Advancements in Portable Instruments Based on Affinity-Capture-Migration and Affinity-Capture-Separation for Use in Clinical Testing and Life Science Applications.

The rate of technological advancements in medicine and life sciences is accelerating exponentially. Among the latest innovations are miniaturized and portable instruments that have the potential to bring analytical and diagnostic testing to the most remote locations [1], [2], [3], [4]. For example, NASA's Jet Propulsion Laboratory (JPL) has taken astrobiology research to new heights by using capillary electrophoresis (CE) as a tool for detecting biosignatures in extraterrestrial oceans. To achieve this, they have developed a state-of-the-art instrument called the “Organic Capillary Electrophoresis Analysis System” (OCEANS). OCEANS was designed to be sent to Jupiter and Saturn's moons, Europa and Enceladus, respectively, where NASA suspects that expansive oceans are present. The instrument will collect samples of the moons' oceans to identify “biosignature” molecules, which could indicate the presence of past or present life. The fact that the data will be transmitted back to Earth, which is 390 and 790 million miles away, adds to the complexity and awe of this endeavor [5].

This is an example of how portable instruments can have incredible applications even beyond our planet. It showcases not only the level of portability that is achievable but also the remarkable level of connectivity that we have today.

In recent years, the demand for point-of-care (POC) diagnostic tests has increased due to their user-friendly nature, affordability, and fast turnaround time [6], [7], [8]. These tests are specifically designed to be performed outside of conventional laboratory settings, such as at a patient's bedside, in the field, or remote locations. They have also been found to be effective screening tools for various diseases, including infectious diseases, cancers, and cardiovascular conditions [9], [10], [11], [12], [13].

Aside from their application in acute care settings, POC diagnostics also have significant potential for use in telemedicine and remote patient monitoring [8,14]. Digital advancements, such as cloud computing and smartphones, have paved the way for POC devices that can be connected, allowing for remote data collection, analysis, and interpretation. This has the potential to improve patient outcomes, reduce healthcare expenses, and increase accessibility to care for marginalized communities.

However, despite the numerous benefits of POC diagnostics, there are limitations and challenges that require attention [15], [16], [17]. For instance, some POC tests have lower sensitivity and specificity than traditional laboratory tests. Moreover, regulatory oversight is necessary to ensure that POC tests are precise, dependable, and safe for patient use [18], [19], [20], [21].

Lateral flow immunoassays (LFIA) are a widely used POC diagnostic platform. These tests operate based on the use of antibodies to detect specific molecules in biological samples, making them effective for point-of-care diagnosis in both clinical and non-clinical settings. This technology has demonstrated its efficiency, especially for diseases that require rapid diagnosis and management [22], [23], [24], [25], [26].

LFIA technology is ideal for settings where access to advanced diagnostic equipment and facilities is limited. LFIA tests are easy to use, require minimal training, and yield results within a rapid time frame of 15-20 minutes. They have increasingly shown value in various medical conditions, including infectious diseases, cancer, and pregnancy testing [27], [28], [29], [30], [31], [32].

Early detection through effective screening is vital for disease prevention. With the world becoming more interconnected, the spread of infectious diseases has increased, underscoring the importance of rapid and accurate screening tools like LFIA. During the COVID-19 pandemic, LFIA played a crucial role in identifying infected individuals and curbing the spread of the virus. Due to their cost-effectiveness, LFIA tests have been extensively utilized to provide rapid and accurate information to millions of individuals worldwide regarding their infection status. Furthermore, LFIA technology is also a valuable tool for detecting and managing other acute and chronic diseases [33], [34], [35], [36], [37], [38], which makes it an excellent choice for point-of-care diagnosis due to its simplicity, low cost, and fast turnaround time.

Immunoaffinity capillary electrophoresis (IACE) is a powerful analytical technique that combines the high specificity of immunoaffinity binding with the high-resolution separation capabilities of capillary electrophoresis. IACE provides a two-dimensional format that includes an affinity-capture step followed by electrophoretic separation of captured constituents [39], [40], [41], [42], [43], [44], [45], [46], [47], [48], [49], [50]. This allows for greater selectivity and sensitivity in detecting and quantifying biomolecules relative to one-dimensional immunoassays, such as ELISA and LFIA. The separation dimension provides new levels of clarity to the diagnostic process, thereby reducing the rate of false positives, false negatives, and inconclusive results.

IACE is a highly adaptable technology that can be easily miniaturized, making it ideal for telehealth applications [49,50]. Cloud computing and high-speed internet connections can be leveraged to remotely monitor patients in real-time, allowing healthcare providers to quickly detect changes in a patient's condition and respond accordingly [51], [52], [53]. Furthermore, IACE's highly accurate and quantitative results make it useful for remotely monitoring the effectiveness of treatment regimens and making informed decisions about ongoing care. Overall, the use of IACE in telehealth has the potential to transform healthcare, making it more accessible, affordable, and effective for patients worldwide [49,50].

The synergy between LFIA and IACE offers a powerful screening and confirmatory approach for the early detection of diseases. LFIA serves as an initial screening tool to detect biomarkers of disease, while IACE confirms and monitors the presence of these biomarkers with greater sensitivity and selectivity. This approach will lead to improved disease diagnosis accuracy and treatment precision.

In addition, the combined use of LFIA and IACE offers an economical and effective approach to the early detection of diseases. With the increasing demand for point-of-care diagnostics, this approach can be easily adapted to a variety of settings and remote locations, enabling widespread disease screening, and monitoring, and improving disease management and patient outcomes.

This review aims to evaluate the advantages and challenges of LFIA and IACE technologies. It will highlight their broad range of applications and emphasize their value in clinical diagnostics, the benefits of their "screen and confirm" synergy, and their use in telemedicine [49,50].

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