Evolving Toward Highly Sensitive Immunoassay Technologies

Immunochemistry analyzers have proved to be an effective tool in endocrinology, oncology, cardiology, therapeutic drug development and monitoring, infectious disease testing, drugs of abuse testing, autoimmune diseases, and have attracted major attention because they allow fast analysis. With the development of science and technology, several new features are being continuously added in the systems to further increase speed and sensitivity of tests. The new immunodiagnostic systems feature standardized test menus, assay protocols, instrument processes, and reference ranges. Together, these features minimize training requirements and streamline inventory management tasks for labor cost savings while providing consistent results across the healthcare delivery network. Presence of intuitive interfaces and easy-to-use features empower virtually any technologist, regardless of experience or expertise, to run tests and maintenance; while streamlined maintenance procedures, ready-to-use reagents, and load-on-the-fly capabilities ensure maximum system availability, reducing emergency service calls, and improving reliability.

Globally the immunoassay market is expected to reach USD 27.15 billion by 2023, up from USD 20.19 billion in 2018, at a CAGR of 6.1 percent, according to MarketsandMarkets. The players are expanding their market share with introduction of new advanced instruments and assays, and also by M&A activities.

In June 2018, BioAgilytix expanded its advanced bioanalytical technology suite with the addition of Sword Bio’s detection platform for immunoassays that represents an important advancement in enzyme immunoassays, providing enhanced sensitivity, precision, and accuracy for the rapid and high-performance measurement and quantification of biological markers

In April 2018, Mindray launched its new laboratory solution, the SAL 9000 chemi-immuno modular system, which is so far the speediest integrated workstation for clinical chemistry and immunoassay testing with a comprehensive test menu

In March 2018, Roche launched the first fully automated Zika IgG immunoassay, the Elecsys Zika IgG immunoassay for CE Mark countries, to help detect the high-risk Zika virus infection

In September 2017, Siemens Healthineers made the global commercial availability of its Atellica solution – flexible, scalable, automation-ready immunoassay analyzers that run up to 440 tests per hour

Technology trends
The immunochemistry instruments and reagents industry is experiencing rapid technological developments. Advanced cutting-edge technologies are being added owing to the need for highly accurate tests, ease of testing, wider test menu, flexibility of workload in individual parameters, demand for near patient testing, and difficulties faced in safe transportation of samples from distant places.

Lateral flow immunoassay technology. LFIA, a paper-based, point-of-care strip biosensor technology is designed to detect a specific analyte in a given sample. It is now of great interest for its cost-effectiveness, simplicity, portability, and rapidness of detection of analytes. Various nanoparticles (such as metal nanoparticles, carbon-based nanoparticles, quantum dots, lanthanides, and up-converting phosphor) functionalized by an antibody to detect an analyte protein or molecular marker present in the surface of an infectious pathogen are being used in LFIAs.

Morffi technology is being used to increase the sensitivity of LFIAs. It offers up to ten times increase in sensitivity, improved signal intensity, and faster time-to-result for situations where a quick diagnosis is critical to patient care. It is proving very popular.

Ultra-sensitive immunoassays. They are providing key pharmacologic data to advance complex drug development pipelines across all therapeutic areas.  The traditional trial and error practice of medicine is progressively eroding in favor of more precise marker-assisted diagnosis, and safer and more effective treatment of disease. Utilizing the ability to measure low femtogram/mL concentrations of cytokines, chemokines, neurologic markers in blood, and other biomolecules (including nucleic acids by hybridization) provides differentiating information relevant to advancing drug discovery and development pipelines.  In addition to biomarker analysis, researchers now utilize SIMOA (single molecule array) for PK and immunogenicity applications to solve complex issues. Given the rapid uptake, they present many opportunities to further enhance the understanding of this rapidly advancing field that will lead to new predictive and companion diagnostics.

Superparamagnetic nanoparticles. SPMNPs have attracted interest for various biomedical applications due to their unique magnetic behavior, excellent biocompatibility, easy surface modification, and low cost. Their unique magnetic properties, superparamagnetism, and magnetophoretic mobility have led to their inclusion in immunoassays to enhance biosensor sensitivity and allow for rapid detection of various analytes. The current status of SPMNP-based immunoassays is to increase detection capabilities of surface plasmon resonance and giant magneto-resistive biosensors, and to improve the sensitivity of rapid diagnostic tests in immunoassays.

Multiplex immunoassays. Multiplexed bead immunoassays result in more cost-effective measurements of selected analytes, diminishing inter-assay variations, and reducing the volume of sample needed. Recent advances have been made allowing for the simultaneous detection of multiple analytes in a single reaction by combining immunoassay chemistries with flow cytometric analysis. As technologies continue to evolve, vendors are opening up multiplexing formats for those who previously did not have access to these powerful research options, making it increasingly likely that reliance on multiplex immunoassays will continue to show significant growth.

Chemiluminescence technology. The wide dynamic range, greater than that of immunoenzymatic methods, the high sensitivity and specificity of the results expressed in quantitative form, the high degree of automation and the clinical implications related to the reduction in the turnaround time, and the ability to run a large number of antibody tests (even of different isotypes), directed toward large antigenic panels in random access mode, make CLIA technology the most advanced in the clinical laboratory, with enormous repercussions on the workflow. Further improvements are expected in the coming years with the development of new analytical platforms such as the flow-injection chemiluminescent immunoassay, the two-dimensional resolution for chemiluminescence multiplex immunoassay, and the magnetic nanoparticles chemiluminescence immunoassay, which will likely result in additional increases in the clinical efficacy of antibody tests.

Way forward
Innovation and affordability are the two key growth factors and manufacturers are moving toward development of compact and affordable solutions. Cartridge-based immunology testing systems are gaining momentum because of the simple operation, compact hardware, and smaller pack sizes. Through all of the technological advances, systems are evolving according to the needs of users in terms of operator convenience, accuracy, specificity, speed, robustness, and sensitivity. Despite these tremendous advances, there is a critical need for novel diagnostic platforms in order to increase the outreach of immunodiagnostics to the remote settings.

From standalone high cost floor model systems, the customers are moving toward highly affordable bench top systems with very low recurring cost. More systems are entering into the market to capture the entry level segment with throughput as low as 60 tests per hour. With more parameters being added regularly, the immunochemistry market in India is expected to increase at a CAGR of 15-16 percent over the next 5 years. Increasing number of patients with various diseases such as cardiovascular diseases and cancer, rising demand for technological advances in immunochemistry techniques, increasing R&D activities, government initiatives, increasing disease-specific immunoassays, test volumes, and growing aging population are some of the factors that will further drive the market.