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Prattes, J; Dichtl, K; Sedik, S; Glatz, U; Egger, M; Wölfler, A; Zajic, P; Kessler, HH; Hoenigl, M.
Diagnostic accuracy of Mucorales PCR testing in bronchoalveolar lavage fluid samples: a retrospective analysis of a prospectively collected cohort.
Clin Microbiol Infect. 2026; Doi: 10.1016/j.cmi.2026.01.017
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Autor*innen der Med Uni Graz:

Dichtl Karl

Egger Matthias Florian

Glatz Ulrike

Hönigl Martin

Kessler Harald

Prattes Jürgen

Sedik Sarah

Wölfler Albert

Zajic Paul

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Abstract:

OBJECTIVES: To evaluate the diagnostic performance, particularly specificity, of the MucorGenius® polymerase chain reaction (PCR) assay for detecting pulmonary mucormycosis in bronchoalveolar lavage fluid (BALF) samples from at-risk patients. METHODS: This is a retrospective diagnostic accuracy study using prospectively collected BALF samples. All consecutive BALF samples obtained from patients who were considered to be at-risk for invasive mold infections (IMI) were prospectively collected. Patients were retrospectively classified according to EORTC/MSGERC and adapted FUNDICU definitions. All samples were retrospectively tested with the MucorGenius® assay. RESULTS: 1,407 BALF samples obtained from 1,330 patients had been included and tested for Mucorales DNA. 256 patients (19.6%) fulfilled EORTC/MSGERC host factors and 664 (49.9%) FUNDICU host factors. Proven or probable pulmonary mucormycosis was routinely diagnosed (without Mucorales PCR) in four patients (0.3%), 26 patients had proven or probable invasive pulmonary aspergillosis (IPA) (2%) and 25 (1.9%) had possible IMI. Overall, 32 positive MucorGenius® results had been observed. Per patient the MucorGenius® assay gave a specificity of 98.6% (95% CI: 97.8 - 99.2; N = 1251/1269) and a sensitivity of 100% (95% CI: 39.8 - 100; N = 4/4 ). Two cases with IPA were routinely diagnosed with mixed Mucorales infection and three additional IPA cases had a positive MucorGenius® PCR. In total, 5/26 IPA cases were therefore diagnosed with a mixed mold infection. Six out of the 25 possible IMI cases (24%) also turned out positive on MucorGenius® PCR. 19 Mucorales PCR positive samples had been obtained from patients without any routinely diagnosed IMI. CONCLUSIONS: We observed a near-to-perfect specificity of the MucorGenius® assay in BALF, making diagnosis of pulmonary mucormycosis very likely in patients with a positive PCR. In addition, the test was able to identify mucormycosis in a relevant proportion of cases with possible IMI and probable IPA, potentially indicating otherwise missed mixed-mold infections.

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