulin or C-reactive protein (CRP) in relation to medication levels and adjust their dosage accordingly. Devices like smartphones and smartwatches, along with corresponding apps, will play an increasingly important role for such platforms. The scope for applications depends on the service providers’ skills; integration will first take place in outpatient clinics, emergency medical interventions and hospitals, so among the service providers with the highest skill levels.
POCT will facilitate the transformation from a static healthcare system into a dynamic one: In the future, the clinical workflow will become broader, covering not just conventional face-to-face consultations, but also self-testing at home, as well as phone and video consultations. Thus, the IoMT is taking shape for diagnosis, therapy and monitoring. Digitalisation is leading to more effective medical care and should help to lower costs. In addition, the patients’ quality of life is improving, as they can stay at home longer when they are ill and have to make fewer physical visits to their doctor’s practice.
The sales market for POCT is very large, experiencing a worldwide boom that is benefiting Switzerland’s internationally competitive pharmaceuticals, medtech and watch companies. Start-ups are also increasingly invigorating the market, mostly seeking entry via the loosely regulated lifestyle sector and only tackling the high regulatory hurdles facing the pharmaceuticals industry once they are successfully underway.
One technical challenge is the sensitivity of the testing systems. Interdisciplinary work between bioanalytics, computer modelling, artificial intelligence, molecular biology and structural biology could provide solutions to this challenge.
Correct use of POCT in the home setting is still a major challenge. Users must follow the instructions to the letter, and take responsibility for themselves and the process. It is essential that, in the future, the test results are delivered with substantiated recommendations for action, in order to prevent users from searching for them on the internet. Older people, who benefit greatly from the use of POCT, are among those most likely to falter when faced with the challenges of tests and telemedicine. One solution has been presented in a strategic project by FHNW. The ‘laboratory in a backpack’ contains the most important tools that home-nursing providers needs to provide all-round telemedical care. This includes not only physical diagnostic equipment, but also the instruments required to carry out POCT. The COVID pandemic has shown that a significant portion of the Swiss population is sceptical about technical progress in medicine. In this context, it is essential to resolve issues around data ownership, data protection and data sovereignty.
The complex processes in the healthcare sector, the large number of different players and the lack of clear assignment of responsibility are hindering effective implementation of the transformation outlined above. However, setting up modern healthcare networks is a national (or even international) task. It would be a very suitable subject for an Innosuisse Flagship Initiative proposal, which should also encompass clinical studies and improved access to data. Even though access to EU programmes is severely limited at present, there should be political attempts to make knowledge from such projects available for research and business in Switzerland.
