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
© 2022 Wiley Periodicals LLC..
BACKGROUND: Invasive fungal disease (IFD) is a major source of morbidity and mortality for hematopoietic cell transplant (HCT) recipients. Non-invasive biomarkers, such as the beta-D-glucan assay, may improve the diagnosis of IFD. The objective was to define the utility of surveillance testing using Fungitell® beta-D-glucan (BDG) assay in children receiving antifungal prophylaxis in the immediate post-HCT period.
METHODS: Weekly surveillance blood testing with the Fungitell® BDG assay was performed during the early post-HCT period in the context of a randomized trial of children, adolescents, and young adults undergoing allogeneic HCT allocated to triazole or caspofungin prophylaxis. Positivity was defined at the manufacturer cutoff of 80 pg/ml. IFD was adjudicated using blinded central reviewers. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for the Fungitell® BDG assay for the outcome of proven or probable IFD.
RESULTS: A total of 51 patients (out of 290 patients in the parent trial) contributed blood specimens. In total, 278 specimens were evaluated. Specificity was 80.8% (95% confidence interval [CI]: 75.6%-85.3%), and NPV was over 99% (95% CI: 86.8%-99.9%). However, there were no true positive results, resulting in sensitivity of 0% (95% CI: 0.0%-84.2%) and PPV of 0% (95% CI: 0.0%-6.7%).
CONCLUSIONS: Fungitell® BDG screening is of limited utility in diagnosing IFD in the post-HCT period, mainly due to high false-positive rates. Fungitell® BDG surveillance testing should not be performed in children during the early post-HCT period while receiving antifungal prophylaxis as the pretest probability for IFD is low.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
|---|---|
| Enthalten in: |
Pediatric transplantation - 27(2023), 1 vom: 20. Feb., Seite e14399 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Otto, William R [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antifungal Agents |
|---|
| Anmerkungen: |
Date Completed 12.01.2023 Date Revised 02.02.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1111/petr.14399 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM348136390 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM348136390 | ||
| 003 | DE-627 | ||
| 005 | 20240202231902.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/petr.14399 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1278.xml |
| 035 | |a (DE-627)NLM348136390 | ||
| 035 | |a (NLM)36299233 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Otto, William R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |b A Report from the Children's Oncology Group |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.01.2023 | ||
| 500 | |a Date Revised 02.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND: Invasive fungal disease (IFD) is a major source of morbidity and mortality for hematopoietic cell transplant (HCT) recipients. Non-invasive biomarkers, such as the beta-D-glucan assay, may improve the diagnosis of IFD. The objective was to define the utility of surveillance testing using Fungitell® beta-D-glucan (BDG) assay in children receiving antifungal prophylaxis in the immediate post-HCT period | ||
| 520 | |a METHODS: Weekly surveillance blood testing with the Fungitell® BDG assay was performed during the early post-HCT period in the context of a randomized trial of children, adolescents, and young adults undergoing allogeneic HCT allocated to triazole or caspofungin prophylaxis. Positivity was defined at the manufacturer cutoff of 80 pg/ml. IFD was adjudicated using blinded central reviewers. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for the Fungitell® BDG assay for the outcome of proven or probable IFD | ||
| 520 | |a RESULTS: A total of 51 patients (out of 290 patients in the parent trial) contributed blood specimens. In total, 278 specimens were evaluated. Specificity was 80.8% (95% confidence interval [CI]: 75.6%-85.3%), and NPV was over 99% (95% CI: 86.8%-99.9%). However, there were no true positive results, resulting in sensitivity of 0% (95% CI: 0.0%-84.2%) and PPV of 0% (95% CI: 0.0%-6.7%) | ||
| 520 | |a CONCLUSIONS: Fungitell® BDG screening is of limited utility in diagnosing IFD in the post-HCT period, mainly due to high false-positive rates. Fungitell® BDG surveillance testing should not be performed in children during the early post-HCT period while receiving antifungal prophylaxis as the pretest probability for IFD is low | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a beta-D-glucan | |
| 650 | 4 | |a hematopoietic cell transplantation | |
| 650 | 4 | |a invasive fungal disease | |
| 650 | 4 | |a sensitivity | |
| 650 | 4 | |a specificity | |
| 650 | 7 | |a Antifungal Agents |2 NLM | |
| 650 | 7 | |a beta-Glucans |2 NLM | |
| 700 | 1 | |a Dvorak, Christopher C |e verfasserin |4 aut | |
| 700 | 1 | |a Boge, Craig L K |e verfasserin |4 aut | |
| 700 | 1 | |a Ostrosky-Zeichner, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Esbenshade, Adam J |e verfasserin |4 aut | |
| 700 | 1 | |a Nieder, Michael L |e verfasserin |4 aut | |
| 700 | 1 | |a Alexander, Sarah |e verfasserin |4 aut | |
| 700 | 1 | |a Steinbach, William J |e verfasserin |4 aut | |
| 700 | 1 | |a Dang, Ha |e verfasserin |4 aut | |
| 700 | 1 | |a Villaluna, Doojduen |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Lu |e verfasserin |4 aut | |
| 700 | 1 | |a Skeens, Micah |e verfasserin |4 aut | |
| 700 | 1 | |a Zaoutis, Theoklis E |e verfasserin |4 aut | |
| 700 | 1 | |a Sung, Lillian |e verfasserin |4 aut | |
| 700 | 1 | |a Fisher, Brian T |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Pediatric transplantation |d 1997 |g 27(2023), 1 vom: 20. Feb., Seite e14399 |w (DE-627)NLM097406473 |x 1399-3046 |7 nnns |
| 773 | 1 | 8 | |g volume:27 |g year:2023 |g number:1 |g day:20 |g month:02 |g pages:e14399 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/petr.14399 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 27 |j 2023 |e 1 |b 20 |c 02 |h e14399 | ||