NCT07272915

Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique in the Diagnosis of Major Invasive Fungal Infections (IFI)

Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique and the Number of Determinations in the Diagnosis of Major Invasive Fungal Infections (IFI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 280 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Invasive fungal infections (IFI) are a major concern for immunocompromised or vulnerable patients. Associated mortality is significant and depends on the timeliness of diagnostic and therapeutic management. Consequently, biomarkers play a key role in therapeutic strategies compared to conventional phenotypic techniques, due to their shorter turnaround time. Beta-D-glucan (BDG) is a pan-fungal serum marker that enables the detection of invasive fungal infections (primarily candidiasis, aspergillosis, and pneumocystosis). This marker was initially introduced by CapeCod, and most studies are based on this test. More recently, the Wako test has been proposed and implemented in our center. Our study aims to report our experience using the Wako test for BDG measurement, focusing on true and false positives. The objective is to estimate the test performance, within the patient population, and the percentage of confirmed IFI diagnoses when at least two positive Wako test results are observed in the same patient within a consecutive 15-day period.

Conditions

• Candidemia
• Aspergillosis Invasive
• Pneumocystosis; Pneumonia (Etiology)
• IFI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Beta-1,3/1,6-D-Glucan	BDG test Fujifilm Wako

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: France