Clinical evaluation of a novel rapid test for Aspergillus galactomannan

He Wang, Jie Peng, Yuan Zhang, Kevin Sun, Junli Wen, Yan Su, Zeqi Zhou

Author address: 

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


Abstract third-party references: Thuy Tien TT, Park H, Tuong HT, Yu ST, Choi DY, Yeo SJ: Development of a Rapid Fluorescent Immunochromatographic Test to Detect Respiratory Syncytial Virus. Int J Mol Sci 2018, 19. 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.

Background: Invasive Aspergillosis (IA) is a life-threatening complication in patients with hematological malignancy, early and rapid diagnosis is crucial for the treatment. Aspergillus Galactomannan (GM) has been proved as a biomarker for detection of IA. Recently, GM Lateral Flow Assay (QuicGMTM , Dynamiker, China) was released as a screening test of IA. It is a fluorescent immunochromatographic cassette test which using a monoclonal antibody against GM and Europium nanoparticles (Eu NP). After pretreatment of serum samples, pretreatmented supernatant was added into the pad and then read the fluorescent signal after 15 mins (Fig). It is a semi-quantitative test as compared with the traditional GM ELISA assay (Bio-Rad, USA).

Materials/methods: A total of 209 serum samples were collected according to the revised EORTC/MSG guideline (2008), and tested by QuicGMTM(Dynamiker, China). Those included 82 IA samples (proven, n=30; probable, n=52) and 127 negative samples. Those samples were compared with PlateliaTM GM ELISA (Bio-Rad, USA).

Results: A total of 209 serum samples were analyzed by ROC, the sensitivity and specificity of QuicGMTM was 87.8% and 90.6%, respectively. The positive coincidence rate, negative coincidence rate and total coincidence rate of QuicGMTM compared with PlateliaTM was 87.8%, 90.55% and 89.47%, respectively.The Kappa value was 0.821>0.75

Conclusions:The Dynamiker QuicGMTM was significantly consistent with Bio-Rad PlateliaTM GM ELISA. It could be used as an aid for the early rapid screening test for the IA. Additionally, the Dynamiker QuicGMTM test was showed significant consistency with that Bio-Rad PlateliaTM GM.

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Full conference title: 

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