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

  • author:yirui
  • date:2015-09-29
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Measurement of (1, 3)-β-D-glucan (BG) has emerged as an adjunct diagnostic strategy for invasive fungal infections (IFI). Scientists conducted a multicenter validation study to evaluate the performance of the BG assay as adiagnostic adjunct for IFI. 

Results: At a cutoff of 60 pg/mL, the sensitivity and specificity of the assay were 69.9% and 87.1%, respectively, with a positive predictive value (PPV) of 83.8% and a negative predictive value (NPV) of 75.1%. At a cutoff value of 80 pg/mL, the sensitivity and specificity were 64.4% and 92.4%, respectively, with a PPV of 89% and an NPV of 73%. Of the 107 patients with proven candidiasis, 81.3% had positive results at a cutoff value of 60 pg/mL, and 77.6% had positive results at a cutoff value of 80 pg/mL. Of the 10 patients with aspergillosis, 80% had positive results at cutoff values of 60 and 80 pg/mL. The 3 subjects diagnosed with Fusarium species had positive results at a cutoff value of 60 pg/mL. Patients infected with Mucor or Rhizopus species (both of which lack BG) had negative results at both cutoff values, and of the 12 patients with Cryptococcus infection, 3 had positive results at a cutoff value of 60 pg/ mL, and 2 had positive results at a cutoff value of 80 pg/ mL. Of the subjects with proven positive results who were receiving antifungal therapy (n=118), 72.9% had results positive for BG at a cutoff value of 60 pg/ mL, and 69.5% had results positive for BG at a cutoff value of 80 pg/ mL. The inter-laboratory sample test r2 was 0.93.

Conclusively, 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.


Ostrosky-Zeichner et al. Clinical Infectious Diseases 2005; 41:654–9