[Development of the quantitative immunochromatography tests for somatic deasease markers detection]

Area of Science:

• Biochemistry
• Immunology
• Medical Diagnostics

Background:

• Somatic diseases require accurate monitoring of key biomarkers.
• Existing diagnostic methods may have limitations in speed or accessibility.
• Quantitative immunochromatographic tests (ICT) offer a potential solution for rapid biomarker quantification.

Purpose of the Study:

• To develop quantitative immunochromatographic tests (ICT) for measuring immunoglobulin E (IgE), C-reactive protein (CRP), and fibrin D-dimer.
• To validate these ICTs using videodigital analyzers and assess their performance against established methods.
• To evaluate the clinical applicability of the developed analytical complex.

Main Methods:

• Sandwich-format ICTs were designed utilizing colloid gold and monoclonal antibodies.
• Quantitative measurements were performed using domestic videodigital analyzers (Reflecom and Zondaj).
• Calibration curves were established and approximated by an exponential dependence model.

Main Results:

• Developed ICTs demonstrated high sensitivity: 7.5 IU/mL for IgE, 5.7 ng/mL for CRP, and 500 ng/mL for fibrin D-dimer.
• Results showed good correlation with electrochemiluminescent immunoassay, ELISA, latex agglutination, and other ICT methods.
• Calibration curves generated by ICTs and videodigital analyzers followed a predictable exponential function.

Conclusions:

• The developed ICTs provide accurate quantitative measurements of IgE, CRP, and fibrin D-dimer in blood serum or plasma.
• The analytical complex, comprising ICTs and the Zondaj videodigital analyzer, is suitable for laboratory practice and clinical research.
• This approach offers a viable alternative or complementary tool to existing immunochemistry methods for disease marker assessment.