Prior to the pandemic, rapid diagnostic testing was near the exclusive domain of healthcare professionals, available to those in hospitals, clinical facilities, and emergency departments as invaluable tools for real-time data when making critical care decisions. While this left patients, in most cases, without initiative or control over their care, it was not until Covid-19 that many were aware that this was the case.
At the height of the pandemic, with medical systems worldwide groaning under the weight of high patient numbers and extreme isolation requirements, researchers and innovators rose to provide rapid testing methods that could be performed by anyone, anywhere—proving to stakeholders across the industry the possibility and viability of rapid testing for use at the point of care and in patients' homes.
While these new testing methods provided much-needed relief to overburdened healthcare systems worldwide and enabled vastly improved decision-making for providers, they also stoked in patients a new demand for greater access and control within their care that has only grown. Today, innovators are stretching to improve testing and efficiency for providers further while also seizing upon this new demand to produce novel, patient-led methods of diagnosis and delivery.
Whether administered at home by the patient or at the point of care by a healthcare professional, next-generation rapid diagnostics aims to improve the efficiency and quality of care while making it more accessible and affordable to the patient than ever before.
Most often associated with infectious diseases, these tests are commonplace already in several applications requiring fast, informed decision-making, such as:
- Cardiovascular, with tests including
- Brain natriuretic peptide (BNP) test (heart failure)
- PT/INR test (clotting disorder/VTE)
- Troponin test (heart attack)
- D-dimer test (clotting disorder/DVT)
- STI/GYN-OB, including tests for
- HIV
- Hepatitis B
- Hepatitis C
- Pregnancy
- Streptococcus B
- Endocrine applications primarily concerning diabetes, including
- Rapid blood glucose test
- Hemoglobin A1c (HbA1c) test
- Ketone test
- Gastrointestinal and colorectal tests, including
- Clostridium difficile
- Fecal occult blood test
- General health applications such as
- Blood gas analysis (ABG test)
- Hemoglobin tests
- Lipid profile
- Traumatic brain injury (TBI)
- And, of course, infectious disease panels, including
- RSV
- Influenza
- Streptococcus/Strep throat
- COVID-19 test
- C-reactive protein (CRP) test (inflammation/infection)
- Procalcitonin (PCT) test (sepsis/bacterial infections)
While these rapid tests have been essential tools in managing immediate clinical decisions for some time, this relatively new genre of diagnostics is now expanding to cover many other applications and use cases that have long been overlooked.
Responding to physicians' demands for enhanced data collection and patients' desire for greater involvement in their healthcare, rapid general wellness panels are increasingly commonplace, testing for vitamin, mineral, and cholesterol levels. In oncology, rapid screenings for cancer biomarkers are in high demand for numerous common cancer types. New rapid tests have emerged checking fecal occult blood (important in detecting colorectal cancers) and HPV status (a risk factor for cervical cancer). Meanwhile, neurological applications have emerged that allow rapid detection of stroke activity and quicker diagnosis of dementia. This is all while existing application areas have and continue to expand steadily; new tests and improved tests have emerged for some STIs and infectious diseases, particularly those respiratory, including meningitis, various strains of flu and COVID-19, gonorrhea, and chlamydia.
Even with the rise of at-home diagnostic tests and other personal health solutions, point-of-care rapid testing is still a critically important component of the diagnostic market overall, a tool serving distinct, equally important roles to physicians, whether in the clinic or ICU. These tests enable rapid and effective triage in ERs and offices, quickly informing courses of action and treatment by providing real-time information via simple, easy-to-perform tests, and often significantly impact time to diagnosis and appropriate treatment. Still, they are not without their challenges. Because rapid diagnostic tests must often be more sensitive than their more time-consuming counterparts, they are more likely, on average, to return false positives while costing more. Meanwhile, their development can be particularly challenging as designers must balance the complexity of collecting samples for accurate results with respecting the existing workflows of healthcare professionals, a critical component for adoption and proper use. Even so, rapid point-of-care testing methods are in high demand and projected to become only more relevant over time, particularly as they find more use in oncological applications.
Yet, innovation in point-of-care testing has an additional driving force many may not consider: artificial intelligence (AI) advancement. Already viewed as an invaluable tool to physicians worldwide, the algorithmic capabilities offered by machine learning have enabled data collection and analysis on a scale never before possible. This newly found tool in diagnostic decision-making has already permeated areas such as medical imaging. AI is currently used to detect anomalies in scans often invisible to the human eye. As AI, connected health, and rapid diagnostics continue to evolve; there is no doubt their development will be intertwined, with AI bridging the gap between traditional point-of-care testing and the newly established data source of at-home diagnostics.
Alongside improved POC testing, rapid at-home diagnostic tests have also seen vast advancement, particularly since the invention and wide dissemination of COVID-19 screening tools. While these rapid diagnostics relieved the burden of testing for healthcare providers, they also imparted several benefits to patients that stoked a fresh desire for new initiatives and control in their healthcare. Today, patients are more interested than ever in performing their tests, engaging deeply with their treatment plans, and building functional working relationships with the physicians entrusted with their care. Since the pandemic's start, the boom in at-home diagnostic testing has widely reflected this desire. While not a replacement for proper clinical care, at-home rapid tests provide affordable access to critical health services even where facilities are overfilled or cannot be accessed, relieving pressure on understaffed and overworked healthcare teams worldwide.
Meanwhile, they allow for faster, better-informed decisions pertaining to isolation measures, diagnoses, and treatments, ensuring that patients receive the care best suited to their exact status when treated. While any concerning results must be confirmed with more complex POC testing at a clinic or hospital, at-home screenings remain a significant improvement in both convenience and function. They are set to become a mainstay of the future medical landscape.
While diagnostics is hardly a new or even young segment of the medical field, it is currently seeing innovation at a pace unlike ever before, with research and technology advancing on the micro and macro levels at breakneck speeds as designers seize upon areas of interest previously underserved in the field. At present, there are four primary areas of diagnostic testing experiencing rapid growth and advancement:
- Therapy Market Areas: Useful in far more applications than just viral infection screening, rapid diagnostic tests are now being designed to serve several use cases, from critical life services to general well-being management. Notably, our growing aging population has driven a need for improved diagnostics in dementia and stroke cases and at-home versions of various cardiovascular POC tests.
- Ease of Use: Whether intended for at-home or POC use, one of the most critical aspects of effective rapid diagnostics is proper, seamless integration into the workflow of providers and the lifestyle of patients. Indeed, new methods must be more intuitive than their predecessors to see adoption and success truly. Because of this, much attention is being paid to new and improved methods of sample collection, analysis, and interpretation, each of which is critical to both efficacies and CLIA waiver status.
- Connected Health and AI: While connected health services have grown and evolved alongside at-home testing measures, AI has become an invaluable tool for patient data analysis and effective diagnostic decision-making. As patients continue to seek and gain influence in the nature and delivery of their healthcare, demanding greater personalization and control, these high-tech solutions are projected to grow at considerable rates.
- Multiplex Testing: The process of simultaneously detecting or identifying multiple biomarkers in a singular POC or at-home diagnostic screening, multiplex testing has been a hot topic in healthcare for some time, presenting vast opportunities for optimized, more efficient tests costing less time and money than their traditional counterparts.
On our latest series in the MIDI Innovation Vault, MIDI Principal Greg Montalbano will expound upon these areas and more as he takes listeners on a deep dive into this newest wave of innovation in the world of rapid diagnostic testing. To learn more about the opportunities, challenges, and strategies for success in this vastly important healthcare market segment, tune in today!
