| DB ID | MyCo_3543 |
| Title | Prospective Evaluation of the Fungitell® (1→3) Beta-D-Glucan Assay as a Diagnostic Tool for Invasive Fungal Disease in Pediatric Allogeneic Hematopoietic Cell Transplantation: A Report from the Children's Oncology Group |
| Year | 2022 |
| PMID | 36299233 |
| Fungal Diseases involved | Invasive fungal infection |
| Associated Medical Condition | Pediatric Allogeneic Hematopoietic Cell Transplantation |
| Genus | None |
| Species | None |
| Organism | None |
| Ethical Statement | This study was approved by the National Cancer Institute’s Central Institution Review Board (IRB) and IRBs at each participating institution. Participants or guardians provided informed consent and assent to participate in both the parent trial and this ancillary study. |
| Site of Infection | None |
| Opportunistic invasive | None |
| Sample type | Body fluid |
| Sample source | Blood |
| Host Group | Human |
| Host Common name | Human |
| Host Scientific name | Homo sapiens |
| Biomarker Name | BDG |
| Biomarker Full Name | 1-3-beta-D-Glucan |
| Biomarker Type | Negative |
| Biomolecule | Protein |
| Geographical Location | USA |
| Cohort | This prospective study assessed the operating characteristics of the Fungitell® BDG Assay in children above or equal to 3 months of age to younger than 21 years of age undergoing allogeneic HCT. A total of 51 patients (out of 290 patients in the parent trial) contributed blood specimens. In total, 278 specimens were evaluated. |
| Cohort No. | 51 |
| Age Group | 3 Months - 21 Years |
| P Value | None |
| Sensitivity | 0 |
| Specificity | 0.808 |
| Positive Predictive Value | 0 |
| MIC | None |
| Fold Change | None |
| Pathway | None |
| Disease Introduction Mechanism | Invasive fungal disease (IFD) remains an important source of morbidity and mortality for hematopoietic cell transplant (HCT) recipients. The negative consequences of IFD in immunocompromised hosts are hypothesized to result in part from their non-specific clinical presentation and limited diagnostic tools for efficient detection. Collectively, this leads to delayed or missed pre-mortem diagnosis of IFD. |
| Technique | Assay |
| Analysis Method | Fungitell assay |
| ELISA kits | None |
| Assay Data | FDA- Fungitell® beta-D-glucan (BDG) assay |
| Validation Techniques used | Fungitell assay |
| Up Regulation Down Regulation | None |
| Sequence Data | None |
| External Link | None |