Rapid and Sensitive Lateral Flow Immunoassay Method for Procalcitonin (PCT) Based on Time-Resolved...

Area of Science:

• Biochemistry
• Immunology
• Medical Diagnostics

Background:

• Procalcitonin (PCT) is a key biomarker for severe bacterial infections.
• Current detection methods may lack cost-effectiveness, speed, or on-site capabilities.
• There is a need for improved diagnostic tools for timely infection management.

Purpose of the Study:

• To develop a cost-effective, rapid, quantitative, and on-site detection kit for procalcitonin (PCT).
• To evaluate the performance characteristics of the newly developed PCT detection kit.
• To assess the clinical utility of the new kit compared to existing methods.

Main Methods:

• Development of a double-antibody sandwich immunofluorescent assay.
• Integration of time-resolved immunofluorescent assay (TRFIA) with lateral flow immunoassay (LFIA).
• Performance evaluation including linearity, precision, accuracy, specificity, and comparison with a commercial kit using 234 serum samples.

Main Results:

• The new kit demonstrated high sensitivity (0.08 ng/mL).
• Excellent precision with inter-assay CV of 5.4%-7.7% and intra-assay CV of 5.7%-13.4%.
• High correlation (r = 0.977) and consistency (Kappa = 0.875) with the Roche Elecsys BRAHMS PCT kit.

Conclusions:

• A successful quantitative method for PCT detection has been established.
• The TRFIA-LFIA based system is suitable for rapid, on-site PCT detection.
• This platform holds potential for other point-of-care biomarker tests.