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

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 pe...

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Veröffentlicht in:Journal of clinical laboratory analysis 2023-03, Vol.37 (6), p.e24867-n/a
Hauptverfasser: Petruzziello, Arnolfo, Sabatino, Rocco, Catapane, Livia Anna, De Falco, Carmela, Petti, Antonella, Tripaldelli, Elena, Loquercio, Giovanna, Annecchiarico, Angela, Salzillo, Angela, Caradonna, Eugenio, Maggi, Paolo
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container_title Journal of clinical laboratory analysis
container_volume 37
creator Petruzziello, Arnolfo
Sabatino, Rocco
Catapane, Livia Anna
De Falco, Carmela
Petti, Antonella
Tripaldelli, Elena
Loquercio, Giovanna
Annecchiarico, Angela
Salzillo, Angela
Caradonna, Eugenio
Maggi, Paolo
description 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 
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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 &lt; Ct &lt; 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. The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. The data obtained show that SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission.</description><identifier>ISSN: 0887-8013</identifier><identifier>EISSN: 1098-2825</identifier><identifier>DOI: 10.1002/jcla.24867</identifier><identifier>PMID: 36972465</identifier><language>eng</language><publisher>United States: John Wiley &amp; Sons, Inc</publisher><subject>Age ; Antigens ; Asymptomatic ; Automation ; comparison ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 - epidemiology ; Emergency medical care ; Emergency Service, Hospital ; Enzymes ; Females ; Humans ; Immunoassay ; Immunologic Tests ; Infections ; Monoclonal antibodies ; Pandemics ; Patients ; Performance evaluation ; Polymerase chain reaction ; Public health ; ROC Curve ; RT‐PCR ; SARS-CoV-2 - genetics ; SARS‐CoV‐2 antigen ; Sensitivity and Specificity ; Severe acute respiratory syndrome coronavirus 2</subject><ispartof>Journal of clinical laboratory analysis, 2023-03, Vol.37 (6), p.e24867-n/a</ispartof><rights>2023 The Authors. published by Wiley Periodicals LLC.</rights><rights>2023 The Authors. 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Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4497-80a4b660b3f22980ab7265cf3118744534c5961af13b75b351ff854fa5eab4923</citedby><cites>FETCH-LOGICAL-c4497-80a4b660b3f22980ab7265cf3118744534c5961af13b75b351ff854fa5eab4923</cites><orcidid>0000-0003-0353-9151</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10156099/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10156099/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11542,27903,27904,45553,45554,46030,46454,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36972465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Petruzziello, Arnolfo</creatorcontrib><creatorcontrib>Sabatino, Rocco</creatorcontrib><creatorcontrib>Catapane, Livia Anna</creatorcontrib><creatorcontrib>De Falco, Carmela</creatorcontrib><creatorcontrib>Petti, Antonella</creatorcontrib><creatorcontrib>Tripaldelli, Elena</creatorcontrib><creatorcontrib>Loquercio, Giovanna</creatorcontrib><creatorcontrib>Annecchiarico, Angela</creatorcontrib><creatorcontrib>Salzillo, Angela</creatorcontrib><creatorcontrib>Caradonna, Eugenio</creatorcontrib><creatorcontrib>Maggi, Paolo</creatorcontrib><title>Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients</title><title>Journal of clinical laboratory analysis</title><addtitle>J Clin Lab Anal</addtitle><description>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 &lt; Ct &lt; 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. The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. 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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 &lt; Ct &lt; 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. The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. The data obtained show that SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission.</abstract><cop>United States</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>36972465</pmid><doi>10.1002/jcla.24867</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-0353-9151</orcidid><oa>free_for_read</oa></addata></record>
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subjects Age
Antigens
Asymptomatic
Automation
comparison
Coronaviruses
COVID-19
COVID-19 - diagnosis
COVID-19 - epidemiology
Emergency medical care
Emergency Service, Hospital
Enzymes
Females
Humans
Immunoassay
Immunologic Tests
Infections
Monoclonal antibodies
Pandemics
Patients
Performance evaluation
Polymerase chain reaction
Public health
ROC Curve
RT‐PCR
SARS-CoV-2 - genetics
SARS‐CoV‐2 antigen
Sensitivity and Specificity
Severe acute respiratory syndrome coronavirus 2
title Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients
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