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Detection of Mucorales antigen in bronchoalveolar lavage samples using a newly developed lateral-flow device

Summary

Researchers developed and tested a new rapid test (TG11-LFD) for detecting mucormycosis, a dangerous fungal infection, using a simple device similar to a COVID rapid test. The test detects a specific protein marker released by Mucorales fungi in lung fluid samples. In testing with 62 clinical samples, the new test correctly identified about 77% of actual infections and was negative in about 76% of non-infected samples. This affordable, simple test could help doctors quickly diagnose mucormycosis and start life-saving treatment faster, especially in countries with limited laboratory resources.

Background

Mucormycosis is a severe emerging invasive fungal infection with high mortality rates (~50%). Current diagnostic methods including histopathology and culture have poor sensitivity and long turnaround times. A new monoclonal antibody-based lateral-flow device (TG11-LFD) targeting a Mucorales-specific extracellular polysaccharide antigen has been developed for rapid detection.

Objective

This study aimed to evaluate the clinical performance of the newly developed TG11-LFD test on bronchoalveolar lavage (BAL) fluids for diagnosing mucormycosis. The diagnostic performance was assessed using receiver operating characteristics (ROC) curve analysis on clinical samples.

Results

The area under the ROC curve was 0.739. Using a threshold value of ≤531 artificial units, the TG11-LFD test achieved sensitivity of 76.92% and specificity of 75.51%, with a positive predictive value of 45.45% and negative predictive value of 92.5%. Three false-negative results were observed primarily in samples from treated patients, while twelve false-positive results included cases of possible invasive fungal infection.

Conclusion

The TG11-LFD demonstrates significant potential for rapid detection of mucormycosis in clinical samples, with performance superior to culture methods. Combining antigen detection with qPCR, as used for aspergillosis diagnosis, is recommended for the most reliable diagnostic approach. This innovative test offers an affordable, rapid, and equipment-free alternative particularly valuable for low-to-middle income countries.
  • Published in:Journal of Clinical Microbiology,
  • Study Type:Clinical Validation Study,
  • Source: 10.1128/jcm.00226-25, PMID: 40530880
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