Quantitative detection of mpox antigen using time-resolved fluorescence immunochromatography

Area of Science:

• Virology
• Immunodiagnostics
• Biotechnology

Background:

• Rising concerns about human mpox virus spread necessitate rapid diagnostic tools.
• Increased demand for efficient mpox virus detection reagents is evident.

Purpose of the Study:

• To establish a time-resolved fluorescence immunochromatography (TRFICO) method for mpox virus detection.
• To enable both qualitative and quantitative analysis of mpox virus antigen.

Main Methods:

• Optimization of a double-antibody sandwich TRFICO assay using mpox recombinant fusion antigen and monoclonal antibodies.
• Evaluation of assay performance including sensitivity, linearity, specificity, precision, and stability.
• Assessment of TRFICO strip stability under accelerated storage conditions (37°C for 7 days).

Main Results:

• Successfully established a TRFICO method for mpox antigen detection with a linearity range of 0-100 ng/mL.
• Achieved analytical sensitivity of 0.017 ng/mL and established reference intervals > 0.045 ng/mL.
• Demonstrated high specificity with no cross-reactivity, excellent precision (CVs < 10%), and good stability.

Conclusions:

• The developed TRFICO method is highly sensitive, specific, precise, and stable for mpox virus detection.
• Offers a rapid (16-minute detection time) and convenient option for qualitative and quantitative mpox virus testing.
• Represents a valuable new tool for addressing the growing need for mpox virus diagnostics.