Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay.

Autor:	Pighi L; Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.; Service of Laboratory Medicine, Pederzoli Hospital, Peschiera del Garda, Italy., Henry BM; Clinical Laboratory, Division of Nephrology and Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati OH, USA., De Nitto S; Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.; Service of Laboratory Medicine, Pederzoli Hospital, Peschiera del Garda, Italy., Gianfilippi G; Medical Direction, Pederzoli Hospital, Peschiera del Garda, Italy., Salvagno GL; Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.; Service of Laboratory Medicine, Pederzoli Hospital, Peschiera del Garda, Italy., Plebani M; Department of Medicine, University of Padova, Padova, Italy., Lippi G; Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2023 Mar 08; Vol. 61 (8), pp. 1506-1510. Date of Electronic Publication: 2023 Mar 08 (Print Publication: 2023).
DOI:	10.1515/cclm-2023-0181
Abstrakt:	Objectives: Given that SARS-CoV-2 antigen tests will represent a pillar for supporting or surrogating molecular testing in the endemic period, we report here the clinical performance of the new SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay (MAG-CLIA SARS-CoV-2 Ag). Methods: The study population consisted of 181 subjects (mean age 61 ± 21 years; 92 females) undergoing coronavirus disease 2019 (COVID-19) testing at the local diagnostic facility, from December 2022 to February 2023. Routine diagnostic practice involved the collection of a double nostril nasopharyngeal swab, analyzed in duplicate with SARS-CoV-2 antigen (MAG-CLIA SARS-CoV-2 Ag) and molecular (Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit) tests. Results: A significant Spearman's correlation was found between MAG-CLIA SARS-CoV-2 Ag and mean Ct values of SARS-CoV-2 E and S genes (r=-0.95; p<0.001). In all nasopharyngeal samples, the area under the curve (AUC) of MAG-CLIA SARS-CoV-2 Ag was 0.86 (95% CI, 0.81-0.90), with 0.71 sensitivity and 1.00 specificity at 7 ng/L cut-off, increasing to 0.98 (95% CI, 0.96-1.00) AUC and 0.96 sensitivity (with 0.97 specificity) in high viral load samples. When SARS-CoV-2 N protein concentration was replaced with raw instrumental readings (i.e., relative light units [RLU]), the AUC in all samples increased to 0.94. A RLU value of 945 was associated with 88.4% accuracy, 0.85 sensitivity, 0.95 specificity, 0.77 negative predictive value (NPV) and 0.97 positive predictive value (PPV), respectively. Conclusions: We found satisfactory analytical performance of MAG-CLIA SARS-CoV-2 Ag, which could be used as surrogate of molecular testing for identifying high viral load samples. Broadening the reportable range of values may generate even better performance. (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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