Related Experiment Video
Updated: May 19, 2026
Detection of Invasive Pulmonary Aspergillosis in Haematological Malignancy Patients by using Lateral-flow Technology
Published on: March 22, 2012
Detection of (1, 3)-β-D-glucan in bronchoalveolar lavage and serum samples collected from immunocompromised hosts
Elitza S Theel1, Deborah J Jespersen, Seher Iqbal
1Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First Street SW, SDSC 1-526, Rochester, MN 55905, USA.
Abstract:
The incidence of invasive fungal infections (IFI) has increased in recent years, especially among immunocompromised hosts (ICH). In 2003, the Fungitell(®) assay received FDA clearance for the presumptive diagnosis of IFI using serum and detects (1-3)-β-D-glucan, which is a major cell wall component of certain fungi (e.g., Candida, Aspergillus, and Pneumocystis). The goal of the current study was to assess the performance of the assay on bronchoalveolar lavage (BAL) fluid and serum to identify IFI in ICH. Patients were classified as having proven, probable, possible, or no IFI according to the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) guidelines. Among 109 patients for whom the results of Fungitell were compared to the EORTC/MSG criteria, Fungitell showed a low positive predictive value for the identification of IFI from both BAL (20.0%) and serum (26.7%). However, the negative predictive value of Fungitell was significantly higher for both sample types (BAL, 83.0%; serum, 84.8%). Interestingly, the results of Fungitell were positive in BAL and serum in 7/8 (87.5%) patients diagnosed with Pneumocystis pneumonia (PcP) by real-time, non-nested PCR. These data indicate that the Fungitell assay has a low positive predictive value for the diagnosis of IFI in ICH, regardless of the specimen type that is tested. However, testing of serum samples by Fungitell may permit a rapid and noninvasive initial screening approach in patients with presumed PcP.
Insights
The Fungitell assay shows low accuracy for diagnosing invasive fungal infections (IFI) in immunocompromised hosts (ICH). However, it may serve as a useful initial screening tool for suspected Pneumocystis pneumonia (PcP).
Area of Science:
- Medical Diagnostics
- Clinical Microbiology
- Infectious Diseases
Background:
- Invasive fungal infections (IFI) are a growing concern, particularly in immunocompromised hosts (ICH).
- The Fungitell assay detects (1-3)-β-D-glucan, a fungal cell wall component, for presumptive IFI diagnosis.
- Previous FDA clearance was for serum samples, but performance in other bodily fluids like bronchoalveolar lavage (BAL) fluid needed evaluation.
Purpose of the Study:
- To evaluate the diagnostic performance of the Fungitell assay using both serum and BAL fluid samples.
- To compare Fungitell assay results against established European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria for IFI diagnosis.
- To assess the assay's utility in identifying specific fungal infections, such as Pneumocystis pneumonia (PcP).
Main Methods:
- The study analyzed 109 immunocompromised patients.
- Fungitell assay results from serum and BAL fluid were compared with EORTC/MSG diagnostic criteria.
- Real-time PCR was used to confirm Pneumocystis pneumonia (PcP) diagnoses.
Main Results:
- The Fungitell assay demonstrated a low positive predictive value (PPV) for IFI diagnosis in both BAL fluid (20.0%) and serum (26.7%).
- The negative predictive value (NPV) was notably high for both sample types (BAL: 83.0%, serum: 84.8%).
- The assay showed high positivity (87.5%) in patients diagnosed with PcP, suggesting potential utility for this specific infection.
Conclusions:
- The Fungitell assay exhibits limited positive predictive value for diagnosing invasive fungal infections in immunocompromised patients, irrespective of sample type.
- Its high negative predictive value suggests it can be useful for ruling out IFI.
- Serum testing with the Fungitell assay may offer a rapid, noninvasive initial screening method for patients with suspected Pneumocystis pneumonia.
