Performance of the Urinary MycoMEIA Aspergillus Assay as an Aid to Diagnose Invasive Aspergillosis.

BACKGROUND

Invasive aspergillosis (IA) is difficult to diagnose, contributing to poor clinical outcomes and unnecessary antifungal therapies. The MycoMEIA Aspergillus assay (MycoMEIA), which detects Aspergillus glycans in urine, does not require invasive specimens. We report data that supported regulatory approval.

METHODS

A case-control study and prospective cohort study were conducted to evaluate MycoMEIA as an aid to diagnose IA. Performance was assessed using consensus criteria of "proven" or "probable" IA and controls. Additional analyses evaluated positivity in "possible" IA, agreement with serum galactomannan (GM EIA), cross-reactivity, and timing of positivity relative to clinical diagnosis. Reproducibility was assessed across three laboratories.

RESULTS

In brief, 469 urine samples from 50 IA cases and 240 controls demonstrated MycoMEIA 92% (95% CI 80.8-97.8) sensitivity and 87.6% (95% CI 82.8-91.8) specificity. All cases with positive serum GM EIA were positive by MycoMEIA. Urine testing identified 19/24 (79.2%) IA cases diagnosed by bronchoalveolar lavage (BAL) but negative by serum GM EIA and provided lead-time positivity of 5 days (range -21 to +14) before clinical diagnosis. Prospective testing confirmed a specificity of 89.7% (95% CI 75.8-97.1) and identified IA in 28/102 (27.5%) people with suspected "possible" IA. Some cross-reactivity was observed with other Ascomycetes fungi. Results were reproducible across sites.

CONCLUSIONS

MycoMEIA shows strong performance as an aid to diagnose IA. Its high sensitivity and negative predictive value may help reduce unnecessary empirical antifungals. Further studies are needed to define its role in screening and broader patient populations.