Comparative Analysis of Chemiluminescence Immunoassay (CLIA)-Based Tests in the Diagnosis of Invasive Aspergillosis in Patients With Hematologic Malignancies.

Abstract

Background and aim: Rapid chemiluminescence immunoassays (CLIA) have emerged as a promising alternative to traditional serological methods for the diagnosis of invasive aspergillosis (IA). The aim of this study was to compare the diagnostic performance of rapid CLIA tests in IA.

Methods: Patient group consisted of 17 patients who were diagnosed with probable IA according to EORTC/MSG criteria. Patients without invasive fungal infection (IFI) were defined as the control group, whereas healthy volunteers were also included. A total of 93 serum samples were used in this study. Platelia Aspergillus Ag test and Dynamiker Aspergillus Ag Kit, CLIA tests Aspergillus Galactomannan Detection Kit and Fungus (1-3) ꞵ-D-Glucan Detection Kit, were used. Specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV) were calculated. Receiver operating characteristic (ROC) curve was used to evaluate the overall diagnostic performance of CLIA tests comparing FDA-approved GM ELISA test.

Results: The sensitivity of the CLIA galactomannan (CLIA GM) test was 70.6%, specificity 92.1%, PPV 66.7% and NPV 93.3% (p < 0.001), while the sensitivity of the CLIA beta-glucan (CLIA BDG) test was 88.2%, specificity 81.6%, PPV 51.7% and NPV 96.9% (p < 0.001). Using the PlateliaTM Aspergillus Ag Test as the reference method, the areas under the curve (AUC) of the ROC curve were 0.878 for CLIA BDG and 0.869 for CLIA GM.

Conclusions: CLIA-based tests were evaluated as being rapid diagnostic tests for IA since their NPVs were found to be very high. Integrating CLIA into clinical practice may significantly improve diagnostic efficiency and patient outcomes.