tetano
Editor, Senior Moderator
J Clin Lab Anal
. 2023 Mar 27;e24867.
doi: 10.1002/jcla.24867. Online ahead of print.
Analytical performance evaluation of Lumipulse® SARS-CoV-2 antigen assay in 392 asymptomatic patients
Arnolfo Petruzziello[SUP] 1 [/SUP], Rocco Sabatino[SUP] 1 [/SUP], Livia Anna Catapane[SUP] 1 [/SUP], Carmela De Falco[SUP] 1 [/SUP], Antonella Petti[SUP] 1 [/SUP], Elena Tripaldelli[SUP] 1 [/SUP], Giovanna Loquercio[SUP] 1 [/SUP], Angela Annecchiarico[SUP] 2 [/SUP], Angela Salzillo[SUP] 3 [/SUP], Eugenio Caradonna[SUP] 4 [/SUP], Paolo Maggi[SUP] 5 [/SUP]
Affiliations
Abstract
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID-19-positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real-time RT-PCR, the gold standard for the diagnosis of SARS-CoV-2 infection, in a strictly selected asymptomatic population.
Materials and methods: A total of 392 consecutive oro-nasopharyngeal swabs were collected from patients with no symptoms related to COVID-19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS-CoV-2 antigen compared to qualitative real-time RT-PCR in asymptomatic patients.
Results: Lumipulse® SARS-CoV-2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (C[SUB]t[/SUB] )-value reaching 100% and 86% with 15 < C[SUB]t[/SUB] < 25 and C[SUB]t[/SUB] ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS-CoV-2.
Conclusion: Our data showed that Lumipulse® SARS-CoV-2 antigen assay might be an efficient tool in the identification and limitation of SARS-CoV-2 transmission in large asymptomatic populations.
Keywords: COVID-19; RT-PCR; SARS-CoV-2 antigen; asymptomatic; comparison.
. 2023 Mar 27;e24867.
doi: 10.1002/jcla.24867. Online ahead of print.
Analytical performance evaluation of Lumipulse® SARS-CoV-2 antigen assay in 392 asymptomatic patients
Arnolfo Petruzziello[SUP] 1 [/SUP], Rocco Sabatino[SUP] 1 [/SUP], Livia Anna Catapane[SUP] 1 [/SUP], Carmela De Falco[SUP] 1 [/SUP], Antonella Petti[SUP] 1 [/SUP], Elena Tripaldelli[SUP] 1 [/SUP], Giovanna Loquercio[SUP] 1 [/SUP], Angela Annecchiarico[SUP] 2 [/SUP], Angela Salzillo[SUP] 3 [/SUP], Eugenio Caradonna[SUP] 4 [/SUP], Paolo Maggi[SUP] 5 [/SUP]
Affiliations
- PMID: 36972465
- DOI: 10.1002/jcla.24867
Abstract
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID-19-positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real-time RT-PCR, the gold standard for the diagnosis of SARS-CoV-2 infection, in a strictly selected asymptomatic population.
Materials and methods: A total of 392 consecutive oro-nasopharyngeal swabs were collected from patients with no symptoms related to COVID-19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS-CoV-2 antigen compared to qualitative real-time RT-PCR in asymptomatic patients.
Results: Lumipulse® SARS-CoV-2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (C[SUB]t[/SUB] )-value reaching 100% and 86% with 15 < C[SUB]t[/SUB] < 25 and C[SUB]t[/SUB] ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS-CoV-2.
Conclusion: Our data showed that Lumipulse® SARS-CoV-2 antigen assay might be an efficient tool in the identification and limitation of SARS-CoV-2 transmission in large asymptomatic populations.
Keywords: COVID-19; RT-PCR; SARS-CoV-2 antigen; asymptomatic; comparison.