Multicenter Clinical Evaluation of the (1->3)  -D-Glucan Assay as an Aid to Diagnosis of Fungal Infections in Humans

Abstract

Reproducible assay results with high specificity and high PPV in a multicenter setting demonstrate that use of an assay to detect serum BG derived from fungal cell walls is a useful diagnostic adjunct for IFI.

Detection of (1→3)-β- d -Glucan as an Adjunct to Diagnosis in a Mixed Population with Uncommon Proven Invasive Fungal Diseases or with an Unusual Clinical Presentation

“…BG was positive, which is in agreement with previously reported studies (7,9). Case 8 suggests that since both fungal markers (GM and BG) have limitations for the diagnosis of invasive aspergillosis, the two markers should be combined as diagnostic tools (10).…”

“…Its presence in serum and normally sterile body fluids is a marker of IFD and is an indirect mycological criterion in the revised definitions of IFD (4). Different studies have established its diagnostic value in invasive candidiasis and invasive aspergillosis (9,10). However, currently numerous non-Candida and non-Aspergillus fungi are important causes of IFD in the immunocompromised host, and in this setting, clinical and mycological experience with the use of BG as a tool for diagnosis is scarce (7)(8)(9)(10)(11).…”

“…Different studies have established its diagnostic value in invasive candidiasis and invasive aspergillosis (9,10). However, currently numerous non-Candida and non-Aspergillus fungi are important causes of IFD in the immunocompromised host, and in this setting, clinical and mycological experience with the use of BG as a tool for diagnosis is scarce (7)(8)(9)(10)(11). The aim of this report was to assess the usefulness of BG detection (Fungitell; Associates of Cape Cod, Falmouth, MA) as a diagnostic adjunct in proven IFD in a mixed population with uncommon fungal infections due to emerging dematiaceous and hyaline septate molds (14) or with an unusual clinical presentation.…”

ECIL recommendations for the use of biological markers for the diagnosis of invasive fungal diseases in leukemic patients and hematopoietic SCT recipients

“…As the design of these studies was very variable, only 10 (4 case-control and 6 cohort studies) [17][18][19][20][21][22][23][24][25][26] were considered appropriate for analysis on the basis of the following parameters: type of population (hematological patients), sample size (X20 IFD cases and X50 non-IFD controls) and reference standard of IFD (definition according to the EORTC/MSG criteria). 10 Whereas sensitivity, specificity, positive and negative predictive values derived from these analyses in hematological patients were variable (Table 3), no major differences were observed among the different assays.…”

“…Overall, the results of cohort studies tend to exhibit a larger variability of test performance when compared with case-control studies. Different cutoffs for positivity have been investigated in seven studies, 17,[19][20][21][22]24,26 suggesting that the optimal cutoff if compared with the recommended value may be lower for the Wako and Maruha assays 19,26 and higher for the Fungitec-G assay. 21 The prerequisite of two consecutive positive tests for IFD diagnosis was investigated in four studies and resulted in a specificity approaching 100% and a lower sensitivity ranging between 45 and 65%.…”