Evaluation of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening
Objectives: To compare the Lumipulse® SARS-CoV-2 antigen test with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) for diagnosis of SARS-CoV-2 infection and to evaluate its role in screening programs. Methods: Lumipulse® SARS-CoV-2 antigen assay was compared with the gold standard RT-PCR test in a selected cohort of 226 subjects with suspected SARS-CoV-2 infection, and its accuracy was evaluated. Subsequently, the test was administered to a real-life screening cohort of 1738 cases. ROC analysis was performed to explore test features and cutoffs. All tests were performed in the regional reference laboratory in Umbria, Italy. Results: A 42.0% positive result at RT-PCR was observed in the selected cohort. The Lumipulse® system showed 92.6% sensitivity (95% CI 85.4–97.0%) and 90.8% specificity (95% CI 84.5–95.2%) at 1.24 pg/mL optimal cutoff. In the screening cohort, characterized by 5.2% prevalence of infection, Lumipulse® assay showed 100% sensitivity (95% CI 96.0–100.0%) and 94.8% specificity (95% CI 93.6–95.8%) at 1.645 pg/mL optimal cutoff; the AUC was 97.4%, NPV was 100% (95% CI 99.8–100.0%) and PPV was 51.1% (95% CI 43.5–58.7%). Conclusions: The Lumipulse® SARS-CoV-2 antigen assay can be safely employed in the screening strategies in small and large communities and in the general population..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:105 |
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| Enthalten in: |
International Journal of Infectious Diseases - 105(2021), Seite 391-396 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Alessio Gili [VerfasserIn] |
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| Links: |
doi.org [kostenfrei] |
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| Themen: |
Antigen NP |
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| doi: |
10.1016/j.ijid.2021.02.098 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
DOAJ050564978 |
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| 245 | 1 | 0 | |a Evaluation of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening |
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| 520 | |a Objectives: To compare the Lumipulse® SARS-CoV-2 antigen test with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) for diagnosis of SARS-CoV-2 infection and to evaluate its role in screening programs. Methods: Lumipulse® SARS-CoV-2 antigen assay was compared with the gold standard RT-PCR test in a selected cohort of 226 subjects with suspected SARS-CoV-2 infection, and its accuracy was evaluated. Subsequently, the test was administered to a real-life screening cohort of 1738 cases. ROC analysis was performed to explore test features and cutoffs. All tests were performed in the regional reference laboratory in Umbria, Italy. Results: A 42.0% positive result at RT-PCR was observed in the selected cohort. The Lumipulse® system showed 92.6% sensitivity (95% CI 85.4–97.0%) and 90.8% specificity (95% CI 84.5–95.2%) at 1.24 pg/mL optimal cutoff. In the screening cohort, characterized by 5.2% prevalence of infection, Lumipulse® assay showed 100% sensitivity (95% CI 96.0–100.0%) and 94.8% specificity (95% CI 93.6–95.8%) at 1.645 pg/mL optimal cutoff; the AUC was 97.4%, NPV was 100% (95% CI 99.8–100.0%) and PPV was 51.1% (95% CI 43.5–58.7%). Conclusions: The Lumipulse® SARS-CoV-2 antigen assay can be safely employed in the screening strategies in small and large communities and in the general population. | ||
| 650 | 4 | |a Lumipulse® | |
| 650 | 4 | |a Antigen NP | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a Diagnosis | |
| 650 | 4 | |a Screening | |
| 653 | 0 | |a Infectious and parasitic diseases | |
| 700 | 0 | |a Riccardo Paggi |e verfasserin |4 aut | |
| 700 | 0 | |a Carla Russo |e verfasserin |4 aut | |
| 700 | 0 | |a Elio Cenci |e verfasserin |4 aut | |
| 700 | 0 | |a Donatella Pietrella |e verfasserin |4 aut | |
| 700 | 0 | |a Alessandro Graziani |e verfasserin |4 aut | |
| 700 | 0 | |a Fabrizio Stracci |e verfasserin |4 aut | |
| 700 | 0 | |a Antonella Mencacci |e verfasserin |4 aut | |
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