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- Title
Analytical and clinical evaluations of SNIBE Maglumi chemiluminescent immunoassay for the detection of SARS-CoV-2 antigen in salivary samples.
- Authors
Padoan, Andrea; Talli, Ilaria; Cosma, Chiara; Moz, Stefania; Furlan, Giulia; Navaglia, Filippo; Marchioro, Lucio; Zaninotto, Martina; Basso, Daniela; Plebani, Mario
- Abstract
In this study, we describe the analytical and clinical performances of the SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay (MAG-CLIA) on salivary samples. Limit of detection (LOD), linearity and precision were tested for values close to or below the declared LOD. Clinical performance of MAG-CLIA was evaluated on leftover salivary samples from the healthcare workers (HCW) surveillance program, at the University-Hospital of Padova. Salivary samples were analyzed by Lumipulse G SARS-CoV-2 Ag, and in case where the values exceeded 0.41 ng/L, further testing was conducted using TaqPathTM COVID-19 RT-PCR (Applied Biosystems, Thermo Fisher Scientific). The estimated MAG-CLIA LOD was 3 ng/L, with repeatability of 7.5 %. Good linearity was demonstrated by diluting two samples at 52.7 ng/L and 211.4 ng/L. Of the 228 HCW samples, 59/228 (25.9 %) were positive, 169/228 (74.1 %) were negative. MAG-CLIA SARS-CoV-2 sAg median level (and interquartile range [IQR]) was 5.03 ng/L (<0.001–35.8 ng/L) for positive and <0.001 ng/L (<0.001 ng/L) for negative samples. MAG-CLIA AUC was 0.795 (95 % CI: 0.720–0.871). Using the best cut-off, 3.5 ng/L, sensitivity and specificity were 57.1 % (95 % CI: 42.2–71.2 %) and 97.0 % (95 % CI: 93.2–99.0 %), respectively. The agreement with the molecular assay was 88.1 % (Cohen's kappa 0.606 [SE=0.066, p<0.001]). The analytical performances of MAG-CLIA are satisfactory, also when values below LOD were tested. In saliva samples, although specificity was elevated, clinical performance was not comparable with that on nasopharyngeal swabs (NPS).
- Subjects
PADUA (Italy); SARS-CoV-2; IMMUNOASSAY; THERMO Fisher Scientific Inc.; ANTIGENS; MEDICAL personnel; CHEMILUMINESCENCE assay; DETECTION limit
- Publication
Clinical Chemistry & Laboratory Medicine, 2024, Vol 62, Issue 3, p572
- ISSN
1434-6621
- Publication type
Article
- DOI
10.1515/cclm-2023-0947