| DB ID | MyCo_5587 |
| Title | Beta-d-Glucan for Diagnosing Pneumocystis Pneumonia: a Direct Comparison between the Wako β-Glucan Assay and the Fungitell Assay |
| Year | 2019 |
| PMID | 30918045 |
| Fungal Diseases involved | Pneumocystis pneumonia |
| Associated Medical Condition | None |
| Genus | Pneumocystis |
| Species | jirovecii |
| Organism | Pneumocystis jirovecii |
| Ethical Statement | This study was approved by the Ethical Committee Research UZ/KU Leuven (reference number S61842). Due to the retrospective nature of this study, the need for informed consent was waived. This study was performed in accordance with the 2015 STARD guidelines for diagnostic accuracy studies. |
| Site of Infection | Lungs |
| Opportunistic invasive | Opportunistic |
| Sample type | Body fluid |
| Sample source | Bronchoalveolar lavage fluid (BALF) |
| 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 | Diagnostic |
| Biomolecule | Protein |
| Geographical Location | Belgium |
| Cohort | We performed a retrospective case-control study on archived serum samples collected as part of routine clinical care between January 2010 and July 2018 at the University Hospitals Leuven, Leuven, Belgium, a tertiary care center. We included PCP cases and controls in a 1:1 ratio, stratified by HIV serostatus. Based on an expected sensitivity of 0.92 (8), a 95% confidence interval (CI) 5 percentage points wide, a power of 0.8, and an alpha value of 0.95, we required a sample size of 227 patients. Starting from all patients who had a Pneumocystis-specific quantitative PCR (qPCR) performed on BALf, we included patients that (i) had either strongly positive qPCR results (threshold cycle [CT] 28) or strictly negative qPCR results (threshold cycle 45), (ii) had had a chest X-ray or computed tomography within 1 week of BALf sampling, and (iii) had available a serum sample collected from between 48 h before BALf sampling up to 7 days after BALf sampling that had been stored at less than or equal to 20°C. Patients with a positive qPCR result in the absence of clinical signs or symptoms of respiratory infection and patients with other fungal infections, as defined by the 2008 EORTC-MSG consensus definitions, were excluded. |
| Cohort No. | 116 Patients and 114 Control |
| Age Group | None |
| P Value | None |
| Sensitivity | None |
| Specificity | None |
| Positive Predictive Value | None |
| MIC | None |
| Fold Change | None |
| Pathway | None |
| Disease Introduction Mechanism | Pneumocystis pneumonia (PCP) is an opportunistic pulmonary fungal infection caused by Pneumocystis jirovecii in patients with reduced cellular immunity, especially in those with lowered CD4 T lymphocyte counts. The diagnosis classically relied on direct microscopy of respiratory samples (sputum, tracheal aspirate, bronchoalveolar lavage fluid [BALf], or biopsy samples) after tinctorial staining and with immunofluorescent staining since the 1990s. Later, Pneumocystis-specific PCRs were introduced, further increasing the diagnostic sensitivity. However, given the high sensitivity of these PCR tests, some patients have positive test results while all other clinical and radiological data suggest the absence of active disease. In such patients and in patients from which no high-quality respiratory sample can be obtained (e.g., due to hypoxemia, which is present in up to half of all patients), serum (1,3)-beta-D-glucan (BDG) can be helpful to exclude the possibility of PCP. |
| Technique | PCR |
| Analysis Method | qPCR |
| ELISA kits | Fungitell assay Kit (Associates of Cape Cod, East Falmouth, MA, USA), Wako-BDG Kit ( Beta-glucan test; Fujifilm Wako Pure Chemical Corporation, Osaka, Japan) |
| Assay Data | FDA- Fungitell assay (Associates of Cape Cod) |
| Validation Techniques used | FDA Approved Assay, qPCR |
| Up Regulation Down Regulation | None |
| Sequence Data | None |
| External Link | None |
