Evaluation of the diagnostic performances of two commercially available assays for the detection of enteric adenovirus antigens

• Published in: Diagnostic microbiology and infectious disease Vol. 101; no. 3; p. 115459
• Main Authors: Bonura, Floriana, Mascarella, Chiara, Filizzolo, Chiara, Bonura, Celestino, Ferraro, Donatella, Di Bernardo, Francesca, Collura, Antonella, Martella, Vito, Giammanco, Giovanni M., De Grazia, Simona
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-11-2021
• Subjects: Acute gastroenteritis; Adenoviridae - genetics; Adenoviridae - immunology; Adenoviridae Infections - diagnosis; Adolescent; Antigens, Viral - genetics; Antigens, Viral - immunology; Chemiluminescent immunoassay; Child; Child, Preschool; Diagnostic performances; Enteric adenoviruses; Fecal antigens detection; Feces - virology; Gastroenteritis - diagnosis; Gastroenteritis - virology; Hospitalization; Humans; Immuno chromatography; Infant; Infant, Newborn; Italy; Luminescent Measurements - methods; Luminescent Measurements - standards; Reagent Kits, Diagnostic - standards; Sensitivity and Specificity; Italy; Enteric adenoviruses; Immuno chromatography; Chemiluminescent immunoassay; Fecal antigens detection; Diagnostic performances; Acute gastroenteritis
• ISSN: 0732-8893; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2021.115459

•Enteric Adenovirus are important causes of acute gastroenteritis in children.•Several assays are commercialized for the diagnosis of adenovirus infection.•Performance of bioNexia Rota-Adeno ICT and LIAISON® Adenovirus Clinical Laboratory Improvement Amendments was evaluated.•Clinical Laboratory Improvement Amendments showed a higher accuracy (94.4 vs 90.1) and concordance (k: 0.81 vs 0.67) to Real time PCR than ImmunoChromatographic Tests .•Both tests are suitable for the diagnosis of enteric adenovirus infection in symptomatic patients.
The performance of 2 antigenic commercial assays for enteric adenovirus (AdV) infection, bioNexia Rota-Adeno ImmunoChromatographic Tests (ICT) and LIAISON® Adenovirus ChemiLuminescence Immuno Assays (CLIA), was evaluated on 321 stools from children hospitalized for acute gastroenteritis in Palermo, Italy, using a Real time-PCR (Rt-PCR) as reference method. The CLIA showed higher sensitivity (77% vs 60%), accuracy (94.4 vs 90.9) and concordance (k: 0.81 vs 0.67) with respect to ICT, despite equivalent specificity (98.8%). Using the Ct values of the Rt-PCR as a proxy of the fecal viral load, similar Ct values (mean 9.32 vs 9.89) were observed among the true positive samples, whilst a significant difference (P < 0.05) was observed in false negative samples of CLIA (mean Ct 25.68) and ICT (mean Ct 19.87). Cross-reactivity with other enteric viruses was not observed. These results indicate that both the assays tested are suitable for diagnosis of AdV gastroenteritis.