MycoMEIA Aspergillus Assay

The MycoMEIA Aspergillus Assay is an enzyme immunoassay (EIA) that detects Aspergillus antigens in human urine from adults aged 18 and older suspected of having invasive aspergillosis. It is not intended for lung transplant recipients. Results must be interpreted by trained healthcare professionals alongside other diagnostic methods such as culture, histology, and imaging.

Both the MycoMEIA and predicate (Bio-Rad Platelia) are sandwich enzyme immunoassays using microplate readers and incubation at 37°C. Key differences: MycoMEIA uses two mouse monoclonal antibodies (mAb476 and mAb501) recognizing galactofuranose epitopes, whereas the predicate uses mAbEBA2. MycoMEIA tests urine samples with sample processing columns for inhibitor removal; the predicate tests serum and BAL fluid with EDTA pretreatment and boiling. Incubation times differ slightly (120 minutes total for MycoMEIA versus 90±5 minutes for predicate), and cutoff calculations differ (MycoMEIA uses threshold control normalization with multiplication factor; predicate uses direct sample-to-cutoff ratio).

CLSI Guideline EP17-A2 for limit of detection; CLSI Guideline EP05-A3 for precision and reproducibility; CLSI Guideline EP07 for interference testing. EORTC/MSG diagnostic criteria (2020) used for clinical diagnosis adjudication in performance studies.

MycoMEIA is substantially equivalent because it achieves the same clinical purpose as the predicate—detecting Aspergillus antigens to aid in invasive aspergillosis diagnosis—using the same sandwich EIA technology and microplate format with comparable analytical performance. Although it tests a different specimen type (urine vs. serum/BAL) and uses different monoclonal antibodies, both assays target galactofuranose-containing antigens specific to Aspergillus. Clinical data demonstrate per-subject sensitivity of 92.4% and specificity of 86.1%, establishing diagnostic utility comparable to the predicate. The analytical validation shows acceptable precision, reproducibility across three sites, and no high-dose hook effect, supporting safe and effective use as claimed.