(1-3)-β-D-glucan (BDG) is a major biomarker of invasive fungal diseases (IFDs), which are life-threatening for immunodeficient patients. We compared the clinical performance of two BDG-detection assays. The precision, linearity, reference interval, and limit of quantitation of the Wako BDG assay were analyzed and the performance was compared with that of the Goldstream BDG assay using 272 clinical serum samples. The repeatability, within-laboratory imprecision, and limit of quantitation of the Wako BDG assay were 3.8%, 5.9%, and 7.35 pg/mL, respectively (linearity, 23.8-557 pg/mL; R2 = 0.998). The correlation coefficient, slope, and y-intercept for the Wako BDG assay versus Goldstream BDG assay were 0.29, 3.82, and 0.04, respectively. The sensitivity and specificity were 43.8% and 94.9% for the Wako BDG assay and 39.6% and 83.5% for the Goldstream BDG assay, respectively. In clinical settings, the Wako BDG assay is suitable for diagnosing patients with IFDs.
Keywords: Beta-D-glucan; Invasive fungal disease; Kinetic colorimetry; Kinetic turbidimetry.
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