Invasive Fungal Disease
Conditions
Interventions
Gold Standard:Fungal culture and identification by mass spectrometry(MALDI-TOF MS)
Index test:After fluorescence staining, the specimens are loaded into an AI-based automatic scanning and recognition system, which automatically performs whole-slide scanning, pathogen capture, and mo
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with high clinical suspicion of fungal infection (deep or superficial) and whose specimens are sent for fungal testing; 2.Specimens of clear and reliable types, including but not limited to blood, BALF, CSF, sputum, secretions, and urine; 3.Sufficient specimen volume to permit completion of three distinct assays;
Exclusion criteria
Exclusion criteria: 1.The container is severely contaminated, broken, or mislabeled; 2.The specimen volume is inadequate to perform fluorescence staining, culture, and repeat/verification assays in parallel; 3.The specimen has been chemically fixed or improperly stored (e.g., at elevated temperatures), resulting in damage to fungal structures;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance evaluation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consistency test.;Morphological parameter analysis.;Comparison of report turnaround time (TAT).; | — |
Countries
China
Contacts
Public ContactSha Lu
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed