The diagnosis of invasive fungal infections (IFIs) is a challenging issue, as it is crucial for managing these potentially fatal diseases. Prompt and accurate diagnosis plays a vital role in determining an appropriate therapeutic procedure, leading to desired clinical outcomes and reduced mortality rates in patients with IFIs [1]. Guidelines for diagnosis of IFIs have introduced the culture method as the reference procedure for diagnosis of invasive candidiasis [2]. However, the diagnosis of candidemia, which is the most common type of invasive candidiasis, poses difficulties due to the low sensitivity and lengthy processing time of blood cultures. Typically, it takes 2-3 days for the cultures to yield positive results, but in some cases, this can extend to 8 days [3].
The detection of fungal antigens in easily obtained specimens such as serum has been advised due to the rising incidence of Candida bloodstream infections in immunocompromised or critically ill patients [4]. Beta-D-glucan (BDG) is one such antigens that can be measured in sera of high-risk patients suspicious of invasive fungal infections including candidiasis, aspergillosis, and pneumocystosis [5,6]. BDG is a polysaccharide component of the cell wall of most fungi that are released into body fluids during the fungal infections, with the exception of Zygomycetes and Cryptococcus. BDG can be measured with turbidimetric or colorimetric assays through the activation of factor G extracted from amebocytes of horseshoe crab species during a coagulation cascade [7,8]. Measurement of BDG in at least two consecutive serum samples is validated as a criterion for diagnosis of invasive candidiasis and pneumocystosis in terms of its capacity to identify IFIs [2,9].
There are now just a few commercial BDG diagnostic tests available for the detection of fungal infections. According to a recent systematic review evaluating the diagnostic performance of currently available BDG kits in immunocompromised or critically ill patients, there are significant differences in the sensitivity, specificity, and accuracy of the various kits [10]. Fungitell assay (FA; Associates of Cape Cod, MA, USA) is the first FDA-approved test that quantitatively measures BDG levels. Fungitell assay is widely used in the USA and European countries; therefore, numerous studies have reported its useful performance in clinical settings to diagnose such fungal infections as aspergillosis, candidemia, and Pneumocystis jirovecii pneumonia [8,11,12]. Also, diagnostic performance of FA has been evaluated among specific populations including patients with hematologic malignancies or solid organ tumors, and ICU patients [13], [14], [15]. The Dynamiker® Fungus BDG assay (DFA; Dynamiker Biotechnology; Tianjin; China) is another available kit that measures the level of BDG based on colorimetric assay in a similar way to FA. A few studies have previously evaluated the performance of DFA in the diagnosis of fungal infections such as aspergillosis [16], invasive candidiasis, and Pneumocystis pneumonia [17]. However, there is not sufficient data to compare the performance of DFA to FA for diagnosis of candidemia. Thus, this work aimed to evaluate the performance of DFA for diagnosis of candidemia, and to compare its performance to FA assay.
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