Point-of-care testing: promises and challenges

Article tags In-vitro diagnosticsPoint-of-care testing (POCT)Uncategorised

Point-of-care testing (POCT) has long been touted as a revolutionary technology that has the potential to transform healthcare. By providing fast, convenient and affordable testing options, POCT can help improve patient care and reduce costs.

Despite its many advantages, point-of-care technology has not yet achieved widespread adoption. POCT currently only accounts for less than 15% of the in vitro diagnostic (IVD) market, while routine testing accounts for around 45%.

There are a number of factors that have contributed to this slow adoption rate. One challenge is the relative inaccuracy of some current point-of-care tests. Additionally, point-of-care testing devices can be expensive, and there is a lack of standardisation across different devices and tests.

Another challenge concerns training healthcare professionals on how to use point-of-care equipment and interpret test results correctly. This can be a barrier for adoption in remote or underserved areas. Clinicians are sometimes wary of the results provided from POCT by unaccredited personnel. 

However, the recent Covid-19 pandemic has revived new interest in POCT’s potential. During the pandemic, POCT was used extensively to test for covid-19, demonstrating that point-of-care diagnostics are a valuable tool for rapidly diagnosing, monitoring and managing infectious diseases.

We talked to Ivy Teh, Managing Director for The Economist Intelligence Unit Healthcare, to understand the challenges and potential facing the point-of-care diagnostics market. 

1.) What is influencing the point-of-care testing market?

Ivy: We know point-of-care testing is not a new technology and has been around for decades. Covid-19 has made POCT more prevalent. 

Essentially, covid-19 has generated the wide adoption of POCT. It has heightened awareness and acceptance by healthcare professionals, providers, consumers and governments alike on the benefits and effectiveness of POCT in the quick diagnosing and prevention of covid-19 spread at the community level, which has opened up possibilities of POCT to be considered widely across different care settings.

2.) How did the pandemic change clinical utilisation of point-of-care testing?

The pandemic has also exposed a clear weakness in healthcare delivery systems that has an over-dependence on lab-based Dx technologies. These are slow, costly and limited in their reach to respond to an outbreak.

On the other hand, POCT has shown to be a cost-effective, reliable tool that can provide immediate results, therefore helping to deter the spread of the infection and determine the next actions. 

The fact that POCT can be easily and effectively carried out by non-laboratory-trained personnel highlights the adaptability of the technology to be applied in various non-acute settings—such as primary care, community care, long-term care and home care. This opens up the possibility of point-of-care testing to be an integral technology to help healthcare delivery systems transition to a more decentralised model, decrease overall healthcare expenditure and improve quality of life.

3.) Are there new patient care needs that will change the point-of-care market?

I mentioned decentralisation of healthcare delivery earlier. Because of that, the main burden and cost of patient care is no longer centralised in a hospital or acute care setting. Patient-care needs, such as disease detection, monitoring and management are now spread and performed across different care settings. 

This shift in the patient care pathway is happening in both developed and developing markets with different emphasis. 

In developing markets, governments (sometimes in collaboration with NGOs) have launched or are launching disease prevention and surveillance programs for infectious diseases using POCT in primary care clinics and community care centres for faster treatment and prevention of spread (ie. tropical fevers like Malaria or dengue, STIs and HIV). In recent years, even self-tests have been increasingly integrated into public health programs. For instance, Thailand approved HIVST—an HIV self-testing kit available commercially to the public.

In developed markets like EU-5—Japan, which faces a large ageing population—care providers (particularly primary care physicians) are starting to see the benefit of point-of-care testing in the diagnosis, treatment and management of NCDs and chronic conditions like cardiovascular diseases, diabetes, cancers and neurological diseases (such as strokes or dementia). GPs acknowledge that POCT can improve diagnostic certainty, be more targeted for treatment, allow patients to self-manage their chronic conditions, and improve clinician-patient communication and relationships.

During the pandemic, many people became familiar with home-based covid-19 tests. These tests were easy to use and provided results quickly. As a result, people are now more comfortable using home-based tests for other conditions, such as respiratory infections and STIs.

4.) What is on the horizon for point-of-care testing?

I believe POCT in the horizon will be increasingly adopted for inpatient, outpatient, and non-clinical settings, such as homes and airports.  

We know diagnostic companies are investing in expanding their rapid testing portfolio by covering more therapy areas—such as rapid testing cancer biomarkers for common cancers to better support patients at home. 

Advances in biosensor technology and microfluidics have improved the accuracy and sensitivity of POCT devices while allowing for multiplexing. The high penetration of smartphones has made it possible to develop POCT devices that can connect to the internet and transmit data to healthcare providers in real time. This allows healthcare providers to monitor patients’ health conditions more closely and offer more timely intervention.

5.) Are there new tests that will move out of the lab and closer to the community?

I believe in the near-term, new tests will expand towards:

• More respiratory diseases (influenza A/B, RSV) and different strains of covid
• STIs, such as gonorrhoea and chlamydia

In the mid-term and longer term, I believe we will see rapid testing and POCT supporting disease management of chronic conditions and NCDs for patients at home, including:

• More cancer biomarkers may be available for common cancers such as lung or stomach cancer
• POCT tests to screen for neurological conditions, typical of an ageing population, like dementia or strokes

Its advantages are especially apparent in a patient population with limited resources and poor follow up.

6.) What are your thoughts on the home market and patient self-testing? Are there advantages or limitations for patient-directed laboratory testing?

I think the patient self-testing market has moved from a very nascent to an early growth potential, post-pandemic. Before covid-19, we were mainly familiar with two at-home tests. We can do blood sugar testing or pregnancy testing. But the pandemic has made us realise we can diagnose infections at home—it raised consumer awareness of the role that testing plays.

However, there are hurdles to overcome for a wider application of home testing for more chronic and infectious diseases. Generally, there is a need for increased education for patients and even retailers (like pharmacies) on how to provide and use self-testing appropriately, what results mean and how to interpret the next steps. It’s not sufficient for home tests to say ‘negative’ or ‘positive’ and there needs to be a tie-in of home tests to the patient’s disease management and treatment plan (such as the ability to upload to the EMR) for self-testing to be truly effective.

Another important use of POCT includes patient monitoring, where tests are required to track patient progress in recovery or monitor their health conditions. Some of the most common POCT tests used for patient monitoring include:

• Glucose monitoring: POCT blood glucose metres are widely used by people with diabetes to monitor their blood sugar levels throughout the day. Since 2016, after the first FDA-approved continuous glucose monitor (CGM) hit the market, adoption has expanded rapidly. Some CGM devices are now integrated with smartphones, allowing users to view their glucose levels and trends directly on their phones. This can make it even easier for people with diabetes to manage their condition. 
• Coagulation testing: POCT coagulation monitors can be used to monitor the effectiveness of blood thinners and to detect bleeding disorders. This information can help clinicians adjust medication dosages and to provide appropriate care for patients who are at risk of bleeding.
• Cardiac monitoring: POCT cardiac monitors can be used to monitor heart rate, rhythm and blood pressure. This information can be used to diagnose and manage heart conditions, such as arrhythmia and heart failure.

7.) Are there concerns with the supply chain for point-of-care testing reagents and controls in some parts of the world?

It is indeed the case, that robust procurement systems are vital to effectively implement new POC technologies, especially when reagents and quality control panels have limited shelf lives and frequently require cold chain management

Supply chain deficiencies can lead to suboptimal or poor-quality POC tests, which may discredit point-of-care testing. However, supply chain concerns usually plague more developing nations (like African or Latin American regions) where bottlenecks also exist in inventory management, inefficient admin procurement processes and lack of expertise and training of healthcare workers to maintain a sustainable supply chain.

8.) There has been growth in pharmacy clinics over the past decade for point-of-care testing because of its portability, ease-of-use and limited space requirements. This has resulted in a need in delivering testing while the patient is being seen. Do you see this market expanding and in which ways?

• The evolution of community pharmacies into convenient and accessible care providers using POCT has become more prominent in Europe and America in the last decade. But I believe there are different models implemented with different levels of success, even in the US itself. In the EU, Britain is at the forefront and the rest have fragmented programs for certain diseases but not as fully developed yet. 
• I think the growing adoption of self testing will help expand pharmacy clinics. There are concerns that self testing done on its own is ineffective without consultation and healthcare advice, as there is also the risk of accuracy and abuse. However, such POCT devices could potentially be linked with smart devices given the high level of usage, and having the data managed or the use of AI could improve diagnostics accuracy.
• In-pharmacy POCT models in close collaboration with doctors can address most of the concerns raised with self-testing. For example, patients can be counselled or referred to an infectious disease specialist if tested positive, rather than being lost to follow-up.
• So I think over the long-term, we can see POCT in community pharmacies playing an important role in the diagnosis of common diseases and the monitoring and management of chronic diseases.

9.) What is the next technology that will revolutionise the point-of-care testing market?

• I think I can see three key technologies that will raise POCT adoption to the next level:
• 1. Syndromic/multiplex testing in POC Molecular Diagnostics testing: if this technology can be improved in terms of accuracy, reliability, and cost, it has huge benefits in helping to make faster Dx decisions and optimising processes at the primary care level, as it offers a simple test to detect multiple pathogens. This can further empower PCPs. Some of the new POC MDx multiplex tests coming out have 30 assays and even specific multiplexes with more than 50 assays.
• 2. AI: I think AI is the next game changer. Most physicians see AI as a means to assist them with clinical decision support. Innovative POCT solutions combining connected health (tech that will link the test results from self-testing or clinic-based testing to hospital EMR and vice versa) with AI capability to help interpret the results and identify potential blind spots will be widely attractive, especially in this post-covid era of severe healthcare workforce shortages. 
• 3. Connectivity: the pandemic has shown us the possibility of self-testing combined with telemedicine as an effective way to empower patients to take care of their own health, and help to reduce the workload in the healthcare system. So the growth of home tests supported by telemedicine can filter patients who require symptom management at home and those who require more complex treatments. Home tests will provide an initial screening at home, but will not replace laboratory testing. Moreover, with the high penetration rate of smartphones, data from point-of-care testing devices can be collected and managed, enabling clinicians to better monitor their patients.

10.) The pandemic brought new opportunities for point-of-care testing with covid screening of sports players prior to practice, screening event and concert attendees prior to entrance and travel clinics for testing passengers prior to international travel.  Do you see other opportunities in the global market for testing such as malaria, dengue fever, sexually transmitted infections, or other diseases?

We have done projects where toxicology is increasing in corporations e.g. mining companies, industrial manufacturing companies and even maritimes (shipping companies for sailors/staff). They test for drug abuse, STI, and other infectious diseases. As these staff are usually in isolated or rural areas, there is a need for continuous testing to ensure safety on their jobs. As governments input more industry requirements, these tests of POCT will rise in the future. Other testing includes schools, and universities for drugs which is also becoming much more prevalent

Conclusion

Overall, point-of-care testing is a powerful tool that has the potential to improve healthcare delivery in a number of ways. As POCT technology continues to advance, it is likely to play an even greater role in the future.

Fri, 13th Oct 2023 Article tags In-vitro diagnosticsPoint-of-care testing (POCT)Uncategorised