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

Summary

Researchers tested a new rapid test device that detects a specific protein released by dangerous mold infections (mucormycosis) in patient respiratory samples. The test uses a special antibody to identify these molds quickly, which is important because mucormycosis can be life-threatening and requires fast treatment. The device showed promise with about 77% accuracy in identifying infections, though larger studies are needed to confirm these findings.

Background

Mucormycosis is a severe invasive fungal infection with high mortality rates (~50%) that requires rapid diagnosis and prompt treatment. Current diagnostic methods including histopathology and culture are insensitive with long turnaround times. A newly developed monoclonal antibody (TG11) specific to Mucorales extracellular polysaccharide antigen has been integrated into a lateral-flow device (TG11-LFD) for rapid detection.

Objective

To establish the clinical performance of TG11-LFD on bronchoalveolar lavage (BAL) fluids for diagnosing mucormycosis by evaluating sensitivity, specificity, and predictive values.

Results

Using a threshold value of ≤531 artificial units, TG11-LFD demonstrated 76.92% sensitivity and 75.51% specificity with positive predictive value of 45.45% and negative predictive value of 92.5%. The area under the ROC curve was 0.739. Three false-negative and twelve false-positive results were observed.

Conclusion

The TG11-LFD shows significant potential for rapid detection of mucormycosis with promising performance characteristics. Combining antigen detection with qPCR is likely to provide the most reliable diagnostic approach. Further prospective studies with larger sample sizes and standardized conditions are needed to validate findings.
  • Published in:Journal of Clinical Microbiology,
  • Study Type:Clinical Evaluation, Retrospective Study,
  • Source: 10.1128/jcm.00226-25, PMID: 40530880
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