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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT02058316. Registered 20 January 2014.
Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, A- 8036, Graz, Austria. susanne.eigl@medunigraz.at.|Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. susanne.eigl@medunigraz.at.
Susanne
S
Eigl
Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, A- 8036, Graz, Austria. juergen.prattes@medunigraz.at.
Juergen
J
Prattes
Division of Hygiene and Medical Microbiology, Medical University of Innsbruck, Schoepfstraße 41/III, 6020, Innsbruck, Austria. michaela.lackner@i-med.ac.at.
Michaela
M
Lackner
Division of Clinical Microbiology, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. birgit.willinger@meduniwien.ac.at.
Birgit
B
Willinger
Department of Hematology and Oncology, Mannheim University Hospital, University of Heidelberg, Theodor-Kutzer-Ufer 1 - 3, 68167, Mannheim, Germany. birgit.spiess@medma.uni-heidelberg.de.
Birgit
B
Spiess
Department of Hematology and Oncology, Mannheim University Hospital, University of Heidelberg, Theodor-Kutzer-Ufer 1 - 3, 68167, Mannheim, Germany. mark.reinwald@umm.de.
Mark
M
Reinwald
Division of Clinical Microbiology, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. birgitte.selitsch@meduniwien.ac.at.
Brigitte
B
Selitsch
Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. michael.meilinger@medunigraz.at.
Michael
M
Meilinger
Division of Hematology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 38D, 8036, Graz, Austria. peter.neumeister@medunigraz.at.
Peter
P
Neumeister
Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, A- 8036, Graz, Austria. frederike.reischies@medunigraz.at.
Frederike
F
Reischies
Division of Hematology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 38D, 8036, Graz, Austria. albert.woelfler@medunigraz.at.
Albert
A
Wölfler
Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. reinhard.raggam@medunigraz.at.
Reinhard B
RB
Raggam
Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. holger.flick@medunigraz.at.
Holger
H
Flick
Department of Anesthesia and Intensive Care Medicine, Innsbruck Medical University, Anichstraße 35, 6020, Innsbruck, Austria. stephan.eschertzhuber@uki.at.
Stephan
S
Eschertzhuber
Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, A- 8036, Graz, Austria. robert.krause@medunigraz.at.
Robert
R
Krause
Department of Hematology and Oncology, Mannheim University Hospital, University of Heidelberg, Theodor-Kutzer-Ufer 1 - 3, 68167, Mannheim, Germany. dieter.buchheidt@umm.de.
Dieter
D
Buchheidt
Biosciences, College of Life and Environmental Sciences, University of Exeter, Stocker Road, EX4 4QD, Exeter, UK. c.r.thornton@exeter.ac.uk.
Christopher R
CR
Thornton
Division of Hygiene and Medical Microbiology, Medical University of Innsbruck, Schoepfstraße 41/III, 6020, Innsbruck, Austria. cornelia.lass-floerl@i-med.ac.at.
Cornelia
C
Lass-Flörl
Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, A- 8036, Graz, Austria. martin.hoenigl@medunigraz.at.|Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. martin.hoenigl@medunigraz.at.|Division of Infectious Diseases, Department of Medicine, University of California, 200 West Arbor Drive #8208, San Diego, CA, 92103, USA. martin.hoenigl@medunigraz.at.
Martin
M
Hoenigl
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001992:Bronchoalveolar Lavage Fluid / Q000382:microbiology*; D005260:Female; D006801:Humans; D007362:Intensive Care Units / Q000592:standards*; D055744:Invasive Pulmonary Aspergillosis / Q000175:diagnosis* / Q000382:microbiology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult