Usefulness of Sōna Aspergillus Galactomannan LFA with digital readout as diagnostic and as screening tool of COVID-19 associated pulmonary aspergillosis in critically ill patients. Data from a multicenter prospective study performed in Argentina

Abstract

COVID-19 associated pulmonary aspergillosis (CAPA) incidence varies depending on the country. Serum galactomannan quantification is a promising diagnostic tool since samples are easy to obtain with low biosafety issues. A multicenter prospective study was performed to evaluate the CAPA incidence in Argentina and to assess the performance of the lateral flow assay with digital readout (Sōna Aspergillus LFA) as a CAPA diagnostic and screening tool. The correlation between the values obtained with Sōna Aspergillus LFA and Platelia® EIA was evaluated. In total, 578 serum samples were obtained from 185 critically ill COVID patients. CAPA screening was done weekly starting from the first week of ICU stay. Probable CAPA incidence in critically ill patients was 10.27% (19/185 patients when LFA was used as mycological criteria) and 9% (9/100 patients when EIA was used as mycological criteria). We found a very good correlation between the two evaluated galactomannan quantification methods (overall agreement of 92.16% with a Kappa statistic value of 0.721). CAPA diagnosis (>0.5 readouts in LFA) were done during the first week of ICU stay in 94.7% of the probable CAPA patients. The overall mortality was 36.21%. CAPA patients' mortality and length of ICU stay were not statistically different from for COVID (non-CAPA) patients (42.11% vs 33.13% and 29 vs 24 days, respectively). These indicators were lower than in other reports. LFA-IMMY with digital readout is a reliable tool for early diagnosis of CAPA using serum samples in critically ill COVID patients. It has a good agreement with Platelia® EIA.

Diagnostic performance and longitudinal analysis of fungal biomarkers in COVID-19 associated pulmonary aspergillosis

“…Previous studies have generally evaluated the accuracy of GM-LFA on clinical suspicion of CAPA and compared GM-LFA and GM-ELISA in patients diagnosed with CAPA. In just one study, GM-LFA was performed as a screening test in critically ill patients [ 22 ]. In that study, there was a good agreement between GM-ELISA and GM-LFA at 92 %.…”

Microbiological Diagnosis of Pulmonary Aspergillus Infections

“…[89][90][91] Several studies have investigated the use of LFTs in CAPA patients on serum and BALF (and TA), which showed good accordance with GM on the same samples. [92][93][94][95] In summary, bronchoscopy-based diagnostics remain the mainstay for diagnosis of VAPA.…”

Developments in Fungal Serology

“…Lateral flow assays to aid in the diagnosis of IFD are well established for cryptococcosis and gaining traction for the diagnosis of IA, including CAPA where acceptable performance was attained when testing deep respiratory tract specimens, but has also demonstrated utility for the early diagnosis of CAPA in serum [19,23,24,25]. Their simplicity of use provides rapid sample processing and together with relatively low cost negates the need for batch testing and permits application in resource-limited settings where access to BioRad GM ELISA may be limited [26].…”