DESEMPENHO DO TESTE RÁPIDO IMMY® SONA ASPERGILLUS PARA DETECÇÃO DE GALACTOMANANA EM AMOSTRAS DE SECREÇÃO TRAQUEAL DE PACIENTES COM ASPERGILOSE PULMONAR ASSOCIADA À COVID-19 (CAPA): UM ESTUDO DE VIDA REAL

Abstract

Aspergillosis is a fungal infection caused by fungi of the genus Aspergillus, with Aspergillus fumigatus being the most common species. This fungus is present in the environment and is constantly inhaled by people. In individuals without immunosuppressive factors or pre-existing lung diseases, aspergillosis tends not to develop. However, in some situations, aspergillosis can become a significant concern, especially in patients with compromised immune systems due to conditions such as cancer, organ transplants, and immunosuppressive treatments. Additionally, patients under intensive care are also more prone to developing this fungal disease. Thus, during the COVID-19 pandemic, COVID-19-associated pulmonary aspergillosis (CAPA) has become very significant, mainly due to the large number of cases, difficult diagnosis, challenging management, and high mortality.The diagnostic criterion for proven CAPA, in addition to the presence of clinical and radiological criteria, requires visualization and/or isolation of the fungus from bronchoalveolar lavage samples or lung biopsies. However, collecting these biological materials requires invasive procedures and equipment that are not readily available in developing countries, such as Brazil. The use of biomarkers, such as the determination of Aspergillus galactomannan (GM) in body fluids, is a valuable tool in the diagnosis of invasive pulmonary aspergillosis. Similarly, the use of tracheal secretion (TS) as easily accessible biological material has been a valuable option for the diagnosis of CAPA. However, real-life studies to evaluate the performance of diagnostic tests using TS are scarce. Thus, the aim of the present study was to determine the performance of the IMMY® sona Aspergillus rapid test for detecting GM in TS samples from patients suspected of CAPA.The study was conducted at two tertiary hospitals in Campo Grande, MS, Brazil, from June 2021 to September 2022. The definitions of proven, probable, and possible CAPA diagnosis followed the ECMM/ISHAM recommendation, which includes clinical, tomographic, and microbiological criteria. For the present study, GM detection in TS by ELISA method (Platelia Aspergillus EIA, Bio‐Rad®) was used as the microbiological criterion, as recommended by the ECMM/ISHAM guideline.Among 121 COVID-19 patients under intensive care, 64 patients presented with clinical and radiological features suspicious of CAPA and were evaluated for the presence of GM in TS by the ELISA method. TS samples were also subjected to the rapid test (IMMY® sona Aspergillus), and accuracy parameters were determined. Fifteen patients (23.4%) were diagnosed with possible CAPA. These patients had a mean age of 65 (minimum 34, maximum 98) years, and mortality was 66.7%. The accuracy analysis of the rapid test for TS samples compared to the ELISA test revealed sensitivity=93%, specificity=94%, positive predictive value=83%, negative predictive value=97%, and positive likelihood ratio=15.3. The agreement between the tests was 83.3%, and the overall accuracy was 93%. Under the conditions tested, the rapid test for GM detection in TS samples showed excellent performance, proving to be a rapid option for the diagnosis of possible CAPA, thus providing earlier antifungal treatment and subsequent reduction in mortality in settings where bronchoscopy is limited or unavailable.