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

December 8, 2025 updated by: Anne DEBOURGOGNE, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Diagnostic test: Beta-1,3/1,6-D-Glucan

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Vandœuvre-lès-Nancy, France, 54500
    - Chru Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients at risk of IFI undergoing one or more BDG measurements performed at CHRU Nancy.

Description

Inclusion Criteria:

BDG test in CHRU Nancy

Exclusion Criteria:

other hospitals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BDG level Time Frame: day 0	day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Actual)

June 11, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)