title: Automation of serum (1→3)-beta-D-glucan testing allows reliable and rapid discrimination of patients with and without candidemia.
abstract: Testing for (1→3)-beta-D-glucan (BDG) is used for detection of invasive fungal infection. However, current assays lack automation and the ability to conduct rapid single-sample testing. The Fungitell assay was adopted for automation and evaluated using clinical samples from patients with culture-proven candidemia and from culture-negative controls in duplicate. A comparison with the standard assay protocol was made in order to establish analytical specifications. With the automated protocol, the analytical measuring range was 8-2500 pg/ml of BDG, and precision testing resulted in coefficients of variation that ranged from 3.0% to 5.5%. Samples from 15 patients with culture-proven candidemia and 94 culture-negative samples were evaluated. All culture-proven samples showed BDG values >80 pg/ml (mean 1247 pg/ml; range, 116-2990 pg/ml), which were considered positive. Of the 94 culture-negative samples, 92 had BDG values <60 pg/ml (mean, 28 pg/ml), which were considered to be negative, and 2 samples were false-positive (≥80 pg/ml; up to 124 pg/ml). Results could be obtained within 45 min and showed excellent agreement with results obtained with the standard assay protocol. The automated Fungitell assay proved to be reliable and rapid for diagnosis of candidemia. It was demonstrated to be feasible and cost efficient for both single-sample and large-scale testing of serum BDG. Its 1-h time-to-result will allow better support for clinicians in the management of antifungal therapy.
authors.affiliation: Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.
authors.forename: Florian
authors.initials: F
authors.lastname: Prüller
authors.affiliation: Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Austria.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Wagner
authors.affiliation: Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.
authors.forename: Reinhard B
authors.initials: RB
authors.lastname: Raggam
authors.affiliation: Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Hoenigl
authors.affiliation: Institute of Hygiene, Microbiology and Environmental Health, Medical University of Graz, Austria.
authors.forename: Harald H
authors.initials: HH
authors.lastname: Kessler
authors.affiliation: Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.
authors.forename: Martie
authors.initials: M
authors.lastname: Truschnig-Wilders
authors.affiliation: Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Austria robert.krause@medunigraz.at florian.prueller@medunigraz.at.
authors.forename: Robert
authors.initials: R
authors.lastname: Krause
mesh_terms: D000946:Antigens, Fungal / Q000097:blood*; D057205:Automation, Laboratory / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D002175:Candida / Q000302:isolation & purification*; D058387:Candidemia / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D047071:beta-Glucans / Q000097:blood*
chemical_list: D000946:Antigens, Fungal; D047071:beta-Glucans
keywords: (1→3)-beta-D-glucan; candidemia; invasive fungal infection; laboratory diagnosis; single-sample testing