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Clinical Trial
. 2015 Apr 17;19(1):178.
doi: 10.1186/s13054-015-0905-x.

Multicenter evaluation of a lateral-flow device test for diagnosing invasive pulmonary aspergillosis in ICU patients

Susanne Eigl  1   2 , Juergen Prattes  3 , Michaela Lackner  4 , Birgit Willinger  5 , Birgit Spiess  6 , Mark Reinwald  7 , Brigitte Selitsch  8 , Michael Meilinger  9 , Peter Neumeister  10 , Frederike Reischies  11 , Albert Wölfler  12 , Reinhard B Raggam  13 , Holger Flick  14 , Stephan Eschertzhuber  15 , Robert Krause  16 , Dieter Buchheidt  17 , Christopher R Thornton  18 , Cornelia Lass-Flörl  19 , Martin Hoenigl  20   21   22
Affiliations
Clinical Trial

Multicenter evaluation of a lateral-flow device test for diagnosing invasive pulmonary aspergillosis in ICU patients

Susanne Eigl et al. Crit Care. .

Abstract

Introduction: The incidence of invasive pulmonary aspergillosis (IPA) in intensive care unit (ICU) patients is increasing, and early diagnosis of the disease and treatment with antifungal drugs is critical for patient survival. Serum biomarker tests for IPA typically give false-negative results in non-neutropenic patients, and galactomannan (GM) detection, the preferred diagnostic test for IPA using bronchoalveolar lavage (BAL), is often not readily available. Novel approaches to IPA detection in ICU patients are needed. In this multicenter study, we evaluated the performance of an Aspergillus lateral-flow device (LFD) test for BAL IPA detection in critically ill patients.

Methods: A total of 149 BAL samples from 133 ICU patients were included in this semiprospective study. Participating centers were the medical university hospitals of Graz, Vienna and Innsbruck in Austria and the University Hospital of Mannheim, Germany. Fungal infections were classified according to modified European Organization for Research and Treatment of Cancer/Mycoses Study Group criteria.

Results: Two patients (four BALs) had proven IPA, fourteen patients (sixteen BALs) had probable IPA, twenty patients (twenty-one BALs) had possible IPA and ninety-seven patients (one hundred eight BALs) did not fulfill IPA criteria. Sensitivity, specificity, negative predictive value, positive predictive value and diagnostic odds ratios for diagnosing proven and probable IPA using LFD tests of BAL were 80%, 81%, 96%, 44% and 17.6, respectively. Fungal BAL culture exhibited a sensitivity of 50% and a specificity of 85%.

Conclusion: LFD tests of BAL showed promising results for IPA diagnosis in ICU patients. Furthermore, the LFD test can be performed easily and provides rapid results. Therefore, it may be a reliable alternative for IPA diagnosis in ICU patients if GM results are not rapidly available.

Trial registration: ClinicalTrials.gov NCT02058316. Registered 20 January 2014.

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References

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