Mucorales PCR Testing from BAL – Results from a Multicenter ECMM Study

Mucormycosis is a severe fungal infection that is challenging to diagnose as traditional methods lack sensitivity and serological testing is unavailable. As part of the ECMM Pilot Study program, the ECMM supported a multicenter study evaluating the MucorGenius® PCR assay on respiratory and biopsy samples from high-risk patients with probable/proven invasive pulmonary aspergillosis (IPA), mucormycosis, or possible invasive mold infections (IMIs).

The multicenter cohort study was conducted across 4 sites in Austria, Belgium and the UK. A total of 132 respiratory and biopsy samples from 114 patients with IMI diagnosed in clinical routine (10 proven IPA, 13 proven mucormycosis, 62 probable IPA, 5 probable mucormycosis, and 35 possible IMI according to EORTC/MSGERC 2020 and FUNDICU criteria; 11 IPA/ mucormycosis coinfections) were analyzed using the MucorGenius® PCR assay in ISO-certified laboratories. Results were compared with standard fungal diagnostics, and the results have just been published at Open Forum Infectious Diseases  https://academic.oup.com/ofid/article/13/1/ofaf801/8407034?login=true

The study found that  Mucorales DNA was detected in 37/132 samples (28%) including 29 BAL fluids, 1 bronchial aspirate, 1 endotracheal aspirate, and 6 biopsies from 37 patients. Sensitivity was 94.4% (17/18) for detecting probable/proven mucormycosis (including 11 cases routinely diagnosed with IPA/mucormycosis coinfection). Among 72 patients with probable/proven IPA, 21 (29.2%) tested positive for Mucorales DNA, including 11 missed by routine diagnostics. Mucorales DNA was also detected in 9/35 (25.7%) of patients with possible IMI.

Overall, MucorGenius® PCR showed high sensitivity for detecting Mucorales and may support improved diagnosis of probable mucormycosis when included as a mycological criterion. It appears particularly valuable for identifying Aspergillus– Mucorales coinfections and detecting mucormycosis in patients with host factors, clinical or radiological evidence of IMI when routine diagnostics are negative.

Full article: ofaf801 Mucor PCR