Determination of serum CA724 levels using fluorescence immunochromatography

Area of Science:

• Biochemistry
• Analytical Chemistry
• Immunology

Background:

• Carbohydrate antigen 724 (CA724) is a recognized biomarker for various malignancies.
• Accurate and efficient detection of CA724 is crucial for cancer diagnosis and monitoring.

Purpose of the Study:

• To develop and validate a novel Europium-time resolved fluorescence immunochromatography (Eu-TRFICO) assay for the quantitative determination of CA724 in human serum.
• To assess the analytical performance and clinical utility of the developed Eu-TRFICO method.

Main Methods:

• Optimization and assembly of Eu-TRFICO strips.
• Evaluation of sensitivity, specificity, and precision using standard dilutions and serum samples.
• Assessment of clinical performance with gastric cancer patient samples, including reference interval determination and comparison studies.

Main Results:

• The Eu-TRFICO assay exhibited high sensitivity (0.42 U/mL) and specificity, with minimal interference from common serum components.
• Excellent precision was demonstrated with intra- and inter-batch recoveries ranging from 102.38% to 106.40% and CVs below 10%.
• Clinical evaluation showed high correlation (Pearson r = 0.9503) with high sensitivity (92.86%) and specificity (94.20%) for gastric cancer detection.

Conclusions:

• The developed Eu-TRFICO method provides a sensitive, specific, and precise tool for quantitative CA724 detection.
• This assay offers a valuable alternative for convenient and reliable clinical testing of CA724, aiding in cancer diagnostics.