Immunoassay technology trajectory | Marked by innovation

There is a continued evolution of immunoassay technology, thanks to the growing demand for such tests, which is helping drive innovation in this field.

With advancements in technology and a growing emphasis on precision medicine, the field of immunochemistry continues to evolve rapidly, shaping the landscape of healthcare diagnostics. The availability of advanced diagnostic technologies contributes to early diagnosis and monitoring of the prognosis of patients. The rising incidence rate of cancer is foreseen to be the key driver in immunochemistry.

Advancement in gene activity and protein localization, provided by Spatial PrOtein and Transcriptome Sequencing (SPOTS) represents a paradigm shift in tissue analysis, offering unprecedented insights into cellular behaviors within their native microenvironment. This technology holds immense promise for advancing basic research, clinical diagnostics, and therapeutic development, particularly in the fields of immunochemistry and cancer biology.

Traditional methods often involve the dissociation of cells from tissues, resulting in the loss of spatial information. However, SPOTS retains this crucial spatial context, allowing researchers to map gene activity and protein localization with unprecedented resolution. This advancement enables the creation of detailed maps of organs and tumors, providing insights into the spatial organization of cell types, activities, and interactions.

SPOTS integrates information on gene activity patterns with the presence of key proteins within tissues. By capturing both mRNA transcripts and selected proteins, researchers gain a comprehensive view of cellular functions within their native microenvironment.

Moreover, SPOTS offers valuable insights into the cellular organization of tumors, particularly the immune microenvironment. By identifying distinct subsets of immune cells and their spatial distribution within tumors, researchers can elucidate how the tumor microenvironment influences immune cell activity.

While the initial version of SPOTS offers impressive spatial resolution, ongoing efforts aim to further enhance its capabilities to achieve single-cell resolution and incorporate additional layers of cellular information, advancing the ability to dissect complex tissue dynamics comprehensively.

Innovative reagents
Continuous innovation in immunochemistry reagents is driving improvements in assay sensitivity and specificity. The newly developed solutions for immunochemistry offer a transformative approach to address key challenges in the field. Their highly selective and adaptable nature enables researchers to target a broader range of biomarkers with improved accuracy and specificity, thus overcoming limitations associated with traditional antibody-based approaches. These innovative solutions not only cater to the increasing demand for novel reagents in IHC but also offer opportunities to explore previously inaccessible targets and advance the capabilities of research, diagnostics, and forensic analysis.

The USDA-NIFA swine immune toolkit initiative has developed priority immune reagents for swine immunity and biomedical research. Notably, sensitive sandwich ELISA assays have been established, with ongoing optimization for other targets. Additionally, efforts include intracellular staining and immunohistochemistry analyses, as well as evaluating cross-reactivity with commercial human CD antigen mAbs. The ultimate goal is to provide the veterinary community with new commercial reagents and standardized assay techniques to advance research on swine immune responses to disease and vaccines, thereby contributing to biomedical research efforts.

Multiplex immunoassays represent a transformative advancement in immunoassay technology, facilitating the simultaneous detection and quantification of multiple analytes within a single sample. This capability is particularly valuable in the diagnosis and monitoring of complex diseases, such as cancer, autoimmune disorders, and infectious diseases. Multiplex immunoassay platforms utilize advanced technologies, such as microarray-based assays and bead-based assays, to enhance sensitivity, specificity, and versatility for a wide range of applications in biomedical research, clinical diagnostics, and drug discovery.

Moreover, multiplex immunoassays, emphasize their advantages in terms of time, cost, and sample volume compared to traditional singleplex assays. With offerings, such as cytokine and chemokine profiling panels, researchers can explore complex biological pathways and disease mechanisms with enhanced efficiency and accuracy.

Magnetic bead-based multiplex immunoassays, utilize magnetic particles for analyte capture and detection, and offer superior sensitivity, specificity, and automation, making them indispensable tools for various fields, including clinical diagnostics, drug discovery, and biomarker research.

Therefore, multiplex immunoassays revolutionize the detection and quantification of analytes, offering unparalleled efficiency, sensitivity, and versatility.

Technological advancement
Chemiluminescence immunoassay (CLIA) represents a paradigm shift toward precision medicine and personalized diagnostics, with its adoption reflecting a significant advancement in diagnostic technology. The robust technological advancements in CLIA provide enhanced sensitivity and multiplexing capabilities, enabling faster and more accurate detection of chronic diseases, such as cancer, neurological diseases, cardiovascular disease, and others.

The recent development of CLIA assays has been particularly notable in diagnosing HBV and HIV infections. CLIA offers several benefits over traditional assays, including higher sensitivity, accurate detection of high concentrations, stability of reagents, and shorter incubation times. Moreover, CLIA provides improved specificity and a higher positive predictive value, compared to conventional assays.

This new development in CLIA signifies a significant leap forward in diagnostic technology, offering greater precision, reliability, and technical simplicity. It enables automated quantification, reducing the potential for human error and ensuring consistent and reliable results. The high sensitivity of CLIA allows for accurate and precise detection of even minimal levels of HBsAg, thereby enhancing the effectiveness of diagnosis and monitoring of HBV and HIV infections.

Additionally, CLIA assays are cost-effective compared to DNA tests for HBV quantification, making them economically feasible for diagnostic laboratories. However, limitations may include dependency on chemiluminescent reactions, which may restrict its application in certain scenarios where other detection methods are more suitable.

Single-molecule immunoassays has significantly improved disease detection at the molecular level. Unlike conventional methods with sensitivities between 10 and 16 and 10 and 12 mol/L, single-molecule immunoassays can reach sensitivities as low as 10–18 mol/L, enabling early diagnosis and treatment. These assays confine molecules to be detected in small spatial areas and provide absolute counting of signals, ensuring high efficiency and accuracy.

Two prominent single-molecule immunoassay techniques are gaining strength, microarray-based and microdroplet-based. The microarray-based technique demonstrates the ability to test 66 samples in just 1 hour, surpassing the efficiency of conventional methods. On the other hand, microdroplet-based techniques excel in speed, generating 107 droplets in only 10 minutes – more than 100 times faster than a single-droplet generator. These advancements offer a substantial improvement in detection sensitivity, enhancing diagnostic capabilities for a range of diseases.

Comparative analysis of these techniques underscores the current limitations and future development trends in POC applications, highlighting the pivotal role of immunochemistry in advancing disease detection technologies.

A new frontier in diagnostic development
Nanoparticle-based bioaffinity assays explore the potential of nanoparticles (NPs) in revolutionizing bioaffinity assays, particularly in replacing traditional enzymatic or molecular labels. There have been successful implementations of NP-based assays in commercial settings, highlighting the imperative need for rapid tests that incorporate NPs in various roles.

Challenges hindering the widespread adoption of NP-based assays include difficulties in analyzing real samples, steric hindrance, and optimization complexities.

Despite these challenges, NP-based assays offer advantages like enhanced performance and novel optical features. While there are fewer NP-based labels in commercial platforms currently, NP-based diagnostic POC platforms have demonstrated significant benefits and are increasingly utilized in various commercial settings. These advancements suggest a promising future for NP bioaffinity assays, enabling affordable quantitative testing and extremely sensitive diagnostics with high-tech instrumentation.

Artificial Intelligence
One of the prominent trends in immunochemistry instruments is the incorporation of artificial intelligence (AI) algorithms to improve accuracy, efficiency, and performance, and aid in result interpretation. Improved wireless connectivity features may also be a feature of future immunoassay analyzers. Such features will seamlessly integrate immunoassay analyzers with laboratory information systems (LIS) and electronic health records (EHR). Improvements in wireless connectivity would likely help to enhance traceability, streamline processes, and allow for remote monitoring of analyzer function and performance.

Outlook
The rapid advancements in immunochemistry herald a new era of precision diagnostics, transforming healthcare with cutting-edge technologies. These innovations offer hope for earlier diagnoses, more effective treatments, and improved patient outcomes. As AI continues to enhance immunochemistry instruments, it is poised for even greater strides in accuracy, efficiency, and result interpretation. The future of immunochemistry is bright, promising affordable, and highly sensitive diagnostics with seamless integration into healthcare systems.