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Published on: October 21, 2010
Multicenter Prospective Study of Biomarkers for Diagnosis of Invasive Candidiasis in Children and Adolescents
Brian T Fisher1,2, Craig L K Boge1, Rui Xiao2
1Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Background:
Diagnosis of invasive candidiasis (IC) relies on insensitive cultures; the relative utility of fungal biomarkers in children is unclear.
Methods:
This multinational observational cohort study enrolled patients aged >120 days and <18 years with concern for IC from 1 January 2015 to 26 September 2019 at 25 centers. Blood collected at onset of symptoms was tested using T2Candida, Fungitell (1→3)-β-D-glucan, Platelia Candida Antigen (Ag) Plus, and Platelia Candida Antibody (Ab) Plus assays. Operating characteristics were determined for each biomarker, and assays meeting a defined threshold considered in combination. Sterile site cultures were the reference standard.
Results:
Five hundred participants were enrolled at 22 centers in 3 countries, and IC was diagnosed in 13 (2.6%). Thirteen additional blood specimens were collected and successfully spiked with Candida species, to achieve a 5.0% event rate. Valid T2Candida, Fungitell, Platelia Candida Ag Plus, and Platelia Candida Ab Plus assay results were available for 438, 467, 473, and 473 specimens, respectively. Operating characteristics for T2Candida were most optimal for detecting IC due to any Candida species, with results as follows: sensitivity, 80.0% (95% confidence interval, 59.3%-93.2%), specificity 97.1% (95.0%-98.5%), positive predictive value, 62.5% (43.7%-78.9%), and negative predictive value, 98.8% (97.2%-99.6%). Only T2Candida and Platelia Candida Ag Plus assays met the threshold for combination testing. Positive result for either yielded the following results: sensitivity, 86.4% (95% confidence interval, 65.1%- 97.1%); specificity, 94.7% (92.0%-96.7%); positive predictive value, 47.5% (31.5%-63.9%); and negative predictive value, 99.2% (97.7%-99.8%).
Conclusions:
T2Candida alone or in combination with Platelia Candida Ag Plus may be beneficial for rapid detection of Candida species in children with concern for IC.
Clinical Trials Registration:
NCT02220790.
Insights
Accurate diagnosis of invasive candidiasis (IC) in children is challenging. The T2Candida assay, alone or combined with Platelia Candida Antigen Plus, shows promise for rapid detection of Candida species.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Pediatric Medicine
Background:
- Invasive candidiasis (IC) diagnosis in children often relies on insensitive culture methods.
- The diagnostic utility of fungal biomarkers for IC in pediatric populations remains unclear.
Purpose of the Study:
- To evaluate the operating characteristics of fungal biomarkers for diagnosing IC in children.
- To determine the effectiveness of T2Candida, Fungitell, Platelia Candida Antigen Plus, and Platelia Candida Antibody Plus assays.
Main Methods:
- A multinational observational cohort study enrolled pediatric patients (>120 days and <18 years) with suspected IC.
- Blood specimens were tested using T2Candida, Fungitell, Platelia Candida Antigen Plus, and Platelia Candida Antibody Plus assays.
- Sterile site cultures served as the reference standard for IC diagnosis.
Main Results:
- The T2Candida assay demonstrated optimal operating characteristics for detecting IC due to any Candida species (sensitivity 80.0%, specificity 97.1%).
- Combination testing of T2Candida and Platelia Candida Antigen Plus assays yielded high sensitivity (86.4%) and specificity (94.7%).
- Thirteen of 500 participants were diagnosed with IC, representing a 2.6% event rate.
Conclusions:
- The T2Candida assay, individually or combined with Platelia Candida Antigen Plus, may enhance rapid detection of Candida species in children with suspected IC.
- These biomarkers offer potential improvements over traditional culture methods for pediatric IC diagnosis.
