Diagnosing invasive pulmonary aspergillosis in hematology patients: a retrospective multicenter evaluation of a novel lateral flow device

BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a potentially lethal infection in patients with hematological diseases or following allogeneic stem cell transplantation. Early diagnosis is essential as delayed treatment results in increased mortality. Recently, a lateral flow device (LFD) for the diagnosis of IPA was CE-marked and commercialized by OLM Diagnostics. METHODS: We retrospectively analyzed bronchoalveolar lavage fluid (BALf) collected from adult hematology patients from 4 centers in the Netherlands and Belgium. Galactomannan was retested in all samples. All samples were applied to an LFD and read out visually by two independent researchers, blinded to the diagnosis of the patient. All samples were also read out using a digital reader. RESULTS: We included 11 patients with proven IPA, 68 patients with probable IPA, 44 patients with possible IPA, and 124 patients with no signs of IPA (‘controls’). In cases of proven IPA versus controls, sensitivity and specificity were 0.82 and 0.86 (visual readout), and 0.82 and 0.96 (digital readout), respectively. When comparing patients with proven and probable IPA as cases versus controls, sensitivity and specificity were 0.71 and 0.86 respectively. When excluding serum and BALf galactomannan as mycological criteria from the 2008 EORTC/MSG consensus definitions, the LFD was less specific than galactomannan when comparing proven and probable IPA to controls (0.86 vs 0.96, p=0.005), but had similar sensitivity (0.76 vs 0.85, p=0.18). CONCLUSIONS: In this large study of the CE-marked LFD in BALf from hematology patients, the LFD had a good performance for the diagnosis of IPA.