What is Chemiluminescence Immunoassay?
Chemiluminescence immunoassay (CLIA) is an advanced laboratory technique used to detect and quantify analytes such as proteins, hormones, drugs and metabolites in biological samples. It relies on the principle of chemiluminescence, which is the emission of light following a chemical reaction. In CLIA, specific antibodies are used to capture the analyte in a biological sample. The bound analyte is then reacted with an enzyme-labeled secondary antibody to form a sandwich complex. Adding a suitable chemiluminescent substrate leads to an enzyme-catalyzed chemical reaction that generates light, which is then measured by a luminometer. The amount of emitted light is proportional to the concentration of analyte present in the original sample.
Advantages of CLIA Over Other Immunoassay Techniques
While immunoassays such as enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), and fluorescence immunoassay (FIA) have been used for decades, CLIA offers several distinct advantages. Compared to ELISA, CLIA avoids the need for color development steps and produces results faster. Unlike RIA, CLIA is non-radioactive and thus safer. CLIA has greater sensitivity than FIA and does not require excitation light sources. This makes CLIA systems simpler to use and maintain. Another major advantage is the wide dynamic range and linearity of CLIA, allowing measurement of analytes over several orders of magnitude of concentration from the same standard curve. CLIA systems can also analyze 96 samples simultaneously, maximizing throughput. Automation further streamlines workflow and reduces manual labor.
Applications of CLIA in Clinical Diagnostics
Due to its superior analytical performance, CLIA has become the preferred platform for high-volume routine clinical diagnostics. CLIA is commonly used to measure Chemiluminescence Immunoassay drugs of abuse, therapeutic drug monitoring, hormones, vitamins, biomarkers, and infectious disease antigens or antibodies. Examples include troponin tests for heart attack diagnosis, TSH for thyroid function, digoxin levels after heart medication, vitamin D, testosterone, cortisol, tumor markers, and immunoassays for hepatitis, HIV, Lyme disease, and more. CLIA's high sensitivity allows it to detect disease at earliest stages and monitor response to therapy. CLIA results precisely guide clinical management decisions and improve patient outcomes. Automated random-access analyzers running CLIA can handle large test volumes efficiently in centralized clinical laboratories serving hospitals and clinics.
Growing CLIA Market Boosted by COVID-19 Pandemic
The global chemiluminescence immunoassay market size was valued at USD 5.3 billion in 2019 and is projected to expand at a compound annual growth rate (CAGR) of 5.8% from 2020 to 2027 according to a recent report. Increasing incidence of chronic and infectious diseases, technological advancements, automation of CLIA platforms, and growing emphasis on preventive healthcare are major factors driving market growth. The ongoing COVID-19 pandemic has further propelled CLIA usage as laboratories worldwide have relied on CLIA tests to diagnose coronavirus infection using antibodies or antigens. CLIA manufacturers have rapidly scaled up production to meet unprecedented demand for SARS-CoV-2 testing. As the pandemic underscores the critical role of laboratory diagnostics, continued CLIA market growth is expected in the coming years. Large multinational corporations dominate the in-vitro diagnostic industry and invest heavily in CLIA product development to capitalize on the expanding market opportunity.
Challenges to CLIA Implementation and Need for Standardization
While CLIA automation and high-throughput testing have clear benefits, designing and validating large-scale automated systems comes with technical challenges. Reagent stability, sample cross-contamination, probe malfunctions, and software integration issues need meticulous troubleshooting. Quality control across multisite distributed testing also requires rigorous oversight to ensure accuracy and reliability of results. There exists variability in CLIA performance between instruments and calibrator traceability can be problematic. Standardized assay platforms and reagent kits promoting instrument independence would simplify workflow. Regulatory agencies are working with manufacturers to promote assay harmonization and calibration traceability. Widespread adoption of reference measurement procedures by the CLIA industry will help advance globally standardized high-quality diagnostics.
In Summary, chemiluminescence immuno has revolutionized clinical laboratory practice with its precision, automation and efficiency advantages. Continued technological progress and market expansion of CLIA are expected to further transform disease management paradigms and improve patient care worldwide. However, standardization initiatives must continue in parallel to fully unlock CLIA’s potential as a robust clinical diagnostic solution.
Get More Insights On, Chemiluminescence Immunoassay
Explore More Article, Benzodiazepine Drugs
About Author:
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163)_
Comments
0 comment