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. 2023 Mar;37(6):e24867.
doi: 10.1002/jcla.24867. Epub 2023 Mar 27.

Analytical performance evaluation of Lumipulse® SARS-CoV-2 antigen assay in 392 asymptomatic patients

Arnolfo Petruzziello  1 , Rocco Sabatino  1 , Livia Anna Catapane  1 , Carmela De Falco  1 , Antonella Petti  1 , Elena Tripaldelli  1 , Giovanna Loquercio  1 , Angela Annecchiarico  2 , Angela Salzillo  3 , Eugenio Caradonna  4 , Paolo Maggi  5
Affiliations

Analytical performance evaluation of Lumipulse® SARS-CoV-2 antigen assay in 392 asymptomatic patients

Arnolfo Petruzziello et al. J Clin Lab Anal. 2023 Mar.

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 (Ct )-value reaching 100% and 86% with 15 < Ct < 25 and Ct ≥ 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.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

FIGURE 1
FIGURE 1
Comparison of the results between the SARS‐CoV‐2 antigen (Ag) test and RT‐PCR. Box plot shows that mean antigen concentration among the PCR‐positive samples was significantly higher than among PCR‐negative samples (p < 0.00001, W = 720.5).
FIGURE 2
FIGURE 2
Receiver operating characteristic (ROC) curve analysis. The Ag test achieved an area under the ROC curve (AUC) value of 0.9785 (95% CI: 0.9613–0.9958).
See this image and copyright information in PMC

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