Rapid and high-throughput chemiluminescence immunoassay for detection of Aspergillus galactomannan.

Invasive aspergillosis (IA), caused by Aspergillus, requires prompt diagnosis and treatment. Here, the efficacy of a chemiluminescence immunoassay (CLIA) for detecting Aspergillus galactomannan (GM) antigen in serum and bronchoalveolar lavage fluid (BALF) was evaluated. Overall, 265 patients with suspected IA were enrolled between March and May 2023 and were stratified into IA (n = 48) and non-IA (n = 217) cohorts. A total of 265 samples (208 serum, 57 BALF) were analyzed with GM-CLIA. The specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV) were calculated. Diagnostic performance was assessed with receiver operating characteristic (ROC) curves. GM-CLIA demonstrated sensitivity/specificity values of 88.00%/93.44% in serum and 91.30%/76.47% in BALF. The sensitivity for all samples was 89.58% with a specificity of 90.78%, while PPV and NPV were 69.25% and 97.52%, respectively. The AUC (area under the ROC curve) was 0.93 (95% confidence interval [CI], 0.89-0.97, P < .001), with an optimal cutoff value of 0.70 ng/ml. The GM-CLIA enables automated detection of individual samples (serum/BALF) on a fully integrated chemiluminescence platform. This system delivers high specificity (90.78%), sensitivity (89.58%), enabling prompt diagnosis and treatment of IA.