A Novel Rapid test for Aspergillus Galactomannan

Jie Peng1,2, Junyang Du1,2, Yuan Zhang1,2, Yan Su1,2, He Wang*1,2

1. Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Disease, Tianjin, 300467, China;

2.Tianjin Enterprise Key Laboratory for precision diagnosis technology of invasive fungal diseases, Tianjin 300467, China.

BACKGROUND

Invasive Aspergillosis (IA) is a life-threatening opportunistic mycosis that occurs in some people with a compromised immune system. The detection of Aspergillus galactomannan (GM) rapidly gained widespread acceptance as part of the diagnostic workup of a patient suspected of IA. Recently, a Novel QuicGM Aspergillus Galactomannan Ag Lateral Flow Assay (LFA) from Dynamiker Biotechnology (Tianjin) Co., Ltd. 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) (figure 1). It is a semi-quantitative test which was easy to operate, rapid with portable detection devices, and can be widely accepted by clinical and primary medical (figure 2). We conducted a comparative study between the Dynamiker QuicGMTM Aspergillus Galactomannan Ag (LFA) and the Bio-Rad Platelia? Aspergillus Ag (ELISA) to validate the performance of the novel assay.

Figure 1 Diagram of the Dynamiker GM (LFA)?

Figure 2 Dynamiker GM (LFA) (A) and its reader (B)?

METHOD

A total of 66 serum samples and 54 BALF samples were collected, 15 serum samples from the College of American Pathologists (CAP) certificated lab were also included in this study. The samples were tested in parallel using the Bio-Rad Platelia? Aspergillus Ag (ELISA) and Dynamiker QuicGMTM Aspergillus Galactomannan Ag (LFA).

RESULTS

Results: The total coincidence rate of the two assays was 98.48% (Kappa value was 0.97>0.75) and 90.74% (Kappa value was 0.81>0.75) in 66 serum samples and 54 BALF samples respectively.?

CONCLUSIONS

The performance of the Dynamiker QuicGMTM Aspergillus Galactomannan Ag (LFA) and Bio-Rad Platelia? Aspergillus Ag (ELISA) were highly consistent, and the performance of Dynamiker Aspergillus Galactomannan kit were all in line with the statement of the manufacturer. The results are accurate and reliable, and it could be used as an aid for the early rapid screening test of IA.

References

·??de Heer K, Gerritsen MG, Visser CE, Leeflang MM. Galactomannan detection in broncho-alveolar lavage fluid for invasive aspergillosis in immunocompromised patients. Cochrane Database Syst Rev. 2019 May 20;5(5):CD012399.