Evaluation of a newer (1, 3)-β-D-glucan chemiluminescent immunoassay for invasive candidiasis: A study from a tertiary care center

Document Type : Original Articles

Authors

1 Department of Microbiology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India

2 Department of Anesthesiology, Pain Medicine & Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India

10.22034/cmm.2024.345199.1513

Abstract

Background and Purpose: Invasive candidiasis (IC) in the hospitalized population is one of the leading causes of invasive fungal infections (IFIs). Microbiological diagnosis of IC suffers due to poor sensitivity of blood culture and relative inaccessibility to more sensitive modalities. (1, 3)-β-D-glucan (BDG) is a cell wall polysaccharide found in a range of fungi. Various commercial assays are available based on various detection techniques. We assessed the diagnostic performance of the FungiXpert® Fungus (1, 3)-β-D-glucan Detection Kit by Genobio Pharmaceutical Co. Ltd. (Tianjin, China), based on chemiluminescent method, for diagnosis of candidemia and deep seated candidiasis.
Materials and Methods: 80 patients (34 males and 46 females) were included with a median age of 35. In accordance with EORTC/MSGERC definitions, 39 patients had proven IC. The number of patients within the probable, possible and no IC (taken as control) groups were 8, 4 and 29 respectively. Blood samples were collected for fungal blood culture and BDG assay.
Results: After excluding cases with evidence of concurrent IFI other than IC, median serum BDG was 0.63 ng/ml for proven IC; while it was 0.04 ng/ml for NO IC. Sensitivity, specificity, positive and negative predictive values were 60.52%, 81.81%, 85.18% and 54.54% respectively. Positive likelihood ratio was 3.32. While the assay performed best for Candida tropicalis with median BDG of 1.92 ng/ml and sensitivity of 92.3%, performance was worst for Candida parapsilosis, with median BDG of 0.04 ng/ml and sensitivity of 44.44%. Overall mortality was 65.62% in the BDG positive group, significantly higher than 33.33% in the BDG negative group.
Conclusion: The performance of the FungiXpert® Fungus (1, 3)-β-D-glucan Detection Kit was acceptable for invasive candidiasis in our resource limited setup. The major advantages of this assay were the ease of performance in a semi-automated cartridge format, relatively lower cost per test, non-reliance on glucan-free procedures or instruments and minimal hands-on procedure.
 

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Articles in Press, Accepted Manuscript
Available Online from 01 May 2024
  • Receive Date: 03 February 2024
  • Revise Date: 26 April 2024
  • Accept Date: 01 May 2024
  • First Publish Date: 01 May 2024
  • Publish Date: 01 May 2024