In the 70s, the development of the rapid human pregnancy test was the initial application that drove the development of system POCT.
With the term Point Of Care Testing (POCT) decentralized analyzes that are performed wherever the end user is, such as: outpatient facilities and medical surgeries, nursing homes, ambulances, pharmacies, healthcare homes, clinical laboratories, e-commerce platforms, hospitals, intensive care centers, urgent care, home care and self-test. POCT devices offer rapid, potentially highly accurate detection of a diverse panel of laboratory clinical markers, using easily obtainable samples (peripheral blood, urine) in very small quantities, using portable instruments. The general objective of POCTs is to improve the quality of care with the maximum benefit for the patient, with the minimum risk and at a reasonable cost, by optimizing diagnostic pathways and allowing for a more timely medical decision, as well as facilitating the monitoring and management of disease, especially in emergency/urgency conditions, in conditions of remote monitoring of the patient with respect to the hospital structure (telemedicine) or during clinical trials for patient follow-up.
The growing importance of POCTs is confirmed by its market value. In fact these systems represent 30% of all in vitro diagnostic systems, by the estimate of the global size of the market, which was valued at 37.03 billion dollars in 2021, and by the forecast of its expansion, with a growth rate compound annual growth rate (CAGR) of 6.8% from 2022 to 2030. The market shares of POCT systems estimated for the year 2022, broken down by type of analysis, are:
- glucose monitoring (39%),
- blood gas analysis (15%),
- cardiac markers (13%),
- infectious diseases (8%),
- pregnancy and fertility tests (5%),
- alcohol and drug abuse (5%),
- hemoglobin test (4%),
- cholesterol test (3%),
- urine chemistry (3%),
- tumor markers (3%),
- others (2%).
The explosion of the use of POCTs with COVID-19
One of the main effectors of the explosion in POCT use has been the COVID-19 epidemic; This has sparked unprecedented public health concern around the world by highlighting the need for rapid diagnostic results in the general population and policy makers. Thus, POCT tests have become a vital diagnostic tool; the use of POCT tests in diagnosing COVID-19 has increased at a more than exponential rate due to multiple benefits such as small size, portability, convenience, and generally relatively accurate results, among others.
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A second effector of the expansion of POCT systems is the global increase in the prevalence of chronic diseases such as: diabetes, cardiovascular disease, arthritis, respiratory disorders. The increase in these pathologies has a particular impact in developing countries where it is associated with infectious pathologies already widely present, and in a context of scarce economic and hospital resources, making the need for low-cost POCT mandatory. In fact, POCT systems can be used to monitor and contain the spread of viruses such as: malaria, dengue and Ebola, also bearing in mind that, in areas where these infectious diseases are more widespread, there is often a lack of qualified personnel and reliable equipment.
Another example of the application of POCT systems in developing countries is the early diagnosis of tuberculosis. This represents a critical health problem, being easily transmissible by air, so it is essential to detect TB at an early stage by rapid POCT testing so that infected individuals can be isolated and treated as soon as possible.
POCT devices are often ‘handheld’ or can be small portable analyzers and often use disposable cartridges/strips for qualitative/quantitative analysis via an integrated reader. Multi-purpose cartridges together with portable bench reading instruments potentially offer qualitative analysis but also, depending on the type of device chosen, precise quantification.
Towards new applications of POCTs
The tremendous progress made in the development of POCT systems and the trend towards intelligent technologies of mobile Health (mHe), classified by WHO as a branch of eHealth that includes the use of integrated multimedia and mobile telecommunications technologies in healthcare delivery systems, open up new and unexplored territories of application. In recent years there have been numerous app smart for personalized mHe, which collects general health parameters of subjects via Bluetooth and synchronizes data in the device to the web portal via wireless connectivity and Cloud computing allowing healthcare staff and patients to effectively monitor and manage their health.
In 1956, Singer and Plotz developed lateral flow technology or lateral flow immunoassay (LFIA) from the latex agglutination test. This technology has evolved significantly over the years and has proven to be the simplest and most successful POCT diagnostic platform. However, the number of technological platforms used in POCT systems has continuously increased in the last decade, among the most widespread are: lateral flow chromatography assays, Dipsticks, Microfluids, Molecular Diagnostics and Immunological Assays. Most POCT devices measure target analytes using electrochemical and/or optical sensing technologies. For example the prevalence of POCT devices for home blood glucose monitoring employ the enzyme glucose dehydrogenase which is independent of oxygen and provides accurate results for all types of blood samples.
Tests are also available POCT is for the determination of biomarkers of cardiac damage (troponin caridaca, myoglobin and creatine kinase isoenzyme) and for cancer biomarkers such as prostate specific antigen, platelet factor 4 and carcinoembryonic antigen. A large panel of different POCT tests have been developed for determining complete blood cell counts for the diagnosis and monitoring of various pathological conditions, such as l’anemia and the human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS); Several POC tests are currently on the market for the detection of antibodies to HIV, influenza virus, P. falciparum, Streptococcus, Treponema pallidum, Chlamydia trachomatis, rotavirus and Trichomonas.
Cancer is the second leading cause of death globally with 8.8 million deaths in 2015 or 70% of cancer deaths in low- and middle-income countries. Of note is the early detection of cancer by developing POCT tests for the detection of new cancer biomarkers with better predictability.
POCT platforms beyond laboratory analysis
The application of POCT platforms is not limited to the field of laboratory analysis but is useful for safeguarding human health by analyzing rapidly and in situ: food, environment and in safety. In fact, POCT tests are employed necessary to detect harmful chemicals (such as pesticides, mercury, arsenic, etc.), toxins (such as botox), pathogens (such as E. coli O157:H7, Salmonella, Campylobacter) or biological warfare agents (such as anthrax spores) in food, ‘water supply, soil and other means. Early-stage detection of these analytes is essential to avoid outbreaks. Not secondary is the growing need to test food products for allergens (gluten, lactose), increasingly widespread and one of the main concerns of Western society.
The challenges to face
The rapid growth of POCT systems has spawned many challenges that need to be addressed so that these technologies can be fully employed for next generation healthcare monitoring and management.
Compliance
A first challenge is the compliance of the POCT technology developed with the guidelines and/or regulations of the various regulatory bodies (FDA, EFSA), and it is perhaps the toughest challenge that must be addressed before the technology can be used in healthcare. This problem is exacerbated by the large and heterogeneous number, which is continuously increasing, of POCT systems and manufacturing companies involved in the analysis of the same molecule. This therefore generates a lack of homogeneity in the analytical performance (robustness, reproducibility, sensitivity, specificity, precision, accuracy) of POCT systems with those obtained by accepted laboratory medicine technologies.
Furthermore, the aforementioned heterogeneity of POCT systems makes theirs difficult integrationso that they can be used in remote and decentralized environments.
privacy
In this regard, the widespread use and communication of electronic data and the advent of cloud computing via Bluetooth and wireless networks raised concerns about data security and ownership. This is particularly pertinent in POCT devices, which are integrated into networks telemedicine where these are intended for mobile healthcare services, i.e. where a patient’s test data is expected to be stored on a device and/or on a network, and then transmitted to certified healthcare personnel. Therefore, you need to maintain ownership of confidential data, such as patient’s personal medical records, by protecting them using algorithms encryption advanced. Recorded data must be synchronized to require two-way communication between POCT instruments at all sites and the central data storage server of the health information network.
Conclusions
The number of potential future target analytes for POCT testing, are many, and only the human imagination is a limit. Among the most significant in this respect are growth hormone, adrenocorticotropic hormone, parathyroid hormone, sepsis biomarkers, stroke biomarkers, tuberculosis biomarkers, malaria pathogen/biomarkers, diarrhea, the pathogen of STDs, immunosuppressants and related metabolites, deoxyribonucleic acid (DNA), and pathogens (borne by air, water, or food) responsible for disease outbreaks and epidemics.
The huge advances in complementary technologies, such as system integration, device automation, long-term storage strategies, and signal reading will play a key role in the development of next-generation POCT technologies in the telehealth space.
*Antonio Solimando, Manuela Mandorino, Roberto Ria, Giuseppe Calamita, Jean-Francois Desaphy, Filippo Lanubile, Donato Malerba, Fabio Manca, Loredana Perla, Giuseppe Pirlo, Giovanni Semeraro – Interdepartmental Research Center in Telemedicine (CITEL), University of Bari Aldo Moro
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