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Multicenter Performance Evaluation of Galactomannan Antigen and (1,3)-ß -D-glucan Chemiluminescence Enzyme Immunoassay for the Diagnosis of Invasive Fungal Disease

Multicenter Performance Evaluation of Galactomannan Antigen and (1,3)-ß -D-glucan Chemiluminescence Enzyme Immunoassay for the Diagnosis of Invasive Fungal Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073796
Enrollment
Unknown
Registered
2023-07-20
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Funagl Disease

Interventions

Gold Standard:Traditional method detection (Microbiological culture, histopathological examination, GM, BDG)
Index test:(1,3)-ß -D-glucan testing(Chemiluminescence Enzyme Immunoassay)
Galactomannan Antigen testing(Chemiluminescence Enzyme Immunoassay)

Sponsors

Jiangxi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 year-old, male or female; 2. According to the Revised Definition of Invasive fungal diseases, and meeting the EORTC-MSG diagnostic criteria, the patients with invasive fungal diseases were proven/probableIFD; 3. Having qualified lower respiratory tract specimens (qualified sputum, BALF) or serum samples.

Exclusion criteria

Exclusion criteria: 1. Patients with incomplete clinical information; 2. Sample size/storage conditions did not meet the requirements; 3. Patients with fungal infections that may cause cross-reactions: Histoplasma, Fusarium and Penicillium; 4. Treated with albumin, immunoglobulin, coagulation factors and other blood products before enrollment; 5. Patients with invasive mucormycosis or Invasive cryptococcosis.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value;—

Countries

China

Contacts

Public ContactBin Xu

JiangXi Cancer Hosipital

469996535@qq.com+86 139 0791 3822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026