The Need for Rapid Advancement in POCT for Autoimmune Disease Diagnosis
Author: Holly Young
Autoimmune disease (AD) affects between 5-10% of the population, worldwide (1). A significant increase in antinuclear antibody prevalence from 11% to 16% has been observed in the last 25 years, however, it is unclear whether the rise is due to changes in diagnosis and reporting (2). The incidence of AD is estimated to increase by 3-9% per year.
Commonalities in generic symptoms between various AD and a lack of specific biomarkers for individual AD has made it difficult and complex to make definitive diagnoses; that in turn impacts patients life expectancy and quality (1). Early diagnosis is critical in determining the type of AD, the appropriate course of treatment and for the best prognosis and quality of life possible for the patient.
Current diagnostic methods used for AD diagnosis lack sensitivity and/or specificity to detect early signs of disease. The tests can be invasive, lengthy and can result in late-stage diagnosis when irreversible damage has occurred and the symptoms developed are difficult to treat (1). The development of readily accessible, rapid, cost-effective methods is needed. Electrochemical biosensors, like KardioPOC that detects the novel biomarker TNF-α, show great promise in tackling some of the issues currently found in the diagnostic methods used today and alleviating some of the burden caused by AD. They are capable of measuring biomarkers of AD and the use of electrochemical biosensors has increased recently to aid in early diagnosis.
Cost
Electrochemical biosensors are an ideal point of care technology (POCT) advancement as they can lower costs, provide both high sensitivity and specificity and produce rapid results. These biosensors can use antibodies, antigens, peptides, and autoantibodies as recognition elements (1).
Rheumatic autoimmune disease types are known to affect between 2-3% of the population. The burden of this disease is great, on the individual, their family and society. The individual’s quality of life is poor and reduces their ability which in turn impacts productivity in society. Up to 25% of patients who visit the hospital suffering from some form of rheumatic disorder will require hospital admission and up to a third of those hospitalised will end up needing prolonged and intensive care (3). These are both factors that increase costs significantly and strain an already in-demand service.
POCT such as electrochemical biosensors can lower the costs associated with autoimmune diseases, reducing the social-economic burden on society. Additionally, making this technology more accessible to developing countries.
Electrochemical biosensors in the detection of AD biomarkers
A new promising novel biomarker, tumour necrosis factor-alpha (TNF-α), is a pro-inflammatory cytokine. It is an “important indicator of the inflammatory process.” A great deal of interest surrounds this biomarker because it is easy to extract from bodily tissues such as saliva, urine, tears etc. The main point of interest of TNF-α is that it indicates early signs of systemic inflammatory disease. The development of a test that measures TNF-α for AD would be beneficial as it would allow for the monitoring and assessment of inflammation in the body for better diagnosis and benefit the prognosis of AD patients (4).
KardioPOC is an electrochemical biosensor developed to detect TNF-α. Its original purpose was to aid in the diagnosis of heart failure in which it has shown great promise and could demonstrate potential in aiding in the diagnosis of AD (4).
A biosensor developed for celiac disease diagnosis has proven to be a beneficial development as standard diagnostic methods involved blood tests followed by a series of invasive biopsies. Standard diagnostic methods for celiac disease involve physical examinations, blood tests and biopsies. E-DNA, an electrochemical biosensor developed to detect celiac disease-specific autoantibodies found in the blood was successful and found to be target-specific (5).
Electrochemical biosensors can detect the concentration of autoantibodies, with some of these processes taking less than half an hour with high sensitivity. Autoantibodies are theorised to be present in the blood long before the onset of the disease. Therefore, the ability to detect and monitor these autoantibodies can aid in the analysis of the progression and severity of the disease (6).
Conclusion
The prevalence of AD is the driving force for the rapid advancements in the diagnostics market. Advances in POCT are extremely promising, especially electrochemical biosensors due to a variety of reasons: they cut down costs, can be miniaturised, reproducible and depending on the materials used to create them, the cost can be cut even further. Most POCT that incorporate electrochemical biosensors, only require a small sample size (which can be blood, saliva, or other bodily fluids) to function: the use is simple, straightforward, rapid, sensitive, specific and the overall cost is low (4,7).
New novel biomarkers are emerging that can help to define specific AD. Current technology isn’t equipped for detecting new biomarkers before symptoms of the disease present, creating a huge gap in the diagnostics for AD. POCT is an exciting and promising new diagnostic tool, specifically electrochemical biosensors in the case of AD, these could be the vital part required to develop the next generation of diagnostics for AD (1).
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References:
Florea A, Melinte G, Simon I, Cristea C. Electrochemical Biosensors as Potential Diagnostic Devices for Autoimmune Diseases. Biosensors (Basel). 2019;9(1):38. doi:10.3390/bios9010038
https://www.nature.com/articles/d41586-021-01834-x Nature 595, S46-S47 (2021) DOI: https://doi.org/10.1038/d41586-021-01834-x
Konstantinov KN, Tzamaloukas A, Rubin RL. Detection of autoantibodies in a point-of-care rheumatology setting. Auto Immun Highlights. 2013;4(2):55-61. doi:10.1007/s13317-013-0052-9
Lu, Y., Zhou, Q. and Xu, L., 2021. Non-Invasive Electrochemical Biosensors for TNF-α Cytokines Detection in Body Fluids. [online] Frontiers. Available at: https://www.frontiersin.org/articles/10.3389/fbioe.2021.701045/full
Nguyen ABN, Maldonado M, Poch D, et al. Electrochemical DNA Biosensor That Detects Early Celiac Disease Autoantibodies. Sensors (Basel). 2021;21(8):2671. doi:10.3390/s21082671
Henderson, E., 2020. Researchers develop novel methods to diagnose and monitor autoimmune disorders. [online] News-Medical.net. Available at: https://www.news-medical.net/news/20200519/Researchers-develop-novel-method-to-diagnose-and-monitor-autoimmune-disorders.aspx
BioSpace. 2021. Autoimmune Disease Diagnostics Market will Create New Growth Opportunities in the Coming Year | BioSpace. [online] Available at: <https://www.biospace.com/article/autoimmune-disease-diagnostics-market-will-create-new-growth-opportunities-in-the-coming-year/>