Clinical Trial: Magnetoplasmonic ELISA for Urine-based Active Tuberculosis Detection and Anti-Tuberculosis Therapy...

Area of Science:

• Biotechnology
• Nanotechnology
• Infectious Disease Diagnostics

Background:

• Rapid and widespread diagnostic testing is crucial for controlling infectious disease epidemics, as highlighted by the COVID-19 pandemic.
• Current tuberculosis (TB) diagnostics face limitations in speed, sensitivity, or noninvasiveness, hindering timely patient isolation and treatment monitoring.

Purpose of the Study:

• To develop a novel, highly sensitive, and rapid diagnostic assay for tuberculosis (TB) using magnetoplasmonic nanozymes (MagPlas NZs).
• To evaluate the performance of the MagPlas ELISA for urine-based TB diagnosis and noninvasive monitoring of anti-TB therapy.

Main Methods:

• Magnetoplasmonic nanozymes (MagPlas NZs), composed of hierarchically coassembled Fe3O4-Au superparticles, were developed to integrate magnetic enrichment and catalytic amplification.
• A MagPlas enzyme-linked immunosorbent assay (ELISA) was designed for detecting urinary TB antigens, achieving high sensitivity (pM to 10 fM).
• A clinical study involving 297 urine samples was conducted to assess the assay's sensitivity and specificity for pulmonary and extra-pulmonary TB.

Main Results:

• The MagPlas ELISA demonstrated fast detection (<3 hours) with ultrahigh sensitivity for urinary TB antigens.
• Clinical evaluation showed robust sensitivity for pulmonary TB (85.0%) and extra-pulmonary TB (52.8%), with high specificity (96.7% and 96.9%).
• The assay proved effective for noninvasive monitoring of therapeutic response, a capability lacking in traditional culture methods.

Conclusions:

• MagPlas ELISA offers a sensitive, rapid, and noninvasive point-of-care diagnostic tool for tuberculosis.
• This novel approach shows potential for effective TB epidemic control and could be adapted for other infectious diseases.