Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups

Compared to RT-PCR, lower performance of antigen detection assays, including the Lumipulse G SARS-CoV-2 Ag assay, may depend on specific testing scenarios. We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold [Ct] values ≤ 40) or non-COVID-19 (Ct values &g...

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Veröffentlicht in:	Clinical chemistry and laboratory medicine 2021-07, Vol.59 (8), p.1468-1476
Hauptverfasser:	Menchinelli, Giulia, Bordi, Licia, Liotti, Flora Marzia, Palucci, Ivana, Capobianchi, Maria Rosaria, Sberna, Giuseppe, Lalle, Eleonora, Romano, Lucio, De Angelis, Giulia, Marchetti, Simona, Sanguinetti, Maurizio, Cattani, Paola, Posteraro, Brunella
Format:	Artikel
Sprache:	eng
Schlagworte:	antigen detection Antigens Assaying Coronaviruses COVID-19 lumipulse assay nasopharyngeal swab Nondestructive testing Polymerase chain reaction Ribonucleic acid RNA SARS-CoV-2 Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 testing group Tomography
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Zusammenfassung:	Compared to RT-PCR, lower performance of antigen detection assays, including the Lumipulse G SARS-CoV-2 Ag assay, may depend on specific testing scenarios. We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold [Ct] values ≤ 40) or non-COVID-19 (Ct values > 40) diagnoses. RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing. With a limit of detection of 1.2 × 10 SARS-CoV-2 RNA copies/ml, Lumipulse showed positive percent agreement (PPA) of 79.9% (155/194) and negative percent agreement of 99.3% (397/400), whereas PPAs were 100% for samples with Ct values of
ISSN:	1434-6621 1437-4331
DOI:	10.1515/cclm-2021-0182