Urinary Aspergillus Assay Shows 92% Sensitivity in Diagnostic Studies

A case-control study and prospective cohort published in Clinical Infectious Diseases evaluated the MycoMEIA Aspergillus assay, which detects Aspergillus glycans in urine, as a noninvasive diagnostic aid for invasive aspergillosis (IA). Performance was assessed against consensus definitions of proven or probable IA and controls. The authors report that these data supported regulatory approval.

Analysis of 469 urine samples from 50 IA cases and 240 controls showed sensitivity of 92% (95% CI 80.8–97.8) and specificity of 87.6% (95% CI 82.8–91.8). All cases positive by serum galactomannan enzyme immunoassay were positive by MycoMEIA. Urine testing also detected 19 of 24 cases (79.2%) diagnosed by bronchoalveolar lavage but negative by serum galactomannan. Reported lead-time positivity was 5 days before clinical diagnosis, with a range of −21 to +14 days.

Prospective testing yielded specificity of 89.7% (95% CI 75.8–97.1), and the abstract reports identification of IA in 28 of 102 people (27.5%) with suspected possible IA. Results were reproducible across three laboratories, although some cross-reactivity occurred with other Ascomycetes fungi.

The findings support further evaluation of urine testing as a diagnostic adjunct. Reduced empirical antifungal use remains a proposed benefit rather than a demonstrated outcome. The abstract does not establish performance in broader populations or screening settings; full methods and funding details were unavailable.