A National Strategy to Diagnose Coronavirus Disease 2019-Associated Invasive Fungal Disease in the Intensive Care Unit.

BACKGROUND: Fungal coinfection is a recognized complication of respiratory virus infections, increasing morbidity and mortality, but can be readily treated if diagnosed early. An increasing number of small studies describing aspergillosis in coronavirus disease 2019 (COVID-19) patients with severe respiratory distress are being reported, but comprehensive data are lacking. The aim of this study was to determine the incidence, risk factors, and impact of invasive fungal disease in adult COVID-19 patients with severe respiratory distress. METHODS: An evaluation of a national, multicenter, prospective cohort evaluation of an enhanced testing strategy to diagnose invasive fungal disease in COVID-19 intensive care patients. Results were used to generate a mechanism to define aspergillosis in future COVID-19 patients. RESULTS: One-hundred and thirty-five adults (median age: 57, M/F: 2.2/1) were screened. The incidence was 26.7% (14.1% aspergillosis, 12.6% yeast infections). The overall mortality rate was 38%; 53% and 31% in patients with and without fungal disease, respectively (P = .0387). The mortality rate was reduced by the use of antifungal therapy (mortality: 38.5% in patients receiving therapy vs 90% in patients not receiving therapy (P = .008). The use of corticosteroids (P = .007) and history of chronic respiratory disease (P = .05) increased the likelihood of aspergillosis. CONCLUSIONS: Fungal disease occurs frequently in critically ill, mechanically ventilated COVID-19 patients. The survival benefit observed in patients receiving antifungal therapy implies that the proposed diagnostic and defining criteria are appropriate. Screening using a strategic diagnostic approach and antifungal prophylaxis of patients with risk factors will likely enhance the management of COVID-19 patients.

Evaluation of the Performance of the Associates of Cape Cod STAT Assay for the Diagnosis of Invasive Fungal Disease in Critical-Care Patients with COVID-19.

During the COVID-19 pandemic, there have been increasing reports of invasive fungal disease (IFD) in critical care, where rapid access to (1-3)-ß-d-glucan (BDG) testing may have enhanced diagnosis. The potential benefit of rapidly accessible BDG results is limited by local availability of BDG testing, with low demand resulting in testing being performed in specialist centers. The recent release of the Associates of Cape Cod STAT assay provides a simple, low-throughput BDG platform, potentially increasing accessibility. During the pandemic, BDG testing using the Fungitell assay (FA) was a critical component of screening for IFD in our critical care. The performance of the STAT was retrospectively determined through a case-control study of 107 serum samples from critical-care COVID-19 patients with IFD defined according to international guidelines. The STAT demonstrated excellent qualitative (observed agreement, 97.2%; kappa, 0.94) and quantitative (Spearman's coefficient, 0.8962) agreement with the FA. Sample positivity was greater (P < 0.0001) in samples from cases (67.7%) versus controls (6.1%). Using the manufacturer's threshold (≥1.2), sensitivity and specificity for the detection of proven/probable IFD were 67.9% and 93.9%, respectively. Using a lower positivity threshold of ≥0.87 increased sensitivity to 71.4% without compromising specificity. When the STAT BDG index was >2.86, specificity was 100%. The STAT provides a simple, comparable alternative to the FA for detecting BDG. Sensitivity is moderate, and specificity is excellent for the diagnosis of IFD in the critical-care COVID-19 patient. The potential for enhancing access to BDG testing through the uptake of STAT at centers where FA is not available is beneficial, especially during the COVID-19 pandemic.