Clinical evaluation of a novel chemiluminescent microparticle immunoassay of Aspergillus galactomannan in diagnosis of invasive aspergillosis

He Wang, Chunlong Liu, Yuan Zhang, Kevin Sun, 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., Wei X, Xia Y, Shen M, Yang Y, Jin J, Xu H, Li Z: Magnetic Nanoparticle-Based Automatic Chemiluminescent Enzyme Immunoassay for Golgi Protein 73 and the Clinical Assessment. J Nanosci Nanotechnol 2019, 19:1971-1977.

Background: Aspergillus galactomannan (GM) ELISA assay has been proved as an important indicator of probable invasive aspergillosis (IA), and it has been widely used especially for patients with haematological malignancy. The disadvantage of ELISA includes cumbersome procedures, false positive problems and numerous interference factors. Other proposed manual or semi-automatic strategies cannot meet the large-scale requirement either. Therefore, developing a specific, sensitive and automatic detection and quantitation strategy for clinical diagnosis and therapeutic monitory of GM is in urgent demand. In this study, we used galactomannan monoclonal antibodies to establish a chemiluminescent quantitative detection method based on an automatic chemiluminescent analyzer (Fig).The clinical assessment was also carried out.

Materials/methods: A total of 321 serum samples were collected according to the revised EORTC/MSG guideline (2008), and tested by Automatic Chemiluminescent microparticle immunoassay for GM (Dynamiker, China). All the samples from the Shandong and Tianjin Provincial Chest Hospital. Those including 126 IA samples (proven, n=43; probable, n=83) and 195 negative samples. Those samples were compared with PlateliaTM GM ELISA (Bio-Rad, USA).

Results: Through the analysis of 321 serum samples, the Automatic Chemiluminescent microparticle immunoassay sensitivity and specificity was 83.33%, 82.05%, respectively. The positive coincidence rate, negative coincidence rate and total coincidence rate of automatic chemiluminescent microparticle immunoassay compared with PlateliaTM was 91.03%, 96.30% and 95.02%, respectively.

Conclusions:The Dynamiker automatic chemiluminescent microparticle immunoassay for GM, with competent specificity and sensitivity, is highly consistent with Bio-Rad PlateliaTM GM ELISA. It could be used as a rapid test to support the diagnosis of IA.

Presenter email address: [email protected]

2020

abstract No: 

2444

Full conference title: 

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