Clinical performance of a novel Point-of-Care testing automation of fungus (1-3)-β-D-glucan assay

He Wang, Baoxue Wang, Yankai Fu, Yuan Zhang, Junyang Du, Yan Su, Zeqi Zhou

Author address: 

Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Disease, Beijing, China

Abstract: 

Abstract third-party references: Patterson TF, Thompson GR, 3rd, Denning DW, Fishman JA, Hadley S, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Nguyen MH, et al: Executive Summary: Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis 2016, 63:433-442., White PL, Price JS, Posso RB, Barnes RA: An evaluation of the performance of the Dynamiker(R) Fungus (1-3)-beta-D-Glucan Assay to assist in the diagnosis of invasive aspergillosis, invasive candidiasis and Pneumocystis pneumonia. Med Mycol 2017, 55:843-850.

Background: At present, Invasive fungal diseases (IFD) have been emerging globally, especially in immunocompromised patients. Diagnostic of IFD still remains a big challenge due to the limit of conventional methods like culture and microscopy. Fungus (1-3)-β-D-Glucan (BDG) had been proved as a useful biomarker for Panfungal detection, except for cryptococcus and zygomycetes. However, the current version of BDG assay needs to pool samples and is easy to be contaminated due to complicated operation. We evaluated a novel POCT Automation of Fungus BDG assay (Dynamiker Funguy D240, China). By using of Funguy D240, the result could be reported within 30mins after adding the sample (only one step operation). The monotest card is based on MICRO-FDSPHERES technology, which could achieve POCT for each sample due to internal standard curve. It contains 24-test channels and allow emergency test. Funguy D240 provides a rapid, flexible and POCT solution for Fungus BDG assay (Fig).

Materials/methods: In total, 210 clinical serum samples previously defined according to revised EORTC/MSG guideline, including 30 proven Invasive Candidiasis (proven IC), 52 Invasive Aspergillosis (probable IA), and 128 negative samples from patients without IFD. All the samples were tested in parallel using Funguy D240 (Dynamiker, China) and Fungitell BDG assay (Associate of Cape Cod, USA).

Results: Through the analysis of 210 serum samples, the sensitivity and specificity of Funguy D240 was 82.92%, 85.15%, respectively. The positive coincidence rate, negative coincidence rate and total coincidence rate of Funguy D240 compared with Fungitell was 87.21%, 96.77% and 92.86%, respectively.

Conclusions: The Dynamiker Funguy D240 is a rapid and flexible POCT to detect Fungus BDG Glucan and could be used as an adjunct diagnostic for IFD.

Presenter email address: [email protected]

2020

abstract No: 

2494

Full conference title: 

European Congress of Clinical Microbiology and Infectious Diseases 2020
    • ECCMID 30th (2020)